Prescription medicine
Pioglitazone Brand names: Actos
Pioglitazone (Actos) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $0.0675 per pioglitazone HCl 15 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the pioglitazone FDA label on DailyMed (effective March 28, 2025, Takeda Pharmaceuticals America, Inc.); the NDA 21073 record on Drugs@FDA; every pioglitazone label on DailyMed.
Highlights of the record
FDA label of March 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CONGESTIVE HEART FAILURE •.
Thiazolidinediones, including ACTOS ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ].
After initiation of ACTOS, 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 ACTOS must be considered.
ACTOS is not recommended in patients with symptomatic heart failure.
Initiation of ACTOS in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: CONGESTIVE HEART FAILURE See full prescribing information for complete boxed warning.
Thiazolidinediones, including ACTOS, cause or exacerbate congestive heart failure in some patients. ( 5.1 )
After initiation of ACTOS, 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 ACTOS must be considered. ( 5.1 )
ACTOS is not recommended in patients with symptomatic heart failure. […]
Used for
From the label: indications and usageMonotherapy and Combination Therapy ACTOS is 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) ].
Forms and strengths
- 15 mg
- 30 mg
- 45 mg
Tablet.
On the market
- Earliest approval on file
- July 15, 1999 Actos, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first August 17, 2012; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 22 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0675 per tablet Pioglitazone HCl 15 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest December 29, 2021; 2 more by firms not listed as its makers
- FAERS reports
- 44,186 through July 30, 2026
What is pioglitazone used for?
From the label: indications and usageMonotherapy and Combination Therapy ACTOS is 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 ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOS 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 Warnings and Precautions (5.3) ]. […]
Conditions named in the indications of pioglitazone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Peroxisome Proliferator Receptor alpha Agonist, Peroxisome Proliferator Receptor gamma Agonist and Thiazolidinedione.
Source: FDA drug label (Actos), Takeda Pharmaceuticals America, Inc., effective March 28, 2025 (SPL set d2ddc491-88a9-4063-9150-443b4fa4330c), via openFDA; the full label on DailyMed
What does the patient leaflet for pioglitazone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ACTOS?ACTOS can cause serious side effects, including new or worse heart failure. • ACTOS can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough • Do not take ACTOS if you have severe heart failure • If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, ACTOS may not be right for you Call your doctor right away if you have any of the following: • swelling or fluid retention, especially in the ankles or legs • shortness of breath or trouble breathing, especially when you lie down • an unusually fast increase in weight • unusual tiredness ACTOS can have other serious side effects. See "What are the possible side effects of ACTOS?" What is ACTOS? ACTOS is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is a diabetes medicine called pioglitazone that may be taken alone or with other diabetes medicines. It is not known if ACTOS is safe and effective in children under the age of 18. ACTOS is not recommended for use in children. ACTOS is not for people with type 1 diabetes. ACTOS is not for people with diabetic ketoacidosis (increased ketones in your blood or urine). Who should not take ACTOS? See "What is the most important information I should know about ACTOS?" Do not take ACTOS if you: • have severe heart failure • are allergic to any of the ingredients in ACTOS. See the end of this Medication Guide for a complete list of ingredients in ACTOS Talk to your doctor before taking ACTOS if you have either of these conditions.
From the patient leaflet: How should I store ACTOS?Store ACTOS at 68°F to 77°F (20°C to 25°C). Keep ACTOS in the original container and protect from light • Keep the ACTOS bottle tightly closed and keep tablets dry • Keep ACTOS and all medicines out of the reach of children
Source: FDA drug label (Actos), Takeda Pharmaceuticals America, Inc., effective March 28, 2025 (SPL set d2ddc491-88a9-4063-9150-443b4fa4330c), via openFDA; the full label on DailyMed
Is there a generic for pioglitazone (Actos)?
The FDA approved the first generic pioglitazone on August 17, 2012. 15 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists pioglitazone from 22 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pioglitazone (Actos)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0675 per Pioglitazone HCl 15 mg tablet, down 7% from $0.0723 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Pioglitazone HCl 15 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pioglitazone HCl 15 mg tablet | Generic | $0.0675 per tablet | $2.02 | -7% |
| Pioglitazone HCl 30 mg tablet | Generic | $0.093 per tablet | $2.79 | -1% |
| Pioglitazone HCl 45 mg tablet | Generic | $0.114 per tablet | $3.43 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pioglitazone been recalled?
The FDA's Enforcement Report lists 4 recalls naming pioglitazone since 2013: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of pioglitazone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 29, 2021 | Class II | Aurobindo Pharma USA Inc. | Superpotent and Failed Tablet/Capsule Specifications |
| September 23, 2019 | Class II | Macleods Pharma Usa Inc | Superpotent |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: PIOGLITAZONE HCL, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE MONOHYDRATE, Capsule … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: PIOGLITAZONE, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: LACTASE ENZYME, Tablet, 3000 units, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pioglitazone label say about other medicines?
The pioglitazone label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 16 other medicines name pioglitazone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Gemfibrozil | drug interactions | Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. |
| Rifampin | drug interactions | CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. |
| Topiramate | drug interactions | Topiramate may decrease pioglitazone concentrations. |
Other labels that name pioglitazone
Source: FDA drug label (Actos), Takeda Pharmaceuticals America, Inc., effective March 28, 2025 (SPL set d2ddc491-88a9-4063-9150-443b4fa4330c), via openFDA; the full label on DailyMed
What do FAERS reports show for pioglitazone?
The FDA Adverse Event Reporting System holds 44,186 reports that list pioglitazone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,418 are coded as a death and 12,322 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (3,875, against a median of 1,157 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pioglitazone?
30 other medicines are given the same way (oral) and in the same FDA class as pioglitazone or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Metformin | Type 2 diabetes | 83 labelers | $0.0145 per tablet 500 mg tablet | No current entry |
| Glipizide | Type 2 diabetes | 31 labelers | $0.0339 per tablet 5 mg tablet | No current entry |
| Glimepiride | Type 2 diabetes | 29 labelers | $0.0507 per tablet 4 mg tablet | No current entry |
| Glyburide | Type 2 diabetes | 16 labelers | $0.0643 per tablet 5 mg tablet | A presentation being discontinued |
| Dapagliflozin and metformin | Type 2 diabetes | 8 labelers | $0.720 per tablet 10-1,000 mg tablet | No current entry |
| Metformin and sitagliptin | Type 2 diabetes | 4 labelers | $1.76 per tablet 50 mg-1,000 mg tablet | No current entry |
| Sitagliptin | Type 2 diabetes | 4 labelers | $3.77 per tablet 100 mg tablet | No current entry |
| Glyburide and metformin | Type 2 diabetes | 11 labelers | $0.171 per unit 2.5-500 mg | No current entry |
Every medicine labeled for the same conditions as pioglitazone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does pioglitazone compare with medicines for the same use?
6 side-by-side pages set pioglitazone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to pioglitazone
- 30 medicines for the same use
- Other peroxisome proliferator receptor alpha agonists
- the pharmacologic class, with prices and generics
- Pioglitazone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other