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  • AVANDIA rosiglitazone maleate | Diabetes Medication
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    Side Effects of AVANDIA

    What are the possible side effects of AVANDIA? This is a common question you might ask about any diabetes medicine.

    AVANDIA may cause serious side effects including:

    New or worse heart failure

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

    Other heart problems

    AVANDIA may increase 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). See "What is the most important information I should know about AVANDIA?".

    • Swelling (edema). AVANDIA can cause swelling due to fluid retention. See "What is the most important information I should know about AVANDIA?".
    • Weight gain. AVANDIA can cause weight gain that may be due to fluid retention or extra body fat. Weight gain can be a serious problem for people with certain conditions including heart problems. See "What is the most important information I should know about AVANDIA?".
    • Liver problems. It is important for your liver to be working normally when you take AVANDIA. Your doctor should do blood tests to check your liver before you start taking AVANDIA and during treatment as needed. Call your doctor right away if you have unexplained symptoms such as:
      • nausea or vomiting
      • stomach pain
      • unusual or unexplained tiredness
      • loss of appetite
      • dark urine
      • yellowing of your skin or the whites of your eyes
    • Macular edema (a diabetic eye disease with swelling in the back of the eye). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly. Very rarely, some people have experienced vision changes due to swelling in the back of the eye while taking AVANDIA.
    • Fractures (broken bones), usually in the hand, upper arm or foot, in females. Talk to your doctor for advice on how to keep your bones healthy.
    • Low red blood cell count (anemia).
    • Low blood sugar (hypoglycemia). Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. This can happen if you skip meals, if you use another medicine that lowers blood sugar, or if you have certain medical problems.
      Call your doctor if low blood sugar levels are a problem for you.
    • Ovulation (release of egg from an ovary in a woman) leading to pregnancy. Ovulation may happen in premenopausal women who do not have regular monthly periods. This can increase the chance of pregnancy. See "What should I tell my doctor before taking AVANDIA?".

    The most common side effects of AVANDIA reported in clinical trials included cold-like symptoms and headache.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    For more information about AVANDIA, please see the Medication Guide.




    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.