Possible Side Effects of Onglyza

Do not take Onglyza if you are allergic to any of its ingredients. Serious allergic reactions can occur with Onglyza and may include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin, hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking Onglyza and contact your doctor right away.

Serious side effects can happen to people taking Onglyza, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking Onglyza, tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high triglyceride levels. Stop taking Onglyza and contact your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Low blood sugar (hypoglycemia) may become worse in people who already take another medication to treat diabetes, such as sulfonylureas or insulin. Tell your doctor if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your doctor. Symptoms of low blood sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, or change in vision.

Swelling or fluid retention in your hands, feet, or ankles (peripheral edema) may become worse in people who also take a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to treat high blood sugar. If you have symptoms of peripheral edema, such as swelling of hands, feet, or ankles, call your doctor. If you do not know whether you are already on this type of medication, ask your doctor.

Common side effects of Onglyza include:

  • Upper respiratory tract infection
  • Urinary tract infection
  • Headache

These are not all of the possible side effects of Onglyza. Tell your doctor if you have any side effects that bother you or that do not go away. For more information, ask your doctor.

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IMPORTANT SAFETY INFORMATION for ONGLYZA (saxagliptin)

Do not take ONGLYZA if you are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin, hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and contact your doctor right away.

Serious side effects can happen to people taking ONGLYZA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking ONGLYZA, tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high triglyceride levels. Stop taking ONGLYZA and contact your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

When ONGLYZA is used with certain other diabetes medicines to treat high blood sugar, such as a sulfonylurea or insulin, the risk of low blood sugar (hypoglycemia) is higher. Symptoms of low blood sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, and change in vision. Follow your doctor’s instructions for treating low blood sugar.

When ONGLYZA is used with a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to treat high blood sugar, peripheral edema (fluid retention) may become worse. If you have symptoms of peripheral edema, such as swelling of hands, feet, or ankles, call your doctor.

The most common side effects with ONGLYZA include upper respiratory tract infection, urinary tract infection, and headache.

Your doctor should test your blood to measure how well your kidneys are working before and during treatment with ONGLYZA. You may need a lower dose if your kidneys are not working well.

Tell your doctor if you start or stop taking other medications, including antibiotics, antifungals or HIV/AIDS medications, as your doctor may need to change your dose of ONGLYZA.

Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please click here for Medication Guide, and click here for US Full Prescribing Information for ONGLYZA (saxagliptin).