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Precautions and Warnings With Pioglitazone and Glimepiride

Specific Precautions and Warnings With Pioglitazone and Glimepiride

Warnings and precautions with pioglitazone and glimepiride to be aware of prior to taking it include the following:
  • Studies suggest that pioglitazone (one of the active ingredients in this medication) may increase the risk of bladder cancer, particularly in people who have taken the medication for one year or longer. You should not take this medication if you have bladder cancer. Additionally, this medication should be used very cautiously in people who have had bladder cancer in the past.


  • Oral diabetes drugs (including pioglitazone and glimepiride) may increase the risk of death due to heart or blood vessel problems when compared to diabetes treatment with diet or insulin. This warning is based on one research study that looked at a diabetes medication similar to pioglitazone and glimepiride. However, it is unclear at this time how important this risk may be in people taking pioglitazone and glimepiride.
  • Pioglitazone and glimepiride can cause fluid retention (known medically as edema). For most people, this is not dangerous. However, fluid retention can be serious in people with congestive heart failure (CHF). It is possible for fluid retention to lead to heart failure even in people who have no history of heart failure or any other heart disease. There may be an increased risk of edema or heart failure for people taking both pioglitazone and glimepiride and insulin. Contact your healthcare provider if you notice:
    • Unexplained weight gain (three to five pounds or more in a week)
    • Swelling of the ankles, feet, or legs
    • Cough
    • Shortness of breath.
(Click Symptoms of Congestive Heart Failure for more information.)
  • If you are allergic to sulfonamides ("sulfa" medications), you may also be allergic to pioglitazone and glimepiride. Not everyone who has a sulfa allergy, however, will be allergic to the combination medicine. To be safe, let your healthcare provider know if you have a sulfa allergy.
  • Pioglitazone and glimepiride can cause low blood sugar (hypoglycemia) in some people. This has been more common in elderly people and in people with adrenal, pituitary, liver, or kidney problems. It is also more likely to occur during fasting before surgery and after prolonged exercise. Symptoms of low blood sugar include irritability, trembling, cold sweats, or blurry vision, among other things (see Duetact and Blood Sugar).
  • Pioglitazone and glimepiride cannot be used to treat type 1 diabetes or diabetic ketoacidosis (a life-threatening condition that may occur with uncontrolled diabetes). These conditions need to be treated with insulin.
  • There have been reports of pioglitazone and glimepiride causing macular edema (a condition of the eye). Tell your healthcare provider if you have any vision changes while taking the drug.
  • Pioglitazone and glimepiride can cause weight gain. In studies, people taking pioglitazone and glimepiride gained about four to seven pounds, on average, over 28 weeks (see Duetact and Weight Gain). Talk to your healthcare provider about rapid weight gain, however, as this may be a sign of fluid retention.
  • If you are a premenopausal woman who has infertility problems due to lack of ovulation, pioglitazone and glimepiride may increase your for chance of ovulation (and pregnancy). Talk to your healthcare provider about birth control options if you would like to avoid pregnancy while taking the drug.
  • Pioglitazone and glimepiride may cause increased liver enzymes. In rare cases, this has lead to liver damage. It is recommended that liver enzymes be checked in all people before starting pioglitazone and glimepiride and then checked again periodically. Liver enzymes are checked using a simple blood test. Pioglitazone and glimepiride should not be started in people with high liver enzymes. In addition, the drug should be stopped if liver enzymes increase and continue to stay high, as this may be a sign of liver damage.
  • Pioglitazone and glimepiride can interact with certain medications (see Drug Interactions With Pioglitazone and Glimepiride).
  • Pioglitazone and glimepiride is considered a pregnancy Category C medication. This means that it may not be safe to use during pregnancy. Talk to your healthcare provider about the risks and benefits of using pioglitazone and glimepiride during pregnancy (see Duetact and Pregnancy).
  • It is not known if pioglitazone and glimepiride passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, discuss this with your healthcare provider.
  • Sulfonylurea medicines, such as glimepiride (one of the components of pioglitazone and glimepiride), have been reported to increase a person's sensitivity to the sun. Therefore, when going outdoors, try wearing long sleeves, pants, and a hat. Any exposed skin should be covered with a sunscreen that is at least SPF 15.


  • Sulfonylurea medicines such as glimepiride, have been reported to cause hemolytic anemia in people with a genetic condition known as glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency). This medication may not be a good choice for people with this condition. 


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Pioglitazone and Glimepiride Info

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