Real-world safety profile of bisoprolol: signal detection and demographic stratification using the FAERS database

Bisoprolol, a selective β₁-blocker, is widely prescribed for cardiovascular disease. Real-world pharmacovigilance can clarify adverse drug reactions (ADRs) across demographic strata and identify signals not fully characterized in trials. We analyzed bisoprolol-associated reports in the FDA Adverse Event Reporting System. Disproportionality was assessed using complementary algorithms-reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC with IC025), and empirical Bayes geometric mean (EBGM with EBGM05). To stabilize sparse strata, we required a ≥ 3 and multi-algorithm concordance (EBGM05 > 2, IC025 > 0, lower95_ROR > 1). Multiple testing was controlled using Benjamini-Hochberg FDR and Bonferroni adjustments. Signals were summarized overall and stratified by sex and age (