Adverse Drug Reactions Associated with Cardiovascular Medications: A Systematic Review of Pharmacovigilance Data from FAERS and PvPI Databases (2009-2026)

Cardiovascular Diseases (CVDs) are the leading cause of morbidity and mortality worldwide. Their management requires long-term, multi-drug therapy, which increases the risk of Adverse Drug Reactions (ADRs) in patients. The objective of this systematic review was to summarize the pattern, severity, and drug-class distribution of ADRs associated with cardiovascular drugs, using published studies alongside FAERS and PvPI pharmacovigilance data. The review was conducted following PRISMA guidelines. Studies published between 2009 and 2026 were searched on PubMed and Google Scholar. Following final screening, 15 studies were included, comprising 12 global FAERS-based studies and 3 India-based hospital pharmacovigilance studies. ADRs were reported across all major cardiovascular drug classes. Dry cough with ACE inhibitors, myalgia with statins, and peripheral edema with calcium channel blockers were consistently observed. Global FAERS studies reported more serious ADRs, while Indian studies predominantly reported mild-to-moderate ADRs. Elderly patients and those on polypharmacy were identified as high-risk groups. Overall, the present systematic review demonstrates that ADR underreporting remains a major challenge in India. Structured pharmacovigilance, improved ADR reporting, and active involvement of clinical pharmacists can further enhance cardiovascular drug safety and patient outcomes.