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U.S. Department of Health and Human Services

Safety

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Janumet (sitagliptin/metformin hydrochloride) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2011

Summary View

 

5 WARNINGS AND PRECAUTIONS

5.4 Assessment of Renal Function
  • section added

 

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • ...worsening renal function..

 

MEDICATION GUIDE

  • ...worsening renal function...