Important Information About Possible Side Effects
What is the most important information I should know about JANUVIA?
Serious side effects can happen in people taking JANUVIA, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death.
Certain medical problems make you more likely to get pancreatitis.
Before you start taking JANUVIA:
Tell your doctor if you have ever had
- stones in your gallbladder (gallstones)
- a history of alcoholism
- high blood triglyceride levels
- kidney problems
Stop taking JANUVIA and call 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.
What are the possible side effects of JANUVIA?
Serious side effects have happened in people taking JANUVIA.
- Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your health care provider right away. Your health care provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
- Kidney problems, sometimes requiring dialysis
The most common side effects of JANUVIA include:
- upper respiratory infection
- stuffy or runny nose and sore throat
JANUVIA may have other side effects, including:
- stomach upset and diarrhea
- swelling of the hands or legs, when JANUVIA is used with rosiglitazone (Avandia®). Rosiglitazone is another type of diabetes medicine.
These are not all the possible side effects of JANUVIA. For more information, ask your health care provider or pharmacist.
Tell your doctor if you have any side effect that bothers you, is unusual or does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.