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Details

Stereochemistry ACHIRAL
Molecular Formula C3H5N3O9
Molecular Weight 227.0865
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of Nitroglycerin

SMILES

[O-][N+](=O)OCC(CO[N+]([O-])=O)O[N+]([O-])=O

InChI

InChIKey=SNIOPGDIGTZGOP-UHFFFAOYSA-N
InChI=1S/C3H5N3O9/c7-4(8)13-1-3(15-6(11)12)2-14-5(9)10/h3H,1-2H2

HIDE SMILES / InChI

Molecular Formula C3H5N3O9
Molecular Weight 227.0865
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Pentaerythritol tetranitrate is an organic nitrate that has been used for the treatment of angina pectoris. Upon administration, the drug undergoes exstensive metabolism to NO which causes vasodilation and the relaxation of smooth muscle cells. The compound belongs to a familiy of explosive substances and may be used accordingly.

CNS Activity

Curator's Comment: NO can be generated in large quantities and has detrimental effects on the CNS. NO has been shown to increase permeability of the BBB, allowing substances to enter into the brain passively.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
NIPRIDE

Approved Use

Sodium Nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with Sodium Nitroprusside can be minimized. Sodium Nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium Nitroprusside injection is also indicated for the treatment of acute congestive heart failure.

Launch Date

1974
Primary
NIPRIDE

Approved Use

Sodium Nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with Sodium Nitroprusside can be minimized. Sodium Nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium Nitroprusside injection is also indicated for the treatment of acute congestive heart failure.

Launch Date

1974
Palliative
INOMAX

Approved Use

INOmax is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Launch Date

1999
Primary
DILATRATE-SR

Approved Use

dilatrate®-SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Launch Date

1998
Primary
MONOKET

Approved Use

monoket® is indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Launch Date

1993
Primary
Unknown

Approved Use

Unknown
Primary
Unknown

Approved Use

Unknown
Primary
NITROSTAT

Approved Use

Acute relief of angina pectoris secondary to CAD; acute prophylactic management in situations likely to provoke angina attacks; and long-term prophylactic management of angina pectoris.

Launch Date

2000
Primary
NITROGLYCERIN

Approved Use

Management of patients with acute myocardial infarction (MI). Nitroglycerin is one of the principal initial therapies of MI.

Launch Date

1981
Primary
NITROGLYCERIN

Approved Use

IV nitroglycerin is used to control BP in perioperative hypertension, especially hypertension associated with cardiovascular procedures; to control BP in patients with severe hypertension† or in hypertensive crises for the immediate reduction of BP in patients in whom such reduction is considered an emergency (hypertensive emergencies), especially those associated with coronary complications (e.g., coronary ischemia, acute coronary insufficiency, acute left ventricular failure, postoperative hypertension [especially following coronary bypass surgery]); and to produce controlled hypotension during surgical procedures.

Launch Date

1981
Primary
NITROGLYCERIN

Approved Use

IV nitroglycerin has been used in the management of acutely decompensated (e.g., congestive) heart failure and other low cardiac-output states.

Launch Date

1981
Primary
Metamine

Approved Use

https://www.ncbi.nlm.nih.gov/pubmed/13426891 | https://www.ncbi.nlm.nih.gov/pubmed/13284675
Primary
PERITRATE

