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Review
. 2025 Aug;39(8):782-789.
doi: 10.1177/02698811251344684. Epub 2025 Jun 27.

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

Mohammad Ali Omrani  1 , Christian T Tsobo  2 , Niaz Chalabianloo  1 , Fatemeh Ahmadi  3   4 , Sheikh S Abdullah  3   5 , Flory T Muanda  2   3   4   5
Affiliations
Review

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

Mohammad Ali Omrani et al. J Psychopharmacol. 2025 Aug.

Abstract

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.

Keywords: Fluoroquinolones; disproportionality analysis; nightmares; pharmacovigilance.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
ROR forest plots with IC025 for active-comparator restricted disproportionality analyses of nightmares for ciprofloxacin, levofloxacin, and moxifloxacin compared to (a) azithromycin, (b) trimethoprim-sulfamethoxazole, and (c) other fluoroquinolones in FAERS.
See this image and copyright information in PMC

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