Tell your doctor if you have serious side effects of Actos including:

Dose is dependent on patient response and the prescribing doctor's clinical judgment; glucose tests may help determine doses.Our Actos Drug Center provides a comprehensive view of available drug information as well as related drugs, user reviews, This is not a complete list of side effects and others may occur. 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. None of the events were fatal.Patients with type 2 diabetes and NYHA class II or early class III congestive heart failure were randomized to receive 24 weeks of double-blind treatment with either ACTOS at daily doses of 30 mg to 45 mg (n=262) or Congestive heart failure events leading to hospitalization that occurred during the PROactive trial are summarized in Table 8.In the PROactive trial, 5238 patients with type 2 diabetes and a history of Although there was no statistically significant difference between ACTOS and placebo for the three-year incidence of a first event within this composite, there was no increase in mortality or in total macrovascular events with ACTOS. Most patients had peripheral edema at time of diagnosis. Ondansetron is often used as front-line therapy for management of nausea/vomiting. Available from: URL: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM532691.pdf." The majority of fractures were nonvertebral including lower limb and distal upper limb. Actos is available as tablets in strengths of 15, 30 or 45 mg. Compared to the interim 5-year results, the 10-year results found weaker associations that were not statistically significant.

and one patient discontinued ACTOS due to the elevation. O 04.

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). The incidence in men was 1.7% and no different than placebo (2.1%).The US FDA has released results of its review of pioglitazone and bladder cancer and concluded that the data suggests use of this drug may be linked to an increase risk of bladder cancer. The number of first occurrences and total individual events contributing to the primary composite endpoint is shown in Table 9.Dose-related weight gain occurs when ACTOS is used alone or in combination with other antidiabetic medications. In the 16-week add-on to insulin trial, the incidence of reported hypoglycemia was 7.9% with ACTOS 15 mg, 15.4% with ACTOS 30 mg, and 4.8% with placebo.The incidence of reported hypoglycemia was higher with ACTOS 45 mg compared to ACTOS 30 mg in both the 24-week add-on to sulfonylurea trial (15.7% vs. 13.4%) and in the 24-week add-on to insulin trial (47.8% vs. 43.5%).Three patients in these four trials were hospitalized due to hypoglycemia.
Patients who experience such increases should be assessed for fluid accumulation and volume-related events such as excessive edema and congestive heart failure [see © Actos Patient Information is supplied by Cerner Multum, Inc. and Actos Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.Copyright © 2020 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment.

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). Cerner Multum, Inc. "Australian Product Information." Call your doctor for medical advice about side effects. Other side effects include: cardiac failure, exacerbation of congestive heart failure, bone fracture, headache, and pharyngitis.

During clinical trials, there was no evidence of drug-induced hepatotoxicity.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 most common adverse events leading to withdrawal were related to inadequate glycemic control, although the incidence of these events was lower (1.5%) with ACTOS than with placebo (3.0%).In the PROactive trial, the incidence of withdrawals due to adverse events was 9.0% for patients treated with ACTOS and 7.7% for placebo-treated patients. These patients were receiving ACTOS 45 mg in combination with sulfonylurea (n=2) or ACTOS 30 mg or 45 mg in combination with insulin (n=12).During protocol-specified measurement of serum creatine phosphokinase (CPK) in ACTOS clinical trials, an isolated elevation in CPK to greater than 10 times the upper limit of the reference range was noted in nine (0.2%) patients treated with ACTOS (values of 2150 to 11400 IU/L) and in no comparator-treated patients.
26-week randomized, double-blind monotherapy and 16-to 24-week combination add-on therapy trials and in the PROactive trial.Edema induced from taking ACTOS is reversible when ACTOS is discontinued. You may report side effects to FDA at 1-800-FDA-1088.Stop using pioglitazone and call your doctor at once if you have Some people taking this medicine have had bladder cancer, but it is not clear if pioglitazone was the actual cause.This is not a complete list of side effects and others may occur.

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