Real-world safety profile of fezolinetant: a disproportionality analysis based on the FAERS database.

Fezolinetant, the first approved non-hormonal neurokinin-3 receptor antagonist for moderate-to‑severe vasomotor symptoms of menopause, demonstrated acceptable safety in phase 3 trials. However, real-world postmarketing safety evidence remains limited, and rare but serious liver injury has emerged as a regulatory concern. This study aimed to systematically characterize adverse event (AE) signals associated with fezolinetant using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database and to assess their consistency with clinical trial data and regulatory warnings. Retrospective disproportionality analysis was performed using the FAERS database from the second quarter of 2023 to the first quarter of 2026. Only unique cases with fezolinetant designated as the primary suspect drug were included. Four algorithms, namely the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and Multi-item Gamma Poisson shrinker (MGPS), were applied to detect positive AE signals at the system organ class (SOC) and preferred term (PT) levels. Time-to-onset analysis, subgroup analyses stratified by age and reporting period, and sensitivity analysis restricted to physician-submitted reports were also conducted. A total of 1757 unique cases involving 3391 adverse events (AEs) were enrolled, with most cases involving female patients. At the PT level, 20 positive signals simultaneously satisfying all four algorithms were observed. Among these, liver-related laboratory abnormalities were prominent, including aspartate aminotransferase increased (ROR 41.72, 95%CI