Serious side effects can happen in people who take JANUVIA, including pancreatitis, which may be severe and lead to death. Before you start taking JANUVIA, tell your doctor if you've ever had pancreatitis. 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.

Before you start taking JANUVIA, tell your doctor if you have ever had heart failure (your heart does not pump blood well enough) or have problems with your kidneys. Contact your doctor right away if you have 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; or unusual tiredness. These may be symptoms of heart failure.

Do not take JANUVIA if you are allergic to any of its ingredients, including sitagliptin. Symptoms of serious allergic reactions to JANUVIA, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away.

Kidney problems, sometimes requiring dialysis, have been reported.

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.

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.

If you take JANUVIA with another medicine that can cause low blood sugar (hypoglycemia), 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 headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, and feeling jittery.

Your doctor may do blood tests before and during treatment with JANUVIA to see how well your kidneys are working. Based on these results, your doctor may change your dose of JANUVIA.

The most common side effects of JANUVIA are upper respiratory tract infection, stuffy or runny nose and sore throat, and headache.

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 read the accompanying Medication Guide for JANUVIA^® (sitagliptin) tablets and discuss it with your doctor. The physician Prescribing Information also is available.

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