Post-marketing safety surveillance of vortioxetine: a real-world study using the FAERS database

Aims: The FDA Adverse Event Reporting System (FAERS) database was used to study vortioxetine-associated adverse events (ADEs) in a real-world setting to provide recommendations for the safety management of vortioxetine in clinical use. Methods: The FAERS database was retrospectively queried to extract reports related to vortioxetine between the third quarter of 2013 and the second quarter of 2024. To identify and evaluate potential ADEs in patients treated with vortioxetine, various frequentist analytical methods were used, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and multi-item gamma Poisson shrinker (MGPS). Results: Vortioxetine was identified as a “prime suspect” drug in 13097 reports. At the system organ class level, vortioxetine was associated with an increased risk of psychiatric disorders (ROR = 5.36, 95% CI = 5.22–5.50) and gastrointestinal disorders (ROR = 1.89, 95% CI = 1.84–1.95). In addition, 162 preferred terms that simultaneously met the criteria of all four algorithms were identified. Among them, anxiety, nausea, vomiting, dry mouth, constipation, pruritus, sedation, and sexual dysfunction were consistent with common ADEs described in clinical trials. The median time to onset of vortioxetine-associated ADEs was 7 days (interquartile range = 1–31 days) and most ADEs occurred within the first month of vortioxetine treatment. Conclusions: This study validated common adverse events and also identified some potential emerging safety issues related to vortioxetine use in real-world clinical practice. Keywords: Vortioxetine, major depressive disorder, pharmacovigilance, adverse events, FDA Adverse Event Reporting System(FAERS)