Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System

Cataract is a leading cause of irreversible vision loss, particularly among the elderly, with drug-induced cataract being an underrecognized yet significant contributor to visual impairment. This study investigates the associations between medications and cataract development using real-world data from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q3 2024. A total of 54,800 reports were analyzed, including 2,336 cases involving 691 drugs in individuals aged 0-45 years. Disproportionality analysis identified 24 drugs significantly associated with cataract risk, with the highest risks linked to glucocorticoids (e.g., fluticasone furoate, triamcinolone), insulin analogs (e.g., insulin glargine, insulin human), and other agents like nitisinone and ranibizumab. Difluprednate showed the strongest association (Bayesian Confidence Propagation Neural Network [BCPNN] = 7.83), followed by prednisolone (BCPNN = 6.84) and erdafitinib (BCPNN = 5.44). Difluprednate had the shortest median onset time (74 days), while prednisolone's median onset was 141 days. Antineoplastic agents demonstrated the fastest average onset of cataracts (533.89 days). The majority of cases were reported in females (57.9%), with a noticeable annual increase in cases. This study provides a comprehensive pharmacovigilance evaluation, offering insights into high-risk medications, their onset patterns, and demographic trends, contributing to improved clinical decision-making and cataract prevention strategies.