Quick answers
- What is Pioglitazone and glimepiride used for?
- The FDA-approved label (Pioglitazone and Glimepiride, Prasco Laboratories, December 12, 2025) says: “Pioglitazone and glimepiride tablets are 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 […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Pioglitazone and glimepiride?
- The “Adverse Reactions” section of the FDA label (Pioglitazone and Glimepiride, Prasco Laboratories, December 12, 2025) begins: “The following serious adverse reactions are discussed elsewhere in the labeling: Congestive Heart Failure [see Boxed Warning and Warnings and Precautions (5.1)] Hypoglycemia [see Warnings and Precautions (5.2)] Edema [see Warnings and Precautions (5.7)] Fractures [see Warnings and Precautions (5.8)] Hemolytic Anemia [see Warnings and Precautions (5.9)] Most common adverse reactions (≥5%) are upper respiratory tract infection, accidental injury, and combined edema/peripheral edema.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Pioglitazone and glimepiride?
- The “Drug Interactions” section of the FDA label (Pioglitazone and Glimepiride, Prasco Laboratories, December 12, 2025) begins: “Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit pioglitazone dose to 15 mg daily. (2.3, 7.1) CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. (7.2) Topiramate may decrease pioglitazone concentrations. (7.3) Certain medications may affect glucose metabolism, requiring pioglitazone and glimepiride tablet dose adjustment and close monitoring of blood glucose.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pioglitazone and glimepiride have a boxed warning?
- Yes. The FDA label for Pioglitazone and Glimepiride has a boxed warning (“WARNING: CONGESTIVE HEART FAILURE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Pioglitazone and glimepiride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pioglitazone and glimepiride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pioglitazone and glimepiride?
- 2 companies list prescription products of Pioglitazone and glimepiride in the FDA NDC Directory, including Takeda Pharmaceuticals America, Inc. and Prasco Laboratories.
What Pioglitazone and glimepiride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Pioglitazone and glimepiride tablets are 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 […]. …
— FDA label: Pioglitazone and Glimepiride, Prasco Laboratories, effective December 12, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Pioglitazone and Glimepiride, Prasco Laboratories; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: CONGESTIVE HEART FAILURE
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Pioglitazone and glimepiride boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: CONGESTIVE HEART FAILURE Thiazolidinediones, including pioglitazone, which is a component of pioglitazone and glimepiride tablets, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1)]. After initiation of pioglitazone and glimepiride tablets and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema).
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If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone and glimepiride tablets must be considered [see Warnings and Precautions (5.1)]. Pioglitazone and glimepiride tablets are not recommended in patients with symptomatic heart failure [see Warnings and Precautions (5.1)]. Initiation of pioglitazone and glimepiride tablets 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 pioglitazone and glimepiride tablets, cause or exacerbate congestive heart failure in some patients. (5.1) After initiation of pioglitazone and glimepiride tablets, 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 and glimepiride tablets must be considered. (5.1) Pioglitazone and glimepiride tablets are not recommended in patients with symptomatic heart failure. (5.1) Initiation of pioglitazone and glimepiride tablets in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. (4, 5.1)
— FDA label: Pioglitazone and Glimepiride, Prasco Laboratories, effective December 12, 2025. Read the full label on DailyMed →
Pioglitazone and glimepiride side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following serious adverse reactions are discussed elsewhere in the labeling: Congestive Heart Failure [see Boxed Warning and Warnings and Precautions (5.1)] Hypoglycemia [see Warnings and Precautions (5.2)] Edema [see Warnings and Precautions (5.7)] Fractures [see Warnings and Precautions (5.8)] Hemolytic Anemia [see Warnings and Precautions (5.9)] Most common adverse reactions (≥5%) are upper respiratory tract infection, accidental injury, and combined edema/peripheral edema.
Read more of this section
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-825-3327 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. The adverse events reported in at least 5% of patients in the controlled 16 week clinical studies between placebo plus a sulfonylurea and pioglitazone (15 mg and 30 mg combined) plus sulfonylurea treatment arms were upper respiratory tract infection (15.5% and 16.6%), accidental injury (8.6% and 3.5%), and combined edema/peripheral edema (2.1% and 7.2%), respectively. The incidence and type of adverse events reported in at least 5% of patients in any combined treatment group from the 24 week study comparing pioglitazone 30 mg plus a sulfonylurea and pioglitazone 45 mg plus a sulfonylurea are shown in Table 1; the rate of adverse events resulting in study discontinuation between the two treatment groups was 6% and 9.7%, respectively. Table 1. Adverse Events that Occurred in ≥5% of Patients in Any Treatment Group During the 24 Week Study Adverse Event Pioglitazone 30 mg + Sulfonylurea N=351 n (%) Pioglitazone 45 mg + Sulfonylurea N=351 n (%) Hypoglycemia 47 (13.4) 55 (15.7) Upper Respiratory Tract Infection 43 (12.3) 52 (14.8) Weight Increased 32 (9.1) 47 (13.4) Edema Lower Limb 20 (5.7) 43 (12.3) Headache 25 (7.1) 14 (4.0) Urinary Tract Infection 20 (5.7) 24 (6.8) Diarrhea 21 (6.0) 15 (4.3) Nausea 18 (5.1) 14 (4.0) Pain in Limb 19 (5.4) 14 (4.0) In US double-blind studies, anemia was reported in ≤2% of patients treated with pioglitazone plus a sulfonylurea [see Warnings and Precautions (5.9)]. Pioglitazone 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 over 3000 patients have been treated with pioglitazone for at least two years. In six pooled 16 to 26 week placebo-controlled monotherapy and 16 to 24 week add-on combination therapy trials, the incidence of withdrawals due to adverse events was 4.5% for patients treated with pioglitazone and 5.8% for comparator-treated patients.
