A Pharmacovigilance Study of Drug-Reduced Male Semen Quality Based on the Food and Drug Administration Adverse Event Reporting System Database

This study utilized the United States Food and Drug Administration adverse event reporting system database to identify drugs associated with reduced male semen quality. The analysis, covering data from 2004 to 2023, identified 59 drugs with risk signals, with antineoplastic agents, psychoanaleptics, and psycholeptics being the most frequently reported groups. The top five drugs with the highest number of cases were finasteride (845 cases), dutasteride (163 cases), tamsulosin (148 cases), testosterone (101 cases), and valproic acid (54 cases). Notably, clinical information about drug-reduced male semen quality was missing from the Summary of Product Characteristics for 41 drugs. The study highlights the need for further research on the effects of these drugs on male semen quality.