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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

  • pancreatitis
  • 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.

  • 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:
    • headache
    • irritability
    • drowsiness
    • hunger
    • weakness
    • fast heart beat
    • dizziness
    • sweating
    • confusion
    • feeling jittery
  • 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.

The most common side effects of JANUVIA include:

  • upper respiratory infection
  • stuffy or runny nose and sore throat
  • 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 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.