Approved Use

Unknown
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
35 ng/mL
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PENTAERYTHRITOL MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
79 ng/mL
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PENTAERYTHRITOL MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
1151 ng/mL
120 mg 1 times / day steady-state, oral
dose: 120 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
557 ng/mL
60 mg 1 times / day steady-state, oral
dose: 60 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
388 ng/mL
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
356 ng/mL
20 mg single, intravenous
dose: 20 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
1.7 pg/mL
800 μg single, sublingual
dose: 800 μg
route of administration: Sublingual
experiment type: SINGLE
co-administered:
NITROGLYCERIN plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
17 ng/mL
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PENTAERYTHRITOL DINITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
7.5 ng/mL
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PENTAERYTHRITOL DINITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
187 ng/mL
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ISOSORBIDE DINITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
84 ng/mL
13 mg single, oral
dose: 13 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
GLYCERYL 1,2-DINITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
14241 ng × h/mL
120 mg 1 times / day steady-state, oral
dose: 120 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
6979 ng × h/mL
60 mg 1 times / day steady-state, oral
dose: 60 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
2524 ng × h/mL
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
2647 ng × h/mL
20 mg single, intravenous
dose: 20 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
12.3 pg × min/mL
800 μg single, sublingual
dose: 800 μg
route of administration: Sublingual
experiment type: SINGLE
co-administered:
NITROGLYCERIN plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
1458 ng × h/mL
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ISOSORBIDE DINITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
3380 ng × min/mL
13 mg single, oral
dose: 13 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
GLYCERYL 1,2-DINITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
2 min
single, intravenous
NITROPRUSSIDE plasma
Rattus norvegicus
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
10.5 h
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PENTAERYTHRITOL MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
10.5 h
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PENTAERYTHRITOL MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
6.2 h
120 mg 1 times / day steady-state, oral
dose: 120 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
6.2 h
60 mg 1 times / day steady-state, oral
dose: 60 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
4 h
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
4 h
20 mg single, intravenous
dose: 20 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
ISOSORBIDE MONONITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
40 min
800 μg single, sublingual
dose: 800 μg
route of administration: Sublingual
experiment type: SINGLE
co-administered:
NITROGLYCERIN plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
4.5 h
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PENTAERYTHRITOL DINITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
4.5 h
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PENTAERYTHRITOL DINITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
303 min
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ISOSORBIDE DINITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
50 min
13 mg single, oral
dose: 13 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
GLYCERYL 1,2-DINITRATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
100%
ISOSORBIDE DINITRATE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Other AEs: Headache, Dizziness...
Other AEs:
Headache (50%)
Dizziness (32%)
Asthenia (14%)
Nausea (10%)
Bronchitis (8%)
