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Actos Side Effects

Generic Name: pioglitazone

Note: This page contains information about the side effects of pioglitazone. Some of the dosage forms included on this document may not apply to the brand name Actos.

In Summary

Common side effects of Actos include: upper respiratory tract infection, edema, and hypoglycemia. Other side effects include: cardiac failure, exacerbation of congestive heart failure, bone fracture, headache, and pharyngitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pioglitazone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by pioglitazone (the active ingredient contained in Actos). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking pioglitazone:

More common:
  • Chest pain
  • decreased urine output
  • dilated neck veins
  • extreme fatigue
  • irregular breathing
  • irregular heartbeat
  • problems with teeth
  • shortness of breath
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • trouble with breathing
  • weight gain
  • wheezing
Less common:
  • Pain or swelling in the arms or legs without an injury
  • pale skin
  • swelling
  • trouble with breathing when active
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known:
  • Dark urine
  • loss of appetite
  • nausea or vomiting
  • stomach pain
  • unexplained, rapid weight gain
  • yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with pioglitazone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Blurred vision or other changes in vision
  • cough
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • loss of consciousness
  • muscle pain or soreness
  • problems with your teeth
  • runny or stuffy nose
  • sore throat
  • stomachache
  • sweating
  • unexplained weight loss

For Healthcare Professionals

Applies to pioglitazone: oral tablet

Cardiovascular

Very common (greater than 10%): Edema
Common (1% to 10%): Congestive heart failure (including nonfatal and fatal cases), cardiac failure, chest pain[Ref]

In the PROactive trial, a study in 5238 patients with type 2 diabetes and a history of macrovascular disease who were force-uptitrated to pioglitazone 45 mg once a day or given placebo in addition to standard of care, edema occurred in 27.3% of patients treated with pioglitazone (n=2605) compared with 15.9% of placebo (n=2633) patients. Treatment-emergent adverse events leading to at least 1 hospitalized congestive heart failure event occurred in 5.7% of patients receiving pioglitazone and 4.1% of patients receiving placebo.

The primary objective of the 3-year PROactive trial was to examine the effect of pioglitazone on mortality and macrovascular morbidity in high-risk patients. No statistically significant difference between pioglitazone and placebo/standard care were observed for time to the first occurrence of their first event (all-cause mortality, nonfatal myocardial infarction (MI) including silent MI, stroke, acute coronary syndrome, cardiac intervention including coronary artery bypass grafting or percutaneous intervention, major leg amputation above the ankle, and bypass surgery or revascularization in the leg). A total of 514 patients receiving pioglitazone experienced at least 1 event compared with 572 patients receiving placebo/standard care.

Pioglitazone is associated with edema (peripheral, generalized, and pitting edema and fluid retention) when used alone or when used in combination therapy. In pioglitazone monotherapy trials, edema occurred in 2.5% (n=81), 4.7% (n=275), and 6.5% (n=169) of patients receiving 15 mg, 30 mg, and 45 mg of pioglitazone daily for 16 to 26 weeks. Pioglitazone in combination with a sulfonylurea for 16 to 24 weeks resulted in edema in 1.6% (n=184), 11.3% (n=540), and 23.1% (n=351) of patients receiving 15 mg, 30 mg, and 45 mg of pioglitazone daily, respectively. In a study in patients with NYHA class II or III heart failure the percentage of patients experiencing CHF progression during the study was 13.4% and 8.2% in patients receiving pioglitazone (n=262) and glyburide (n=256), respectively.

Postmarketing reports of congestive heart failure have been received in patients treated with pioglitazone. Reports have been received from patients both with and without a history of a known history of heart disease and both with and without concomitant insulin use.[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity and allergic reactions[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (up to 27.3%), increased weight (up to 26.2%)[Ref]

General

The most commonly reported side effects were hypoglycemia, increased weight, edema, and upper respiratory tract infection.[Ref]

Hematologic

Frequency not reported: Small reduction in mean hemoglobin and hematocrit[Ref]

Ocular

Common (1% to 10%): Visual disturbance, abnormal vision
Frequency not reported: Macular edema[Ref]

Visual disturbances have been reported early in treatment and may be related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens. Macular edema has been reported postmarketing in patients taking pioglitazone or another thiazolidinedione. Some patients presented with blurred vision or decreased visual acuity, although some were diagnosed on routine ophthalmologic examination. Most patients had peripheral edema at time of diagnosis. Some patients improved with drug discontinuation.[Ref]

Hepatic

Postmarketing reports of fatal and nonfatal hepatic failure have been received in patients treated with this drug; these reports have been insufficient to establish causality. During clinical trials, there was no evidence of drug-induced hepatotoxicity.[Ref]

Uncommon (0.1% to 1%): Increased alanine aminotransferase
Frequency not reported: Decreased mean values of bilirubin, AST, alkaline phosphatase, and GGT
Postmarketing reports: Fatal and nonfatal hepatic failure, hepatocellular dysfunction[Ref]

Other

Common (1% to 10%): Fatigue, accidental injury, peripheral edema, asthenia, malaise[Ref]

Gastrointestinal

Common (1% to 10%): Tooth disorder, tooth abscess, gastroenteritis, diarrhea, upper abdominal pain[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Musculoskeletal

Common (1% to 10%): Fractures, myalgia, pain in extremity, back pain, cramped legs, arthralgia[Ref]

In the prospective pioglitazone clinical trial in macrovascular events (PROactive), the incidence of bone fractures in female patients with this drug was 5.1% (44/870) compared to 2.5% (23/905) for placebo treated patients. The majority of fractures were nonvertebral including lower limb and distal upper limb. The incidence in men was 1.7% and no different than placebo (2.1%).[Ref]

Nervous system

Common (1% to 10%): Headache, Hypoesthesia[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 13.2%)
Common (1% to 10%): Sinusitis, pharyngitis, bronchitis, influenza[Ref]

Oncologic

The US FDA has released results of its review of pioglitazone (the active ingredient contained in Actos) and bladder cancer and concluded that the data suggests use of this drug may be linked to an increase risk of bladder cancer. A 10-year prospective cohort study in diabetic patients performed by the manufacturer (n=158,918 never users; n=34,181 ever users) identified 1075 newly diagnosed cases of bladder cancer in never users and 186 cases in ever users. The fully adjusted hazard ratio (HR) showed pioglitazone use was not associated with an increased risk (HR 1.06 (95% confidence interval 0.89 to 1.26). And while a modest trend towards higher risk with increasing duration was observed, this trend was not statistically significant. Compared to the interim 5-year results, the 10-year results found weaker associations that were not statistically significant. However, there are studies that have shown a statistically significant association between exposure to this drug and bladder cancer and an association between cumulative dose or cumulative duration of exposure and bladder cancer. Overall, this drug may be associated with an increase in the risk of urinary bladder tumors, however there is insufficient data to determine whether this drug is a tumor promoter for urinary bladder tumors.[Ref]

Uncommon (0.1% to 1%): Bladder cancer[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Actos (pioglitazone)" Takeda Pharmaceuticals America, Lincolnshire, IL.

4. US Food and Drug Administration "Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer. Available from: URL: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM532691.pdf." ([2016, Dec 12]):

Not all side effects for Actos may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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