Monopril

[Fosinopril]

Side Effects & Drug Interactions
ADVERSE REACTIONS

MONOPRIL (fosinopril sodium tablets) has been evaluated for safety in more than 2100 individuals in hypertension and heart failure trials, including approximately 530 patients treated for a year or more. Generally adverse events were mild and transient, and their frequency was not prominently related to dose within the recommended daily dosage range.

Hypertension In placebo-controlled clinical trials (688 MONOPRIL-treated patients), the usual duration of therapy was two to three months. Discontinuations due to any clinical or laboratory adverse event were 4.1% and 1.1% in MONOPRIL-treated and placebo-treated patients, respectively. The most frequent reasons (0.4 to 0.9%) were headache, elevated transaminases, fatigue, cough (see PRECAUTIONS: General, Cough), diarrhea, and nausea and vomiting. During clinical trials with any MONOPRIL (fosinopril sodium tablets) regimen, the incidence of adverse events in the elderly ( 65 years old) was similar to that seen in younger patients.

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

Clinical Adverse Events in Placebo-Controlled Trials (Hypertension)
MONOPRIL Placebo (N= 688) (N= 184)
Incidence Incidence (Discontinuation) (Discontinuation)

Cough 2.2 (0.4) 0.0 (0.0)
Dizziness 1.6 (0.0) 0.0 (0.0)
Nausea/ Vomiting 1.2 (0.4) 0.5 (0.0)

The following events were also seen at >1% on MONOPRIL but occurred in the placebo group at a greater rate: headache, diarrhea, fatigue, and sexual dysfunction.

Other clinical events probably or possibly related, or of uncertain relationship to ther-apy occurring in 0.2 to 1.0% of patients (except as noted) treated with MONOPRIL in controlled or uncontrolled clinical trials (N = 1479) and less frequent, clinically sig-nificant events include (listed by body system):

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