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U.S. Department of Health and Human Services

Safety

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Januvia (sitagliptin) Tablet


 

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2008, April 2011, February 2012 and October 2012

 

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.

October 2012

Summary View

 

ADVERSE REACTIONS

Post-Marketing Experience
  • Arthralgia, myalgia, pain in extremity and back pain

 

February 2012
Summary View

 

DOSAGE AND ADMINISTRATION

Recommended Dosing
  • The tablets must not be split, crushed, or chewed before swallowing.

 

PATIENT COUNSELING INFORMATION

Instructions
  • Patients should be informed that the tablets must be swallowed whole and never split, crushed or chewed.

How should I take Januvia

  • Take Januvia tablets whole. Do not split, crush, or chew Januvia tablets before swallowing. If you cannot swallow Januvia tablets whole tell your doctor.

 

April 2011

Summary View

 

5 WARNINGS AND PRECAUTIONS

5.2 Renal Impairment
  • section added

 

6 ADVERSE REACTIONS

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

 

MEDICATION GUIDE

  • ...worsening renal function...

 

July 2008

Summary View

 

Sections ModifiedSummary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Macrovascular Outcomes

WARNINGS AND PRECAUTIONS

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Januvia or any other anti-diabetic drug.