Suspected Captopril-Associated Adverse Drug Reactions among Hypertensive Patients: A Prospective Study in a Primary Healthcare Setting Evaluation of Adverse Drug Reactions of captopril using a causality approach
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Abstract
Adverse Drug Reactions (ADRs) are unintended and harmful responses to medicines occurring at doses normally used for disease prevention, diagnosis, or treatment. Hypertension is a chronic condition requiring long-term pharmacological therapy, and captopril, an Angiotensin-Converting Enzyme (ACE) inhibitor, is commonly used as an antihypertensive agent. This study aimed to determine the incidence and classification of ADRs and examine the association between sociodemographic characteristics, captopril treatment patterns, and the occurrence of captopril-related ADRs among hypertensive patients. This prospective observational study employed a cross-sectional assessment, with data collected prospectively through patient interviews from March to May 2024 at Andalas Community Health Center, Padang City, Indonesia. The Naranjo Algorithm was used to assess the probability of a causal relationship between captopril use and suspected ADRs. Ethical approval was obtained from the Faculty of Pharmacy, Universitas Andalas (No. 39/UN16.10.D.KEPK-FF/2024). Of the 44 patients receiving captopril therapy, 22 (50.0%) experienced at least one suspected ADR, with a total of 26 suspected ADR events identified. Dry cough was the most frequently reported ADR (69%), followed by dizziness (11%) and nausea (8%), swollen gums (4%), frequent urination (4%), and flatulence (4%). Based on the Naranjo Algorithm, 73% of ADRs were classified as probable and 27% as possible. No significant associations were found between sociodemographic characteristics or captopril treatment patterns and ADR occurrence (p > 0.05). Suspected ADRs were relatively common among patients receiving captopril, with dry cough being the most frequently reported reaction.
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