What Is Actos? (Pioglitazone) Side Effects and Risks

Pioglitazone is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body’s sensitivity to insulin, a natural substance that helps control blood sugar levels. Pioglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).

Pioglitazone comes as a tablet taken by mouth. It is usually taken once daily with or without meals. Your doctor may start you on a low dose of pioglitazone and gradually increase your dose.

Pioglitazone controls type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease and several weeks longer for you to feel the full effect of pioglitazone. Do not stop taking pioglitazone without talking to your doctor.

Pioglitazone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • runny nose and other cold symptoms
  • head ache
  • muscle pain
  • tooth or mouth pain
  • sore throat

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

  • nausea
  • vomiting
  • loss of appetite
  • excessive tiredness
  • dark urine
  • yellowing of the skin or whites of the eyes
  • blurred vision
  • vision loss

In clinical studies, more people who took pioglitazone developed bladder cancer than people who did not take pioglitazone. Talk to your doctor about the risk of taking this medication.

In clinical studies, more women who took pioglitazone developed fractures, especially of the hands, arms, feet, ankles, and lower legs than women who did not take pioglitazone. Men who took pioglitazone did not have a greater risk of developing fractures than men who did not take the medication. If you are a woman, talk to your doctor about the risk of taking this medication.

Pioglitazone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Additional Information for Patients

  • There may be an increased chance of having bladder cancer when you take pioglitazone.
  • You should not take pioglitazone if you are receiving treatment for bladder cancer.
  • Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
  • Read the Medication Guide you get along with your pioglitazone medicine. It explains the risks associated with the use of pioglitazone.
  • Talk to your healthcare professional if you have questions or concerns about pioglitazone medicines.
  • Report side effects from the use of pioglitazone medicines to the FDA MedWatch program.

If you have any of these symptoms or diagnosis, see or tell your doctor immediately!

  • Seeing blood in the urine
  • Pain and burning during urination
  • Strong urge to urinate
  • Bladder infections that do not stop even after medication
  • Finding red blood cells in urine in laboratory tests
  • X-rays showing an abnormality in the bladder wall
  • Ultrasound, CT, or MRI scans showing a growth in or around the bladder
  • Biopsy of a suspicious swelling in the bladder
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