Frequently asked questions about ACTOS

Type 2 diabetes

  1. What is type 2 diabetes?
  2. Why is it important to control type 2 diabetes?
  3. What else can I do to help control type 2 diabetes?

ACTOS

  1. What is ACTOS?
  2. What is the most important information I should know about ACTOS?
  3. How does ACTOS help treat type 2 diabetes?
  4. What should I discuss with my doctor before taking ACTOS?
  5. How soon will ACTOS begin to work?
  6. Where can I find more information about ACTOS?

Dosing and storing ACTOS

  1. How should I take ACTOS?
  2. What should I do if I miss a dose?
  3. Who should not use ACTOS?
  4. How should I store ACTOS?

Side effects of ACTOS

  1. Will ACTOS increase my risk of having a heart attack or stroke?
  2. Will ACTOS increase my risk of having bladder cancer?
  3. What are the possible side effects of ACTOS?
  4. Can ACTOS increase my risk for pregnancy?

Testing my blood sugar

  1. Do I still need to test my blood sugar while using ACTOS?
  2. What other routine laboratory tests are recommended?

Taking other medications

  1. Can I take ACTOS with other diabetes medications?
  2. Will ACTOS interact with other medications?

ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.

Please see Important Safety Information, including warnings about heart failure and lactic acidosis, below.

What is type 2 diabetes?

Type 2 diabetes (formerly called non–insulin-dependent diabetes mellitus or adult-onset diabetes) occurs when the body does not produce enough insulin or cannot properly use the insulin it makes to control blood sugar. Insulin allows sugar to enter the cells of your body. Once inside the cells, sugar is used as a source of energy. If your body is resistant to the effects of insulin—a condition known as insulin resistance—and if it cannot make enough insulin to overcome that resistance, sugar builds up in the blood (hyperglycemia).

Why is it important to control type 2 diabetes?

It is important to control type 2 diabetes because the buildup of sugar in the blood, if not controlled, can lead to serious medical problems.

What else can I do to help control type 2 diabetes?

It is important to eat the right foods, lose weight if needed, and exercise regularly in order to manage your type 2 diabetes. Diet, weight loss, and exercise are the main treatments for type 2 diabetes and they also help your diabetes medicines work better for you.

To help control type 2 diabetes, prescription medications such as ACTOS should be used along with nutritional counseling, weight reduction as needed, and physical activity. Your doctor can help determine the best treatment plan for you.

What is ACTOS?

ACTOS is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is a diabetes medicine called pioglitazone hydrochloride that may be taken alone or with other diabetes medicines.

It is not known if ACTOS is safe and effective in children.

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

ACTOS can cause serious side effects, including new or worse heart failure.

  • ACTOS can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough
  • Do not take ACTOS if you have severe heart failure
  • If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, ACTOS may not be right for you

Call your doctor right away if you have any of the following:

  • swelling or fluid retention, especially in the ankles or legs
  • shortness of breath or trouble breathing, especially when you lie down
  • an unusually fast increase in weight
  • unusual tiredness

ACTOS can have other serious side effects. See "What are the possible side effects of ACTOS?"

How does ACTOS help treat type 2 diabetes?

ACTOS, along with healthy eating and physical activity, works by reducing insulin resistance, an important defect of type 2 diabetes. ACTOS helps your body use insulin more effectively by making your cells more sensitive to insulin. It does not cause your body to produce more insulin; instead, it helps your body respond better to insulin’s effects.

What should I discuss with my doctor before taking ACTOS?

Before you start taking ACTOS, tell your doctor if you:

  • have heart failure
  • have type 1 ("juvenile") diabetes or had diabetic ketoacidosis
  • have a type of diabetic eye disease that causes swelling in the back of the eye (macular edema)
  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if ACTOS will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant about the best way to control your blood glucose levels while pregnant
  • are a premenopausal woman (before the "change of life"), who does not have periods regularly or at all. ACTOS may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking ACTOS. Tell your doctor right away if you become pregnant while taking ACTOS
  • are breast-feeding or plan to breast-feed. It is not known if ACTOS passes into your milk and if it can harm your baby. You should not take ACTOS if you breastfeed your baby. Talk to your doctor about the best way to control your blood glucose levels while breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

ACTOS and some of your other medicines can affect each other. You may need to have your dose of ACTOS or certain other medicines changed.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is okay to take ACTOS with other medicines.

How soon will ACTOS begin to work?

Your blood sugar levels may be reduced in as quickly as 2 weeks, it may take 2–3 months to see the full effect of ACTOS. If you do not respond adequately to your starting dose of ACTOS, your doctor may increase your daily dose to improve your blood sugar control.

