Pharmacovigilance study of drug-induced eye movement disorder based on FDA adverse event reports from 2004 to 2024

Eye movement disorder (EMD) is a significant cause of visual impairment and disruption of daily activities. Drug-induced EMD is an underrecognized but critical risk factor for patients. This study aimed to explore the relationship between medications and EMD using real-world data to improve patient safety and clinical decision-making. A total of 6,158 reports of drug-induced EMD, involving 1,834 unique drugs, were analyzed from the FDA Adverse Event Reporting System (FAERS) spanning Q1 2004 to Q4 2024. Disproportionality analysis revealed 30 drugs with significant associations with EMD, primarily within the central nervous system drug class, including antiseizure medications (vigabatrin, topiramate), antipsychotics (aripiprazole, risperidone), and antidepressants (sertraline, venlafaxine). The highest risks were observed with zonisamide (BCPNN = 3.03), vigabatrin (BCPNN = 2.82), and tiagabine (BCPNN = 2.79). Acyclovir and donepezil had the shortest onset times (median: 2 days). EMD-related adverse events were most commonly reported in middle-aged and elderly women (55.3%), and the number of cases has been steadily increasing over time. This study provides essential pharmacovigilance insights, identifying high-risk medications and demographic factors associated with drug-induced EMD, which can inform clinical practice and optimize patient care.