Monopril

[Fosinopril]

General

Chest pain, edema, weakness, excessive sweating.

Cardiovascular

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Angina/ myocardial infarction, cerebrovascular accident, hyperten-sive
crisis, rhythm disturbances, palpitations, hypotension, syncope, flushing, clau-dication.

Orthostatic hypotension occurred in 1.4% of patients treated with fosinopril monotherapy. Hypotension or orthostatic hypotension was a cause for discontinua-tion of therapy in 0.1% of patients.

Dermatologic

Urticaria, rash, photosensitivity, pruritus.

Endocrine/ Metabolic

Gout, decreased libido.

Gastrointestinal

Pancreatitis, hepatitis, dysphagia, abdominal distention, abdomi-nal pain, flatulence, constipation, heartburn, appetite/ weight change, dry mouth.

Hematologic

Lymphadenopathy.

Immunologic

Angioedema. (See WARNINGS: Head and Neck Angioedema and Intestinal Angioedema.)

Musculoskeletal

Arthralgia, musculoskeletal pain, myalgia/ muscle cramp.

Nervous/ Psychiatric

Memory disturbance, tremor, confusion, mood change, paresthesia, sleep disturbance, drowsiness, vertigo.

Respiratory:

Bronchospasm, pharyngitis, sinusitis/ rhinitis, laryngitis/ hoarseness, epistaxis. A symptom-complex of cough, bronchospasm, and eosinophilia has been observed in two patients treated with fosinopril.

Special Senses

Tinnitus, vision disturbance, taste disturbance, eye irritation.

Urogenital

Renal insufficiency, urinary frequency.

Heart Failure

In placebo-controlled clinical trials (361 MONOPRIL-treated patients), the usual dura-tion of therapy was 3-6 months. Discontinuations due to any clinical or laboratory adverse event, except for heart failure, were 8.0% and 7.5% in MONOPRIL-treated and placebo-treated patients, respectively. The most frequent reason for discontinuation of MONOPRIL was angina pectoris (1.1%). Significant hypotension after the first dose of MONOPRIL occurred in 14/ 590 (2.4%) of patients; 5/ 590 (0.8%) patients discontinued due to first dose hypotension.

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