Indications and Usage
ACTOS is a prescription medication used with diet and exercise to improve blood sugar
(glucose) control in adults with type 2 diabetes.
ACTOplus met is a prescription medication used with diet and exercise to improve blood
sugar (glucose) control in adults with type 2 diabetes.
Duetact is a prescription medication used with diet and exercise to improve blood sugar
(glucose) control in adults with type 2 diabetes.
ACTOS, ACTOplus met, and duetact are not for patients with type 1 “juvenile” diabetes
or diabetic ketoacidosis.
ACTOS, ACTOplus met, and duetact have not been studied in children and are not
recommended for children under the age of 18.
Important Safety Information
ACTOS, ACTOplus met, and duetact are not for everyone. Certain patients with
heart failure should not start taking ACTOS, ACTOplus met, or duetact. ACTOS,
ACTOplus met, and duetact can cause new, or worsen, heart failure. Talk to your
doctor immediately if you experience unusually fast weight gain, fluid retention
(swelling), shortness of breath, unusual tiredness, or slow heartbeat.
Warnings Specific to ACTOplus met
Metformin, one of the medicines in ACTOplus met, 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 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 should not be taken by people with metabolic acidosis.
ACTOplus met should not be taken by people 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.
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.
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 your red blood cells to be destroyed too quickly.
Do not take ACTOS, ACTOplus met, or duetact if you have active liver disease. Your
doctor should perform a blood test to check for liver problems before you start ACTOS,
ACTOplus met, or duetact and periodically thereafter. Talk to your doctor immediately if
you experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark
urine, or yellowing of the skin or eyes.
If you are of childbearing age, talk to your doctor before taking ACTOS, ACTOplus met,
or duetact, as this could increase your chance of becoming pregnant. Talk to your doctor
if you are pregnant, planning to become pregnant, breastfeeding, or planning to
breastfeed.
Some people taking ACTOS, ACTOplus met, or duetact may experience flulike
symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain.
ACTOS may cause low blood sugar when taken in combination with insulin or
sulfonylureas. 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.
Patients with diabetes should have regular eye exams. If you experience vision problems,
consult your doctor immediately. Some patients have experienced visual changes while
taking ACTOS, ACTOplus met, or duetact.
Some people, particularly women, are at higher risk of having bone fractures while taking
pioglitazone.
Other side effects of ACTOS may include cold-like symptoms, headache, sinus infection,
muscle pain, tooth disorder, and sore throat.
Other side effects of ACTOplus met may include cold-like symptoms, diarrhea, nausea,
headache, urinary tract infection, dizziness, sinus infection, and anemia.
Other side effects of duetact may include cold-like symptoms, headache, urinary tract
infection, diarrhea, nausea, and limb pain.
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 boxed warning and Medication Guide.
Please see ACTOplus met Complete Prescribing Information, including boxed warnings and Medication Guide.
Please see duetact Complete Prescribing Information, including boxed warning and Medication Guide.