Where can I find more information about ACTOS?

This is a summary of some of the most important information about ACTOS. If you have any further questions about type 2 diabetes or ACTOS, you should talk to your doctor. Please see Important Safety Information below or click here for ACTOS Complete Prescribing Information and Medication Guide for more information, or call 1-877-825-3327.

How should I take ACTOS?

  • Take ACTOS exactly as your doctor tells you to take it.
  • Your doctor may change your dose of ACTOS. Do not change your ACTOS dose unless your doctor tells you to
  • ACTOS may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled
  • Take ACTOS 1 time each day, with or without food
  • If you miss a dose of ACTOS, take your next dose as prescribed unless your doctor tells you differently. Do not take two doses at one time the next day
  • If you take too much ACTOS, call your doctor or go to the nearest hospital emergency room right away
  • If your body is under stress such as from a fever, infection, accident, or surgery the dose of your diabetes medicines may need to be changed. Call your doctor right away
  • Stay on your diet and exercise programs and test your blood sugar regularly while taking ACTOS
  • Your doctor should do certain blood tests before you start and while you take ACTOS
  • Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with ACTOS
  • Your doctor should check your eyes regularly while you take ACTOS
  • It may take 2–3 months to see the full effect of ACTOS on your blood sugar level

What should I do if I miss a dose?

If you miss a dose of ACTOS, take your next dose as prescribed unless your doctor tells you differently. Do not take 2 doses at one time the next day.

Who should not use ACTOS?

See "What is the most important information I should know about ACTOS?"

How should I store ACTOS?

  • Store ACTOS at 59°F to 86°F (15°C to 30°C). Keep ACTOS in the original container and protect from light
  • Keep the ACTOS bottle tightly closed and protect from getting wet (away from moisture and humidity)
  • Keep ACTOS and all medicines out of the reach of children

Will ACTOS increase my risk of having a heart attack or stroke?

In clinical studies, ACTOS did not increase the risk of having a heart attack or stroke. The ACTOS product information includes FDA-reviewed data from a study of more than 5,000 high-risk patients with a history of macrovascular disease (ie, recent heart attack, stroke, bypass surgery, etc).

No studies have shown a reduction in the risk of heart disease with ACTOS or any other antidiabetic drug.

ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause or worsen heart failure. Please see Important Safety Information, including warning about heart failure, below.

Will ACTOS increase my risk of having bladder cancer?

There may be an increased chance of having bladder cancer when you take ACTOS. You should not take ACTOS 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 a red color in your urine
  • an increased need to urinate
  • pain while you urinate

Talk to your doctor if you have questions or concerns about your ACTOS treatment.

What are the possible side effects of ACTOS?

ACTOS may cause serious side effects including:

  • See "What is the most important information about ACTOS?"
  • liver problems. Call your doctor right away if you have:
    • nausea or vomiting
    • stomach pain
    • unusual or unexplained tiredness
    • loss of appetite
    • dark urine
    • yellowing of your skin or the whites of your eyes
  • broken bones (fractures). Usually in the hand, upper arm, or foot in women. Talk to your doctor for advice on how to keep your bones healthy
  • bladder cancer. There may be an increased chance of having bladder cancer when you take ACTOS. You should not take ACTOS 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 a red color in your urine
    • an increased need to urinate
    • pain while you urinate
  • low blood sugar (hypoglycemia). This can happen if you skip meals, if you also use another medicine that lowers blood sugar, or if you have certain medical problems. Lightheadedness, dizziness, shakiness, or hunger may happen if your blood sugar is too low. Call your doctor if low blood sugar levels are a problem for you
  • diabetic eye disease with swelling in the back of the eye (macular edema). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly
  • release of an egg from an ovary in a woman (ovulation) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take ACTOS. This can increase your chance of getting pregnant

The most common side effects of ACTOS include:

    • cold-like symptoms (respiratory tract infection)
    • headache
    • sinus infection
    • muscle pain
    • sore throat

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the side effects of ACTOS. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Can ACTOS increase my risk for pregnancy?

If you are a premenopausal woman who is not ovulating, you should know that ACTOS might increase your risk of pregnancy by causing you to ovulate. Therefore, you may need to consider birth control options. However, women using oral contraceptives should talk with their doctor, as they may be at increased risk for pregnancy if appropriate contraceptive methods or adjustments are not used.

Do I still need to test my blood sugar while using ACTOS?

Yes. You should test your blood sugar as often as your doctor recommends.

What other routine laboratory tests are recommended?

