Real-world safety assessment of tamsulosin based on adverse event analysis from the FAERS database

Tamsulosin, an alpha-1-adrenergic receptor antagonist, is a commonly used drug in urology. The purpose of this study was to evaluate the safety of tamsulosin during its use by examining the FDA Adverse Event Reporting System (FAERS) database. This study was a retrospective pharmacovigilance analysis using FAERS data from the first quarter of 2004 to the second quarter of 2024. Four disproportionate analyses were used to detect safety signals. Bonferroni correction was applied to control for type I error due to multiple testing at the Preferred Term (PT) level. Further evoked time-series analysis and subgroup analysis were performed to assess the stability of the results of the associated adverse events (AEs). A total of 10,071 reports listing tamsulosin as the primary suspected drug were identified. The time-to-onset analysis revealed a polarized distribution, with a concentration of AEs occurring during the early phase of treatment. Subgroup analysis demonstrated gender-specific differences in AEs reporting patterns, particularly between men with benign prostatic hyperplasia (BPH) and women with ureteral stones. Age-related differences were also noted, with increased reporting of certain AEs in middle-aged and elderly populations. In addition to well-known AEs, several unexpected and rarely reported signals were detected. Most findings were expected, but new signals of previously unreported hyperhidrosis, cystitis, panic reaction, and painful erection were reported. These signals should be interpreted cautiously and require further validation in clinical settings.