Hypotension (8%)
Sinusitis (4%)
Ventricular tachycardia (4%)
Hyperglycemia (4%)
Rhinitis (4%)
Paresthesia (4%)
Vomiting (4%)
Amblyopia (3%)
Hyperlipidemia (3%)
Tachycardia (2%)
Sources: Page: label/2005/020727lbl.pdf - p.13
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Disc. AE: Chest pain, Heart arrest...
AEs leading to
discontinuation/dose reduction:
Chest pain (0.6%)
Heart arrest (0.6%)
Heart failure (0.6%)
Hypotension (0.6%)
Kidney failure (0.6%)
Infection (0.4%)
Ventricular fibrillation (0.4%)
Dizziness (0.4%)
Arrhythmia (0.2%)
Cerebrovascular accident (0.2%)
Syncope (0.2%)
Gastroenteritis (0.2%)
Myasthenia (0.2%)
Dyspnea (0.2%)
Edema lung (0.2%)
Angioedema (0.2%)
Breast carcinoma (0.2%)
Uremia (0.2%)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Other AEs: Neurolysis, Ophthalmitis...
Other AEs:
Neurolysis (0.2%)
Ophthalmitis (0.2%)
Chest pain (6.4%)
Heart failure (3.1%)
Ventricular tachycardia (2.7%)
Pneumonia (2.3%)
Syncope (2.1%)
Dyspnea (1.9%)
Arrhythmia (1.7%)
Hypotension (1.5%)
Heart arrest (1.4%)
Cerebrovascular accident (1.4%)
Dizziness (1.4%)
Cellulite (1.2%)
Cerebral ischemia (1%)
Coronary artery disease (1%)
Anemia (1%)
Bronchitis (1%)
Dehydration (1%)
Angina pectoris (1%)
Hyperglycemia (1%)
Hypoglycemia (1%)
Infection (1%)
Acute kidney failure (1%)
Neoplasm (0.8%)
Gout (0.8%)
Atrial fibrillation (0.8%)
Gastrointestinal hemorrhage (0.8%)
Kidney failure (0.8%)
Myocardial infarct (0.8%)
Sepsis (0.6%)
Asthma (0.6%)
Accidental injury (0.6%)
Cholecystitis (0.6%)
Cholelithiasis (0.6%)
Supraventricular tachycardia (0.6%)
Esophagitis (0.4%)
Edema lung (0.4%)
Headache (0.4%)
Osteomyelitis (0.4%)
Peripheral vascular disease (0.4%)
Bradycardia (0.4%)
Digitalis intoxication (0.4%)
Gastroenteritis (0.4%)
Hyperkalemia (0.4%)
Hemorrhage subarachnoid (0.4%)
Deep thrombophlebitis (0.4%)
Angioedema (0.4%)
Ascites (0.4%)
Infection (0.4%)
Fibrillation ventricular (0.4%)
Anomaly vascular (0.2%)
Coagulation disorder (0.2%)
Creatinine increased (0.2%)
Hyponatremia (0.2%)
Diarrhea (0.2%)
Failure liver (0.2%)
Neoplasm of the prostate (0.2%)
Myasthenia (0.2%)
Palpitations (0.2%)
Urinary tract infection (0.2%)
Dyspepsia (0.2%)
Function kidney abnormal (0.2%)
Anemia iron deficiency (0.2%)
Alkalosis (0.2%)
Arrhythmia nodal (0.2%)
Arthralgia (0.2%)
Breast carcinoma (0.2%)
Hypokalemia (0.2%)
Ketosis (0.2%)
Cerebral infarct (0.2%)
Emotional lability (0.2%)
Edema face (0.2%)
Gastritis hemorrhagic (0.2%)
Abnormal gait (0.2%)
Hematemesis (0.2%)
Herpes zoster (0.2%)
Uremia (0.2%)
Leucopenia (0.2%)
Thrombocytopenia (0.2%)
Disorder parathyroid (0.2%)
Disorder respiratory system (0.2%)
Skin ulcer (0.2%)
Abnormal thinking (0.2%)
Vascular disorder NOS (0.2%)
Wrist drop (0.2%)
Gastritis (0.2%)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Disc. AE: Asthenia, Headache...
AEs leading to
discontinuation/dose reduction:
Asthenia (2.3%)
Headache (7.4%)
Dizziness (3.7%)
Pain (0.8%)
Chest pain (1.5%)
Nausea (1.5%)
Hypotension (1.4%)
Abdominal pain (0.4%)
Chills (0.4%)
Kidney failure (0.4%)
Malaise (0.4%)
Heart arrest (0.6%)
Confusion (0.4%)
Diarrhea (0.4%)
Gastroenteritis (0.2%)
Back pain (0.2%)
Acute kidney failure (0.2%)
Myasthenia (0.2%)
Nervousness (0.2%)
Pruritus (0.2%)
Heart failure (0.6%)
Dyspepsia (0.2%)
Cerebrovascular accident (0.2%)
Constipation (0.2%)
Dyspnea (0.2%)
Vomiting (0.6%)
Paresthesia (0.6%)
Function kidney abnormal (0.4%)
Palpitations (0.4%)
Syncope (0.4%)
Rash (0.6%)
Rectal hemorrhage (0.4%)
Ventricular fibrillation (0.4%)
Angioedema (0.2%)
Amblyopia (0.2%)
Anorexia (0.2%)
Neck pain (0.2%)
Carcinoma (0.2%)
Breast carcinoma (0.2%)
Dehydration (0.2%)
Edema face (0.2%)
Edema peripheral (0.2%)
Edema lung (0.2%)
Fever (0.2%)
Hyperglycemia (0.2%)
Hypertension (0.2%)
Infection (0.2%)
Fungal infection (0.2%)
Impotence (0.2%)
Ketosis (0.2%)
Breast neoplasm (0.2%)
Lab test abnormal (0.2%)
Myalgia (0.2%)
Photophobia (0.2%)
Pleural effusion (0.2%)
Somnolence (0.2%)
Sweaty (0.2%)
Vasodilation (0.2%)
Weight decrease (0.2%)
Uremia (0.2%)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
240 mg 1 times / day steady, oral
Highest studied dose
Dose: 240 mg, 1 times / day
Route: oral
Route: steady
Dose: 240 mg, 1 times / day
