Actos Side Effects

Actos (pioglitazone) is an antidiabetic medication used to treat Type 2 diabetes. It has a number of side effects, some of which may be severe or even life-threatening. Serious side effects of Actos may include bladder cancer, bone fractures, lactic acidosis and congestive heart failure.

Quick Summary
Actos Side Effects

Most Actos side effects may be most bothersome when beginning medication or increasing the dosage amounts and some may go away with time. In other cases, side effects can be serious or life-threatening.

Common side effects of Actos may include:

  • Low blood sugar
  • Fluid retention
  • Leg, arm, back or muscle pain
  • Headache or muscle aches
  • Dizziness
  • Nose and throat irritation
  • Weight Gain
  • Diarrhea or gassiness
Actos Complications

Serious side effects are those which can be medically significant and may cause physical harm. In some cases, Actos may cause adverse events or complications which result in permanent injury or may be life-threatening.

Serious side effects of Actos may include:

  • Bladder cancer
  • Congestive heart failure
  • Lactic acidosis and kidney failure
  • Bone fractures
  • Macular edema and vision loss
  • Liver damage
  • Unexpected ovulation
  • Drug interactions

Actos Side Effects

Actos (pioglitazone) is an antidiabetic medication used to treat Type 2 diabetes. Actos is a member of the thiazolidine class of antidiabetic medication which works to treat Type 2 diabetes by increasing sensitivity to insulin and decreasing glucose storage in the liver. Because of the way that Actos works to treat diabetes, it may cause a number of side effects, some of which may be severe or even life-threatening. Serious side effects of Actos may include bladder cancer, blindness, bone fractures, lactic acidosis, kidney failure and congestive heart failure.

After its approval, the U.S. Food and Drug Administration (FDA) required more stringent warnings to be added on prescribing information and has issued a “black box warning” for both Actos and a similar medication, Avandia. Both medications have been restricted or recalled in several countries due to concerns over toxicities and serious adverse events.

Common Actos Side Effects

All medications carry a risk of some side effects. Most Actos side effects may be most bothersome when beginning medication or increasing the dosage amounts and some may go away with time. In other cases, side effects can be serious or life-threatening.

Common side effects include:

The most common side effects of Actos are mild to moderate, may be worse at higher doses or certain times of day and may go away with time.

  • Hypoglycemia
  • Edema
  • Leg, Arm, Back or Chest Pain
  • Headache
  • Muscle Aches
  • Dizziness
  • Sinusitis and Pharyngitis
  • Weight Gain
  • Flatulence or Gassiness
  • Diarrhea
  • Low Blood Sugar

If symptoms occur suddenly or become bothersome, they should be reported to a health care provider right away.

Serious Side Effects and Complications of Actos

Serious side effects are those which can be medically significant and may cause physical harm. In some cases, Actos may cause serious adverse events which result in permanent injury or may be life-threatening.

Serious side effects of Actos may include:

  • Congestive heart failure
  • Lactic acidosis and kidney failure
  • Bone fractures
  • Bladder cancer
  • Macular edema and vision loss
  • Liver damage
  • Unexpected ovulation
  • Drug interactions

Actos Congestive Heart Failure

Actos has been shown to cause or increase the risk of heart failure, particularly in those who have a pre-existing cardiac condition. The increased risk of heart failure after taking Actos may be worsened by other effects of the medication such as water retention and sudden weight gain related to edema.

When the body is unable to rid itself of excess water, a greater burden is placed on the heart and kidneys. Water may collect in the lungs and peripheral body cavity spaces. Congestive heart failure can become a medical emergency.

In June of 2007, the FDA required the manufacturer of Actos to include a black-box warning about the increased risk of heart failure worsening or development. A black-box is a severe warning printed at the top of prescribing information meant to call attention to the serious side effects that may be posed by a medication.

The black box warning on prescribing information for Actos warns practitioners that the medication may cause or worsen heart failure and that some patients with certain cardiac conditions should not take the medication.

Symptoms of heart failure may include:

  • Fluid retention (edema)
  • Sudden weight gain
  • Painful or difficulty breathing (dyspnea)
  • Extreme tiredness or lack of energy (fatigue)
  • Unusual swelling of the abdomen or legs

Over time or in severe cases, congestive heart failure may lead to heart attack. Symptoms of heart attack should be treated as a medical emergency.

Actos Lactic Acidosis

Actos may increase the chance for developing lactic acidosis. Lactic acidosis is a medical condition in which the blood pH becomes dangerously low due to a buildup of lactic acid. Though it is rare, in certain patients it may be fatal. Diabetics are at higher than normal risk for developing lactic acidosis and Actos may increase that risk.

Symptoms of lactic acidosis may include:

  • Nausea, vomiting
  • Fatigue, tiredness, loss of consciousness
  • Abdominal pain, muscle pain

Elderly patients and those with hepatic or renal impairment may be at higher risk for lactic acidosis and should be closely monitored by a physician. Symptoms of lactic acidosis may vary and may worsen over time and should be reported to a healthcare provider immediately.

