A pharmacovigilance study of vortioxetine based on data from the FDA adverse event reporting system.

ABSTRACT: Vortioxetine is an antidepressant approved for the treatment of major depressive disorder (MDD). Given its widespread post-marketing clinical use, it is essential to explore its real-world safety. Reports were extracted from the FDA Adverse Event Reporting System (FAERS) from the third quarter of 2013 to the first quarter of 2025. Four disproportionality analysis methods, commonly used in pharmacovigilance to evaluate the relative reporting frequency of adverse events (AEs), were employed to identify AE signals associated with vortioxetine. These included the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-item Gamma Poisson Shrink (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN). The median was used to describe the time to onset (TTO) of AEs, and We

SUBMITTER: Liu M 

PROVIDER: S-EPMC12332032 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature