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Brand Names: Avandia

Generic Name: rosiglitazone (Pronunciation: row zi GLI ta zone)

• What is rosiglitazone (Avandia)?
• What are the possible side effects of rosiglitazone (Avandia)?
• What is the most important information I should know about rosiglitazone (Avandia)?
• What should I discuss with my healthcare provider before taking rosiglitazone (Avandia)?
• How should I take rosiglitazone (Avandia)?
• What happens if I miss a dose (Avandia)?
• What happens if I overdose (Avandia)?
• What should I avoid while taking rosiglitazone (Avandia)?
• What other drugs will affect rosiglitazone (Avandia)?
• Where can I get more information?

What is rosiglitazone (Avandia)?

Rosiglitazone is an oral diabetes medicine that helps control blood sugar levels.

Rosiglitazone is for people with type 2 (non-insulin-dependent) diabetes. Rosiglitazone is sometimes used in combination with other medicines, but it is not for treating type 1 diabetes.

Rosiglitazone is not recommended for use with insulin.

Taking rosiglitazone may increase your risk of serious heart problems, such as heart attack or stroke. Therefore, rosiglitazone is available only to certain people with type 2 diabetes that cannot be controlled with other diabetes medications.

Rosiglitazone is available only under a special program called Avandia-Rosiglitazone Medicines Access Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Rosiglitazone may also be used for purposes not listed in this medication guide.

Avandia 2 mg

pentagonal, pink, imprinted with SB, 2

Avandia 4 mg

pentagonal, orange, orange, imprinted with SB, 4

Avandia 8 mg

pentagonal, brown, imprinted with SB, 8, SKB

What are the possible side effects of rosiglitazone (Avandia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using rosiglitazone and call your doctor at once if you have a serious side effect such as:

• feeling short of breath, even with mild exertion;
• swelling or rapid weight gain;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• blurred vision;
• increased thirst or hunger, urinating more than usual; or
• pale skin, easy bruising or bleeding, weakness.

Less serious side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• headache; or
• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rosiglitazone (Avandia)?

Taking rosiglitazone may increase your risk of serious heart problems, such as heart attack or stroke. Therefore, rosiglitazone is available only to certain people with type 2 diabetes that cannot be controlled with other diabetes medications.

Rosiglitazone is available only under a special program called Avandia-Rosiglitazone Medicines Access Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Do not use rosiglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking rosiglitazone, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking rosiglitazone. Talk with your doctor if you are concerned about this possibility.

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