Evaluating the safety profile of α-1 blockers, 5α-reductase inhibitors, and PDE5I for BPH: a disproportionality analysis of real-world adverse events based on FDA adverse event reporting system (FAERS)

This study analyzed 25,796 reports from the FDA Adverse Event Reporting System to evaluate the safety profiles of α-1 blockers, 5α-reductase inhibitors (5ARIs), and PDE5 inhibitors for treating benign prostatic hyperplasia (BPH). It found significant differences in the onset time of adverse events among these drug classes, with PDE5I-related events occurring earlier. Sixteen significant adverse events were identified, including pollakiuria, gynecomastia, and decreased libido, with some not listed on FDA-approved labels, such as rhinorrhea for tamsulosin. The study emphasizes the importance of clinical vigilance, especially during the first month of treatment, and suggests combination therapies may improve symptom control. However, due to limitations of the FAERS database, such as lack of reliable exposure data and potential reporting biases, these findings should be interpreted cautiously, and further prospective studies are recommended.