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Disproportionality and Case-Based Evidence for a Possible Association Between Fluoroquinolones and Kounis Syndrome
Milena Cmiljanić1, Miloš Milosavljević2, Filip Jovčić3
1Medicines and Medical Devices Agency of Serbia, 11000 Belgrade, Serbia.
Pharmaceuticals (Basel, Switzerland)
|May 27, 2026
Summary
Fluoroquinolones may be associated with Kounis syndrome (KS), a hypersensitivity reaction affecting coronary arteries. Ciprofloxacin and levofloxacin showed the strongest links in this pharmacovigilance and literature review.
Area of Science:
- Pharmacovigilance
- Clinical Toxicology
- Cardiology
Background:
- Drug-induced hypersensitivity and cardiotoxicity are significant clinical issues.
- Fluoroquinolones, widely used antibiotics, have known safety concerns.
- Limited evidence exists on fluoroquinolone association with Kounis syndrome (KS).
Purpose of the Study:
- To investigate the potential association between fluoroquinolones and Kounis syndrome.
- To explore the possibility of a fluoroquinolone class effect in KS.
- To analyze safety data from pharmacovigilance databases and literature.
Main Methods:
- Retrospective analysis of VigiBase individual case safety reports.
- Systematic literature search for additional fluoroquinolone-associated KS cases.
- Quantitative analysis using VigiLyze and qualitative assessment using Bradford Hill framework.
Main Results:
- A disproportionality signal for fluoroquinolones in KS was detected in VigiBase.
- Seventeen cases of fluoroquinolone-associated KS were identified from VigiBase and literature.
- Ciprofloxacin and levofloxacin were most frequently implicated, showing a consistent clinical pattern.
Conclusions:
- Kounis syndrome cases linked to fluoroquinolones were found in safety data and literature.
- While a class effect wasn't confirmed, a potential association warrants further investigation.
- Additional research is needed to understand mechanisms, drug-specific risks, and clinical relevance.
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