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.
Who should not take JANUVIA?
Do not take JANUVIA if:
- you are allergic to any of the ingredients in JANUVIA. See the end of this 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 should I tell my doctor before taking JANUVIA?
Before you take JANUVIA, tell your doctor if you:
- have or have had inflammation of your pancreas (pancreatitis).
- have kidney problems.
- have any other medical conditions.
- are pregnant or plan to become pregnant. It is not known if JANUVIA will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
Pregnancy Registry: If you take JANUVIA at any time during your pregnancy, talk with your doctor about how you can join the JANUVIA pregnancy registry. The purpose of this registry is to collect information about the health of you and your baby. You can enroll in this registry by calling 1-800-986-8999.
- are breast-feeding or plan to breast-feed. It is not known if JANUVIA will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUVIA.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
What are the possible side effects of JANUVIA?
Serious side effects have happened in people taking JANUVIA.
- See “What is the most important information I 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.
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.