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.