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U.S. Department of Health and Human Services

Safety

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Temodar (temozolomide) for Injection; vial and capsules

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

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • There have been reported cases of hepatotoxicity including elevations of liver enzymes, hyperbillirubinemia, cholestasis, and hepatitis.