Adverse Events of Eye Disorders Related to the Use of Vortioxetine: A Disproportionality Analysis

Aim: The present study aims to evaluate the potential risk of ocular adverse events with vortioxetine use by analyzing real-world adverse events reported in the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) database. Material and Method: The OpenVigil 2.1-MedDRA-v24 disproportionality analysis software package, including the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) algorithms, was used to determine the potential risk of ocular adverse events associated with vortioxetine and to determine signal strength. Ocular adverse event reports related to the generic name vortioxetine as the primary suspect in the FAERS database between 16 May 2014 and 30 September 2024 were included in this study. Risk signal strength for ROR and PRR were classified as low, medium and strong in line with the signal intensity. Results: Twenty-nine ‘preferred terms’ with 3 or more reports were included in this study. Given the results of the disproportionality analysis, 5 adverse events with potential positive signals were found. These were halo vision (ROR=8.205, PRR=8.202; medium signal), angle-closure glaucoma (ROR=5.646, PRR=5.642; medium signal), blepharospasm (ROR=3.408, PRR=3.406; weak signal), oculogyric crisis (ROR=2.394, PRR=2.393; weak signal), and blurred vision (ROR=2.023, PRR=2.011; weak signal). Conclusion: The disproportionality analysis conducted on the FAERS database revealed possible adverse events associated with vortioxetine in eye disorders and not documented in the drug’s package insert (except for angle-closure glaucoma). In conclusion, these findings indicate that continued post-marketing surveillance plays a decisive role in signaling potential new ocular adverse drug events.