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U.S. Department of Health and Human Services

Safety

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Ondansetron injection, premix for intravenous use

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

 

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • Cardiac Disorders: Torsade de pointes, ventrcular fibrilation and chest discomfort
  • Gastrointestinal Disorders: nausea and vomiting
  • Hepatobiliary Disorders: Specific hepatic enzyme abnormalities listed, hepatic necrosis, and abnormal hepatic function
  • General Disorders and Administrative Site Conditions: Chills and lethargy
  • Skin and Subcutaneous Tissue Disorders:  hyperhidrosis, pruritus, and purpura 
  • Musculoskeletal and Connective Tissue Disorders: arthralgia