What to Know About Actos (Pioglitazone)

This oral medication is used to treat type 2 diabetes

Close up of blood sugar measurement devices and pills

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Actos (pioglitazone) is an oral medication prescribed for people with type 2 diabetes to help control blood glucose (sugar) levels. It belongs to a class of drugs known as thiazolidinediones (TZDs). Actos works by making muscle and fat cells more sensitive to insulin, a hormone produced by the pancreas that controls the levels of sugar in the blood. Actos also cuts down on the amount of glucose the liver produces.

Actos usually is not prescribed on its own as a first-line treatment for type 2 diabetes. Most often, it's prescribed in combination with another medication such as metformin or sulfonylurea and insulin. The active ingredient is also found in a number of combination drugs, including Oseni (alogliptin, pioglitazone), Actoplus Met (metformin, pioglitazone), and Duetact (glimepiride, pioglitazone).

Uses

For managing type 2 diabetes, Actos is strictly used as part of a comprehensive treatment plan that includes diet, exercise, and other medications (such as insulin or a first-line diabetes drug).

Because it acts on the body's ability to use insulin, Actos is not used to treat type 1 diabetes or diabetic ketoacidosis.

Off-Label Uses

Actos may be used off-label to treat high cholesterol. Actos is also sometimes prescribed to improve fertility in women with polycystic ovary syndrome (PCOS). When used with metformin, Actos has been shown to normalize menstrual cycles in 50% of women with PCOS within six months.

Before Taking

If you're prescribed Actos as part of your type 2 diabetes management plan, it is because other treatment measures haven't been enough to control your blood sugar. The goal of adding Actos is to help you hit the target blood glucose level.

Your healthcare provider may want to perform a liver function test before you begin taking Actos. If you have abnormal liver enzymes, treatment may be delayed until your liver condition is treated, or your practitioner may monitor your condition to ensure the liver remains unharmed while taking Actos.

Precautions and Contraindications

Actos may not be safe for people with certain health problems. Make sure your healthcare provider knows your complete medical history before starting treatment.

Your healthcare provider may need to monitor your condition, or they may decide not to prescribe Actos if you have or have had any of the following:

  • Bladder cancer
  • Diabetic eye disease
  • Kidney disease
  • Liver disease

The same may apply if you are in your childbearing years. Actos can increase the risk of pregnancy even if you don't have regular monthly periods.

Actos should be used with caution during pregnancy, as no well-controlled studies have been conducted in humans. In some people, benefits of treatment may still outweigh the risks.

Women who take Actos are at an increased risk of bone fractures. According to a 2016 study in the Journal of Clinical Endocrinology & Metabolism, women who take Actos for five years have a 53% risk of fractures, mainly of the hands, upper arms, or feet.

Dosage

Actos is available as a tablet in three different strengths: 15 milligrams (mg), 30 mg, and 45 mg. When you first start Actos, you should begin with one of the lower doses—15 mg or 30 mg—once daily. If you respond well to this initial dose, you can increase incrementally up to 45 mg once daily, per your healthcare provider's instructions.

It can take up to two weeks for your blood sugar to decrease, and you may not feel any significant effects for two to three months.

Actos should be used with caution in people with mild heart failure and only if the benefits outweigh the risk. In people with moderate to severe heart failure, Actos should be avoided without exception.

All listed dosages are according to the drug manufacturer. Check your prescription and talk to your healthcare provider to make sure you are taking the right dose for you.

How to Take and Store

You can take Actos at any time of day, but it is recommended that you take it around the same time each day.

If you forget to take your Actos dose, go ahead and take it regardless of the time of day. If you don't remember until the following day, skip the missed dose and take the next one as scheduled. In other words, don't double up doses to make up for missing yesterday's dose.

Actos should be stored in a cool place away from light and moisture. Keep it in its original light-resistant container and make sure it's out of the reach of children or pets.

If you take more Actos than you should at one time, call the Poison Control Helpline at 800-222-1222.

