Monopril

[Fosinopril]

Clinical adverse events probably or possibly related or of uncertain relationship to therapy, occurring in at least 1% of patients treated with MONOPRIL and at least as common as the placebo group, in placebo-controlled trials are shown in the table below.

Clinical Adverse Events in Placebo-Controlled Trials (Heart Failure)
MONOPRIL Placebo (N = 361) (N = 373)
Incidence Incidence (Discontinuation) (Discontinuation)

Dizziness 11.9 (0.6) 5.4 (0.3)
Cough 9.7 (0.8) 5.1 (0.0)
Hypotension 4.4 (0.8) 0.8 (0.0)
Musculoskeletal Pain 3.3 (0.0) 2.7 (0.0)
Nausea/ Vomiting 2.2 (0.6) 1.6 (0.3)
Diarrhea 2.2 (0.0) 1.3 (0.0)
Chest Pain (non-cardiac) 2.2 (0.0) 1.6 (0.0)
Upper Respiratory Infection 2.2 (0.0) 1.3 (0.0)
Orthostatic Hypotension 1.9 (0.0) 0.8 (0.0)
Subjective Cardiac 1.4 (0.6) 0.8 (0.3)
Rhythm Disturbance
Weakness 1.4 (0.3) 0.5 (0.0)

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The following events also occurred at a rate of 1% or more on MONOPRIL but occurred on placebo more often: fatigue, dyspnea, headache, rash, abdominal pain, muscle cramp, angina pectoris, edema, and insomnia. The incidence of adverse events in the elderly ( 65 years old) was similar to that seen in younger patients. Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.4 to 1.0% of patients (except as noted) treated with MONOPRIL (fosinopril sodium tablets) in controlled clinical trials (N = 516) and less frequent, clinically significant events include (listed by body system):

General

Fever, influenza, weight gain, hyperhidrosis, sensation of cold, fall, pain.

Cardiovascular: Sudden death, cardiorespiratory arrest, shock (0.2%), atrial rhythm disturbance, cardiac rhythm disturbances, non-anginal chest pain, edema lower extremity, hypertension, syncope, conduction disorder, bradycardia, tachycardia.

Dermatologic: Pruritus.

Endocrine/ Metabolic: Gout, sexual dysfunction.

Gastrointestinal: Hepatomegaly, abdominal distension, decreased appetite, dry mouth, constipation, flatulence. Immunologic: Angioedema (0.2%).

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