Sources:
unhealthy, adult
n = 312
Health Status: unhealthy
Condition: chronic stable angina pectoris
Age Group: adult
Sex: unknown
Population Size: 312
Sources:
Other AEs: Headache...
Other AEs:
Headache (57%)
Sources:
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 267
Health Status: unhealthy
Condition: chronic stable angina pectoris
Age Group: adult
Sex: unknown
Population Size: 267
Sources:
Disc. AE: Headache...
AEs leading to
discontinuation/dose reduction:
Headache (6 patients)
Sources:
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 159
Health Status: unhealthy
Condition: myocardial infarction or congestive heart failure
Age Group: adult
Sex: unknown
Population Size: 159
Sources:
Disc. AE: Headache, Nausea...
AEs leading to
discontinuation/dose reduction:
Headache (5%)
Nausea (2%)
Sources:
5 mg 1 times / day steady, oral
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
n = 54
Health Status: unhealthy
Condition: myocardial infarction or congestive heart failure
Age Group: adult
Sex: unknown
Population Size: 54
Sources:
Disc. AE: Rash, Pruritus...
AEs leading to
discontinuation/dose reduction:
Rash (2%)
Pruritus (2%)
Sources:
1 ug/kg/min multiple, intravenous (starting)
Dose: 1 ug/kg/min
Route: intravenous
Route: multiple
Dose: 1 ug/kg/min
Sources:
pregnant, 26 years
n = 16
Health Status: pregnant
Condition: Preterm labor
Age Group: 26 years
Sex: F
Population Size: 16
Sources:
Disc. AE: Hypotension...
AEs leading to
discontinuation/dose reduction:
Hypotension (4 patients)
Sources:
8 ug/kg/min multiple, intravenous
Dose: 8 ug/kg/min
Route: intravenous
Route: multiple
Dose: 8 ug/kg/min
Sources:
pregnant, 26 years
n = 1
Health Status: pregnant
Condition: Preterm labor
Age Group: 26 years
Sex: F
Population Size: 1
Sources:
Disc. AE: Nausea, Vomiting...
AEs leading to
discontinuation/dose reduction:
Nausea (severe, 1 patient)
Vomiting (severe, 1 patient)
Headache (severe, 1 patient)
Sources:
35 ug/kg/min single, intravenous
Dose: 35 ug/kg/min
Route: intravenous
Route: single
Dose: 35 ug/kg/min
Sources:
unhealthy, 50 years (range: 19 ± 74 years)
n = 105
Health Status: unhealthy
Age Group: 50 years (range: 19 ± 74 years)
Sex: M+F
Population Size: 105
Sources:
Disc. AE: Hemodynamic test abnormal...
AEs leading to
discontinuation/dose reduction:
Hemodynamic test abnormal (8 patients)
Sources:
0.6 mg/h 1 times / day multiple, transdermal
Highest studied dose
Dose: 0.6 mg/h, 1 times / day
Route: transdermal
Route: multiple
Dose: 0.6 mg/h, 1 times / day
Sources:
unhealthy, 51.4 ±4.3 years
n = 11
Health Status: unhealthy
Condition: menopausal hot flashes
Age Group: 51.4 ±4.3 years
Sex: F
Population Size: 11
Sources:
2 % 6 times / day multiple, topical
Dose: 2 %, 6 times / day
Route: topical
Route: multiple
Dose: 2 %, 6 times / day
Sources:
unhealthy, 57 - 71 years
n = 2
Health Status: unhealthy
Age Group: 57 - 71 years
Sex: M
Population Size: 2
Sources:
Disc. AE: Pruritic rash, Erythema edematous...
AEs leading to
discontinuation/dose reduction:
Pruritic rash (2 patients)
Erythema edematous (2 patients)
Vesicular eruption (2 patients)
Sources:
40 mg single, oral
Overdose
unhealthy, 80 years
n = 1
Health Status: unhealthy
Condition: angina pectoris
Age Group: 80 years
Sex: M
Population Size: 1
Sources:
Other AEs: Methemoglobinemia...
0.2 mg/h 1 times / day multiple, transdermal (starting)
Recommended
Dose: 0.2 mg/h, 1 times / day
Route: transdermal
Route: multiple
Dose: 0.2 mg/h, 1 times / day
Sources:
unhealthy, adult
n = 307
Health Status: unhealthy
Age Group: adult
Sex: M+F
Population Size: 307
Sources:
Other AEs: Headache, Lightheadedness...
Other AEs:
Headache (63%)
Lightheadedness (6%)
Hypotension (4%)
Syncope (4%)
Sources:
1.5 mg 2 times / day multiple, rectal
Dose: 1.5 mg, 2 times / day
Route: rectal
Route: multiple
Dose: 1.5 mg, 2 times / day
Sources:
unhealthy, adult
Disc. AE: Hypotension...
AEs leading to
discontinuation/dose reduction:
Hypotension
Sources:
5 ug/kg 1 times / day single, subcutaneous
Dose: 5 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 5 ug/kg, 1 times / day
Sources:
unhealthy, pediatric
n = 57
Health Status: unhealthy
Age Group: pediatric
Population Size: 57
Sources:
AEs

