Objective  Brinzolamide is a topical carbonic anhydrase inhibitor commonly prescribed for the treatment of primary open-angle glaucoma and ocular hypertension. To comprehensively evaluate its medication safety in clinical practice, this study aims to identify and analyze brinzolamide-associated adverse drug events (ADEs) based on data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), thereby providing evidence to support rational drug combinations and pharmacovigilance strategies.

Methods  ADE reports listing brinzolamide as the primary suspected drug were extracted from the FAERS database, covering the period from January 1, 2004, to March 1, 2025. Signal mining was performed using two disproportionality analysis methods: Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN). The basic characteristics of ADEs, their distribution across system organ classes (SOCs), frequency of preferred terms (PTs), and time-to-onset patterns were analyzed.

Results  A total of 12,922 ADE reports involving brinzolamide were included, corresponding to 5,435 patients and 191 ADE signals across 17 SOCs. The five most frequently reported PTs were eye irritation, ocular hyperemia, blurred vision, eye pain, and visual impairment. PTs with the highest signal strength included visual impairment, increased intraocular pressure, eyelash growth, vision decreased, and eyelid edema. Several ADEs such as visual disturbances, intraocular pressure fluctuations, corneal lesions, and abnormal eyelash growth were not listed in the current drug labeling. The median time to onset of ADEs was 28 days, with 58.33% of cases occurring within the first month after drug initiation. The proportion of female patient reports exceeded that of males, suggesting a potential gender-related susceptibility to ADEs.

Conclusion  In addition to monitoring brinzolamide-related ADEs already documented in the labeling, healthcare professionals should pay close attention to unlisted but potentially significant adverse events—particularly those affecting visual function and intraocular pressure. Enhanced vigilance is recommended in high-risk populations, such as female and elderly patients, to ensure medication safety.

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