Generic Name: pioglitazone (PYE-oh-GLI-ta-zone)
Brand Name: Actos
Treating type 2 diabetes in certain patients. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.
Actos is a thiazolidinedione antidiabetic. It works by lowering blood sugar by making the cells of the body more sensitive to the action of insulin.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Actos. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Actos. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Actos may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Actos as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Actos.
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Cold-like symptoms; headache; muscle aches; sinus pain; sore throat; weight gain.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; swelling of the hands, ankles, or feet; symptoms of heart failure (eg, shortness of breath; sudden, unexplained weight gain); symptoms of liver problems (eg, dark urine; stomach pain; unexplained nausea, vomiting, or loss of appetite; yellowing of the skin or eyes); symptoms of low blood sugar (eg, anxiety; chills, increased hunger, headache; increased dizziness or drowsiness; tremors); unusual bone pain; unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Actos:
Store Actos between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Actos out of the reach of children and away from pets.
This information should not be used to decide whether or not to take Actos or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Actos. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Actos. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Actos.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
Note: This page contains information about the side effects of pioglitazone. Some of the dosage forms included on this document may not apply to the brand name Actos.
Not all side effects for Actos may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
Applies to pioglitazone: oral tablet
In addition to its needed effects, some unwanted effects may be caused by pioglitazone (the active ingredient contained in Actos). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking pioglitazone:More common
Some of the side effects that can occur with pioglitazone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
Applies to pioglitazone: oral tablet
Common (1% to 10%): Congestive heart failure (including nonfatal and fatal cases), cardiac failure, chest pain[Ref]
Frequency not reported: Hypersensitivity and allergic reactions[Ref]
Very common (10% or more): Hypoglycemia (up to 27.3%), increased weight (up to 26.2%)[Ref]
The most commonly reported side effects were hypoglycemia, increased weight, edema, and upper respiratory tract infection.[Ref]
Frequency not reported: Small reduction in mean hemoglobin and hematocrit[Ref]
Common (1% to 10%): Visual disturbance, abnormal vision
Frequency not reported: Macular edema[Ref]
Uncommon (0.1% to 1%): Increased alanine aminotransferase
Frequency not reported: Decreased mean values of bilirubin, AST, alkaline phosphatase, and GGT
Postmarketing reports: Hepatocellular dysfunction[Ref]
Very common (10% or more): Edema (up to 26.7%)
Common (1% to 10%): Fatigue, accidental injury, peripheral edema, asthenia, malaise[Ref]
Common (1% to 10%): Tooth disorder, tooth abscess, gastroenteritis, diarrhea, upper abdominal pain[Ref]
Uncommon (0.1% to 1%): Bladder cancer, urinary tract infection[Ref]
Common (1% to 10%): Fractures, myalgia, pain in extremity, back pain, cramped legs, arthralgia[Ref]
Common (1% to 10%): Headache, Hypoesthesia[Ref]
Uncommon (0.1% to 1%): Insomnia[Ref]
Very common (10% or more): Upper respiratory tract infection (up to 13.2%)
Common (1% to 10%): Sinusitis, pharyngitis, bronchitis, influenza[Ref]
Uncommon (0.1% to 1%): Bladder cancer[Ref]
This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Comments: Premenopausal anovulatory women may be at risk for pregnancy; these women should be informed of pregnancy risk. AU TGA pregnancy category: B3 US FDA pregnancy category: C
Animal studies have shown increased rates of post-implantation loss, delayed development, reduced fetal weights, and delayed parturition. There are no adequate and well-controlled studies in pregnant women. Additionally, abnormal blood glucose concentrations during pregnancy are associated with a higher incidence of congenital anomalies, increased neonatal morbidity, and mortality. Use of insulin in diabetics during pregnancy is recommended because it maintains blood glucose concentrations close to normal levels. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.