It is important to have your blood glucose and hemoglobin A1C, a measure of your average blood sugar levels over 2–3 months, checked regularly by your doctor. You will also need to have blood tests to check your liver before you start taking ACTOS.

While taking ACTOS, call your doctor immediately if:

  • You experience an unusually rapid increase in weight or mild-to-moderate swelling (edema) or develop shortness of breath or other symptoms of heart failure
  • You experience unexplained nausea, vomiting, stomach pain, fatigue, anorexia, or dark urine

Can I take ACTOS with other diabetes medications?

Only your doctor can determine which prescription medications are best for your type 2 diabetes. If healthy eating, physical activity, and a single drug are not enough to control your diabetes, ACTOS can be taken in combination with certain other medicines. Combining ACTOS with another diabetes medication, such as sulfonylurea, metformin, or insulin, can provide additional improvements in your blood sugar levels.

ACTOS is not likely to cause low blood sugar when taken alone, because it does not cause your body to produce more insulin. However, people taking ACTOS with sulfonylureas or insulin may be at increased risk for low blood sugar, and an adjustment in the dose of sulfonylurea or insulin may be needed. When taking ACTOS with insulin, the chance of fluid retention is increased which may lead to or worsen heart failure. You should tell your doctor right away if you develop fluid retention especially in the ankles or legs.

Will ACTOS interact with other medications?

ACTOS can be taken with other common prescription medications, such as digoxin and warfarin, and other diabetes medications such as glipizide (a sulfonylurea) and metformin. Tell your doctor about all the medicines, vitamins and supplements you take. ACTOS and some other medicines can affect each other. You may need to have your dose of ACTOS or certain other medicines changed.

Indications and Usage

ACTOS, ACTOplus met, ACTOplus met XR, and duetact are prescription medications used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. They are not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.

Important Safety Information

Warning: Heart Failure

ACTOS, ACTOplus met, ACTOplus met XR, and duetact are not for everyone. These medications can cause or worsen heart failure. Heart failure means your heart does not pump blood well enough. Talk to your doctor immediately if you experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness. Certain patients with symptoms of heart failure should not start taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact. Do not take these medications if you have severe heart failure.

Warning: Lactic Acidosis Specific to ACTOplus met and ACTOplus met XR

Metformin, one of the medicines in ACTOplus met and ACTOplus met XR, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met and ACTOplus met XR should not be used in people with kidney disease or in people 80 years of age or older whose kidneys do not work properly. ACTOplus met and ACTOplus met XR should not be taken by people with metabolic acidosis or who drink excessive amounts of alcohol.

Talk to your doctor if you are going to have an X-ray procedure using injectable dye and are taking ACTOplus met and ACTOplus met XR.

Do not take ACTOS, ACTOplus met, ACTOplus met XR, or duetact if you are allergic to any of their ingredients.

Warning Specific to duetact: The chance of death from serious heart or blood vessel problems may be higher when using a sulfonylurea, an ingredient in duetact.

ACTOS, ACTOplus met, ACTOplus met XR, and duetact may cause liver problems. Talk to your doctor immediately if you experience unexplained nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes as these could be symptoms of liver damage.

Women are at higher risk of having broken bones (fractures) while taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact.

There may be an increased chance of having bladder cancer when you take ACTOS, ACTOplus met, ACTOplus met XR, or duetact. You should not take these medications if you are receiving treatment for bladder cancer. Tell your doctor right away if you have blood or a red color in your urine, have an increased need to urinate, or have pain while you urinate as these may be symptoms of bladder cancer.

Hypoglycemia may occur when taking anti-diabetic medications. Lightheadedness, shakiness, dizziness, or hunger may mean that your blood sugar is too low. Talk to your doctor if low blood sugar is a problem for you.

Some patients have experienced visual changes while taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact. If you experience vision problems, consult your doctor immediately. Have your eyes checked regularly.

If you are of childbearing age, but do not have regular monthly periods, talk to your doctor before taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact, as they could increase your chance of becoming pregnant.

Precaution Specific to duetact: Taking glimepiride along with having an inherited condition where you don’t produce enough of the enzyme G6PD (G6PD deficiency) can cause hemolytic anemia, which causes red blood cells to be destroyed too quickly.

The most common side effects of these products include:

  • ACTOS: cold-like symptoms, headache, sinus infection, muscle pain, and sore throat
  • ACTOplus met and ACTOplus met XR: cold or flu-like symptoms, diarrhea, nausea, headache, urinary tract infection, dizziness, and sinus infection
  • duetact: cold or flu-like symptoms, headache, urinary tract infection, diarrhea, nausea, and limb pain

Tell your doctor about all the medicines, vitamins, and supplements you take. Some medicines can affect each other. You may need to have your doses of certain medicines changed.

