U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C6H8N2O8
Molecular Weight 236.1366
Optical Activity UNSPECIFIED
Defined Stereocenters 4 / 4
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of ISOSORBIDE DINITRATE

SMILES

C1[C@]([H])([C@]2([H])[C@@]([H])([C@]([H])(CO2)ON(=O)=O)O1)ON(=O)=O

InChI

InChIKey=MOYKHGMNXAOIAT-JGWLITMVSA-N
InChI=1S/C6H8N2O8/c9-7(10)15-3-1-13-6-4(16-8(11)12)2-14-5(3)6/h3-6H,1-2H2/t3-,4+,5-,6-/m1/s1

HIDE SMILES / InChI

Molecular Formula C6H8N2O8
Molecular Weight 236.1366
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 4 / 4
E/Z Centers 0
Optical Activity UNSPECIFIED

Isosorbide dinitrate (ISDN) is a vasodilator used in the treatment of angina pectoris. Its actions are similar to nitroglycerin but with a slower onset of action. The principal pharmacological action of isosorbide dinitrate is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. isosorbide dinitrate is converted to nitric oxide (NO), an active intermediate compound that activates the enzyme guanylate cyclase (atrial natriuretic peptide receptor A). This stimulates the synthesis of cyclic guanosine 3',5'-monophosphate (cGMP) which then activates a series of protein kinase-dependent phosphorylation in the smooth muscle cells, eventually resulting in the dephosphorylation of the myosin light chain of the smooth muscle fiber. The subsequent release of calcium ions results in the relaxation of the smooth muscle cells and vasodilation. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
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
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
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
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
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
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
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
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
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
PubMed

