Drug-induced male infertility: a real-world study using FAERS and EudraVigilance databases.

ABSTRACT:

Objective

To systematically identify medications potentially causing male infertility or sperm abnormalities and provide risk alerts for clinical practice.

Methods

A pharmacovigilance study was conducted using the FAERS database (Q1 2004-Q2 2025) and EudraVigilance (EV) database (January 2002-October 2025). Adverse events related to male reproductive toxicity were screened using the MedDRA dictionary. Drug safety signals were detected using ROR, PRR, IC, and EBGM, with reliability enhanced through cross-database validation and dechallenge/rechallenge analyses.

Results

The study included 1,955 FAERS cases and 1,384 from EV, with a median patient age of 35 years and 37% being reproductive-age males (18-44 years). The median time to event onset was 132 days, consistent w

SUBMITTER: Gong Z 

PROVIDER: S-EPMC12894360 | biostudies-literature | 2026

REPOSITORIES: biostudies-literature