This study aims to evaluate post-marketing adverse events (AEs) associated with its clinical use by analyzing data from the FDA Adverse Event Reporting System (FAERS). We collected all adverse reaction reports associated with omaveloxolone from the first quarter of 2023 (Q1 2023) to the fourth quarter of 2024 (Q4 2024) in the FAERS database and performed signal detection using four distinct pharmacovigilance methods: the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM).
Saturday, August 9, 2025
Characteristics of Adverse Events and Clinical Risks of Omaveloxolone Based on FAERS Data
Liu H, Fan D, Tao H, Shen Z, Yao K. Characteristics of Adverse Events and Clinical Risks of Omaveloxolone Based on FAERS Data. Cerebellum. 2025 Jun 18;24(4):119. doi: 10.1007/s12311-025-01873-4. PMID: 40533692.