PubMed

TitleDatePubMed
Comparison between isosorbide dinitrate in aerosol and in tablet form for the treatment of hypertensive emergencies in the elderly.
2000
[Clinical and cost-effective aspects of nitrate therapy in patients with ischemic heart disease after aortocoronary bypass surgery].
2001
Nitric oxide and airway reactivity.
2001
[Mononitrates in therapy of ischemic heart disease polycythemia vera].
2001
[Isosorbide-5-mononitrate (mono mac) in the prevention of bleeding from esophageal varicose veins in patients with liver cirrhosis].
2001
Reversal of the gastric effects of nicotine by nitric oxide donor treatment.
2001
[The comparison of the efficacy of atenolol and isosorbide dinitrate therapy in chronic hypotension patients with stable angina pectoris].
2001
Central retinal vein occlusion associated with primary pulmonary hypertension.
2001
Echocardiographical demonstration of a progressively expanding left ventricular aneurysm preceded by endomyocardial tearing.
2001 Apr
Tetrahydrobiopterin improves endothelial dysfunction in coronary microcirculation in patients without epicardial coronary artery disease.
2001 Aug
Somatostatin plus isosorbide mononitrate versus somatostatin in the control of acute gastro-oesophageal variceal bleeding: a double blind, randomised, placebo controlled trial.
2001 Aug
Escape from tolerance of organic nitrate by induction of cytochrome P450.
2001 Dec 1
Left ventricle and arteries: structure, function, hormones, and disease.
2001 Feb
Comparison between isosorbide dinitrate in aerosol and in tablets for the treatment of hypertensive emergencies.
2001 Feb
Variant angina with a strong spasmodic trait.
2001 Jan
Acute congestive heart failure associated with a limited form of systemic sclerosis and primary biliary cirrhosis.
2001 Jan
[Drug treatment of erection disorders in patients with cardiovascular disease].
2001 Jan 27
A validated gas chromatographic method for the determination of isosorbide-5-mononitrate in human plasma and its application to pharmacokinetic studies.
2001 Jul
Susceptibility to cerulein-induced pancreatitis in inducible nitric oxide synthase-deficient mice.
2001 Jul
Potentiation of sildenafil-induced hypotension is minimal with nitrates generating a radical intermediate.
2001 Jul
The effect of nitric oxide donors and L-arginine on the gastric electrolyte barrier.
2001 Jun
Circadian variation of heart rate variability and the rate of autonomic change in the morning hours in healthy subjects and angina patients.
2001 Jun
Endoscopic diagnosis of corkscrew esophagus.
2001 Jun
Potential usefulness of solubility index for prediction of the skin permeation rate of 5-ISMN from pressure-sensitive adhesive tape.
2001 Jun 15
Dobutamine as bridge to angiotensin-converting enzyme inhibitor-nitrate therapy in endstage heart failure.
2001 Mar
A comparison of isosorbide mononitrate, misoprostol and combination therapy for first trimester pre-operative cervical ripening: a randomised controlled trial.
2001 Mar
Age-related changes in skin permeability of hydrophilic and lipophilic compounds in rats.
2001 Mar
Vasoactive response of different parts of human internal thoracic artery to isosorbide-dinitrate and nitroglycerin: an in-vitro study.
2001 Mar
Methylene blue abolishes aortal tone impairment induced by liver ischemia-reperfusion in a dose response manner: an isolated-perfused double-organ rat model study.
2001 Mar
[Use of isosorbide dinitrate and antagonists of angiotensin II in patients with stable angina pectoris in early stages of cardiac insufficiency].
2001 Mar-Apr
Efficacy of a single oral dose of isorsorbide 5-mononitrate in normal dogs and in dogs with congestive heart failure.
2001 Mar-Apr
Isosorbide dinitrate in the treatment of anal fissure: a randomised, prospective, double blind, placebo-controlled trial.
2001 May
Effect of long-acting isosorbide-5-mononitrate administration on large artery distensibility in patients with essential hypertension.
2001 May
[Impact of high remnant-like lipoproteins on the function of peripheral arterial endothelium in patients with hyperlipidemia and normolipidemia: estimation using Doppler flow analysis].
2001 May
Relative bioavailability of two isosorbide dinitrate sublingual tablet formulations administered as single doses in healthy subjects.
2001 May
The human G-protein beta3 subunit C825T polymorphism is associated with coronary artery vasoconstriction.
2001 May
Nitrates and Viagra can be a deadly combination.
2001 May
Tailored treatments.
2001 May
Trimetazidine for stable angina pectoris.
2001 May
Influence of endothelium in dose-dependent inhibition and potentiation by isoniazid of isosorbide dinitrate relaxation of rat aorta.
2001 May
Left ventricular diastolic heart failure with normal left ventricular systolic function in older persons.
2001 May
Medical management of mild-to-moderate heart failure before the advent of beta blockers.
2001 May 7
Effects of angiotensin-converting enzyme inhibition on the development of the atrial fibrillation substrate in dogs with ventricular tachypacing-induced congestive heart failure.
2001 Nov 20
Isosorbide mononitrate in the prevention of first variceal bleed in patients who cannot receive beta-blockers.
2001 Oct
Impact of reference-based pricing of nitrates on the use and costs of anti-anginal drugs.
2001 Oct 16
Excess norepinephrine impairs both endothelium-dependent and -independent vasodilation in patients with pheochromocytoma.
2002 Feb
TIPS versus drug therapy in preventing variceal rebleeding in advanced cirrhosis: a randomized controlled trial.
2002 Feb
Heme oxygenase-1 induction may explain the antioxidant profile of pentaerythrityl trinitrate.
2002 Feb 8
Topical mononitrate treatment in patients with anal fissure.
2002 Jan
Preparation, characterization and in vitro drug release of isosorbide dinitrate microspheres.
2002 Jan-Feb
Patents

