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    • AVANDIA rosiglitazone maleate | Diabetes Medication
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    Understand the Risks of AVANDIA

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

    AVANDIA is a prescription medicine to treat adults with type 2 diabetes. It helps to control high blood sugar. It is important that you take AVANDIA exactly how it is prescribed by your doctor to best treat your diabetes. Before starting AVANDIA, ask your doctor about what the choices are for diabetes medicines, and what the expected benefits and possible risks are for you in particular.

    AVANDIA may cause serious side effects including:

    • New or worse heart failure
      AVANDIA 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 AVANDIA.
      If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, AVANDIA 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
    • Other heart problems
      AVANDIA may raise the risk of heart problems related to reduced blood flow to the heart. These include possible increases in the risk of heart-related chest pain (angina) or "heart attack" (myocardial infarction). This risk seemed to be higher in people who took AVANDIA with insulin or with nitrate medicines. Most people who take insulin or nitrate medicines should not also take AVANDIA.
      If you have chest pain or a feeling of chest pressure, get medical help right away, no matter what diabetes medicines you are taking.
      People with diabetes have a greater risk for heart problems. It is important to work with your doctor to manage other conditions, such as high blood pressure or high cholesterol.
      AVANDIA can have other serious side effects. Be sure to read the section below "What are possible side effects of AVANDIA?"

    What is AVANDIA?

    AVANDIA is a prescription medicine used with diet and exercise to treat adults with type 2 ("adult-onset" or "non-insulin dependent") diabetes mellitus ("high blood sugar"). AVANDIA helps to control high blood sugar. AVANDIA may be used alone or with other diabetes medicines. AVANDIA can help your body respond better to insulin made in your body. AVANDIA does not cause your body to make more insulin. For AVANDIA to work best, it is very important to exercise, lose extra weight, and follow the diet recommended by your doctor. AVANDIA has not been studied enough in children under 18 years of age to know if it is safe or effective in children. AVANDIA is not for people with type 1 diabetes mellitus or to treat a condition called diabetic ketoacidosis.

    Who should not take AVANDIA?

    Many people with heart failure should not start taking AVANDIA. See "What should I tell my doctor before taking AVANDIA?".

    What should I tell my doctor before taking AVANDIA?

    Before starting AVANDIA, 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 AVANDIA, tell your doctor about all your medical conditions, including if you:

    • have heart problems or heart failure.
    • have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis. These conditions should be treated with insulin.
    • 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 AVANDIA and during treatment as needed.
    • had liver problems while taking REZULIN® (troglitazone), another medicine for diabetes.
    • are pregnant or plan to become pregnant. AVANDIA should not be used during pregnancy. It is not known if AVANDIA 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, AVANDIA may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking AVANDIA. Tell your doctor right away if you become pregnant while taking AVANDIA.
    • are breast-feeding or planning to breast-feed. It is not known if AVANDIA passes into breast milk. You should not use AVANDIA while breastfeeding.

    Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. AVANDIA and certain other medicines can affect each other and may lead to serious side effects including high or low blood sugar, or heart problems. Especially tell your doctor if you take:

    • insulin.
    • nitrate medicines such as nitroglycerin or isosorbide to treat a type of chest pain called angina.
    • any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.

    Know the medicines you take. Keep a list of 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 AVANDIA with other medicines.




    Please see important safety information below for AVANDIA, AVANDAMET and AVANDARYL, including who should not take AVANDIA, AVANDAMET or AVANDARYL. See also link to Medication Guides for AVANDIA, AVANDAMET and AVANDARYL.

    AVANDIA (rosiglitazone maleate)

    Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes. Taking AVANDIA with insulin or nitrates is not recommended.

    AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

    AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

    If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take AVANDIA, tell your doctor right away if you: have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

    Before taking AVANDIA, review your medical history and tell your doctor if you:

    • Have heart failure or other heart problems, or are on any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.
    • Take insulin or nitrate medicines.
    • Have a type of diabetic eye disease called macular edema.
    • Have liver problems or had liver problems while taking REZULIN® (troglitazone).
    • Are pregnant or planning to become pregnant.
    • Are breastfeeding or planning to breastfeed.

    Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy. More fractures have been observed in women taking AVANDIA. Other possible side effects of AVANDIA include anemia and hypoglycemia. Your doctor should do blood tests to check your liver before you start AVANDIA and during treatment as needed.

