This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: CONGESTIVE HEART FAILURE • Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients [see ] . • After initiation of pioglitazone, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone must be considered. • Pioglitazone is not recommended in patients with symptomatic heart failure. • Initiation of pioglitazone in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see and ] . • Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients. • After initiation of pioglitazone, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone must be considered. • Piog...
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
Pioglitazone also has a burdensome adverse effect profile, including heart failure, bladder cancer and bone fractures ( Prescrire Int n° 129, 160). Weight loss. The treatment of excess body weight usually primarily relies on changes to the patient’s physical activity and diet, along with psychological support if necessary.
Prescrire is a French independent review funded only by subscribers, with no industry money. Its annual "drugs to avoid" list (2026 edition, section: Allergy) names drugs it judges more harmful than useful in every authorised indication. Its view is one expert opinion, reached without a conflict of interest.
Monotherapy and Combination Therapy Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14) ] . Important Limitations of Use Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see ] . Pioglitazone is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. ( 14) Important Limitations of Use: • Not for treatment of type 1 diabetes or diabetic ketoacidosis. ()
• Initiation in patients with established NYHA Class III or IV heart failure [see ]. • Use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. • Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure [see Boxed Warning] . • Use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets.
• Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk. Monitor patients for signs and symptoms. • Hypoglycemia: When used with insulin or an insulin secretagogue, a lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia. • Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt pioglitazone and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart pioglitazone if liver injury is confirmed and no alternate etiology can be found. • Bladder cancer: May increase the risk of bladder cancer. Do not use in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. • Edema: Dose-related edema may occur. • Fractures: Increased incidence in female patients. Apply current standards of care for assessing and maintaining bone health. • Macular edema: Postmarketing reports. Recommend regular...
The following serious adverse reactions are discussed elsewhere in the labeling: • Congestive heart failure [see and ] • Edema [see Warnings and Precautions ] • Fractures [see Warnings and Precautions ] Most common adverse reactions (≥5%) are upper respiratory tract infection, headache, sinusitis, myalgia, and pharyngitis. To report SUSPECTED ADVERSE REACTIONS, contact Rising Health, LLC at 1-833-395-6928 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Over 8500 patients with type 2 diabetes have been treated with pioglitazone in randomized, double-blind, controlled clinical trials, including 2605 patients with type 2 diabetes and macrovascular disease treated with pioglitazone in the PROactive clinical trial. In these trials, over 6000 patients have been treated with pioglitazone for six months or longer, over 4500 patients have been treated with pioglitazone for one year or longer, and ov...
Warnings and Precautions Urinary bladder tumors () 12/2016
Source: FDA SPL label for Pioglitazone (Preferred Pharmaceuticals, Inc.), effective 20260817. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 1,892 | 1,586 | 1,230 | 1,081 | 999 | 1,037 | 975 | 469 |
769 reports blaming this drug for every million Medicare prescriptions filled, which is 0.3× the typical drug on this site. (2,475 reports in 2024–2026, against 3,218,582 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 12/2021 | Class II | Aurobindo Pharma USA Inc. | Superpotent and Failed Tablet/Capsule Specifications |
| 09/2019 | Class II | Macleods Pharma Usa Inc | Superpotent |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $57 in payments to US physicians and hospitals tied to this drug across 3 transactions (Actos $57).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Pioglitazone HCl | 3,217,957 | $13 |
| Actos | 625 | $1,041 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.