Label Changes for:

Janumet (sitagliptin/metformin hydrochloride) Tablets

April 2011

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

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...
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