AEs

AESignificanceDosePopulation
Nausea 10%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Asthenia 14%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Tachycardia 2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Amblyopia 3%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Hyperlipidemia 3%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Dizziness 32%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Hyperglycemia 4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Paresthesia 4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Rhinitis 4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Sinusitis 4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Ventricular tachycardia 4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Vomiting 4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Headache 50%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Bronchitis 8%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Hypotension 8%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: label/2005/020727lbl.pdf - p.13
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: label/2005/020727lbl.pdf - p.13
Angioedema 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Arrhythmia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Breast carcinoma 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Cerebrovascular accident 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Dyspnea 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Edema lung 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Gastroenteritis 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Myasthenia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Syncope 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Uremia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Dizziness 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Infection 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Ventricular fibrillation 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Chest pain 0.6%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Heart arrest 0.6%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Heart failure 0.6%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Hypotension 0.6%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Kidney failure 0.6%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56
Abnormal gait 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Abnormal thinking 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Alkalosis 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Anemia iron deficiency 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Anomaly vascular 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Arrhythmia nodal 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Arthralgia 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Breast carcinoma 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Cerebral infarct 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Coagulation disorder 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Creatinine increased 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Diarrhea 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Disorder parathyroid 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Disorder respiratory system 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Dyspepsia 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Edema face 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Emotional lability 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Failure liver 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Function kidney abnormal 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Gastritis hemorrhagic 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Gastritis 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Hematemesis 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Herpes zoster 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Hypokalemia 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Hyponatremia 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Ketosis 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Leucopenia 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Myasthenia 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Neoplasm of the prostate 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Neurolysis 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Ophthalmitis 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Palpitations 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Skin ulcer 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Thrombocytopenia 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Uremia 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Urinary tract infection 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Vascular disorder NOS 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Wrist drop 0.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Angioedema 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Ascites 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Bradycardia 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Deep thrombophlebitis 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Digitalis intoxication 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Edema lung 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Esophagitis 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Fibrillation ventricular 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Gastroenteritis 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Headache 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Hemorrhage subarachnoid 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Hyperkalemia 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Infection 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Osteomyelitis 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Peripheral vascular disease 0.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Accidental injury 0.6%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Asthma 0.6%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Cholecystitis 0.6%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Cholelithiasis 0.6%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Sepsis 0.6%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Supraventricular tachycardia 0.6%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Atrial fibrillation 0.8%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Gastrointestinal hemorrhage 0.8%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Gout 0.8%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Kidney failure 0.8%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Myocardial infarct 0.8%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Neoplasm 0.8%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Acute kidney failure 1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Anemia 1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Angina pectoris 1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Bronchitis 1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Cerebral ischemia 1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Coronary artery disease 1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Dehydration 1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Hyperglycemia 1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Hypoglycemia 1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Infection 1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Cellulite 1.2%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Cerebrovascular accident 1.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Dizziness 1.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Heart arrest 1.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Hypotension 1.5%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Arrhythmia 1.7%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Dyspnea 1.9%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Syncope 2.1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Pneumonia 2.3%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Ventricular tachycardia 2.7%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Heart failure 3.1%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Chest pain 6.4%
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57