    For more information about AVANDIA, please see Medication Guide. For further information on AVANDIA, please see full Prescribing Information.

    AVANDAMET (rosiglitazone maleate/metformin HCl)

    Prescription AVANDAMET, along with diet and exercise, helps improve blood sugar control in patients with type 2 diabetes. It is a combination of two drugs - rosiglitazone maleate and metformin HCl. Taking AVANDAMET with insulin or nitrates is not recommended.

    AVANDAMET can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on AVANDAMET. AVANDAMET is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe.

    Rosiglitazone, one of the medicines in AVANDAMET, may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

    If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take AVANDAMET, tell your doctor right away if you: have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

    A small number of people who have taken metformin, another medicine in AVANDAMET, have developed a rare yet serious condition called lactic acidosis (a buildup of lactic acid in the blood) that can cause death. You have a higher chance of getting lactic acidosis if you have kidney problems; have liver problems; drink alcohol very often or excessively; get dehydrated, as when you are sick with a fever, vomiting or diarrhea; or you are going to have surgery. Tell your doctor if you have any of these problems before or while taking AVANDAMET. You should not take AVANDAMET if you have kidney problems or metabolic acidosis. Tests should be used to check your kidneys and liver before and while taking AVANDAMET. If you are taking medicines for heart failure, you may be at increased risk of lactic acidosis.

    Call your doctor right away if you feel any of the following, which may be signs of lactic acidosis: very weak or tired; you have unusual (not normal) muscle pain; you have stomach pains; you have trouble breathing; you feel dizzy or lightheaded; or you have a slow or irregular heartbeat.

    Before taking AVANDAMET, review your medical history and tell your doctor if you:

    • Have heart failure or other heart problems, or are on any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.
    • Take insulin or nitrate medicines.
    • Have kidney problems.
    • Are going to have dye injected into a vein for an X-ray, CAT scan, heart study, or other type of scanning.
    • Drink a lot of alcohol.
    • Develop a serious condition such as a heart attack, severe infection, or a stroke.
    • Are 80 years of age or older.
    • Have a type of diabetic eye disease called macular edema.
    • Have liver problems or had liver problems while taking REZULIN® (troglitazone).
    • Are pregnant or planning to become pregnant.
    • Are breastfeeding or planning to breastfeed.

    Women taking AVANDAMET should know that AVANDAMET may increase the risk of pregnancy. More fractures have been observed in women taking AVANDAMET. Other possible side effects of AVANDAMET include anemia, hypoglycemia, diarrhea, nausea, and upset stomach. Your doctor should do blood tests to check your liver before you start AVANDAMET and during treatment as needed.

    For more information about AVANDAMET, please see Medication Guide. For further information on AVANDAMET, please see full Prescribing Information.

    AVANDARYL (rosiglitazone maleate and glimepiride)

    Prescription AVANDARYL, along with diet and exercise, helps improve blood sugar control in patients with type 2 diabetes. AVANDARYL is a combination of two drugs - rosiglitazone maleate and glimepiride. Taking rosiglitazone with insulin or with nitrates is not recommended.

    AVANDARYL can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on AVANDARYL. AVANDARYL is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe.

    Rosiglitazone, one of the medicines in AVANDARYL, may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

    If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take AVANDARYL, tell your doctor right away if you: have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

    AVANDARYL may cause low blood sugar. Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. If you have kidney problems, you may need a lower dose of AVANDARYL to reduce problems with low blood sugar. Talk to your doctor if low blood sugar is a problem for you.

    Before taking AVANDARYL, review your medical history and tell your doctor if you:

    • Have heart failure or other heart problems, or are on any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.
    • Take insulin or nitrate medicines.
    • Have a type of diabetic eye disease called macular edema.
    • Have liver problems or had liver problems while taking REZULIN® (troglitazone).
    • Are pregnant or planning to become pregnant.
    • Are breastfeeding or planning to breastfeed.

    Women taking AVANDARYL should know that AVANDARYL may increase the risk of pregnancy. More fractures have been observed in women taking AVANDARYL. Another possible side effect of AVANDARYL is anemia. Your doctor should do blood tests to check your liver before you start AVANDARYL and during treatment as needed.

    For more information about AVANDARYL, please see Medication Guide. For further information on AVANDARYL, please see full Prescribing Information.