Assessing the risk of cataracts associated with medications: A pharmacovigilance analysis of the FAERS database

Cataracts are a leading cause of global blindness and visual impairment, with drug-induced cataracts emerging as a significant yet understudied contributor. This study aimed to comprehensively and systematically investigate medication-related cataract risk signals using data from the FDA Adverse Event Reporting System. We searched the FDA Adverse Event Reporting System database for all reported cases of medication-related cataracts from October 2014 to September 2024. Disproportionality analysis, employing the information component and reporting odds ratio, identified the medications most commonly associated with cataracts. Demographic characteristics, drug categories, and time-to-onset were also evaluated. After deduplication, 37,838 cataract-related reports were included. A total of 588 drugs were linked to cataracts. The top 50 medications with the highest signal association strength were identified based on information component values, including anti-cancer agents, immunomodulators, glucocorticoids, adrenergic medications, and anticholinergic medications. Mirvetuximab soravtansine, nitisinone, and belantamab mafodotin demonstrated the strongest signals. Most cases involved individuals over 60 years old, with females accounting for 68.7% of the reports. Significant variability in time-to-onset was also observed. In conclusion, this large-scale signal detection analysis utilizes real-world data to provide a comprehensive list of medications potentially associated with cataracts. Future research is required to validate these statistical associations.