Acute kidney failure 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Amblyopia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Angioedema 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Anorexia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Back pain 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Breast carcinoma 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Breast neoplasm 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Carcinoma 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Cerebrovascular accident 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Constipation 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Dehydration 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Dyspepsia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Dyspnea 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Edema face 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Edema lung 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Edema peripheral 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Fever 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Fungal infection 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Gastroenteritis 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Hyperglycemia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Hypertension 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Impotence 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Infection 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Ketosis 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Lab test abnormal 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Myalgia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Myasthenia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Neck pain 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Nervousness 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Photophobia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Pleural effusion 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Pruritus 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Somnolence 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Sweaty 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Uremia 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Vasodilation 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Weight decrease 0.2%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Abdominal pain 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Chills 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Confusion 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Diarrhea 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Function kidney abnormal 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Kidney failure 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Malaise 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Palpitations 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Rectal hemorrhage 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Syncope 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Ventricular fibrillation 0.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Heart arrest 0.6%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Heart failure 0.6%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Paresthesia 0.6%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Rash 0.6%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Vomiting 0.6%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Pain 0.8%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Hypotension 1.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Chest pain 1.5%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Nausea 1.5%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Asthenia 2.3%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Dizziness 3.7%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Headache 7.4%
Disc. AE
75 mg 3 times / day multiple, oral
Recommended|MTD
Dose: 75 mg, 3 times / day
Route: oral
Route: multiple
Dose: 75 mg, 3 times / day
Co-administed with::
isosorbide dinitrate(40 mg; 3/day)
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
unhealthy, mean age 57 years
n = 517
Health Status: unhealthy
Condition: heart failure
Age Group: mean age 57 years
Sex: M+F
Population Size: 517
Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59
Headache 57%
240 mg 1 times / day steady, oral
Highest studied dose
Dose: 240 mg, 1 times / day
Route: oral
Route: steady
Dose: 240 mg, 1 times / day
Sources:
unhealthy, adult
n = 312
Health Status: unhealthy
Condition: chronic stable angina pectoris
Age Group: adult
Sex: unknown
Population Size: 312
Sources:
Headache 6 patients
Disc. AE
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 267
Health Status: unhealthy
Condition: chronic stable angina pectoris
Age Group: adult
Sex: unknown
Population Size: 267
Sources:
Nausea 2%
Disc. AE
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 159
Health Status: unhealthy
Condition: myocardial infarction or congestive heart failure
Age Group: adult
Sex: unknown
Population Size: 159
Sources:
Headache 5%
Disc. AE
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 159
Health Status: unhealthy
Condition: myocardial infarction or congestive heart failure
Age Group: adult
Sex: unknown
Population Size: 159
Sources:
Pruritus 2%
Disc. AE
5 mg 1 times / day steady, oral
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
n = 54
Health Status: unhealthy
Condition: myocardial infarction or congestive heart failure
Age Group: adult
Sex: unknown
Population Size: 54
Sources:
Rash 2%
Disc. AE
5 mg 1 times / day steady, oral
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
n = 54
Health Status: unhealthy
Condition: myocardial infarction or congestive heart failure
Age Group: adult
Sex: unknown
Population Size: 54
Sources:
Hypotension 4 patients
Disc. AE
1 ug/kg/min multiple, intravenous (starting)
Dose: 1 ug/kg/min
Route: intravenous
Route: multiple
Dose: 1 ug/kg/min
Sources:
pregnant, 26 years
n = 16
Health Status: pregnant
Condition: Preterm labor
Age Group: 26 years
Sex: F
Population Size: 16
Sources:
Headache severe, 1 patient
Disc. AE
8 ug/kg/min multiple, intravenous
Dose: 8 ug/kg/min
Route: intravenous
Route: multiple
Dose: 8 ug/kg/min
Sources:
pregnant, 26 years
n = 1
Health Status: pregnant
Condition: Preterm labor
Age Group: 26 years
Sex: F
Population Size: 1
Sources:
Nausea severe, 1 patient
Disc. AE
8 ug/kg/min multiple, intravenous
Dose: 8 ug/kg/min
Route: intravenous
Route: multiple
Dose: 8 ug/kg/min
Sources:
pregnant, 26 years
n = 1
Health Status: pregnant
Condition: Preterm labor
Age Group: 26 years
Sex: F
Population Size: 1
Sources:
Vomiting severe, 1 patient
Disc. AE
8 ug/kg/min multiple, intravenous
Dose: 8 ug/kg/min
Route: intravenous
Route: multiple
Dose: 8 ug/kg/min
Sources:
pregnant, 26 years
n = 1
Health Status: pregnant
Condition: Preterm labor
Age Group: 26 years
Sex: F
Population Size: 1
Sources:
Hemodynamic test abnormal 8 patients
Disc. AE
35 ug/kg/min single, intravenous
Dose: 35 ug/kg/min
Route: intravenous
Route: single
Dose: 35 ug/kg/min
Sources:
unhealthy, 50 years (range: 19 ± 74 years)
n = 105
Health Status: unhealthy
Age Group: 50 years (range: 19 ± 74 years)
Sex: M+F
Population Size: 105
Sources:
Erythema edematous 2 patients
Disc. AE
2 % 6 times / day multiple, topical
Dose: 2 %, 6 times / day
Route: topical
Route: multiple
Dose: 2 %, 6 times / day
Sources:
unhealthy, 57 - 71 years
n = 2
Health Status: unhealthy
Age Group: 57 - 71 years
Sex: M
Population Size: 2
Sources:
Pruritic rash 2 patients
Disc. AE
2 % 6 times / day multiple, topical
Dose: 2 %, 6 times / day
Route: topical
Route: multiple
Dose: 2 %, 6 times / day
Sources:
unhealthy, 57 - 71 years
n = 2
Health Status: unhealthy
Age Group: 57 - 71 years
Sex: M
Population Size: 2
Sources:
Vesicular eruption 2 patients
Disc. AE
2 % 6 times / day multiple, topical
Dose: 2 %, 6 times / day
Route: topical
Route: multiple
Dose: 2 %, 6 times / day
Sources:
unhealthy, 57 - 71 years
n = 2
Health Status: unhealthy
Age Group: 57 - 71 years
Sex: M
Population Size: 2
Sources:
Methemoglobinemia grade 5, 1 patient
40 mg single, oral
Overdose
unhealthy, 80 years
n = 1
Health Status: unhealthy
Condition: angina pectoris
Age Group: 80 years
Sex: M
Population Size: 1
Sources:
Hypotension 4%
0.2 mg/h 1 times / day multiple, transdermal (starting)
Recommended
Dose: 0.2 mg/h, 1 times / day
Route: transdermal
Route: multiple
Dose: 0.2 mg/h, 1 times / day
Sources:
unhealthy, adult
n = 307
Health Status: unhealthy
Age Group: adult
Sex: M+F
Population Size: 307
Sources:
Syncope 4%
0.2 mg/h 1 times / day multiple, transdermal (starting)
Recommended
Dose: 0.2 mg/h, 1 times / day
Route: transdermal
Route: multiple
Dose: 0.2 mg/h, 1 times / day
Sources:
unhealthy, adult
n = 307
Health Status: unhealthy
Age Group: adult
Sex: M+F
Population Size: 307
Sources:
Lightheadedness 6%
0.2 mg/h 1 times / day multiple, transdermal (starting)
Recommended
Dose: 0.2 mg/h, 1 times / day
Route: transdermal
Route: multiple
Dose: 0.2 mg/h, 1 times / day
Sources:
unhealthy, adult
n = 307
Health Status: unhealthy
Age Group: adult
Sex: M+F
Population Size: 307
Sources:
Headache 63%
0.2 mg/h 1 times / day multiple, transdermal (starting)
Recommended
Dose: 0.2 mg/h, 1 times / day
Route: transdermal
Route: multiple
Dose: 0.2 mg/h, 1 times / day
Sources:
unhealthy, adult
n = 307
Health Status: unhealthy
Age Group: adult
Sex: M+F
Population Size: 307
Sources:
Hypotension Disc. AE
1.5 mg 2 times / day multiple, rectal
Dose: 1.5 mg, 2 times / day
Route: rectal
Route: multiple
Dose: 1.5 mg, 2 times / day
Sources:
unhealthy, adult
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG



