Benazepril has been evaluated for safety in over 6000 hypertensive patients. Over 400 elderly patients have participated in controlled hypertension trials. Long-term safety has been assessed in more than 700 patients treated for 1 year or more. There was no increase in the incidence of adverse reactions in elderly patients given the same daily dose. The overall frequency of adverse reactions was not related to duration of therapy or total daily dose.

The most severe adverse reactions occurring in clinical trials with benazepril were: angioedema (full clinical syndrome, 1 case; edema of lips or face without the other manifestations of angioedema, 0.5%), hypotension (0.3%), postural hypotension (0.4%) and syncope (0.1%). Hypotension or postural dizziness was a cause for discontinuation of therapy in <0.2% of patients treated with benazepril alone. Myocardial infarction and cerebral vascular accident occurred, possibly secondary to excessive hypotension in high risk patients.

The most frequent clinical adverse reactions in placebo-controlled clinical trials with benazepril monotherapy (N=964) were headache (6.2%), dizziness (3.6%), fatigue (2.4%), somnolence (1.6%), postural dizziness (1.5%), nausea (1.3%) and cough (1.2%). Discontinuation of therapy due to adverse experiences was required in 4% of patients treated with benazepril.

Adverse reactions occurring in 1% or more of the 2004 patients in controlled hypertension trials who were treated with benazepril monotherapy, are listed in Table 1.