As ALTACE is an antihypertensive; the most common adverse reactions are effects secondary to its blood-pressure-lowering action.

The long-term safety of ramipril, as monotherapy was assessed in patients with hypertension. The most commonly reported serious adverse reactions were hypotension (0.1%); myocardial infarction (0.3%); cerebrovascular accident (0.1%); edema (0.2%); syncope (0.1%). Angioedema occurred in 0.1% patients treated with ramipril and a diuretic.

The most frequent adverse events occurring in these trials were: headache (15.1%); dizziness (3.7%); asthenia (3.7%); chest pain (2.0%); nausea (1.8%); peripheral edema (1.8%); somnolence (1.7%); impotence (1.5%); rash (1.4%); arthritis (1.1%); dyspnea (1.1%). Discontinuation of therapy due to clinical adverse events was required in 0.8% of patients treated with ALTACE. Approximately 1% of patients in North American controlled clinical trials have required discontinuation because of cough.

Post Acute Myocardial Infarction Adverse reactions (AIRE Study) considered possibly/probably related to study drug that occurred in more than 1% of patients and more frequently on ramipril were: Hypotension, Cough increased, Dizziness/Vertigo, Nausea/Vomiting, Angina pectoris, Postural hypotension, Syncope, Heart failure, Severe/resistant heart failure, Myocardial infarct, Vomiting, Headache, Abnormal kidney function, Abnormal chest pain and Diarrhea. Discontinuation of therapy due to adverse reactions was required in post-AMI patients taking ramipril (36.7%), compared to patients receiving placebo (40.8%).

The safety profile of ALTACE in patients at Increased Risk of Cardiovascular Events (HOPE Study) was consistent with the post-marketing surveillance experience. Reasons for discontinuation of therapy, were cough (ramipril 7.3%, placebo 1.8%), hypotension/dizziness (ramipril 1.9%, placebo 1.5%) and edema (ramipril 0.4%, placebo 0.2%).

1004 post-AMI patients received ALTACE in a controlled clinical trial. In both the ramipril and placebo groups, myocardial infarction, heart failure, atrial fibrillation, peripheral vascular disease and urinary tract infection were more common in elderly than in younger patients. Gastrointestinal disturbances were more frequent in elderly patients on ramipril. Cough and hypotension were more frequent in women receiving ramipril.

Adverse events (except laboratory abnormalities) considered possibly/probably related to study drug that occurred in more than one percent of stabilized patients with clinical signs of heart failure treated with ALTACE following an acute myocardial infarction are shown below. The incidences represent the experiences from the AIRE (Acute Infarction Ramipril Efficacy) study. The follow-up time was between 6 and 48 months for this study (mean follow up=15 months). See Table 1 and Table 2.

Table 1: ALTACE

Percentage of Patients with Adverse Events Possibly/Probably Related to Study Drug Placebo-controlled (AIRE) Mortality Study