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Label Changes for:

Onglyza (saxagliptin)

August 2015

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

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


  • Glyxambi (linagliptin and empagliflozin)
  • Januvia (sitagliptin)
  • Janumet (sitagliptin and metformin)
  • Janumet XR (sitagliptin and metformin extended release)
  • Jentadueto (linagliptin and metformin)
  • Kazano (alogliptin and metformin)
  • Kombiglyze XR (saxagliptin and metformin extended release)
  • Nesina (alogliptin)
  • Onglyza (saxagliptin)
  • Oseni (alogliptin and pioglitazone)
  • Tradjenta (linagliptin) 


August 2015


Severe and Disabling Arthralgia
  • There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue drug if appropriate.