Important Safety Information
- 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
in people who take ONGLYZA:
- 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
- Heart failure. Before taking ONGLYZA tell your doctor if you have ever had heart failure or problems with your kidneys. Contact your doctor right away if you have any of the following symptoms of heart failure: increasing shortness of breath or trouble breathing, especially when you lie down; an unusually fast increase in weight; swelling or fluid retention, especially in the feet, ankles or legs; unusual tiredness
- Low blood sugar. 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
- Joint pain. Some people who take medicines called DPP-4 inhibitors, like ONGLYZA, may develop joint pain that can be severe. Call your doctor if you have severe joint pain
- Skin reaction. Some people who take medicines called DPP-4 inhibitors, like ONGLYZA, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin
- Peripheral edema. 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
- Tell your doctor if you have kidney problems. 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 are pregnant, breast-feeding, or plan to become pregnant or breast-feed
- 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
include upper respiratory tract infection, urinary tract infection, and headache.
Approved Uses
ONGLYZA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
ONGLYZA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).
Please see full Prescribing Information and Medication Guide for ONGLYZA.
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.
