Generic Name: pioglitazone (PYE-oh-GLI-ta-zone)
Brand Name: Actos

Thiazolidinedione antidiabetics such as Actos may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Actos should not be used to treat patients with moderate to severe heart failure. You will be monitored for signs of heart failure when you start Actos and when your dose increases. Contact your doctor at once if you develop swelling of the hands, ankles, or feet; shortness of breath; or sudden, unexplained weight gain. Your doctor may need to stop your medicine or change your dose.


Actos is used for:

Treating type 2 diabetes in certain patients. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Actos is a thiazolidinedione antidiabetic. It works by lowering blood sugar by making the cells of the body more sensitive to the action of insulin.

Do NOT use Actos if:

  • you are allergic to any ingredient in Actos
  • you have bladder cancer or moderate to severe heart failure
  • you have type 1 diabetes or diabetic ketoacidosis (a certain, severe problem associated with diabetes)
  • you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Can Prescription Drugs Lead to Weight Gain?

Before using Actos:

Some medical conditions may interact with Actos. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems, abnormal liver function tests, heart problems (eg, congestive heart failure [CHF]), bladder cancer, or eye or vision problems (eg, macular edema)
  • if you have swelling problems (edema)

Some MEDICINES MAY INTERACT with Actos. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Gemfibrozil, insulin, or oral antidiabetic medicines (eg, glipizide) because the risk of low blood sugar may be increased
  • Rifampin because it may decrease Actos's effectiveness, resulting in high blood sugar
  • Anticoagulants (eg, warfarin) because the risk of their side effects may be increased or their effectiveness may be decreased by Actos

This may not be a complete list of all interactions that may occur. Ask your health care provider if Actos may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Actos:

Use Actos as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Actos comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Actos refilled.
  • Take Actos by mouth with or without food.
  • Continue to take Actos even if you feel well. Do not miss any doses.
  • Taking Actos at the same time each day will help you remember to take it.
  • If you miss a dose of Actos, skip the missed dose and go back to your regular dosing schedule, unless your doctor directs you otherwise. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Actos.

Important safety information:

  • Carry an ID card at all times that says you have diabetes.
  • Proper diet, regular exercise, and regular blood sugar testing are important for best results with Actos. Follow the diet and exercise program given to you by your health care provider.
  • Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Actos exactly as prescribed, tell your doctor.
  • It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
  • It may take 2 to 3 months to get the full effect from Actos. Do NOT take more than the recommended dose without checking with your doctor.
  • Actos may cause low blood sugar levels when it is used along with insulin or other oral diabetic medicines. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
  • Actos may cause ovulation in women who have not reached menopause but do not ovulate. Be sure to use effective birth control while using Actos.
  • Tell your doctor or dentist that you take Actos before you receive any medical or dental care, emergency care, or surgery.
  • Actos may be associated with an increased risk of bladder cancer. Tell your doctor right away if you notice symptoms that could be associated with bladder cancer (eg, a red color or blood in the urine, difficult or painful urination, an increased need to urinate). Discuss any questions or concerns with your doctor.
  • An increased incidence of bone fracture has been reported in women who take Actos. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain.
  • Lab tests, including fasting blood sugar, hemoglobin A1c, eye examinations, and liver function, may be performed while you use Actos. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Actos should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Actos while you are pregnant. It is not known if Actos is found in breast milk. Do not breast-feed while taking Actos.

Possible side effects of Actos:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cold-like symptoms; headache; muscle aches; sinus pain; sore throat; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; swelling of the hands, ankles, or feet; symptoms of heart failure (eg, shortness of breath; sudden, unexplained weight gain); symptoms of liver problems (eg, dark urine; stomach pain; unexplained nausea, vomiting, or loss of appetite; yellowing of the skin or eyes); symptoms of low blood sugar (eg, anxiety; chills, increased hunger, headache; increased dizziness or drowsiness; tremors); unusual bone pain; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Actos:

Store Actos between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Actos out of the reach of children and away from pets.

General information:

  • If you have any questions about Actos, please talk with your doctor, pharmacist, or other health care provider.
  • Actos is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Actos or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Actos. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Actos. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Actos.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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