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U.S. Department of Health and Human Services

Safety

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PegIntron and Rebetol (peginterferon alfa-2b and ribavirin)


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

ADVERSE REACTIONS

  • The adverse event profile in Study 3...

MEDICATION GUIDE

  • The most serious possible side effects of Peglntron and PegIntron/Rebetol therapy include:
    • Body Organ Problems
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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