Prescription medicine
Metformin and pioglitazone Brand names: Actoplus; first approved as Actoplus Met
Metformin and pioglitazone (Actoplus Met) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.283 per unit (Pioglitazone-metformin 15-500) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the metformin and pioglitazone FDA label on DailyMed (effective December 3, 2025, Bryant Ranch Prepack); the NDA 21842 record on Drugs@FDA; every metformin and pioglitazone label on DailyMed.
Highlights of the record
FDA label of December 3, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS FULL PRESCRIBING INFORMATION WARNING: CONGESTIVE HEART.
FAILURE and LACTIC ACIDOSIS Congestive Heart Failure
Thiazolidinediones, including pioglitazone, which is a component of pioglitazone and metformin hydrochloride, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions ( 5.1 )].
After initiation of pioglitazone and metformin hydrochloride, 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 congestive heart failure develops while taking pioglitazone and metformin hydrochloride, consider discontinuation of pioglitazone and metformin hydrochloride or dosage reduction of pioglitazone in pioglitazone and metformin hydrochloride [see Warnings and Precautions ( 5.1 )].
Pioglitazone and metformin hydrochloride is not recommended in patients with symptomatic heart failure [ see Warnings and Precautions ( 5.1 ) ].
Initiation of pioglitazone and metformin hydrochloride 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 )]. […]
Used for
From the label: indications and usagePioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use Pioglitazone and metformin hydrochloride tablets is not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis.
Forms and strengths
- 15 mg / 850 mg
- 15 mg / 500 mg
- 500 mg / 15 mg
- 850 mg / 15 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- August 29, 2005 Actoplus Met, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first February 25, 2011; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 5 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 3, 2029 Actoplus Met tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.283 per unit Pioglitazone-metformin 15-500
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2020 0 Class I among all firms' recalls; latest January 24, 2020
- FAERS reports
- 1,321 through July 30, 2026
What is metformin and pioglitazone used for?
From the label: indications and usagePioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use Pioglitazone and metformin hydrochloride tablets is not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis. Pioglitazone and metformin hydrochloride tablets are a thiazolidinedione and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate. ( 1 , 14 ) Limitations of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis.
Conditions named in the indications of metformin and pioglitazone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Biguanide, Peroxisome Proliferator Receptor alpha Agonist, Peroxisome Proliferator Receptor gamma Agonist and Thiazolidinedione.
Source: FDA drug label (Pioglitazone and metformin hydrochloride), ANDA204802 (Macleods Pharms), as published by Bryant Ranch Prepack, effective December 3, 2025 (SPL set 86ca843a-441b-488d-be1d-2576aeee19cf), via openFDA; the full label on DailyMed
What does the patient leaflet for metformin and 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 pioglitazone and metformin hydrochloride?Pioglitazone and metformin hydrochloride can cause serious side effects, including: • Heart failure. Pioglitazone, one of the medicines in pioglitazone and metformin hydrochloride tablets, 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. Before you start taking pioglitazone and metformin hydrochloride tablets: Tell your healthcare provider if you have ever had heart failure or have problems with your kidneys Call your healthcare provider right away if you have any of the following: o increasing shortness of breath or trouble breathing, especially when you lie down o an unusually fast increase in weight o swelling or fluid retention, especially in the ankles or legs o unusual tiredness These may be symptoms of heart failure • Lactic acidosis. Metformin, one of the medicines in pioglitazone and metformin hydrochloride tablets, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. […]
From the patient leaflet: How should I store pioglitazone and metformin hydrochloride tablets?Store pioglitazone and metformin hydrochloride tablets at 68°F to 77°F (20°C to 25°C). • Keep pioglitazone and metformin hydrochloride tablets in the original container and protect from light • Keep the pioglitazone and metformin hydrochloride tablets bottle tightly closed and keep tablets dry Keep pioglitazone and metformin hydrochloride tablets and all medicines out of the reach of children.
Source: FDA drug label (Pioglitazone and metformin hydrochloride), ANDA204802 (Macleods Pharms), as published by Bryant Ranch Prepack, effective December 3, 2025 (SPL set 86ca843a-441b-488d-be1d-2576aeee19cf), via openFDA; the full label on DailyMed
Is there a generic for metformin and pioglitazone (Actoplus Met)?
The FDA approved the first generic metformin and pioglitazone on February 25, 2011. 6 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists metformin and pioglitazone from 5 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.
The Orange Book lists 2 patents for Actoplus Met tablets, the last expiring on February 3, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2005 earliest approval on file
- 2011 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for metformin and pioglitazone (Actoplus Met)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.283 per unit (Pioglitazone-metformin 15-500), down 45% from $0.514 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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-metformin 15-850 (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pioglitazone-metformin 15-500 | Generic | $0.283 per unit | n/a | -45% |
| Pioglitazone-metformin 15-850 | Generic | $0.239 per unit | n/a | -14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has metformin and pioglitazone been recalled?
The FDA's Enforcement Report lists 1 recall naming metformin and pioglitazone since 2020: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 24, 2020 | Class III | Macleods Pharma Usa Inc | Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the metformin and pioglitazone label say about other medicines?
The metformin and pioglitazone label names 12 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Acetazolamide | drug interactions | Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. |
| Cimetidine | drug interactions | Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. Consider the benefits and risks of concomitant use. |
| Dichlorphenamide | drug interactions | Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. |
| Dolutegravir | drug interactions | Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. Consider the benefits and risks of concomitant use. |
| Gemfibrozil | drug interactions | Strong CYP2C8 inhibitors (e.g., gemfibrozil): Limit pioglitazone and metformin hydrochloride dose to 15 mg/850 mg daily. |
| Isoniazid | drug interactions | These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. |
| Phenytoin | drug interactions | These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. |
| Ranolazine | drug interactions | Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. Consider the benefits and risks of concomitant use. |
| Rifampin | drug interactions | CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. |
| Topiramate | boxed warning | Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart … |
| Vandetanib | drug interactions | Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. Consider the benefits and risks of concomitant use. |
| Zonisamide | drug interactions | Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. |
Source: FDA drug label (Pioglitazone and metformin hydrochloride), ANDA204802 (Macleods Pharms), as published by Bryant Ranch Prepack, effective December 3, 2025 (SPL set 86ca843a-441b-488d-be1d-2576aeee19cf), via openFDA; the full label on DailyMed
What do FAERS reports show for metformin and pioglitazone?
The FDA Adverse Event Reporting System holds 1,321 reports that list metformin and pioglitazone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 121 are coded as a death and 258 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 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 metformin and pioglitazone?
18 other medicines are given the same way (oral) and in the same FDA class as metformin and 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 |
|---|---|---|---|---|
| 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 |
| Sitagliptin | Type 2 diabetes | 4 labelers | $3.77 per tablet 100 mg tablet | No current entry |
| Repaglinide | Type 2 diabetes | 7 labelers | $0.0987 per tablet 1 mg tablet | No current entry |
| Nateglinide | Type 2 diabetes | 9 labelers | $0.179 per tablet 60 mg tablet | No current entry |
| Acarbose | Type 2 diabetes | 6 labelers | $0.274 per tablet 100 mg tablet | No current entry |
| Alogliptin | Type 2 diabetes | none listed | $4.96 per tablet 12.5 mg tablet | No current entry |
Every medicine labeled for the same conditions as metformin and pioglitazone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to metformin and pioglitazone
- 18 medicines for the same use
- Other biguanides
- the pharmacologic class, with prices and generics
- Metformin and pioglitazone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other