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US-based emergency department visits for fluoroquinolone-associated hypersensitivity reactions


Correspondence to: S. Christopher Jones, FDA, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology-Division of Pharmacovigilance, 10903 New Hampshire Ave Bldg. 22 (Room #3464), Silver Spring, MD 20993, USA. E-mail:



To estimate the rate of hypersensitivity reactions per 100,000 prescription dispensings of fluoroquinolones based on care rendered in a nationally representative sample of US hospital emergency departments (ED).


We analyzed the frequency of fluoroquinolone-associated hypersensitivity reactions using the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance system (2004–2010) in conjunction with US retail outpatient prescription data from IMS Health (2004–2010). We further categorized reaction severity into three subgroups (mild, moderate, and severe).


Based on 1422 cases of fluoroquinolone-associated hypersensitivity reactions and national drug utilization projections, we estimated risk of hypersensitivity reactions for moxifloxacin, ciprofloxacin, and levofloxacin. The absolute risk of a fluoroquinolone-related hypersensitivity reaction of any severity was low (44.0 (95% CI 34.8–53.3) ED visits/100,000 prescriptions); however, we identified a statistically significant difference in the relative risk (rate ratios) of seeking care in an ED attributed to moxifloxacin hypersensitivity compared to either levofloxacin or ciprofloxacin. For all reaction severities, the estimated ED visits/100,000 prescriptions were 141.3 (95% CI 99.9–182.7) for moxifloxacin, 40.8 (95% CI 31.5–50.0) for levofloxacin, and 26.3 (95% CI 20.8–31.9) for ciprofloxacin. When the rates were stratified by reaction severity category (mild or moderate–severe), moxifloxacin continued to be implicated in more ED visits per 100,000 prescriptions dispensed than either levofloxacin or ciprofloxacin.


Fluoroquinolones may cause hypersensitivity reactions requiring care in an ED, and relative to use, the rate of moxifloxacin-related hypersensitivity reactions is higher compared to levofloxacin or ciprofloxacin. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.