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U.S. Department of Health and Human Services

Safety

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RotaTeq (rotavirus vaccine, live, oral, pentavalent) Oral Solution


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 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. Read about the new physician labeling format.


Summary View

Sections Modified

ADVERSE REACTIONS

  • Postmarketing Experience
    • Gastrointestinal Disorders
      • Intussusception (including death)

PATIENT COUNSELING INFORMATION

PATIENT PACKAGE INSERT

  • What other important information should I know?
    • ...Death due to intussusception has also occurred...

 

The April 2008 Label not available at this site.