Altace

[Ramipril]

Heart Failure Post Myocardial Infarction Adverse reactions (except laboratory abnormalities) considered possibly/ probably related to study drug that occurred in more than one percent of patients and more frequently on ramipril are shown below. The inci-dences represent the experiences from the AIRE study. The follow-up time was between 6 and 46 months for this study.

HOPE Study:

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Safety data in the HOPE trial were collected as reasons for discontinuation or temporary interruption of treat-ment. The incidence of cough was similar to that seen in the AIRE trial. The rate of angioedema was the same as in previous clinical trials (see WARNINGS).

Other adverse experiences reported in controlled clinical trials (in less than 1% of ramipril patients), or rarer events seen in postmarketing experience, include the following (in some, a causal relationship to drug use is uncertain):

Body As a Whole:

Anaphylactoid reactions. (See WARNINGS.)

Cardiovascular:

Angina/ chest pain, arrhythmias including bradycardia or tachycardia, cardiac arrest, con-gestive heart failure, symptomatic hypotension (reported in 0.5% of patients in US trials) (See WARNINGS and PRECAUTIONS), syncope, palpitations, transient ischemia attack, and myocardial infarction or cerebrovascular accident possibly due to excessive hypotension.

Hematologic:

Pancytopenia, hemolytic anemia and thrombocytopenia.

Renal:

Some hypertensive patients with no apparent pre-existing renal disease have developed minor, usu-ally transient, increases in blood urea nitrogen and serum creatinine when taking ALTACE, particularly when ALTACE was given concomitantly with a diuretic. (See WARNINGS.) Acute renal failure.

Angioneurotic Edema:

Angioneurotic edema has been reported in 0.3% of patients in US clinical trials. (See WARNINGS.)

Gastrointestinal:

Pancreatitis, abdominal pain (sometimes with enzyme changes suggesting pancreatitis), anorexia, constipation, diarrhea, dry mouth, dyspepsia, dysphagia, gastroenteritis, hepatitis, increased saliva-tion and taste disturbance.

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