Comparative Cardiovascular Safety Profiles of Atenolol, Bisoprolol, and Nebivolol: A Pharmacovigilance Disproportionality Analysis of the FDA Adverse Event Reporting System

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Abstract
Background: Beta-blockers are widely prescribed across cardiovascular indications, yet their real-world cardiovascular adverse-event profiles across drug generations remain incompletely characterized in large pharmacovigilance datasets. Objective: To compare the cardiovascular safety profiles of atenolol, bisoprolol and nebivolol using the FDA Adverse Event Reporting System (FAERS). Methods: Retrospective disproportionality analysis of FAERS reports via OpenVigil 2.1, covering each drug’s available reporting history through January 1st, 2026. Cardiovascular events were identified with Standardized MedDRA Queries; signals were assessed with the Reporting Odds Ratio (ROR, 95% CI) and Information Component (IC) under Evans’ criteria. Individual case safety reports were analysed for demographics, seriousness and outcomes. Results: Atenolol was most strongly associated with bradycardia (ROR = 10.513) and left ventricular hypertrophy (ROR = 6.765). Bisoprolol showed the highest signals for diastolic dysfunction (ROR = 24.875), atrial tachycardia (ROR = 23.283) and chronic cardiac failure (ROR = 23.222), together with the highest bradycardia-associated mortality (14.9%). Nebivolol had the lowest overall reporting burden, though counts are not exposure-adjusted; its strongest signals were bradycardia (ROR = 9.619) and coronary artery stenosis (ROR = 9.351), with lower bradycardia mortality (12.6%). Pediatric reports (0–17 years) occurred for all three agents at similar proportions, none FDA-approved in this group. Reports predominantly involved older adults (60–89 years), with a substantial proportion classified as serious. Conclusion: All three agents generated significant signals across a broad range of cardiovascular events, with nebivolol showing the most favourable profile. Because FAERS disproportionality cannot establish causality, these hypothesis-generating findings may inform beta-blocker selection in older or higher-risk patients, particularly those prone to bradyarrhythmias or diastolic dysfunction, pending prospective confirmation.

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