Analysis of FDA reports reveals widespread ocular adverse events linked to antidepressants
Key Takeaways
- A review of FDA adverse event reports identified 62,020 ocular adverse events associated with antidepressant use, with NDDIs showing the strongest overall association with eye disorders.
- Ocular neuromuscular disorders were linked to 33 of 36 antidepressants evaluated, with mydriasis, miosis, and anisocoria among the most frequently reported events.
A pharmacovigilance analysis of FDA adverse event reports identified more than 62,000 ocular adverse event reports linked to antidepressant use.
Norepinephrine-dopamine disinhibitors (NDDIs) and selective serotonin reuptake inhibitors (SSRIs) showed the strongest associations with eye-related complications.
The analysis, which included data from the FDA Adverse Event Reporting System (FAERS), noted 62,020 ocular adverse event reports involving 13,348 patients. The median age was 44 years. Females appeared to be more susceptible to reported ocular adverse events than males.
The strongest link to eye disorders was observed with NDDIs, while SSRIs demonstrated the broadest range of associations across key ocular adverse events.
The investigators also evaluated 36 antidepressants with sufficient reports related to ocular neuromuscular disorders. Of these, 33 were associated with such disorders, with mydriasis, miosis, and anisocoria emerging as the most commonly reported ocular neuromuscular events.
Reference
Peng Y, Cao Y, Liu H, et al. Ocular Adverse Events Associated With Antidepressants: A Large-Scale Data Analysis From the FAERS Database. CNS Neurosci Ther. 2026;32(6):e70994. doi: 10.1002/cns.70994. PMID: 42307213.
