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U.S. Department of Health and Human Services

Safety

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Exjade (deferasirox) Tablets for Oral Suspension

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

 

September 2012

Summary View

BOXED WARNING (section rewritten and revised)

4 CONTRAINDICATIONS (section rewritten, revised)

5 WARNING AND PRECAUTIONS (all sections rewritten, revised)

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • Renal and urinary disorders: ..... tubulointerstitial nephritis
  • Hepatobiliary disorders: ....hepatic failure
  • Gastrointestinal disorders: .....gastrointestinal hemorrhage
     

 

 

 

April 2011

Summary View

 

7 DRUG INTERACTIONS

7.4 Interaction with Theophilline and...
  • multiple changes in first paragraph
  • ...Use caution when.....and zolmitriptan

 

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