Prinivil - Side Effects & Drug Interactions

lisinopril

• Prinivil - Drug Description
• Prinivil - Warnings & Precautions
• Prinivil - Clinical Pharmacology
• Prinivil - Overdosage & Contraindications
• Prinivil - Indications & Dosage
• Prinivil - Patient Info

ADVERSE REACTIONS

In controlled clinical trials involving 3269 patients (2633 patients with hypertension and 636 patients with congestive heart failure), the most frequent clinical adverse reactions were: dizziness (4.4%), headache (5.6%), asthenia/ fatigue (2.7%), diarrhea (1.8%) and cough (3.0%), all of which were more frequent than in placebo-treated patients. Discontinuation of therapy was required in 5.9% of patients.

For adverse reactions which occurred in hypertensive patients and patients with congestive heart failure treated with PRINIVIL ® (lisinopril tablets, Merck Frosst Std.) in controlled clinical trials, comparative incidence data are listed in the table below.

Angioedema

Angioedema has been reported in patients receiving PRINIVIL ® (0.1%). Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/ or larynx occurs, treatment with PRINIVIL ® should be discontinued and appropriate therapy instituted immediately (see WARNINGS, Angioedema).

Hypotension

In hypertensive patients, hypotension occurred in 0.8% and syncope occurred in 0.2% of patients. Hypotension or syncope was a cause for discontinuation of therapy in 0.3% of hypertensive patients (see WARNINGS).

In patients with congestive heart failure, hypotension occurred in 5.2% and syncope occurred in 1.7% of patients. Hypotension and dizziness were causes for discontinuation of therapy in 1.7% of these patients.

Treatment Following Acute Myocardial Infarction

In a controlled, open trial, involving 19,394 acute myocardial infarction patients (GISSI-3, see INDICATIONS AND CLINICAL USE, Treatment Following Acute Myocardial Infarction), comparing lisinopril alone, transdermal glycerol trinitrate, lisinopril and transdermal glycerol trinitrate, or control (no treatment), the most frequent in-hospital adverse events at 6 weeks were as follows:

Control Lisinopril Lisinopril GTN + GTN alone

Event n = 4729 n = 4713 n = 4722 n = 4731

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Persistent hypotension 3.6 8.8 9.3 3.9