What is Actos?

Actos (pioglitazone) is an oral diabetes medicine that helps control blood sugar levels.

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

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

Important information

You should not use Actos if you have severe or uncontrolled heart failure, or if you have bladder cancer. Do not use this medicine if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Actos is not for treating type 1 diabetes.

Actos 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.

Before taking this medicine

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

To make sure Actos 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.

Taking this medicine 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 Actos.

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

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

FDA pregnancy category C. It is not known whether Actos will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Some women using Actos 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.

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.

Do not give this medicine to anyone under 18 years old without medical advice. Actos should not be given to a child.

How should I take Actos?

Take Actos exactly as prescribed by your doctor. 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.

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

Actos 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. 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?

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

Actos side effects

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

Stop using Actos 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, urinating more than usual;
changes in your vision; or
sudden unusual pain in your hand, arm, or foot.

Common Actos 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.

What other drugs will affect Actos?

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

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Actos, 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 Actos 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.