Prescribing Information, including Boxed WARNING                          For Healthcare Professionals
IMPORTANT SAFETY INFORMATION for AVANDIA® (rosiglitazone maleate)
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 (see Boxed WARNING).
SAFETY INFORMATION CONTINUED BELOW 
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.

*Only your doctor can decide if AVANDIA is right for you. AVANDIA is not right for everyone.
Taking AVANDIA with insulin or nitrates is not recommended.

IMPORTANT SAFETY INFORMATION for AVANDIA® (rosiglitazone maleate)

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:

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.

Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes.

For more information about AVANDIA, please see Medication Guide and full Prescribing Information, including Boxed WARNING.