Prinivil - Side Effects & Drug Interactions

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Shock 2.5 2.8 2.2 1.9

Renal dysfunction 1.1 2.4 2.4 1.1

Stroke 0.6 0.6 0.9 0.8

Re-infarction 2.2 2.2 2.2 1.9

Hemorrhagic events 1.2 1.3 1.1 0.9

Post-infarction angina 13.2 13.9 12.3 11.8

Ventricular fibrillation 3.1 2.5 2.4 2.2

Sustained ventricular tachycardia 2.5 2.1 1.8 2.3

Atrial flutter or fibrillation 6.4 6.3 5.3 5.7

Complete atrioventricular block 2.4 2.9 2.5 2.1

Asystole 1.2 1.2 1.3 1.2

Intraventricular septal rupture 0.3 0.4 0.2 0.2

Papillary muscle rupture 0.3 0.4 0.5 0.4

Late CHF (> 4 days) 4.5 4.5 4.2 4.2

Other Events in Controlled Clinical Trials or Post-Marketing Experience

Additional adverse reactions which were reported rarely, either during controlled clinical trials or after the drug was marketed, include:

Cardiovascular

° Myocardial infarction or cerebrovascular accident possibly secondary to excessive hypotension in high risk patients (see WARNINGS, Hypotension) ° Tachycardia

Dermatologic

° Alopecia

° Diaphoresis

° Pruritis

° Urticaria

Severe Skin Disorders such as

° Erythema multiforme

° Pemphigus

° Stevens-Johnson syndrome

° Toxic epidermal necrolysis

Gastrointestinal

° Abdominal pain and indigestion

° Dry mouth

° Pancreatitis

° Vomiting

Hematologic

° Hemolytic anemia

Hepatic

° Hepatitis

° Jaundice (hepatocellular and/ or cholestatic)

° Liver function abnormalities

Nervous System

° Mental confusion

° Mood alterations

° Paresthesia

° Vertigo

Respiratory

° Bronchospasm

° Rhinitis

° Sinusitus

Special Senses

° Taste disorders

Urogenital

° Acute renal failure

° Impotence

° Oliguria/ anuria

° Renal dysfunction

° Uremia

A symptom complex has been reported which may include fever, vasculitis, myalgia, arthralgia/ arthritis, a positive ANA, elevated ESR, eosinophilia, and leukocytosis. Rash, photosensitivity, or other dermatologic manifestations may also occur.

Laboratory Test Findings

Serum Electrolytes

Hyperkalemia and hyponatremia have occurred (see PRECAUTIONS).

Creatinine, Blood Urea Nitrogen:

Increases in blood urea nitrogen and serum creatinine, usually reversible upon discontinuation of therapy, were observed in 1.1% and 1.6% of patients, respectively, with essential hypertension treated with PRINIVIL ® alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis (see PRECAUTIONS). Reversible increases in blood urea nitrogen (14.5%) and serum creatinine (11.2%) were observed in approximately 12.0% of patients with congestive heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.