Keratoconus Cases Associated with Medication Use: A Population-Based Pharmacovigilance Study

Abstract Keratoconus (KC) has been linked to atopy, connective tissue disorders, and mechanical trauma from repeated eye rubbing. However, evidence suggesting that certain medications may exacerbate or potentially trigger KC remains largely limited to case reports. This population-based, real-world pharmacovigilance analysis aimed to comprehensively investigate associations between drugs and reports of KC using data from the Food and Drug Administration Adverse Event Reporting System (FAERS). Overall, several pharmacologic agents were associated with disproportionately high reports of KC, including sex hormones such as progesterone and estradiol, olopatadine, isotretinoin, methylphenidate, spironolactone, antipsychotics such as aripiprazole and risperidone, and dupilumab. These results underscore the need for increased clinical vigilance in monitoring for early signs of KC in patients prescribed these medications. Furthermore, healthcare providers should be aware of the potential drug-related associations for KC, especially in high-risk groups.