Fluoroquinolones and risk of nightmares: A literature review and disproportionality analysis using individual case safety reports from Food and Drug Administration Adverse Event Reporting System database.

Background: Fluoroquinolones (FQs) have been linked to various neuropsychiatric effects, including nightmares, mostly through case reports. However, data on nightmares remain limited and underreported.

Aims: To review the literature on FQ-related nightmares and estimate the risk of nightmares associated with FQs compared to other antibiotics using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: A literature review was conducted to identify studies on FQ-related nightmares. Active-comparator restricted disproportionality analyses were performed in FAERS (2004Q1-2023Q4) for ciprofloxacin, levofloxacin, and moxifloxacin compared to azithromycin and trimethoprim-sulfamethoxazole. We calculated reporting odds ratios (RORs), proportional reporting ratios, adjusted ROR (accounting age, sex, weight, and specific indications), and information components (IC₀₂₅) to detect safety signals for the Medical Dictionary for Regulatory Activities term "nightmare."

Results: The review identified seven studies, with the prevalence of nightmares ranging from 0.01% to 8% across three trials. Disproportionality analyses indicated that FQ-associated nightmare reports were 6- to 10-fold higher than those linked to azithromycin (ROR: 6.18, 95% CI: 4.14-9.23) and trimethoprim-sulfamethoxazole (ROR: 10.38, 95% CI: 4.92-21.89), largely reported by consumers. These findings were consistent across frequentist and Bayesian methods and adjusted analyses.

Conclusion: FQs may increase the risk of nightmares. Our findings provide valuable insights for future research on their safety profile. Further research is needed to validate these findings and guide safe FQ use.