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U.S. Department of Health and Human Services


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Zofran (ondansetron hydrochloride) injection and premixed injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  


November 2012


QT Prolongation
  • Ondansetron prolongs the QT interval in a dose-dependent



September 2011

Summary View


Electrocardiographic Changes
  • Information regarding post-marketing case reports of Torsade de Pointes
  • Recommendation to avoid use in patients with known congenital long QT syndrome
  • ECG monitoring recommendation in patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation