Drug-induced cataract: a real-world study based on the food and drug administration adverse event reporting system database

Purpose: This study aims to investigate the risk of drug-induced cataract and examine its epidemiological patterns using real-world data. Methods: Data from the FDA Adverse Event Reporting System (FAERS), spanning January 2004 to December 2024, were analyzed. A disproportionality analysis was conducted on the FAERS database using four quantitative measures-reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS)-to identify potential safety signals. The study categorized the identified cataract-induced drugs by risk level and quantitatively compared the time to onset across these categories. Results: A total of 671 drugs were reported to be associated with cataract in the FAERS database. Disproportionality analysis identified 64 drugs with a significant risk of cataract formation. The primary therapeutic classes included hormonal, oncological, and ophthalmic medications, along with drugs acting on the nervous system. The highest-risk drugs identified were omidenepag isopropyl, clobazam, and nitisinone, with BCPNN scores of 7.69, 7.36, and 6.02, respectively. Ophthalmic medications showed the shortest mean onset time for drug-induced cataract, averaging 120.29 days. The majority of affected individuals were female (67.59%) and elderly (mean age 63.85 ± 14.54 years). Conclusion: This study provides real-world evidence regarding the risk of drug-induced cataract, offering empirical support for preventive strategies and informed clinical decision-making.