What is the most important information you 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:
- high blood triglyceride levels
- stones in your gallbladder (gallstones)
- kidney problems
- a history of alcoholism
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.
- Heart failure. Heart failure means your heart does not pump blood well enough.
Before you start taking JANUVIA, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms:
- increasing shortness of breath or trouble breathing, especially when you lie down
- swelling or fluid retention, especially in the feet, ankles or legs
- an unusually fast increase in weight
- unusual tiredness
These may be symptoms of heart failure.
Who should not take JANUVIA?
Do not take JANUVIA if:
- you are allergic to any of the ingredients in JANUVIA. See the end of the Medication Guide for a complete list of ingredients in JANUVIA. Symptoms of a serious allergic reaction to JANUVIA may include rash, raised red patches on your skin (hives), or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
What are the possible side effects of JANUVIA?
Serious side effects have happened in people taking JANUVIA. See "What is the most important information you should know about JANUVIA?"
- Low blood sugar (hypoglycemia). If you take JANUVIA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUVIA. Signs and symptoms of low blood sugar may include:
- feeling jittery
- fast heart beat
- Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away. See “Who should not take JANUVIA?”. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
- Kidney problems, sometimes requiring dialysis.
- Joint pain. Some people who take medicines called DPP-4 inhibitors like JANUVIA 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 JANUVIA 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 (erosion). Your doctor may tell you to stop taking JANUVIA.
The most common side effects of JANUVIA include upper respiratory infection, stuffy or runny nose and sore throat, and headache.
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 doctor 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.