Drug as perpetrator​Drug as victim
Sourcing

Sourcing

Vendor/AggregatorIDURL
PubMed

PubMed

TitleDatePubMed
[The classic anti-anginal agents and molsidomine].
1983 Feb
Role of inflammatory cytokines and nitric oxide in hepatic and pulmonary toxicity.
1998 Dec 28
Growth factors prevent changes in Bcl-2 and Bax expression and neuronal apoptosis induced by nitric oxide.
1998 Oct
Heat-shock protein-73 protects against small intestinal warm ischemia-reperfusion injury in the rat.
1999 Apr
Troglitazone upregulates nitric oxide synthesis in vascular smooth muscle cells.
1999 Apr
Pimobendan inhibits the production of proinflammatory cytokines and gene expression of inducible nitric oxide synthase in a murine model of viral myocarditis.
1999 Apr
Diet-induced protection against lipopolysaccharide includes increased hepatic NO production.
1999 Apr
Effects of the wine polyphenolics quercetin and resveratrol on pro-inflammatory cytokine expression in RAW 264.7 macrophages.
1999 Apr 15
Changes of sodium and ATP affinities of the cardiac (Na,K)-ATPase during and after nitric oxide deficient hypertension.
1999 Dec
Nitric oxide induces apoptosis via Ca2+-dependent processes in the pancreatic beta-cell line MIN6.
1999 Dec
Suppression of nitric oxide synthase and the down-regulation of the activation of NFkappaB in macrophages by resveratrol.
1999 Feb
Systemic hypotension on withdrawal from inhaled nitric oxide in an adult patient with acute respiratory distress syndrome.
1999 Feb
Sildenafil ameliorates effects of inhaled nitric oxide withdrawal.
1999 Jul
Spinal antinociceptive effect of epidural nonsteroidal antiinflammatory drugs on nitric oxide-induced hyperalgesia in rats.
1999 Jul
Arterial function in nitric oxide-deficient hypertension: influence of long-term angiotensin II receptor antagonism.
1999 Jun
Nitric oxide prevents anoxia-induced apoptosis in colonic HT29 cells.
1999 Jun 15
Nitric oxide, superoxide radicals and mast cells in pathogenesis of indomethacin-induced small intestinal lesions in rats.
1999 Mar
Protective effect of cyclosporin A and FK506 from nitric oxide-dependent apoptosis in activated macrophages.
1999 Mar
Upregulation of superoxide dismutase and nitric oxide synthase mediates the apoptosis-suppressive effects of shear stress on endothelial cells.
1999 Mar
The use of nitric oxide for managing catastrophic pulmonary vasoconstriction arising from protamine administration.
1999 Mar
The central cannabinoid receptor (CB1) mediates inhibition of nitric oxide production by rat microglial cells.
1999 Mar
Involvement of nitric oxide and nitric oxide synthase activity in anticonvulsive action.
1999 Mar 1
Adverse hemodynamic effects observed with inhaled nitric oxide after surgical repair of total anomalous pulmonary venous return.
1999 May-Jun
Nitric oxide induces Zn2+ release from metallothionein by destroying zinc-sulphur clusters without concomitant formation of S-nitrosothiol.
1999 Nov 15
Nitric oxide stimulates ACTH secretion and the transcription of the genes encoding for NGFI-B, corticotropin-releasing factor, corticotropin-releasing factor receptor type 1, and vasopressin in the hypothalamus of the intact rat.
1999 Sep 1
Vascular effects of endothelin-1 in essential hypertension: relationship with cyclooxygenase-derived endothelium-dependent contracting factors and nitric oxide.
2000
Nociceptin receptor activation produces nitric oxide-mediated systemic hypotension.
2000
Angiotensin in the nucleus tractus solitarii contributes to neurogenic hypertension caused by chronic nitric oxide synthase inhibition.
2000 Aug
[Anorectics and pulmonary hypertension].
2000 Feb 16
Nitric oxide synthase inhibitors attenuate ozone-induced airway inflammation in guinea pigs. Possible role of interleukin-8.
2000 Jan
Female sex steroids: effects upon microglial cell activation.
2000 Nov 1
Endothelins and endothelin receptor antagonists: therapeutic considerations for a novel class of cardiovascular drugs.
2000 Nov 7
Stimulation of cyclooxygenase-2-activity by nitric oxide-derived species in rat chondrocyte: lack of contribution to loss of cartilage anabolism.
2001 Apr 15
Role for endothelin-1-induced superoxide and peroxynitrite production in rebound pulmonary hypertension associated with inhaled nitric oxide therapy.
2001 Aug 17
Effects of Ginkgo biloba extract (EGb 761) and quercetin on lipopolysaccharide-induced release of nitric oxide.
2001 Jul 31
Calcitonin gene-related peptide levels during nitric oxide-induced headache in patients with chronic tension-type headache.
2001 Mar
[The impact of nitrates and mono-therapy and nitrates combined with angiotensin converting enzyme inhibitors on left ventricular remodeling and exercise capacity in patients after acute myocardial infarction].
2003
Band ligation versus propanolol and isosorbide mononitrate for primary prophylaxis of variceal bleeding.
2003 Aug
Aqueous humour flow after a single oral dose of isosorbide-5-mononitrate in healthy volunteers.
2003 Aug
Simultaneous determination of aspirin and isosorbide 5-mononitrate in formulation by reversed phase high pressure liquid chromatography.
2003 Aug 21
Comparative study of the use of diltiazem as an antispasmodic drug in coronary angiography via the transradial approach.
2003 Jul
Beneficial effects of angiotensin-converting enzyme inhibitor and nitrate association on left ventricular remodeling in patients with large acute myocardial infarction: the Delapril Remodeling after Acute Myocardial Infarction (DRAMI) trial.
2003 Jul
Optimal use of propranolol.
2003 Jun
"A la carte" treatment of portal hypertension or just "hors d'oeuvres".
2003 Jun
Isosorbide-5-mononitrate treatment prevents cyclosporin A-induced platelet hyperactivation and the underlying nitric oxide-cyclic guanosine-3',5'-monophosphate disturbances.
2003 May 1
Effect of nitric oxide on exercise-induced proteinuria in rats.
2003 Nov
Acetylcholine and bradykinin enhance hypotension and affect the function of remodeled conduit arteries in SHR and SHR treated with nitric oxide donors.
2005 Jun
The nitric oxide (NO) donor molsidomine antagonizes scopolamine and L-NAME-induced performance deficits in a spatial memory task in the rat.
2009 Jun 8
Selective regulation of cardiac organic cation transporter novel type 2 (OCTN2) in dilated cardiomyopathy.
2011 Jun
Pharmacological screening using an FXN-EGFP cellular genomic reporter assay for the therapy of Friedreich ataxia.
2013
Patents

