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Insert J: Actos and Avandia (Thiazolidinediones)

Thiazolidinedione (THY-uh-ZOHL-ih-deen-DY-ohn)​

Brand Name Generic Name
 __ Actos (AK-tohss)  __ pioglitazone (py-oh-GLIH-tuh-zohn)
 __ Avandia (uh-VAN-dee-uh)  __ rosiglitazone (rohss-ih-GLIH-tuh-zohn)

If you are currently taking the thiazolidinedione medicine pioglitazone (Actos) or a combination diabetes pill containing pioglitazone: See the U.S. Food and Drug Administration (FDA) announcement on the next page about this pill.

Discuss treatment options with your doctor before stopping your diabetes medicines. Stopping your diabetes medicines without talking with your doctor can cause serious short-term health problems and could increase the risk of long-term diabetes-related complications.

See Insert K for more information about combination diabetes pills that contain pioglitazone or rosiglitazone.

In June 2011, the FDA warned that use of Actos for more than 1 year may be associated with an increased risk of bladder cancer. The FDA recommended that people receiving treatment for bladder cancer should not take Actos, and Actos should be used with caution in people with a history of bladder cancer. This warning also applies to the combination diabetes pills containing pioglitazone—Actoplus Met, Actoplus Met XR, and Duetact; see Insert K.

Visit www.fda.gov/Drugs/DrugSafety/ucm259150 or call the FDA at 1–888–INFO–FDA (1–888–463–6332) for more information about the FDA’s warning on the use of Actos.

What does this type o​f pill do?

This type of pill helps treat insulin resistance. With insulin resistance, your body doesn’t use insulin the way it should. Thiazolidinediones help your insulin work properly. Then your blood glucose levels stay on target and your cells get the energy they need.

Who should not ta​ke this type of pill?

People with heart failure, also called congestive heart failure, should not take this type of pill.

This type of pill can cause heart failure or make it worse.


Heart failure is a condition in which your heart no longer pumps properly. Then your body keeps too much fluid in your legs, ankles, and lungs.

Call your doctor right away if you have signs of heart failure. Warning signs include

  • having swelling in your legs or ankles
  • gaining a lot of weight in a short time
  • having trouble breathing
  • having a cough
  • being very tired

People being treated for bladder cancer should not take Actos or combination pills containing pioglitazone.


If you have a history of bladder cancer and are taking Actos, talk with your doctor.

You should also talk with your doctor about whether to take this type of pill if

  • you are pregnant, planning to get pregnant, or breastfeeding
  • you have liver disease

What are the poss​ible side effects?

Heart failure is a serious side effect.

Bladder cancer may be more likely to occur in people who take Actos for more than 1 year. Call your doctor right away if you have symptoms of bladder cancer while taking Actos:

  • pink, red, or cola-colored urine, indicating the presence of blood
  • an urgent need to urinate or pain while urinating
  • pain in your back or lower abdomen

This type of pill doesn't cause low blood glucose by itself. But your risk of having low blood glucose goes up if you also take

  • diabetes pills that cause low blood glucose
  • insulin

Your doctor may ask you to take a lower dose of your other diabetes medicines while you take this type of pill.

Other possible side effects are

  • anemia (uh-NEE-mee-uh), a condition that can make you feel very tired
  • an increased risk of getting pregnant even if you're taking birth control pills

Women who take Actos, Avandia, or combination diabetes pills containing pioglitazone or rosiglitazone may have an increased risk of bone fractures.

If you take Actos or Avandia, your health care provider should make sure your liver is working properly. Call your doctor right away if you have any signs of liver disease: nausea, vomiting, stomach pain, tiredness, dark-colored urine, or loss of appetite.

Return to general information    Go to Insert K