Did you know this version of Internet Explorer is out of date?

To get the latest experience from our website, please upgrade your browser.

Have a drug or medical device concern?

call 888-646-1884

Actos Side Effects

Data from clinical trials along with post-market surveillance are reviewed for any adverse events or side effects to determine the overall safety of a drug such as Actos.  These events can happen when the drug is first administered, during therapy, and/or when use of the drug has stopped.

Jump To Topic

The side effects may also depend on the type of patient (age, weight, sex, ethnicity, etc.) and can range in severity from very minor to more severe or major events that can be life-threatening and require immediate medical attention.

General Side Effects From Diabetes Drugs

Common side effects from insulin, for example, include: low blood sugar levels, mild skin irritations and weight gain. Oral medications, such as Amaryl, Glucotrol, Diabeta, Glynase Prestab, and Micronase can cause stomach problems. 1

Serious side effects have been linked to Actos, which can exacerbate congestive heart failure, increase one’s risk for bladder cancer, or increase the risk of bone fractures in women. If you take or have taken Actos, talk with your doctor about your risks.

Contact your doctor immediately should you experience any of the following symptoms:

  • Rapid weight gain
  • Weakness and fatigue
  • Irregular heart beat
  • Swelling of belly, ankles or feet
  • Loss of appetite or nausea
  • Shortness of breath when you exercise or lie down 2

Common side effects of Actos include:

  • Swelling or fluid retention (edema), especially in the ankles or legs
  • Symptoms of congestive heart failure such as shortness of breath or trouble breathing, especially when you lie down, and unusual fatigue
  • Any rapid weight gain
  • Cold-like symptoms (respiratory tract infection)
  • Headache
  • Sinus infection
  • Muscle pain
  • Sore throat
  • Low blood sugar

A 2013 systematic review of six studies involving patients using pioglitazone showed that patients treated with pioglitazone have an increased risk of bladder cancer compared to the general population. 3

The current label highlights have a warning against using drugs containing pioglitazone in patients with bladder cancer and state to use them with caution in patients with a history of bladder cancer.

Actos and Bladder Cancer

The ACTOS Medication Guide states: “There may be an increased chance of having bladder cancer when you take ACTOS.” 4 Similarly, the current pioglitazone-containing medication label highlights, as first approved by the FDA in 2011, state“[p]reclinical and clinical trial data, and results from an observational study suggest an increased risk of bladder cancer in pioglitazone users,” and “observational data further suggest that the risk increases with duration of use.” 

The current label highlights have a warning against using drugs containing pioglitazone in patients with bladder cancer and state to use them with caution in patients with a history of bladder cancer. 5

Actos Alternatives and Other Diabetes Drugs

The good news is that a variety of diabetic medications are on the diabetic drugs list to treat diabetes. Some diabetics, primarily Type 1, need to take insulin injections. Other diabetics, primarily Type 2, can require pills, non-insulin injections or both.

A variety of oral and non-insulin injectable diabetes drugs are also available. Some of these medications increase the amount of insulin produced by the body, while others help the body utilize insulin. Still others block or inhibit the release of sugar into the bloodstream. 6 Doctors sometimes use combinations of oral and injectable drugs to treat diabetes.

The diabetes drugs list includes standard oral medications such as Metformin, also called Glucophage, and Glipizide, sometimes called Glucotrol. Recently the Food and Drug Administration (FDA) has approved other diabetes drugs such as Januvia and Onglyza (oral), Byetta and Victoza (injectable), all of which warn of serious adverse events, such as pancreatitis, in their labels.

  1. Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Understanding Your Options. (2011, June 30). http://www.effectivehealthcare.ahrq.gov/repFiles/OralHypo_Clin_07.02.08.pdf/. Accessed February 8, 2015. 

  2. Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Understanding Your Options. (2011, June 30). http://www.effectivehealthcare.ahrq.gov/repFiles/OralHypo_Clin_07.02.08.pdf. Accessed February 8, 2015. 

  3. Ferwana M1, Firwana B, Hasan R, Al-Mallah MH, Kim S, Montori VM, Murad MH. Pioglitazone and risk of bladder cancer: a meta-analysis of controlled studies. Diabet Med. 2013 Sep;30(9):1026-32. 

  4. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183833.pdf  

  5. http://www.fda.gov/Drugs/DrugSafety/ucm266555.htm  

  6. Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Understanding Your Options. (2011, June 30). http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=423. Accessed February 8, 2015.