Prescription medicine
Glimepiride and pioglitazone Brand names: Duetact
Glimepiride and pioglitazone (Duetact) is a prescription medicine with an FDA approval on record since 2006. No generic is listed; pharmacies paid $10.52 per unit (Pioglitazone-glimepiride 30-4) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the glimepiride and pioglitazone FDA label on DailyMed (effective March 27, 2025, Takeda Pharmaceuticals America, Inc.); the NDA 21925 record on Drugs@FDA; every glimepiride and pioglitazone label on DailyMed.
Highlights of the record
FDA label of March 27, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CONGESTIVE HEART FAILURE •.
Thiazolidinediones, including pioglitazone, which is a component of DUETACT ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions ( 5.1 )].
After initiation of DUETACT 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 DUETACT must be considered [see Warnings and Precautions ( 5.1 )].
DUETACT is not recommended in patients with symptomatic heart failure [see Warnings and Precautions ( 5.1 )].
Initiation of DUETACT 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 pioglitazone, which is a component of DUETACT, cause or exacerbate congestive heart failure in some patients. ( 5.1 )
After initiation of DUETACT, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). […]
Used for
From the label: indications and usageDUETACT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies ( 14 )].
Forms and strengths
- 30 mg / 4 mg
- 30 mg / 2 mg
Tablet.
On the market
- Earliest approval on file
- July 28, 2006 Duetact, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first January 4, 2013; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 8, 2028 Duetact tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $10.52 per unit Pioglitazone-glimepiride 30-4
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2017 0 Class I among all firms' recalls; latest February 10, 2017
- FAERS reports
- 93 through July 30, 2026
What is glimepiride and pioglitazone used for?
From the label: indications and usageDUETACT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies ( 14 )]. Important Limitations of Use Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. DUETACT 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 ( 5.5 )]. […]
Conditions named in the indications of glimepiride and pioglitazone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Peroxisome Proliferator Receptor alpha Agonist, Peroxisome Proliferator Receptor gamma Agonist, Sulfonylurea and Thiazolidinedione.
Source: FDA drug label (Duetact), Takeda Pharmaceuticals America, Inc., effective March 27, 2025 (SPL set f8b0c917-3fdd-4a28-a47d-6225b8195458), via openFDA; the full label on DailyMed
What does the patient leaflet for glimepiride 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 DUETACT?DUETACT can cause serious side effects, including new or worse heart failure. • Pioglitazone, one of the medicines in DUETACT, 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 DUETACT 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, DUETACT 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 DUETACT can have other serious side effects. See "What are the possible side effects of DUETACT?" What is DUETACT? DUETACT is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. DUETACT contains 2 prescription diabetes medicines called pioglitazone (ACTOS ® ) and glimepiride, a sulfonylurea. DUETACT is not for people with type 1 diabetes. DUETACT is not for people with diabetic ketoacidosis (increased ketones in your blood or urine). It is not known if DUETACT is safe and effective in children under the age of 18. DUETACT is not recommended for use in children. Who should not take DUETACT? See "What is the most important information I should know about DUETACT?" Do not take DUETACT if you: • have severe heart failure • are allergic to any of the ingredients in DUETACT. […]
From the patient leaflet: How should I store DUETACT?Store DUETACT at 68°F to 77°F (20°C to 25°C). Keep DUETACT in the original container to protect from light • Keep the DUETACT bottle tightly closed and keep tablets dry • Keep DUETACT and all medicines out of the reach of children
Source: FDA drug label (Duetact), Takeda Pharmaceuticals America, Inc., effective March 27, 2025 (SPL set f8b0c917-3fdd-4a28-a47d-6225b8195458), via openFDA; the full label on DailyMed
Is there a generic for glimepiride and pioglitazone (Duetact)?
The FDA approved the first generic glimepiride and pioglitazone on January 4, 2013. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 2 patents for Duetact tablets, the last expiring on June 8, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2013 first generic approved
- 2028 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 glimepiride and pioglitazone (Duetact)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $10.52 per unit (Pioglitazone-glimepiride 30-4), down 8% from $11.45 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-glimepiride 30-4 (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pioglitazone-glimepiride 30-2 | Generic | $10.76 per unit | n/a | +2% |
| Pioglitazone-glimepiride 30-4 | Generic | $10.52 per unit | n/a | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has glimepiride and pioglitazone been recalled?
