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U.S. Department of Health and Human Services

Safety

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Resources for You

Amaryl (glimepiride) Tablets February 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • Thrombocytopenia (including severe cases with platelet count less than 10,000/μL) and thrombocytopenic purpura

 

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2009

 

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

PRECAUTIONS

  • General
    • Macrovascular Outcomes
      • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction...
  • Drug Interactions
    • ...Clarithromycin....