Actos Bladder Cancer

Actos has been linked to an increased risk of bladder cancer. Animal studies conducted before the drug was approved for human use showed that male rats experienced a higher rate of bladder tumor formation after receiving Actos. This was confirmed in studies conducted by Takeda, manufacturer of Actos in which two studies conducted over a three-year period, showed a higher incidence of bladder cancer when compared to other drugs.

Once results of these studies became available, the FDA required Takeda to undertake a 10-year safety study examining the increased risk of bladder cancer. The five-year interim results caused the FDA to require that Takeda add warnings regarding bladder cancer risk to Actos prescribing information.

The final results of the 10-year study confirmed a connection and showed bladder cancer risk may be triple when Actos is used for more than five years. Symptoms of bladder cancer may be similar to other bladder conditions but should not be ignored. Certain lifestyle choices, medical conditions, and family history may increase the chance of developing bladder cancer.

Symptoms of bladder cancer may include:

  • Painful urination
  • Increased urge to urinate
  • Blood in the urine
  • Sudden or unusual back pain

Actos bladder cancer may have affected more than ten thousand patients, many of whom have filed lawsuits against Takeda Pharmaceuticals.

Actos Bone Fractures

Actos may increase the risk of bone fracture, particularly in women, but also in some men. Long term studies show that the risk may be up to three times higher than patients who did not take the medication. Actos-related bone fractures may occur due to bone loss caused by activation of certain receptors resulting in slowed production of bone tissue. Most fractures occur after at least one year of Actos treatment and most commonly occur in the lower legs, arms or hips

Patients who are taking the medication should have regular physical exams, including a check for bone density and other measures that show an increased risk for fractures.

Actos Macular Edema

Actos use has been linked to an increased risk of macular edema which may contribute to blindness. Macular edema is a swelling or fluid gathering in the back of the eye or retinal which may result in blurry vision. Over time, patients with macular edema may develop permanent changes in vision due to retinal damage.

Diabetics are at a higher risk of blindness than those without diabetes. Patients with diabetes should have regular eye exams to check for macular edema and retinal damage. Patients taking Actos should report the medication use to their ophthalmologist and see a physician immediately if sudden vision changes occur.

Actos Kidney Disease

Actos may also pose a particular risk to kidney health. A direct link between a worsened risk of kidney disease has not been fully established but a study, published in the medical journal PLoS One, showed that eight percent of study patients using Actos developed chronic kidney disease, even when the drug was given at low doses and used for less than one year. Other side effects of Actos including edema and heart failure can also put an additional burden on the kidney, contributing to kidney disease.

Patients with diabetes are at a higher than normal risk of kidney disease and should have their kidney function tested regularly. Patients taking Actos should report any symptoms of kidney or bladder problems such as inability to produce urine or unexpected swelling, to a physician right away.

Actos Liver Disease

Several cases of liver failure have been reported in patients receiving Actos. Reports include incidents of both non-fatal and fatal hepatic impairment in those using Actos. A direct cause has not been established but it is known that Actos can affect the liver’s metabolism of other medications which demonstrates a possible link.

Actos should only be used with caution in those who have existing mild liver impairment and is not recommended in those with more advanced liver disease. Liver symptoms such as jaundice or yellowing of the skin and whites of the eyes, dark urine, light colored feces or unusual abdominal pain should be reported to a physician.

Actos Ovulation

Actos and similar medications may cause ovulation in women who have a condition known as premenopausal anovulation. These women may be at an increased risk for becoming pregnant while taking Actos. The frequency of this side effect has not been well studied and adequate contraception in all women of child-bearing age is recommended.

Actos Drug Interactions

Actos, like many other medications can cause interactions with other drugs. These interactions can include medications that are taken over-the-counter. Drug interactions can sometimes be serious or even life-threatening.

Drugs that are known to interact with Actos include:

  • Warfarin/Coumadin (blood thinner) – may decrease blood thinning effect
  • Digoxin/Lanoxin (treats congestive heart failure and arrhythmias) – may increase toxicity of digoxin
  • Oral Contraceptives – may increase pregnancy risk
  • Fexofenadine/Allegra (antihistamine) – may increase side effects of fexofenadine and increase the risk of hypoglycemia
  • Midazolam/Versed (antianxiety) – may decrease anti-anxiety effects
  • Cimetidine/Tagamet (anti-ulcer) – may decrease the effectiveness of Actos
  • Calcium Channel Blockers (blood pressure and cardiac effects) – may increase the risk of hypertension and arrhythmia
  • Theophylline (asthma) – may increase the toxicity of theophylline, may decrease the effectiveness of Actos
  • Gemfibrozil/Lopid (cholesterol) – may increase the risk of hypoglycemia
  • Ketoconazole (anti-fungal) –may increase the risk of hypoglycemia
  • Rifampin (antiviral) – may decrease the effectiveness of Actos
  • Other anti-diabetic medications– changes in blood sugar should be closely monitored

Patients should discuss all of their medical conditions and medications that are taken with their doctor and pharmacist.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.