An analysis of the association between atypical antipsychotic drugs and glaucoma risk: a disproportionality assessment based on the FAERS database.

Atypical antipsychotic medications are widely used in the treatment of schizophrenia and other psychiatric disorders; however, emerging evidence suggests a possible link between these agents and glaucoma. As glaucoma is a debilitating condition that can cause irreversible vision loss, clarifying its relationship with antipsychotic use is crucial to guide clinical decision-making. This study utilized the FDA Adverse Event Reporting System (FAERS), a spontaneous reporting database, to explore potential associations between atypical antipsychotic medications and glaucoma. Relevant adverse event reports were systematically retrieved and analyzed through disproportionality methods. The analysis first focused on medications with a higher number of reported cases, followed by a more detailed assessment that incorporated patient-level characteristics. The disproportionality analysis revealed a signal of angle-closure glaucoma associated with olanzapine, with all four statistical measures exceeding predefined thresholds (ROR = 4.64, 95% CI: 3.07-7.01; PRR = 3.33, 95% CI: 2.53-4.38; IC = 1.70, IC025 = 1.16; EBGM = 3.26, EBGM05 = 2.30). In contrast, other antipsychotics such as quetiapine and aripiprazole showed increases in certain metrics but did not simultaneously meet all criteria. The convergence of significant results across multiple methods for olanzapine indicates a more consistent statistical signal of angle-closure glaucoma compared with other agents. However, given the inherent limitations of spontaneous reporting systems, these findings should be interpreted cautiously. This study identified several potential safety signals of glaucoma associated with atypical antipsychotics in the FAERS database, with the statistical signal for olanzapine and angle-closure glaucoma being particularly notable. It is important to emphasize that disproportionality analysis detects reporting signals rather than establishing causality; these findings are therefore hypothesis-generating and intended to raise clinical awareness. Further validation using prospective studies, electronic health records, or other real-world data sources is required to clarify the clinical significance of these observations. In clinical practice, especially for patients with preexisting ocular conditions or elevated intraocular pressure, physicians should strengthen risk assessment, adopt individualized prescribing strategies, and consider regular ophthalmologic evaluations to help manage potential risks.