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U.S. Department of Health and Human Services


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Sitagliptin September 2010 Label Change

  • Janumet (sitagliptin and metformin HCl) fixed-dose combination tablets
  • Januvia (sitagliptin) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010

Summary View



Postmarketing Experience
  • constipation
  • vomiting
  • headache