Side Effects

As with most medications, Actos can cause side effects. Some are mild and easy to deal with. Others are severe and can lead to permanent health problems.

Common

Common side effects of Actos include:

  • Headache
  • Upper respiratory tract infection
  • Sinusitis
  • Myalgia (muscle aches)
  • Pharyngitis (sore throat)
  • Flatulence (gas)

Severe

There are a few more serious adverse side effects associated with Actos. Let your healthcare provider know if you experience any of the following while taking Actos:

  • Changes in or loss of vision
  • Frequent, painful, or difficult urination
  • Cloudy, discolored, or bloody urine
  • Back or stomach pain

Some people who take Actos develop liver problems. Stop taking the drug right away and call your healthcare provider if you experience:

  • Nausea or vomiting
  • Appetite loss
  • Pain in the upper right area of your stomach
  • Flu-like symptoms
  • Dark urine
  • Jaundice (yellowing of the skin or eyes)
  • Unusual bleeding or bruising
  • Fatigue

Warnings and Interactions

In 2007, the U.S. Food and Drug Administration (FDA) issued a black box warning advising healthcare providers and consumers that Actos may cause heart failure in certain people. The advisement went on to describe who can and cannot take Actos based on four classifications of heart failure outlined by the New York Heart Association (NYHA).

People who have NYHA Class I or Class II heart failure (in which symptoms are mild to nonexistent and do not impair physical ability) may take Actos. The drug is contraindicated for people with Class III or Class IV heart failure (in which physical activity is limited).

To avoid serious treatment-related complications, call your healthcare provider immediately if you have any of the following symptoms while taking Actos:

  • Excessive weight gain in a short period of time
  • Dyspnea (shortness of breath)
  • Waking up short of breath during the night
  • Edema (swelling of the arms, hands, feet, ankles, or lower legs)
  • Swelling or pain in the stomach
  • Needing to use extra pillows in order to breathe while lying down
  • Frequent dry cough or wheezing
  • Difficulty thinking clearly; confusion
  • Fast or racing heart
  • Lowered ability to walk or exercise
  • Increased fatigue

Let your healthcare provider know if you were born with a heart defect, or if you have or ever have had edema, heart disease, high blood pressure, coronary artery disease, heart attack, irregular heartbeat, or sleep apnea.

If Taking Actos and Metformin

May 28, 2020: The Food and Drug Administration (FDA) has requested that manufacturers of certain lots of metformin voluntarily withdraw the product from the market after the agency identified unacceptable levels of N-Nitrosodimethylamine (NDMA) in them. People should continue taking their medications as prescribed until their health professional prescribes an alternative treatment, if applicable. Stopping metformin without a replacement can pose serious health risks to patients with type 2 diabetes.

Interactions

Actos can interact with certain medications, including insulin or oral diabetes medications, Nizoral (ketoconazole), midazolam, Procardia (nifedipine), Rifadin (rifampin), and Elixophyllin (theophylline).

Interactions can often be avoided by separating drug doses by several hours. In other cases, a drug may need to be substituted or a dose adjusted.

Alcohol may cause a decrease in blood sugar. If you drink, ask your healthcare provider if there's a safe level you can consume while taking Actos.

10 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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  5. U.S. Food and Drug Administration. Actos (pioglitazone hydrochloride) tablets.

  6. Sharma DC, Asirvatham A, Singh P. Dose modification of antidiabetic agents in patients with type 2 diabetes mellitus and heart failure. Indian J Endocrinol Metab. 2017;21(4):618-29. doi:10.4103/ijem.IJEM_442_16

  7. Desouza CV, Shivaswamy V. Pioglitazone in the treatment of type 2 diabetes: Safety and efficacy reviewClin Med Insights Endocrinol Diabetes. 2010;3:43‐51. doi:10.4137/cmed.s5372

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By Heather M. Ross
Heather M. Ross, PhD, DNP, FAANP is a nurse practitioner and PhD in Human and Social Dimensions of Science and Technology.