The FDA's Enforcement Report lists 1 recall naming glimepiride and pioglitazone since 2017: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 10, 2017 | Class II | Sandoz Inc | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the glimepiride and pioglitazone label say about other medicines?
The glimepiride and pioglitazone label names 26 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 |
|---|---|---|
| Albuterol | drug interactions | … hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. |
| Chloramphenicol | drug interactions | … highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid and monoamine oxidase inhibitors. |
| Clarithromycin | drug interactions | … steroids and androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins … |
| Clonidine | drug interactions | Beta-blockers, clonidine, and reserpine may lead to either potentiation or weakening of DUETACT's glucose-lowering effect. |
| Clozapine | drug interactions | … danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids, phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid … |
| Colesevelam | drug interactions | DUETACT should be administered at least 4 hours prior to colesevelam. |
| Cyclophosphamide | drug interactions | … antagonists, fibrates, propoxyphene, pentoxifylline, somatostatin analogs, anabolic steroids and androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal … |
| Danazol | drug interactions | The following are examples of medications that may reduce the glucose-lowering effect of sulfonylureas including glimepiride, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide … |
| Diazoxide | drug interactions | … somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids, phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e.g. … |
| Disopyramide | drug interactions | … cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid and monoamine … |
| Epinephrine | drug interactions | … phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. |
| Fluconazole | drug interactions | … pentoxifylline, somatostatin analogs, anabolic steroids and androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs … |
| Fluoxetine | drug interactions | … tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid and monoamine oxidase inhibitors. |
| Gemfibrozil | drug interactions | Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. |
Every other medicine the glimepiride and pioglitazone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Glucagon | drug interactions | … including glimepiride, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates … |
| Isoniazid | drug interactions | … sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. |
| Miconazole | drug interactions | Severe hypoglycemia can occur when DUETACT and oral miconazole are used concomitantly. |
| Olanzapine | drug interactions | … somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids … |
| Pentoxifylline | drug interactions | … (ACE) inhibitors, H2 receptor antagonists, fibrates, propoxyphene, pentoxifylline, somatostatin analogs, anabolic steroids and androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole … |
| Phenytoin | drug interactions | … phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. |
| Pramlintide | drug interactions | … and/or intensity of hypoglycemia: oral anti-diabetic medications, pramlintide acetate, insulin, angiotensin converting enzyme (ACE) inhibitors, H2 receptor antagonists, fibrates, propoxyphene … |
| Probenecid | drug interactions | … anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid and monoamine oxidase inhibitors. |
| Rifampin | drug interactions | CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. |
| Somatropin | drug interactions | … glimepiride, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide … |
| Terbutaline | drug interactions | … phenytoin, nicotinic acid, sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. |
| Topiramate | drug interactions | Topiramate may decrease pioglitazone concentrations. |
Source: FDA drug label (Duetact), Takeda Pharmaceuticals America, Inc., effective March 27, 2025 (SPL set f8b0c917-3fdd-4a28-a47d-6225b8195458), via openFDA; the full label on DailyMed
What do FAERS reports show for glimepiride and pioglitazone?
The FDA Adverse Event Reporting System holds 93 reports that list glimepiride and pioglitazone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 16 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.
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 glimepiride and pioglitazone?
29 other medicines are given the same way (oral) and in the same FDA class as glimepiride 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 |
| Glyburide | Type 2 diabetes | 16 labelers | $0.0643 per tablet 5 mg tablet | A presentation being discontinued |
| Glyburide and metformin | Type 2 diabetes | 11 labelers | $0.171 per unit 2.5-500 mg | No current entry |
| Glipizide and metformin | Type 2 diabetes | 9 labelers | $0.242 per unit 2.5-250 mg | No current entry |
| Metformin | Type 2 diabetes | 83 labelers | $0.0145 per tablet 500 mg tablet | No current entry |
| 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 |
Every medicine labeled for the same conditions as glimepiride and pioglitazone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to glimepiride and pioglitazone
- 29 medicines for the same use
- Other peroxisome proliferator receptor alpha agonists
- the pharmacologic class, with prices and generics
- Glimepiride and pioglitazone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other