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U.S. Department of Health and Human Services

Safety

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Gleevec (imatinib mesylate) Tablets

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

February 2013

Summary View

 

ADVERSE REACTIONS

Additional Data from Multiple Clinical Trials
  • Vascular Disorders: subdural hematoma (SDH) [in oncology patients treated with imatinib]

 

April 2011

Summary View

 

5 WARNINGS AND PRECAUTIONS

5.4 Hepatotoxicity
5.12 Children and Adolescents
  • ...growth retardation...
5.13 Tumor Lysis syndrome

 

6 ADVERSE REACTIONS

6.13 Postmarketing Experience
  • ...growth retardation...

 

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