Real-World pharmacovigilance analysis of drug-related conjunctivitis using the FDA adverse event reporting system database

Sci Rep. 2025 Apr 18;15(1):13407. doi: 10.1038/s41598-025-92796-x.

ABSTRACT

Drug-related conjunctivitis can compromise ocular health and quality of life. To evaluate its epidemiology, we analyzed reports from the FDA Adverse Event Reporting System (FAERS) spanning January 2004 to June 2024. The control group in this study comprised individuals using non-target drugs, while the experimental group consisted of individuals using target drugs. Using disproportionality analysis, we identified drugs with a positive signal for conjunctivitis and stratified their risk levels; we also examined induction periods to assess the speed of onset. Among 38 drugs most frequently reported for conjunctivitis, two ophthalmic agents-brimonidine (ROR = 23.04) and latanoprost (ROR = 10.55)-and eight non-ophthalmic drugs, including tralokinumab (ROR = 83.3), dupilumab (ROR = 18.92), and allopurinol (ROR = 5.04), were associated with positive signals. Tralokinumab, brimonidine, dupilumab, and latanoprost were identified as high-association medications. Notably, ophthalmic agents had a significantly shorter induction period than non-ophthalmic drugs (mean 125.9 vs. 298.4 days). These findings underscore the need for vigilant pharmacovigilance and further investigation into the etiology and prevention of drug-related conjunctivitis.

PMID:40251175 | PMC:PMC12008278 | DOI:10.1038/s41598-025-92796-x