By Takeda Pharmaceutical

What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses and cannot be anticipated. It can be mild or severe, temporary or permanent, but does not occur in everyone. Not everyone will experience side effects, and which side effects a person experiences cannot be anticipated. The following side effects have been reported by at least 5% of people taking this medication. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

  • cough
  • gas
  • headache
  • muscle aches and pain
  • problems with teeth
  • respiratory infection
  • runny or stuffy nose
  • sinus infection
  • sore throat
  • swelling of feet or lower legs
  • weight gain
Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.


August 14, 2007

The FDA has issued new safety warnings concerning the use of Actos® (pioglitazone). To read the full FDA Advisory, visit the FDA's web site at

Bladder cancer: Taking pioglitazone for more than 1 year may be associated with an increased risk of bladder cancer. Do not take pioglitazone if you have bladder cancer. If you experience symptoms such as blood or red color in urine, an increased need to urinate or pain while urinating, talk to your doctor immediately.

Bone fractures: This medication may increase the risk of bone fractures. If you experience bone pain or a bone fracture while taking this medication, contact your doctor. Your doctor may do tests to monitor the effect of pioglitazone on your bones.

Heart failure: Pioglitazone can cause fluid buildup in the body, which may lead to congestive heart failure or make existing congestive heart failure worse. This medication should not be used by anyone who has severe heart failure (see section, "Who should not take this medication?"). Due to the risk of worsening heart failure, pioglitazone is not recommended for people with heart failure symptoms. Your doctor will monitor you for heart failure symptoms while you are taking this medication. If you develop fluid buildup or swelling, shortness of breath, fatigue, or excessive weight gain while taking this medication, contact your doctor immediately.

Liver: Although liver problems have not been observed with pioglitazone, another similar medication has caused liver problems in a small number of people. People taking this medication should report any signs of liver problems (abdominal or stomach pain, dark urine, loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellow eyes or skin) to their doctor at once. Your doctor may monitor regular liver tests while you are taking this medication.

Low blood sugar (hypoglycemia): This medication can cause low blood sugar. Know how to recognize and treat low blood sugar. Symptoms of hypoglycemia include hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure, fainting, or coma. Remember to always keep a source of sugar available in case you have hypoglycemia.

Macular edema: There have been some reports of macular edema (swelling of the retina in the eye) with use of this medication. If you have diabetes you should have regular eye exams by an ophthalmologist. If you notice any visual changes, contact your doctor immediately.

Ovulation: Some women using pioglitazone may start having menstrual periods, even after not having a period due to a medical condition. As a result, you may be at increased risks for pregnancy while taking pioglitazone. Adequate contraception is recommended if you are premenopausal.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if pioglitazone passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children. Pioglitazone is not recommended for use in children, based on side effects observed in adults.

What other drugs could interact with this medication?

An interaction between medications does not always mean that you must stop taking one of them. The following medications may affect the way pioglitazone works, be affected by pioglitazone, or increase the risk of side effects:

  • atorvastatin
  • gemfibrozil
  • ketoconazole
  • midazolam
  • nifedipine
  • rifampin

If you are taking any of these or other medications (including non-prescription, herbal, and supplement products), speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want to change your therapy or may suggest ways of managing any interactions. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your doctor know if you use them. Medications other than those listed above may also interact with this medication.

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The contents of this health site are for informational purposes only. Always seek the advice of your physician or other qualified healthcare provider regarding any questions you may have about a medical condition.

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