Ocular Adverse Events Associated With Antidepressants: A Large-Scale Data Analysis From the FAERS Database

Global antidepressant use has risen substantially, raising concerns about their potential ocular adverse effects. Nevertheless, large-scale comprehensive assessments of ocular side effects associated with various classes of antidepressants remain limited.

A retrospective pharmacovigilance analysis was performed using the FDA Adverse Event Reporting System (FAERS) from Q1 2015 to Q4 2024. Reports associated with antidepressants were systematically extracted, and disproportionality analyses were performed to identify potential associations with ocular adverse events (AEs).

62,020 ocular AE reports were identified for 13,348 patients (median age, 44 years), with higher susceptibility observed in females. Norepinephrine-dopamine disinhibitors (NDDIs) showed the strongest association with eye disorders (IC 3.84, 95% CI 3.75-3.90), while selective serotonin reuptake inhibitors (SSRIs) showed the greatest number of positive associations across key ocular AEs. Analysis of the 36 antidepressants with sufficient case reports for ocular neuromuscular disorders revealed that 33 were associated with such disorders, most notably mydriasis, miosis, and anisocoria.

This study delineates the ocular risks of antidepressants, highlighting higher toxicity for NDDIs and SSRIs and widespread associations with ocular neuromuscular disorders. Vigilant monitoring and early intervention are warranted to ensure safe clinical use.