Sample Use Guides

twice-daily 8-mg tablet
Route of Administration: Intravenous
In Vitro Use Guide
Curator's Comment: In epithelial cells, NO increased apoptosis by 2.1 +/- 0.2-fold, augmented mRNA expression of Bax, and reduced expression of Bcl-2 compared with basal cultures. In stromal cells, NO increased cell proliferation in a dose-dependent manner, an effect that was blocked by a NO synthase inhibitor.
Was studied the action of the biologically active metabolite of molsidomine, N-morpholino-N-nitrosoamino-acetonitrile (SIN), on eicosanoid formation and functional behavior of bovine coronary arteries and human platelets in vitro. Molsidomine itself was inactive
Substance Class Chemical
Created
by admin
on Fri Dec 15 15:14:26 GMT 2023
Edited
by admin
on Fri Dec 15 15:14:26 GMT 2023
Record UNII
G59M7S0WS3
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
Nitroglycerin
HSDB   MI   ORANGE BOOK   USP   VANDF  
Systematic Name English
NITRO-DUR
Brand Name English
RECTIV
Brand Name English
NITRO IV
Brand Name English
GLYCERIN TRINITRATE
Systematic Name English
NITROGLYCERIN TABLETS [JAN]
Common Name English
DILUTED NITROGLYCERIN [USP-RS]
Common Name English
NITROGLYCERIN [ORANGE BOOK]
Common Name English
PROPANE-1,2,3-TRIYL TRINITRATE
Systematic Name English
MINITRAN
Brand Name English
GLONOINUM [HPUS]
Common Name English
TRINITRIN
Common Name English
NITROGLYCERIN [MI]
Common Name English
NITORA
Common Name English
NTG
Common Name English
TRINITRINE
Common Name English
NITROGLYCERIN [VANDF]
Common Name English
NITROMIST
Brand Name English
NITRONAL
Brand Name English
NITROL
Brand Name English
GONITRO
Common Name English
GLONOINUM
HPUS  
Common Name English
C01DA02
Code English
NITROGLYCERIN [USP IMPURITY]
Common Name English
NITROLINGUAL
Brand Name English
TRIDIL
Brand Name English
GLYCERYL TRINITRATE
MART.   WHO-DD  
Systematic Name English
NITROSTAT
Brand Name English
DILUTED NITROGLYCERIN [USP MONOGRAPH]
Common Name English
GLYCERYL TRINITRATE [MART.]
Common Name English
TRANSDERM-NITRO
Brand Name English
TRINITROGLYCERIN
Systematic Name English
NITRO-BID
Brand Name English
1,2,3-PROPANETRIOL, TRINITRATE
Systematic Name English
DILUTED NITROGLYCERIN
USP-RS  
Common Name English
GLYCEROL TRINITRATE
Systematic Name English
Glyceryl trinitrate [WHO-DD]
Common Name English
IMX-150
Common Name English
NITROGLYCERIN [HSDB]
Common Name English
GLYCERYL TRINITRATE SOLUTION [EP MONOGRAPH]
Common Name English
1,2,3-PROPANETRIOL TRINITRATE
Systematic Name English
Classification Tree Code System Code
WHO-VATC QC05AE01
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
WHO-VATC QC01DA02
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
CFR 21 CFR 250.102
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
NDF-RT N0000007647
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
NDF-RT N0000007647
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
EU-Orphan Drug EU/3/15/1435
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
NCI_THESAURUS C29707
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
WHO-ATC C01DA52
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
WHO-ATC C05AE01
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
LIVERTOX 691
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
NDF-RT N0000007647
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
NDF-RT N0000009909
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
WHO-ESSENTIAL MEDICINES LIST 12.1
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
WHO-VATC QC01DA52
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
NDF-RT N0000007647
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
NDF-RT N0000175415
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
WHO-ATC C01DA20
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
WHO-ATC C01DA02
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
Code System Code Type Description
WIKIPEDIA
Nitroglycerin (medication)
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
ECHA (EC/EINECS)
200-240-8
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
FDA UNII
G59M7S0WS3
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
DAILYMED
G59M7S0WS3
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
PUBCHEM
4510
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
DRUG CENTRAL
1952
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
WIKIPEDIA
NITROGLYCERIN
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
HSDB
30
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
EVMPD
SUB11999MIG
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
EPA CompTox
DTXSID1021407
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
SMS_ID
100000087614
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
NCI_THESAURUS
C29294
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
IUPHAR
7053
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
ChEMBL
CHEMBL730
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
MERCK INDEX
m7964
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY Merck Index
DRUG BANK
DB00727
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
RS_ITEM_NUM
1466506
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
LACTMED
Nitroglycerin
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
EVMPD
SUB13997MIG
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
CAS
55-63-0
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
RXCUI
4917
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY RxNorm
EVMPD
SUB90670
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
CHEBI
34104
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
CAS
9010-02-0
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
SUPERSEDED
CHEBI
28787
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
MESH
D005996
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
PRIMARY
EVMPD
SUB96541
Created by admin on Fri Dec 15 15:14:26 GMT 2023 , Edited by admin on Fri Dec 15 15:14:26 GMT 2023
ALTERNATIVE
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BINDER->LIGAND
BINDING
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METABOLITE ACTIVE -> PRODRUG
METABOLITE -> PARENT
METABOLITE -> PARENT
METABOLITE -> PARENT
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IMPURITY -> PARENT
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IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
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IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Related Record Type Details
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Volume of Distribution PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC