Label Changes for:

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

September 2010

Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010

 

CONTRAINDICATION

  • The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.

PRECAUTION

Drug Interactions
  • Apomorphine: Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, concomitant use of apomorphine with ondansetron is contraindicated
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