Retrospective cohort study of ocular adverse reactions to systemic drugs: insights from a multi-country spontaneous reporting database

Background: With the rise in long-term medication use, assessing ocular adverse reactions (OARs) from systemic drugs has gained importance. Using large real-world databases like the FDA Adverse Event Reporting System (FAERS) offers valuable clinical and pharmacovigilance insights. Methods: Disproportionality analysis including ratio of reported odds (ROR) was performed on all OARs reports related to systemic medications in the FAERS database from 2004 Q1 to 2024 Q3. The OARs were categorized into disease-based and symptom-based classifications to identify systemic medications with positive signals. Results: In the FAERS database, the most common OARs were cataract, dry eye, and glaucoma, with blurred vision, visual impairment, and eye pain as the leading symptoms. Through disproportionality analysis, 141 systemic medications with positive signal drugs for OAR risks were identified, which were concentrated in the following categories: Antineoplastic Medication (30 drugs, Belantamab Mafodotin ROR [95% confidence interval (CI)]: 59.59 [56.25 to 63.13]), Central Nervous System Medication (21 drugs, Fingolimod, 2.69 [2.63 to 2.75]), Anti-infective Medication (15 drugs, Moxifloxacin, 6.52 [6.21 to 6.84]), Immunological and Inflammation-related Medication (15 drugs, Dupilumab, 4.74 [4.7 to 4.79]), Cardiovascular System Medication (10 drugs, Ivabradine, 3.06 [2.61 to 3.58]), Endocrine and Metabolic Disease Medication (10 drugs, Insulin lispro, 3.63 [3.4 to 3.89]), Respiratory System Medication (6 drugs, Telithromycin, 3.51 [3.14 to 3.93]), and Other Medication (34 drugs, Botulinum toxin type A, 4.24 [4.12 to 4.36]). Conclusion: This pharmacovigilance study underscores the importance of identifying underrecognized OARs from systemic drugs to prevent secondary eye diseases and improve drug safety. Graphical Abstract Validation of ocular adverse reaction risk assessment of systemic medications in the FAERS database.