Post-marketing safety surveillance of vortioxetine hydrobromide: a pharmacovigilance study leveraging FAERS database.

ABSTRACT:

Background

Vortioxetine hydrobromide is a widely prescribed medication for the treatment of major depressive disorder (MDD), primarily exerting its antidepressant effects by inhibiting the reuptake of serotonin (5-HT).The objective of this study was to investigate adverse events (AEs) associated with vortioxetine hydrobromide through data mining in the FDA Adverse Event Reporting System (FAERS) to enhance clinical safety.

Methods

We collected FAERS data from Q3 2013 to Q1 2024 for data cleansing. Disproportionality analysis was employed to quantify relevant AEs associated with vortioxetine. Reported Ratio of Ratios (ROR) was utilized for identifying risk signals within the FAERS data. We employed the System Organ Classes (SOCs) and selected the Preferred Terms (PTs) from the

SUBMITTER: Zhang Y 

PROVIDER: S-EPMC11891171 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature