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Label Changes for:

Glucophage XR (metformin hydrochloride extended-release tablets)

August 2008

Changes have been made to the PRECAUTIONS sections of the safety label.

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


  • General
    • Macrovascular Outcomes
      • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glucophage or Glucophage XR or any other anti-diabetic drug.