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Label Changes for:

Zofran (ondansetron hydrochloride) tablets, oral solution, and orally disintegrating tablets

September 2011

Changes have been made to the WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2011

 

WARNINGS

  • 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
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