Uses of Avandamet

AVANDAMET contains two prescription medicines for treating diabetes, rosiglitazone maleate (AVANDIA®) and metformin hydrochloride. AVANDAMET is used, with diet and exercise, to treat adults with type 2 (“adult-onset” or “non-insulin-dependent”) diabetes (“high blood sugar”). Metformin works mainly by decreasing the production of sugar in your liver. Rosiglitazone helps your body respond better to its natural insulin and does not cause your body to make more insulin. These medicines work together to help control your blood sugar. AVANDAMET may be used alone or with other diabetes medicines.

AVANDAMET is not for people with type 1 diabetes mellitus or to treat a condition called diabetic ketoacidosis. It is not known if AVANDAMET is safe and effective in children younger than 18 years old.

Side Effects of Avandamet

AVANDAMET may cause serious side effects, including:

New or worse heart failure

  • The risk of heart failure may be higher in people who take AVANDAMET with insulin. Most people who take insulin should not also take AVANDAMET.
  • Rosiglitazone, one of the medicines in AVANDAMET, can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough.
  • If you have severe heart failure, you cannot start AVANDAMET.
  • If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, AVANDAMET may not be right for you.

Call your doctor right away if you have any of the following:

  • swelling or fluid retention, especially in the ankles or legs
  • shortness of breath or trouble breathing, especially when you lie down
  • an unusually fast increase in weight
  • unusual tiredness

Lactic acidosis

Metformin, one of the medicines in AVANDAMET, can cause a rare but a serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:

  • you feel cold in your hands or feet
  • you feel dizzy or lightheaded
  • you have a slow or irregular heartbeat
  • you feel very weak or tired
  • you have unusual (not normal) muscle pain
  • you have trouble breathing
  • you feel sleepy or drowsy
  • you have stomach pains, nausea, or vomiting

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance of getting lactic acidosis with AVANDAMET if you:

  • have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye.
  • have liver problems
  • drink alcohol very often or drink a lot of alcohol in short-term “binge” drinking
  • get dehydrated (lose a large number 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 surgery
  • have a heart attack, severe infection, or stroke

The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your AVANDAMET for a while if you have any of these things.

Warnings & Precautions

Do not take AVANDAMET if you:

  • have severe kidney problems. Before you take AVANDAMET and while you take it, your doctor should test your blood to check for signs of kidney problems.
  • have a condition known as metabolic acidosis, including diabetic ketoacidosis. Many people with heart failure should not start taking AVANDAMET.

Do not take AVANDAMET if you are allergic to rosiglitazone or any of the inactive ingredients in AVANDAMET. See the end of this leaflet for a complete list of ingredients in AVANDAMET.

Symptoms of a severe allergic reaction with AVANDAMET may include:

  • swelling of your face, lips, tongue, or throat
  • problems with breathing or swallowing
  • skin rash or itching
  • raised red areas on your skin (hives)
  • blisters on your skin or in your mouth, nose, or eyes
  • peeling of your skin
  • fainting or feeling dizzy
  • very rapid heartbeat

Before starting AVANDAMET, ask your doctor about what the choices are for diabetes medicines, and what the expected benefits and possible risks are for you in particular.

Before taking AVANDAMET, tell your doctor about all of your medical conditions, including if you:

  • have heart problems or heart failure.
  • have severe kidney problems.
  • have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis. These conditions should be treated with insulin.
  • are going to have dye injected into a vein for an x-ray, CAT scan, heart study, or another type of scanning. AVANDAMET may need to be stopped for a short time.
  • drink a lot of alcohol (all the time or short binge drinking).
  • develop a serious condition such as a heart attack, severe infection, or a stroke.
  • have a type of diabetic eye disease called macular edema (swelling of the back of the eye).
  • have liver problems. Your doctor should do blood tests to check your liver before you start taking AVANDAMET and during treatment as needed.
  • had liver problems while taking REZULIN™ (troglitazone), another medicine for diabetes.
  • are pregnant or plan to become pregnant. It is not known if AVANDAMET can harm your unborn baby. You and your doctor should talk about the best way to control your diabetes during pregnancy. If you are a premenopausal woman (before the “change of life”) who does not have regular monthly periods, AVANDAMET may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking AVANDAMET. Tell your doctor right away if you become pregnant while taking AVANDAMET.
  • are breastfeeding or planning to breastfeed. It is not known if AVANDAMET passes into breast milk.  You and your doctor should decide if you will take AVANDAMET or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take including prescription and over-the-counter medicines, vitamins, or herbal supplements. AVANDAMET and certain other medicines can affect each other and may lead to serious side effects including high or low blood sugar, or heart problems. Your doctor may need to change your dose of AVANDAMET or your other medicines.

Especially tell your doctor if you take:

Know the medicines you take. Keep a list of all your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is alright to take AVANDAMET with other medicines.

Avandamet Dosage

Take AVANDAMET exactly as prescribed. Your doctor may need to change your dose until your blood sugar is better controlled.

  • AVANDAMET should be taken by mouth and with meals.
  • AVANDAMET may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled.
  • It can take 2 weeks for AVANDAMET to start lowering your blood sugar. It may take 2 to 3 months to see the full effect on your blood sugar level.
  • If you miss a dose of AVANDAMET, take it as soon as you remember, unless it is time to take your next dose. Take your next dose at the usual time. Do not take double doses to make up for a missed dose.
  • If you take too much AVANDAMET, call your doctor or poison control center right away.
  • Test your blood sugar regularly as your doctor tells you.
  • Diet and exercise can help your body use its blood sugar better. It is important to stay on your recommended diet, lose extra weight, and get regular exercise while taking AVANDAMET.
  • Your doctor should do blood tests to check your liver and kidneys before you start AVANDAMET and during treatment as needed. Your doctor should also do regular blood sugar tests (for example, “A1C”) to monitor your response to AVANDAMET.

There may be times when you will need to stop taking AVANDAMET for a short time. Tell your doctor if you:

  • are sick with severe vomiting, diarrhea, or fever, or if you drink a much lower amount of liquid than normal.
  • plan to have surgery.


Consult your doctor or pharmacist.


All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.