Fluoroquinolone-Associated Psychiatric and Ocular Adverse Events: A Disproportionality Analysis Using Real-World Data From FAERS (2011-2024)
Abstract
Fluoroquinolones (FQs) are widely prescribed antibiotics; however, increasing concerns have arisen over their potential to cause disabling and irreversible adverse effects. Using real-world data from the FDA Adverse Event Reporting System (FAERS) (2011-2024), we performed disproportionality analyses on psychiatric and eye-related adverse events (AEs) using reporting odds ratios (RORs). Of 44 895 FQ-associated adverse event reports, 8518 cases exhibited psychiatric AEs whilst 4367 cases displayed eye-related AEs. Among six FDA-approved FQs, three (ciprofloxacin/levofloxacin/moxifloxacin) showed safety signals for psychiatric disorders and four (ciprofloxacin/levofloxacin/moxifloxacin/ofloxacin) for eye-related disorders. Eight psychiatric and nine eye-related AEs were commonly reported across multiple FQs. Importantly, moxifloxacin exhibited unique safety signals for ocular-related toxicity, including iris transillumination defect [ROR: 6604.89 (4736.76-9209.81)], iris hypopigmentation [1887.66 (1175.44-3031.42)], and pigment dispersion syndrome [2360.62 (1432.71-3889.51)], raising concern for potential progression to pigmentary glaucoma-findings not prominently featured in current safety warnings. Additionally, systematic characterization of suicide cases revealed striking male predominance despite females comprising the majority of psychiatric AEs, identifying middle-aged males as a high-risk demographic. These findings support the need for enhanced pharmacovigilance,…
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