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 acro

SUBMITTER: Chau HT 

PROVIDER: S-EPMC12712350 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature