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
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 been reported with JANUVIA:- Serious allergic reactions. Call your doctor right away if you have any symptoms of a serious allergic reaction. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
- Upper respiratory infection
- Stuffy or runny nose and sore throat
- Headache
- Stomach upset and diarrhea
- Swelling of the hands or legs, when JANUVIA is used with the combination of metformin and rosiglitazone. These are other types of diabetes medicines.
- Elevated liver enzymes
In patients taking JANUVIA with a sulfonylurea medicine, there is an increased chance of getting low blood sugar. Your doctor may tell you to take a lower dose of sulfonylurea medicine when you also take JANUVIA. Ask your doctor if you are not sure if you take a sulfonylurea medicine for your diabetes. Tell your doctor if you have problems with low blood sugar while taking JANUVIA.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of JANUVIA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
JANUVIA (jah-NEW-vee-ah) is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type 2 diabetes.
JANUVIA should not be used in patients with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUVIA.
Selected Risk Information About JANUVIA
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.
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.
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 Medication Guide for JANUVIA and discuss it with your doctor. The physician Prescribing Information also is available.
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