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Precautions and Warnings With Pioglitazone

Prior to starting any medication, it is important to become familiar with the drug's precautions and warnings. With pioglitazone, there are a number of possible side effects that may develop during the treatment process, including: fluid retention, low blood sugar, unexplained weight gain, macular edema, and increased liver enzymes. Before taking pioglitazone, let your healthcare provider know if you have heart or liver problems, are pregnant, or are currently breastfeeding.

Pioglitazone: What Should I Tell My Healthcare Provider?

Prior to taking pioglitazone hydrochloride (Actos®), you should talk with your healthcare provider if you have:
  • Heart problems of any kind, especially congestive heart failure (CHF)
  • Liver problems, including liver failure or cirrhosis
  • An upcoming surgery
  • Any allergies, including allergies to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Having problems getting pregnant
  • Breastfeeding
  • Premenopausal without regular menstrual periods.
Also, tell your healthcare provider about all other medicines you may be taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Some Pioglitazone Precautions and Warnings

Patients taking this drug should be aware of the following precautions and warnings:
  • Studies suggest that pioglitazone may increase the risk of bladder cancer, particularly in people who have taken the medication for one year or longer. You should not take pioglitazone if you have bladder cancer. Additionally, pioglitazone should be used very cautiously in people who have had bladder cancer in the past.


  • Pioglitazone can cause fluid retention (gaining of water weight, 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 insulin.
If you notice any of the following symptoms, contact your healthcare provider: unexplained weight gain (three to five pounds in a week); swelling of the ankles, feet, or legs; cough; and shortness of breath (see Symptoms of Congestive Heart Failure for more signs and symptoms).
  • Pioglitazone 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 (see Actos and Type 1 Diabetes).
  • Taking pioglitazone with other medications for diabetes can increase your risk of low blood sugar (hypoglycemia) (see Actos and Blood Sugar).
  • There have been reports of pioglitazone causing macular edema (a condition of the eye). Tell your healthcare provider if you have any vision changes.
  • Pioglitazone can cause weight gain. In studies, people taking pioglitazone gained about 2 to 12 pounds on average (see Actos and Weight Gain). Talk to your healthcare provider about rapid weight gain, 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 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 pioglitazone.
  • Pioglitazone may cause increased liver enzymes. Very rarely, this has led to liver damage. It is recommended that liver enzymes be checked in all people before starting pioglitazone and should be checked again periodically. Liver enzymes are checked using a blood test. Pioglitazone should not be started in people with high liver enzymes. Pioglitazone should be stopped if liver enzymes increase and continue to stay high, as this may be a sign of liver damage.


  • There is some preliminary data that suggests pioglitazone may be linked to bladder cancer. The United States Food and Drug Administration (FDA) has launched an ongoing safety review to evaluate whether the drug is associated with an increased risk of bladder cancer. At this time, the FDA has not found a clear connection between the two. 
Current recommendations suggest that you should continue your treatment, unless instructed otherwise by your healthcare provider, and to discuss any concerns you may have with your healthcare provider.
  • Pioglitazone can interact with certain medications (see Drug Interactions With Pioglitazone).
  • Pioglitazone is considered a pregnancy Category C medication. This means that pioglitazone may not be safe to use during pregnancy. Talk to your healthcare provider about the risks or benefits of using pioglitazone during pregnancy (see Actos and Pregnancy for more information).
  • It is not known if pioglitazone passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about this.
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Pioglitazone HCl

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