Drug-Induced Male Infertility: A Real-World Study Using FAERS and EudraVigilance Databases

This pharmacovigilance study analyzed data from the FAERS and EudraVigilance databases to identify 19 high-risk drugs potentially causing male infertility or sperm abnormalities. The study included 1,955 cases from FAERS and 1,384 from EudraVigilance, with a median patient age of 35 years. The drugs identified fall into categories such as hormonal agents (e.g., finasteride, testosterone), antineoplastic drugs (e.g., bleomycin), and antidepressants (e.g., citalopram). Finasteride showed strong evidence for causality through dechallenge and rechallenge criteria. The findings highlight the importance of fertility counseling for reproductive-age males, suggesting sperm cryopreservation before chemotherapy and considering it for certain medications like 5α-reductase inhibitors and antidepressants.