Important Information About the Side Effects of JANUMET

What is the most important information I should know about JANUMET?

Serious side effects can happen in people taking JANUMET, including:

1. Lactic Acidosis. Metformin, one of the medicines in JANUMET, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Stop taking JANUMET and call your doctor right away if you get any of the following symptoms, which could be signs of lactic acidosis.

You:

  • feel very weak or tired.
  • have unusual (not normal) muscle pain.
  • have trouble breathing.
  • have unusual sleepiness or sleep longer than usual.
  • have sudden stomach or intestinal problems with nausea and vomiting or diarrhea.
  • feel cold, especially in your arms and legs.
  • feel dizzy or lightheaded.
  • have a slow or irregular heart beat.

You have a higher chance of getting lactic acidosis if you:

  • have kidney problems. People whose kidneys are not working properly should not take JANUMET.
  • have liver problems.
  • have congestive heart failure that requires treatment with medicines.
  • drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking.
  • get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
  • have certain x-ray tests with dyes or contrast agents that are injected into your body.
  • have surgery.
  • have a heart attack, severe infection, or stroke.

2. Pancreatitis (inflammation of the pancreas) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.

Before you start taking JANUMET® (sitagliptin and metformin HCl) tablets:

Tell your doctor if you have ever had:

  • pancreatitis
  • stones in your gallbladder (gallstones)
  • a history of alcoholism
  • high blood triglyceride levels

Stop taking JANUMET 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.

 
 

The most common side effects of JANUMET include:


  • stuffy or runny nose and sore throat
  • upper respiratory infection
  • diarrhea
  • nausea and vomiting
  • gas, upset stomach, indigestion
  • weakness
  • headache
  • low blood sugar (hypoglycemia) when used in combination with certain medications, such as a sulfonylurea or insulin.

 
 
 

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