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Updated: Apr 19, 2026

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
Published on: August 30, 2018
Cardiac risks associated with antibiotics: azithromycin and levofloxacin
Zhiqiang Kevin Lu1, Jing Yuan, Minghui Li
1University of South Carolina, South Carolina College of Pharmacy, Clinical Pharmacy and Outcomes Sciences Department , 715 Sumter Street, CLS Building, Room 311G, Columbia, SC 29208 , USA +1 803 777 2653 ; +1 803 777 2820 ; luk@sccp.sc.edu.
Introduction:
Azithromycin and levofloxacin have been shown to be efficacious in treating infections. The adverse drug events associated with azithromycin and levofloxacin were considered rare. However, the US FDA released warnings regarding the possible risk of QT prolongation with azithromycin and levofloxacin.
Areas Covered:
Case reports/case series, observational studies and clinical trials assessing cardiovascular risks associated with azithromycin and levofloxacin were critically reviewed, including 15 case reports/series, 5 observational studies and 5 clinical trials that investigated the cardiac risks associated azithromycin and levofloxacin.
Expert Opinion:
Results are discordant. Two retrospective studies utilizing large databases demonstrated an increased risk of cardiovascular death with azithromycin, when azithromycin was compared with amoxicillin. Two other retrospective studies found no difference in cardiovascular death associated with azithromycin and other antibiotics. For levofloxacin, the increased risk of cardiovascular death was only found in one retrospective study. Therefore, the risks and benefits of antibacterial therapies should be considered when making prescription decisions. This study should not preclude clinicians from avoiding azithromycin and levofloxacin. If a patient has an indication to receive an antibiotic and if azithromycin or levofloxacin is needed, it may be used, but the potential risks must be understood.
Insights
Azithromycin and levofloxacin, while effective antibiotics, carry rare risks of QT prolongation. Cardiovascular death risks are debated, necessitating careful consideration of benefits versus potential harms.
Area of Science:
- Pharmacology and Therapeutics
- Cardiovascular Risk Assessment
- Infectious Disease Management
Background:
- Azithromycin and levofloxacin are commonly used antibiotics with established efficacy.
- Previously considered rare, potential adverse drug events include QT prolongation, as warned by the US FDA.
- Understanding the cardiovascular risks associated with these antibiotics is crucial for patient safety.
Purpose of the Study:
- To critically review existing literature on the cardiovascular risks of azithromycin and levofloxacin.
- To synthesize findings from various study designs, including case reports, observational studies, and clinical trials.
- To inform clinical decision-making regarding the use of these antibiotics.
Main Methods:
- Systematic review of 15 case reports/series, 5 observational studies, and 5 clinical trials.
- Focus on studies assessing cardiovascular risks, specifically QT prolongation and cardiovascular death.
- Critical appraisal of evidence to evaluate the association between antibiotic use and cardiac events.
Main Results:
- Conflicting evidence exists regarding the cardiovascular risks of azithromycin.
- Some studies suggest an increased risk of cardiovascular death with azithromycin compared to amoxicillin, while others show no difference.
- Limited evidence suggests a potential increased risk of cardiovascular death with levofloxacin in one retrospective study.
Conclusions:
- The risk-benefit profile of azithromycin and levofloxacin requires careful consideration in clinical practice.
- While potential risks exist, these antibiotics may still be prescribed when indicated, provided risks are understood.
- Further research may be needed to clarify the definitive cardiovascular risks associated with these widely used antibiotics.
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