Sample Use Guides

Do not exceed 160 mg (4 capsules) per day.
Route of Administration: Oral
In Vitro Use Guide
The in vitro treatment of isolated aorta with isosorbide dinitrate (ISDN) (100 uM) for 2 hr had no effect on the ISDN-induced relaxation of norepinephrine-induced contraction.
Substance Class Chemical
Created
by admin
on Sat Jun 26 08:00:00 UTC 2021
Edited
by admin
on Sat Jun 26 08:00:00 UTC 2021
Record UNII
IA7306519N
Record Status Validated (UNII)
Record Version
  • Download
Related Record Type
Name Type Language
ISOSORBIDE DINITRATE
HSDB   INN   MART.   MI   ORANGE BOOK   USAN   USP   VANDF   WHO-DD  
USAN   INN  
Official Name English
ISOSORBIDE DINITRATE [MART.]
Common Name English
ISOSORBIDE DINITRATE [INN]
Common Name English
C01DA08
Code English
ISOSORBIDE DINITRATE [USAN]
Common Name English
DILATRATE-SR
Brand Name English
ISOSORBIDE DINITRATE [JAN]
Common Name English
ISOSORBIDE DINITRATE [ORANGE BOOK]
Common Name English
ISOMANNIDE DINITRATE
Common Name English
BIDIL COMPONENT ISOSORBIDE DINITRATE
Common Name English
ISOSORBIDE DINITRATE [VANDF]
Common Name English
D-GLUCITOL, 1,4:3,6-DIANHYDRO-, DINITRATE
Common Name English
ISOSORBIDE DINITRATE COMPONENT OF BIDIL
Common Name English
ISOMANNIDE-DINITRATE
Common Name English
ISOSORBIDI DINITRAS DILUTUS [WHO-IP LATIN]
Common Name English
ISDN
Common Name English
ISOSORBIDE DINITRATE [HSDB]
Common Name English
1,4:3,6-DIANHYDRO-D-GLUCITOL DINITRATE
Common Name English
ISORDIL
Brand Name English
NSC-80038
Code English
SORBITRATE
Brand Name English
DILUTED-ISOSORBIDE DINITRATE [WHO-IP]
Common Name English
ISOSORBIDE DINITRATE [MI]
Common Name English
ISOSORBIDE DINITRATE [USP]
Common Name English
ISOSORBIDE DINITRATE [WHO-DD]
Common Name English
DILATRATE
Brand Name English
Classification Tree Code System Code
NCI_THESAURUS C29707
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
WHO-VATC QC05AE02
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
NDF-RT N0000007647
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
NDF-RT N0000007647
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
NDF-RT N0000009909
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
NDF-RT N0000007647
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
WHO-VATC QC01DA08
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
WHO-ATC C01DA08
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
LIVERTOX 522
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
WHO-ATC C05AE02
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
NDF-RT N0000007647
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
WHO-ATC C01DA58
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
WHO-VATC QC01DA58
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
CFR 21 CFR 250.102
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
WHO-ESSENTIAL MEDICINES LIST 12.1
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
NDF-RT N0000175415
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
Code System Code Type Description
FDA UNII
IA7306519N
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
ChEMBL
CHEMBL6622
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
PUBCHEM
6883
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
NCI_THESAURUS
C29134
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
DRUG CENTRAL
1505
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
INN
996
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
RXCUI
6058
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY RxNorm
EVMPD
SUB08335MIG
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
MERCK INDEX
M6541
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY Merck Index
WIKIPEDIA
ISOSORBIDE DINITRATE
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
IUPHAR
7051
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
CAS
87-33-2
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
HSDB
3417
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
MESH
D007548
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
DRUG BANK
DB00883
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
EPA CompTox
87-33-2
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
ECHA (EC/EINECS)
201-740-9
Created by admin on Sat Jun 26 08:00:01 UTC 2021 , Edited by admin on Sat Jun 26 08:00:01 UTC 2021
PRIMARY
Related Record Type Details
SUB_CONCEPT->SUBSTANCE
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
EP
BASIS OF STRENGTH->SUBSTANCE
It usually contains approximately 25 percent of isosorbide dinitrate
ASSAY (HPLC)
USP
Related Record Type Details
METABOLITE ACTIVE -> PARENT
METABOLITE ACTIVE -> PARENT
MAJOR
METABOLITE ACTIVE -> PARENT
MINOR
PLASMA
Related Record Type Details
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Volume of Distribution PHARMACOKINETIC