pioglitazone (oral)

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Pronunciation: PYE o GLIT a zone

Brand: Actos

Actos 15 mg

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Actos 30 mg

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Actos 45 mg

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What is the most important information I should know about pioglitazone?

You should not use this medicine if you have severe or uncontrolled heart failure, active bladder cancer, or diabetic ketoacidosis (call your doctor for treatment with insulin). Pioglitazone is not for treating type 1 diabetes.

Pioglitazone can cause or worsen congestive heart failure. Stop using this medicine and call your doctor at once if you have shortness of breath (even with mild exertion), swelling, or rapid weight gain.

What is pioglitazone?

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

Pioglitazone is for people with type 2 diabetes. Pioglitazone is not for treating type 1 diabetes.

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

What should I discuss with my healthcare provider before taking pioglitazone?

You should not use this medicine if you are allergic to pioglitazone, or if you have severe or uncontrolled heart failure, active bladder cancer, or diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure pioglitazone is safe for you, tell your doctor if you have:

  • congestive heart failure or heart disease;
  • fluid retention;
  • a history of bladder cancer;
  • a history of heart attack or stroke; or
  • liver disease.

This medication may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

Taking pioglitazone may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with pioglitazone.

Follow your doctor's instructions about using pioglitazone if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy.

Some women using pioglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

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

It is not known whether pioglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Pioglitazone is not approved for use by anyone younger than 18 years old.

How should I take pioglitazone?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Pioglitazone is usually taken once daily. You may take the medicine with or without food.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating.

Keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency. If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Use pioglitazone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Pioglitazone is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking pioglitazone?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

What are the possible side effects of pioglitazone?

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

Stop using pioglitazone and call your doctor at once if you have symptoms of liver damage: nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have:

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • pink or red urine, painful or difficult urination, new or worsening urge to urinate;
  • changes in your vision; or
  • sudden unusual pain in your hand, arm, or foot.

Common side effects may include:

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

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 other drugs will affect pioglitazone?

Tell your doctor if you use insulin. Taking pioglitazone while you are using insulin may increase your risk of serious heart problems.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • gemfibrozil;
  • rifampin; or
  • other oral diabetes medications, such as acetohexamide, chlorpropamide, glimepiride, glipizide, tolbutamide.

This list is not complete and many other medicines may increase or decrease the effects of pioglitazone on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about pioglitazone.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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