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 FDA adverse event reporting system to identify drugs that reduce male semen quality, analyzing data from 2004 to 2023. It found 59 drugs with risk signals, with antineoplastic agents, psychoanaleptics, and psycholeptics being the most frequently reported groups. The top five drugs with the most cases were finasteride (845 cases), dutasteride (163 cases), tamsulosin (148 cases), testosterone (101 cases), and valproic acid (54 cases). Notably, 41 drugs lacked clinical information on this adverse effect in their product summaries. The study highlights the need for further research on the impact of various drugs on male semen quality.