Adverse event of ACE inhibitors: A descriptive analysis of FAERS data

Angiotensin-converting enzyme inhibitors are first-line therapies for hypertension and related cardiovascular and renal conditions. The study aimed to characterize the adverse event profile of ACE inhibitors using the U.S. Food and Drug Administration Adverse Event Reporting System.

This retrospective pharmacovigilance study analyzed FAERS reports submitted from January 1, 1979, through March 31, 2025, for nine ACE inhibitors (benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, quinapril, ramipril, and trandolapril) identified as primary suspect drugs. Extracted variables included patient age, sex, reporter type, and reported adverse events. Descriptive statistics were used to summarize reporting frequencies. Comparisons between subgroups (male vs female, <18 vs ≥18 years, and healthcare professional vs consumer reporters) were conducted using reporting proportions. Reporting proportion ratios (RPRs) were calculated to compare the proportion of specific adverse events between predefined reference categories. As FAERS does not provide denominator data, findings reflect reporting patterns rather than incidence or risk estimates.

A total of 124,638 adverse event reports were identified. ADEs were disproportionately higher in adults and elderly patients compared to those <18 years. Males generally reported more ADEs than females, though some drugs showed the opposite trend. Healthcare professionals submitted the majority of reports (pooled RR = 2.22, 95% CI: 2.20-2.25). The most commonly reported ADEs were angioedema, cough, hypotension, and acute kidney injury.

ACE inhibitor adverse event profiles vary by drug, patient age, and sex. Adults and elderly patients carry the highest burden of ADEs, though pediatric cases remain clinically relevant for specific agents. These findings support tailored monitoring and risk mitigation strategies in clinical practice.