Anaphylaxis related to fluoroquinolones: A disproportionality analysis of the FDA Adverse Event Reporting System data base

Background: Hypersensitivity reactions, including anaphylaxis, have been increasingly reported with quinolones. Objective: To characterize the association of different quinolones with anaphylaxis reports in the FDA Adverse Event Reporting System (FAERS) data base. Methods: We searched the FAERS data base for anaphylactic reaction reports (between 2015 and 2024) associated with the three commonly used fluoroquinolones in the United States, viz., levofloxacin, ciprofloxacin, and moxifloxacin. The reporting odds ratio (ROR) was used to assess disproportional reports of anaphylaxis among the individual fluoroquinolones and between the fluoroquinolones and all medications within the data base. Results: We identified 941 anaphylaxis reports (ciprofloxacin, 390; levofloxacin, 299; and moxifloxacin, 252) of 89,351 adverse reactions reported for all fluoroquinolones between 2015 and 2024. There were disproportionally higher reports of anaphylaxis among fluoroquinolones compared with all medications within the data base (ROR 4.56 [95% confidence interval {CI}, 4.28-4.87]) but lower relative to that of amoxicillin (ROR 0.19 [95% CI, 0.17-0.20]). Within the fluoroquinolones, moxifloxacin was associated with the highest disproportionality signal for anaphylaxis relative to all other medications (ROR 8.65 [95% CI, 7.63-9.80]) and relative to all fluoroquinolones (ROR 1.90 [95% CI, 1.65-2.18]), whereas levofloxacin was associated with a disproportionally lower signal when compared with all other fluoroquinolones (ROR 0.77 [95% CI, 0.67-0.88]). The disproportionally higher anaphylaxis report associated with moxifloxacin was especially pronounced among women (ROR 2.11 [95% CI, 1.78-2.49]) and elderly individuals (ROR 2.74 [95% CI, 2.15-3.48]). Conclusion: Moxifloxacin is associated with relatively higher anaphylaxis reports when compared with all other quinolones, especially among female and elderly individuals.