Real-world pharmacovigilance analysis of drug-related cataracts using the FDA adverse event reporting system database

Front Pharmacol. 2025 Apr 24;16:1498191. doi: 10.3389/fphar.2025.1498191. eCollection 2025.

ABSTRACT

OBJECTIVE: Although numerous drugs have been associated with cataracts, the risk for most drugs remains unclear. This study aimed to investigate the risk factors for drug-induced cataracts by analyzing large-scale data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

METHODS: We used the reporting odds ratio (ROR) to evaluate reports of drug-induced cataracts in FAERS from the first quarter of 2004 to the third quarter of 2024. A univariate analysis, LASSO (least absolute shrinkage and selection operator) regression, and a multivariate regression analysis were performed to identify drug-related risk factors for cataracts, and Bonferroni correction was applied for multiple comparisons.

RESULTS: Multivariate logistic regression ultimately identified 15 drugs as independent risk factors, including immunomodulators (6/15), antineoplastic drugs (3/15), psychotropic drugs (1/15), respiratory drugs (1/15), gastrointestinal drugs (1/15), orthopedic drugs (1/15), metabolic regulators (1/15), and ophthalmic drugs (1/15). The median time to onset of drug-induced cataracts was 449 days (interquartile range [IQR]: 150-901 days), with approximately 75% of adverse events occurring within 747 days.

CONCLUSION: These findings may help clinicians detect drug-related cataracts at an early stage and provide valuable insights for future research on the mechanisms of drug-induced cataracts.

PMID:40343006 | PMC:PMC12058479 | DOI:10.3389/fphar.2025.1498191