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Details

Stereochemistry ACHIRAL
Molecular Formula C5H8N4O12
Molecular Weight 316.1366
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of PENTAERYTHRITOL TETRANITRATE

SMILES

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

InChI

InChIKey=TZRXHJWUDPFEEY-UHFFFAOYSA-N
InChI=1S/C5H8N4O12/c10-6(11)18-1-5(2-19-7(12)13,3-20-8(14)15)4-21-9(16)17/h1-4H2

HIDE SMILES / InChI

Molecular Formula C5H8N4O12
Molecular Weight 316.1366
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

1.50076801E11
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

1.50076801E11
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

9.4582079E11
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

9.046944E11
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

7.4139841E11
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

9.4703039E11
Primary
NITROGLYCERIN

Approved Use

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

Launch Date

3.71174408E11
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

3.71174408E11
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

3.71174408E11
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
Prostaglandin I2 and the nitric oxide donor molsidomine have synergistic effects on thromboresistance in man.
1992 Mar
Nitric oxide donors antagonize N-nitro-L-arginine and haloperidol catalepsy: potential implication for the treatment of Parkinsonism?
1997 Aug
Nitric oxide (NO) pathway and locomotor hyperactivity towards dopaminomimetics in rats.
1997 Sep-Oct
[The effect of nitric oxide administration on pateints with pulmonary hypertension: a dose-response study].
1998 Feb
L-arginine partially reverses established adrenocorticotrophin-induced hypertension and nitric oxide deficiency in the rat.
2000
Sodium nitroprusside-induced seizure and taurine release from rat hippocampus.
2000
Vascular effects of endothelin-1 in essential hypertension: relationship with cyclooxygenase-derived endothelium-dependent contracting factors and nitric oxide.
2000
Angiotensin in the nucleus tractus solitarii contributes to neurogenic hypertension caused by chronic nitric oxide synthase inhibition.
2000 Aug
Nitric oxide induces thymocyte apoptosis via a caspase-1-dependent mechanism.
2000 Aug 1
Nitric oxide metabolites, prostaglandins and trigeminal vasoactive peptides in internal jugular vein blood during spontaneous migraine attacks.
2000 Dec
Residual pulmonary hypertension in children after treatment with inhaled nitric oxide: a follow-up study regarding cardiopulmonary and neurological symptoms.
2000 Dec
Glyceryl trinitrate induced headache in migraineurs - relation to attack frequency.
2000 Jul
Cytokines induce apoptosis in beta-cells isolated from mice lacking the inducible isoform of nitric oxide synthase (iNOS-/-).
2000 Jul
Protective effect of bilobalide against nitric oxide-induced neurotoxicity in PC12 cells.
2000 May
The neurogenic vasodilator response to endothelin-1: a study in human skin in vivo.
2000 Nov
Inhibition of nitric oxide synthase enhances the myocardial toxicity of phenylpropanolamine.
2000 Nov
Role of nitric oxide in adrenocorticotrophin-induced hypertension: L-arginine effects reversed by N-nitro-L-arginine.
2000 Nov
Female sex steroids: effects upon microglial cell activation.
2000 Nov 1
Synergy between ethanol and grape polyphenols, quercetin, and resveratrol, in the inhibition of the inducible nitric oxide synthase pathway.
2000 Nov 15
Inhibition of inducible nitric oxide synthase gene expression by indomethacin or ibuprofen in beta-amyloid protein-stimulated J774 cells.
2000 Nov 17
Endothelins and endothelin receptor antagonists: therapeutic considerations for a novel class of cardiovascular drugs.
2000 Nov 7
High-calcium diet enhances vasorelaxation in nitric oxide-deficient hypertension.
2000 Sep
Nitric oxide-induced headache in patients with chronic tension-type headache.
2000 Sep
Regulation of diaphragmatic nitric oxide synthase expression during hypobaric hypoxia.
2000 Sep
Inhibition of nitric oxide synthase inhibitors and lipopolysaccharide induced inducible NOS and cyclooxygenase-2 gene expressions by rutin, quercetin, and quercetin pentaacetate in RAW 264.7 macrophages.
2001
Beneficial effect of 1,25 dihydroxyvitamin D3 on cytokine-treated human pancreatic islets.
2001 Apr
Induction of JAB/SOCS-1/SSI-1 and CIS3/SOCS-3/SSI-3 is involved in gp130 resistance in cardiovascular system in rat treated with cardiotrophin-1 in vivo.
2001 Apr 13
Stimulation of cyclooxygenase-2-activity by nitric oxide-derived species in rat chondrocyte: lack of contribution to loss of cartilage anabolism.
2001 Apr 15
Lipopolysaccharide and interferon-gamma-induced nitric oxide production and protein oxidation in mouse peritoneal macrophages are affected by glutathione peroxidase-1 gene knockout.
2001 Aug 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 molsidomine on scopolamine-induced amnesia and hypermotility in the rat.
2001 Aug 31
