Comprehensive analysis of adverse events associated with vortioxetine using the FDA adverse event reporting system

Front Pharmacol. 2025 May 2;16:1519865. doi: 10.3389/fphar.2025.1519865. eCollection 2025.

ABSTRACT

BACKGROUND: Vortioxetine is a novel antidepressant belonging to the class of selective serotonin reuptake inhibitors. This study aims to comprehensively analyze the adverse events (AEs) associated with vortioxetine by analyzing the FDA Adverse Event Reporting System (FAERS) database.

METHODS: This study collected reports of vortioxetine as primary suspected drug in FAERS database from the fourth quarter of 2013 to the fourth quarter of 2023. We conducted disproportionality analysis to quantify signals of AEs using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma-Poisson Shrinker (MGPS).

RESULTS: A total of 12,279 reports of vortioxetine as the primary suspected drug and 30,104 AEs were identified. 51.57% of AE reports originated from consumers and 45.85% from health professional. The AEs associated with vortioxetine involved 27 different system organs (SOCs). A total of 158 AE signals of vortioxetine were identified, including some common adverse events such as nausea, vomiting, and unexpected AE signals such as vision blurred, bruxism, disturbance in attention, akathisia, restless legs syndrome, urinary retention, and electrocardiogram QT prolonged. Gender-specific analysis showed high-risk AEs were different for females (nausea, vomiting, crying, contusion, weight increased, pruritus) and males (completed suicide, negative thoughts, anorgasmia, libido decreased, urinary retention, sexual dysfunction). The median onset time of AEs was 7 days (interquartile range [IQR] 0-30 days), and most AEs (75.10%) occurred within the first month after initiation of vortioxetine.

CONCLUSION: Our study identified potential new AE signals, offering a broader understanding of the safety profile of vortioxetine, and providing valuable references for its clinical monitoring and further research. It should be noted that nearly half of the reports originated from patients, highlighting the value of patient-reported data in pharmacovigilance, but also reminding us of the need for cautious interpretation due to potential self-reporting biases.

PMID:40385485 | PMC:PMC12081438 | DOI:10.3389/fphar.2025.1519865