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Onglyza Warnings and Precautions

People with type 1 diabetes or diabetic ketoacidosis should not take Onglyza. Other precautions and warnings for the drug include watching out for potential drug interactions, starting on a lower dosage if you have kidney problems, and avoiding metformin or pioglitazone products during treatment (as combining these drugs with Onglyza could increase the risk of low blood sugar).

What Should I Tell My Healthcare Provider Before Using Onglyza?

You should talk with your healthcare provider prior to taking Onglyza (saxagliptin) if you have:
  • Kidney disease, such as kidney failure (renal failure)
  • Type 1 diabetes
  • Diabetic ketoacidosis
  • Ever had pancreatitis (inflammation or infection of the pancreas
  • Any allergies, including allergies to food, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
Make sure to tell your healthcare provider about all other medicines you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Specific Onglyza Precautions and Warnings

Some warnings and precautions to be aware of with Onglyza include the following:
  • Very preliminary data suggests incretin mimetics, such as Onglyza, may increase the risk of precancerous cellular changes (called pancreatic duct metaplasia) in people with type 2 diabetes. Researchers are continuing to study the possibility that incretin mimetics might increase the risk of pancreatic cancer, although at this time there is not enough information to know for sure if there is any increased risk.
  • There have been rare reports of pancreatitis in people taking Onglyza. Based on reports of this problem with Onglyza or other similar drugs, this is probably most likely to occur shortly after the drug is first started or when the dosage is increased. Be sure to let your healthcare provider know right away if you have signs of pancreatitis, such as:
    • Nausea
    • Vomiting
    • Loss of appetite
    • Severe persistent abdominal (stomach) pain that sometimes radiates to the back.
  • Onglyza should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it is ineffective for such conditions.
  • Onglyza is cleared from the body using the kidneys, and people with kidney problems (including people on dialysis) need to take lower doses of Onglyza. Your healthcare provider should test your kidney function (using a simple blood test) before you start this medicine.
  • The risk of low blood sugar (hypoglycemia) is low for Onglyza. Also, taking this drug with metformin (Fortamet®, Glucophage®, Glucophage XR®, Glumetza®, or Riomet®), pioglitazone (Actos®), or rosiglitazone (Avandia®) usually does not appear to substantially increase the risk of low blood sugar.
  • Combining Onglyza with sulfonylureas increases the risk of low blood sugar (see Onglyza Interactions). Your healthcare provider may need to lower the dosage of your sulfonylurea. Sulfonylureas include:



  • Onglyza is considered a pregnancy Category B medication. This means that it is probably safe for use in pregnant women, although the full risks are not known. Talk to your healthcare provider before taking Onglyza during pregnancy (see Onglyza and Pregnancy).
  • It is unknown if Onglyza passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider (see Onglyza and Breastfeeding).
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