It is not known if ACTOS, ACTOplus met, ACTOplus met XR, or duetact can harm an unborn or nursing baby. Talk to your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see ACTOS Complete Prescribing Information, including warning about heart failure, and Medication Guide.

Please see ACTOplus met Complete Prescribing Information, including warnings about heart failure and lactic acidosis, and Medication Guide.

Please see ACTOplus met XR Complete Prescribing Information, including warnings about heart failure and lactic acidosis, and Medication Guide.

Please see duetact Complete Prescribing Information, including warning about heart failure, and Medication Guide.

Copyright ©1999, 2011 Takeda Pharmaceuticals North America, Inc.

This site is intended for use by U.S. residents only.
ACTOS, ACTOplus met, ACTOplus met XR, and duetact are trademarks of
Takeda Pharmaceutical Company Limited registered with the U.S. Patent and
Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

Important Safety Information

Warning: Heart Failure

ACTOS, ACTOplus met, ACTOplus met XR, and duetact are not for everyone. These medications can cause or worsen heart failure. Heart failure means your heart does not pump blood well enough. Talk to your doctor immediately if you experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness. Certain patients with symptoms of heart failure should not start taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact. Do not take these medications if you have severe heart failure.

Warning: Lactic Acidosis Specific to ACTOplus met and ACTOplus met XR

Metformin, one of the medicines in ACTOplus met and ACTOplus met XR, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met and ACTOplus met XR should not be used in people with kidney disease or in people 80 years of age or older whose kidneys do not work properly. ACTOplus met and ACTOplus met XR should not be taken by people with metabolic acidosis or who drink excessive amounts of alcohol.

Talk to your doctor if you are going to have an X-ray procedure using injectable dye and are taking ACTOplus met and ACTOplus met XR.

Do not take ACTOS, ACTOplus met, ACTOplus met XR, or duetact if you are allergic to any of their ingredients.

Warning Specific to duetact: The chance of death from serious heart or blood vessel problems may be higher when using a sulfonylurea, an ingredient in duetact.

ACTOS, ACTOplus met, ACTOplus met XR, and duetact may cause liver problems. Talk to your doctor immediately if you experience unexplained nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes as these could be symptoms of liver damage.

Women are at higher risk of having broken bones (fractures) while taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact.

There may be an increased chance of having bladder cancer when you take ACTOS, ACTOplus met, ACTOplus met XR, or duetact. You should not take these medications if you are receiving treatment for bladder cancer. Tell your doctor right away if you have blood or a red color in your urine, have an increased need to urinate, or have pain while you urinate as these may be symptoms of bladder cancer.

Hypoglycemia may occur when taking anti-diabetic medications. Lightheadedness, shakiness, dizziness, or hunger may mean that your blood sugar is too low. Talk to your doctor if low blood sugar is a problem for you.

Some patients have experienced visual changes while taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact. If you experience vision problems, consult your doctor immediately. Have your eyes checked regularly.

If you are of childbearing age, but do not have regular monthly periods, talk to your doctor before taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact, as they could increase your chance of becoming pregnant.

Precaution Specific to duetact: Taking glimepiride along with having an inherited condition where you don’t produce enough of the enzyme G6PD (G6PD deficiency) can cause hemolytic anemia, which causes red blood cells to be destroyed too quickly.

The most common side effects of these products include:

  • ACTOS: cold-like symptoms, headache, sinus infection, muscle pain, and sore throat
  • ACTOplus met and ACTOplus met XR: cold or flu-like symptoms, diarrhea, nausea, headache, urinary tract infection, dizziness, and sinus infection
  • duetact: cold or flu-like symptoms, headache, urinary tract infection, diarrhea, nausea, and limb pain

Tell your doctor about all the medicines, vitamins, and supplements you take. Some medicines can affect each other. You may need to have your doses of certain medicines changed.

It is not known if ACTOS, ACTOplus met, ACTOplus met XR, or duetact can harm an unborn or nursing baby. Talk to your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see ACTOS Complete Prescribing Information, including warning about heart failure, and Medication Guide.

Please see ACTOplus met Complete Prescribing Information, including warnings about heart failure and lactic acidosis, and Medication Guide.

Please see ACTOplus met XR Complete Prescribing Information, including warnings about heart failure and lactic acidosis, and Medication Guide.

Please see duetact Complete Prescribing Information, including warning about heart failure, and Medication Guide.

Indications and Usage

ACTOS, ACTOplus met, ACTOplus met XR, and duetact are prescription medications used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. They are not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.