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. It can be mild or severe, temporary or permanent, but does not occur in everyone. The following side effects have been reported by at least 1% 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.
- cold-like symptoms (respiratory tract infection)
- cough
- headache
- muscle aches and pain
- problems with teeth
- 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 taking 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 take this medication.
FDA ADVISORY
June 15, 2011
The FDA has issued a safety alert concerning the use of pioglitazone. To read the full FDA Advisory, visit the FDA's web site at www.fda.gov.
A previous safety alert on pioglitazone was issued on September 17, 2010. To read the full FDA Advisory, visit the FDA's website at www.fda.gov.
Bladder: 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 urgent need to urinate, pain while urinating, or pain in the back or lower abdomen, talk to your doctor right away.
Blood: This medication may decrease the number of red blood cells in your body. This is more likely to occur during the first few months of therapy or after an increase in dose with this medication. Your doctor may run some tests to monitor your red blood cell levels.
Fractures: Women taking pioglitazone may be at greater risk of experiencing bone fractures. Fractures most commonly involve the hand or leg. Women should discuss the risk and benefits of taking this medication with their doctor.
General: Stay on your diet and exercise programs and test your blood sugar regularly while taking pioglitazone.
Heart failure: Pioglitazone can cause fluid buildup in the body, which may lead to congestive heart failure. This medication should not be used by anyone who has severe heart failure (see the 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.
Low blood sugar (hypoglycemia): 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.
Ovulation: Some women taking 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 risk for pregnancy while taking pioglitazone. Adequate contraception (birth control) is recommended if you are premenopausal.
Stress: If your body is under stress from things such as a fever, infection, accident, or surgery the dose of your diabetes medications may need to be changed. Call your doctor right away.
Vision: Pioglitazone may cause swelling of the retina in the eye. If you experience any vision changes while taking pioglitazone, contact your doctor immediately.
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 or this medication.
Children: The safety and effectiveness of this medication have not been established for children.
What other drugs could interact with this medication?
There may be an interaction between pioglitazone and any of the following:
- atorvastatin
- birth control pills
- digoxin
- fexofenadine
- gemfibrozil
- glipizide
- ketoconazole
- metformin
- midazolam
- nifedipine
- ranitidine
- rifampin
- theophylline
- warfarin
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.