Interleukin-1beta down-regulates the expression of glucuronosyltransferase I, a key enzyme priming glycosaminoglycan biosynthesis: influence of glucosamine on interleukin-1beta-mediated effects in rat chondrocytes.
2001 Feb
The phosphodiesterase inhibitors pentoxifylline and rolipram suppress macrophage activation and nitric oxide production in vitro and in vivo.
2001 Feb
Comparison of the effects of nitric oxide, nitroprusside, and nifedipine on hemodynamics and right ventricular contractility in patients with chronic pulmonary hypertension.
2001 Jan
Gastric mucosal resistance to acute injury in experimental portal hypertension.
2001 Jan
Ethanol inhibits cytokine-induced iNOS and sPLA2 in immortalized astrocytes: evidence for posttranscriptional site of ethanol action.
2001 Jan-Feb
15-Deoxy-delta12,14-PGJ2, but not troglitazone, modulates IL-1beta effects in human chondrocytes by inhibiting NF-kappaB and AP-1 activation pathways.
2001 Jul 13
Effects of Ginkgo biloba extract (EGb 761) and quercetin on lipopolysaccharide-induced release of nitric oxide.
2001 Jul 31
Prostaglandins and nitric oxide mediate superoxide-induced myocardial contractile dysfunction in isolated rat hearts.
2001 Jun
Nitric oxide inhalation increases alveolar gas exchange by decreasing deadspace volume.
2001 Jun
Neonatal pulmonary hypertension--urea-cycle intermediates, nitric oxide production, and carbamoyl-phosphate synthetase function.
2001 Jun 14
Calcitonin gene-related peptide levels during nitric oxide-induced headache in patients with chronic tension-type headache.
2001 Mar
Expression of inducible nitric oxide synthase in primary culture of rat bladder smooth muscle cells by plasma from cyclophosphamide-treated rats.
2001 Mar 23
Sildenafil (viagra) facilitates weaning of inhaled nitric oxide following placement of a biventricular-assist device.
2001 May
Nitric oxide and chronic HCV and HIV infections.
2001 May
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 15:04:54 UTC 2023
Edited
by admin
on Fri Dec 15 15:04:54 UTC 2023
Record UNII
10L39TRG1Z
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
PENTAERYTHRITOL TETRANITRATE
HSDB   JAN   MI   VANDF  
Systematic Name English
PENTAERYTHRITOL TETRANITRATE [VANDF]
Common Name English
2,2-Bis(hydroxymethyl)-1,3-propanediol tetranitrate
Systematic Name English
PENTAERYTHRITOL TETRANITRATE [JAN]
Common Name English
PENTAERYTHRITOL TETRANITRATE [HSDB]
Common Name English
PENTAERYTHRITYL TETRANITRATE
Common Name English
Pentaerithrityl tetranitrate [WHO-DD]
Common Name English
1,3-PROPANEDIOL, 2,2-BIS((NITROOXY)METHYL)-, DINITRATE (ESTER)
Common Name English
PENTRITOL TEMPULES
Brand Name English
PENTAERITHRITYL TETRANITRATE [MART.]
Common Name English
PENTAERYTHRITOL TETRANITRATE [MI]
Common Name English
PENTALONG
Brand Name English
pentaerithrityl tetranitrate [INN]
Common Name English
PERITRATE
Brand Name English
PENTAERITHRITYL TETRANITRATE
INN   MART.   WHO-DD  
INN  
Official Name English
Classification Tree Code System Code
WHO-VATC QC01DA05
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
WHO-VATC QC01DA55
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
NCI_THESAURUS C29707
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
WHO-ATC C01DA05
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
CFR 21 CFR 250.102
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
WHO-ATC C01DA55
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
WHO-ATC C01DA20
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
Code System Code Type Description
EPA CompTox
DTXSID2023430
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
CHEBI
17553
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
NCI_THESAURUS
C47660
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
SMS_ID
100000087401
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
ECHA (EC/EINECS)
201-084-3
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
ChEMBL
CHEMBL466659
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
MESH
D010417
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
HSDB
6313
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
RXCUI
7992
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY RxNorm
WIKIPEDIA
PENTAERYTHRITOL TETRANITRATE
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
CAS
78-11-5
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
MERCK INDEX
m8492
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY Merck Index
PUBCHEM
6518
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
CHEBI
25879
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
EVMPD
SUB09676MIG
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
FDA UNII
10L39TRG1Z
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
DRUG BANK
DB06154
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
INN
1455
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
DRUG CENTRAL
2087
Created by admin on Fri Dec 15 15:04:54 UTC 2023 , Edited by admin on Fri Dec 15 15:04:54 UTC 2023
PRIMARY
Related Record Type Details
METABOLITE ACTIVE -> PRODRUG
Related Record Type Details
ACTIVE MOIETY