Safety

Janumet XR (sitagliptin and metformin HCl Extended-Release) Tablets

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

April 2015

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • pruritus
     

 

February 2014

Summary View

17 PATIENT COUNSELING INFORMATION

17.1 Instructions
  • Patients should be informed that incompletely dissolved JANUMET XR tablets may be eliminated in the feces. Tell patients that, if they repeatedly see tablets in feces, they should report this finding to their healthcare provider. If a patient reports repeatedly observing tablets in feces, the healthcare provider should assess adequacy of glycemic control.

MEDICATION GUIDE

  • You may see something that looks like the JANUMET XR tablet in your stool (bowel movement). If you see tablets in your stool several times, talk to your doctor. Do not stop taking JANUMET XR without talking to your doctor.

 

Page Last Updated: 05/13/2015
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