Table from the label
| Adverse Event | Pioglitazone 30 mg + Sulfonylurea N=351 n (%) | Pioglitazone 45 mg + Sulfonylurea N=351 n (%) |
|---|---|---|
| Hypoglycemia | 47 (13.4) | 55 (15.7) |
| Upper Respiratory Tract Infection | 43 (12.3) | 52 (14.8) |
| Weight Increased | 32 (9.1) | 47 (13.4) |
| Edema Lower Limb | 20 (5.7) | 43 (12.3) |
| Headache | 25 (7.1) | 14 (4.0) |
| Urinary Tract Infection | 20 (5.7) | 24 (6.8) |
| Diarrhea | 21 (6.0) | 15 (4.3) |
| Nausea | 18 (5.1) | 14 (4.0) |
| Pain in Limb | 19 (5.4) | 14 (4.0) |
— FDA label: Pioglitazone and Glimepiride, Prasco Laboratories, effective December 12, 2025. This is part of the section. Read the full label on DailyMed →
Pioglitazone and glimepiride drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit pioglitazone dose to 15 mg daily. (2.3, 7.1) CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. (7.2) Topiramate may decrease pioglitazone concentrations. (7.3) Certain medications may affect glucose metabolism, requiring pioglitazone and glimepiride tablet dose adjustment and close monitoring of blood glucose.
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(7.4) Miconazole: Severe hypoglycemia can occur when pioglitazone and glimepiride tablets and oral miconazole are used concomitantly. (7.5) CYP2C9 interactions: Inhibitors and inducers may affect glycemic control by altering glimepiride plasma concentrations. (7.6) Colesevelam: Coadministration may reduce glimepiride absorption. Pioglitazone and glimepiride tablets should be administered at least 4 hours prior to colesevelam. (2.4, 7.7) 7.1 Strong CYP2C8 Inhibitors Pioglitazone An inhibitor of CYP2C8 (e.g., gemfibrozil) significantly increases the exposure (area under the serum concentration-time curve or AUC) and half-life (t ½) of pioglitazone. Therefore, the maximum recommended dose of pioglitazone is 15 mg daily if used in combination with gemfibrozil or other strong CYP2C8 inhibitors. Since the minimum dose of pioglitazone in pioglitazone and glimepiride tablets exceeds 15 mg, patients taking concomitant strong CYP2C8 inhibitors should switch to individual components of pioglitazone and glimepiride tablets, unless the prescribing health care provider determines that the benefit of pioglitazone and glimepiride tablets clearly outweighs the risk of increased pioglitazone exposure [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. 7.2 CYP2C8 Inducers Pioglitazone An inducer of CYP2C8 (e.g., rifampin) may significantly decrease the exposure (AUC) of pioglitazone. Therefore, if an inducer of CYP2C8 is started or stopped during treatment with pioglitazone, changes in diabetes treatment may be needed based on clinical response without exceeding the maximum recommended daily dose of 45 mg for pioglitazone [see Clinical Pharmacology (12.3)]. 7.3 Topiramate Pioglitazone A decrease in the exposure of pioglitazone and its active metabolites were noted with concomitant administration of pioglitazone and topiramate [see Clinical Pharmacology (12.3)]. The clinical relevance of this decrease is unknown; however, when pioglitazone and topiramate are used concomitantly, monitor patients for adequate glycemic control. 7.4 Drugs Affecting Glucose Metabolism Glimepiride A number of medications affect glucose metabolism and may require pioglitazone and glimepiride tablet dose adjustment and particularly close monitoring for hypoglycemia or worsening glycemic control.
— FDA label: Pioglitazone and Glimepiride, Prasco Laboratories, effective December 12, 2025. This is part of the section. Read the full label on DailyMed →
Pioglitazone and glimepiride dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Individualize the starting dose of pioglitazone and glimepiride tablets based on the patient's current regimen. (2.1) May adjust the dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of pioglitazone 45 mg and glimepiride 8 mg. (2.1) Pioglitazone and glimepiride tablets should be given in a single dose once daily with meals. (2.1) Obtain liver tests before starting pioglitazone and glimepiride tablets.
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If abnormal, use caution when treating with pioglitazone and glimepiride tablets, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on pioglitazone and glimepiride tablets is not recommended in patients without liver disease. (5.5) 2.1 Recommendations for All Patients Pioglitazone and glimepiride tablets should be taken once daily with the first main meal. Pioglitazone and glimepiride tablets are available as a 30 mg pioglitazone plus 2 mg glimepiride or a 30 mg pioglitazone plus 4 mg glimepiride tablet. If therapy with a combination tablet containing pioglitazone and glimepiride is considered appropriate the recommended starting dose is: 30 mg/2 mg or 30 mg/4 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, for patients inadequately controlled on glimepiride monotherapy: 30 mg/2 mg or 30 mg/4 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, for patients inadequately controlled on pioglitazone monotherapy: 30 mg/2 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, for patients who are changing from combination therapy of pioglitazone plus glimepiride as separate tablets: pioglitazone and glimepiride tablets should be taken at doses that are as close as possible to the dose of pioglitazone and glimepiride already being taken, for patients currently on a different sulfonylurea monotherapy or switching from combination therapy of pioglitazone plus a different sulfonylurea (e.g., glyburide, glipizide, chlorpropamide, tolbutamide, acetohexamide): 30 mg/2 mg once daily and adjusted after assessing adequacy of therapeutic response. Observe for hypoglycemia for one to two weeks due to the potential overlapping drug effect. for patients with systolic dysfunction, the lowest approved dose of pioglitazone and glimepiride tablets should be prescribed only after titration from 15 mg to 30 mg of pioglitazone has been safely tolerated. After initiation of pioglitazone and glimepiride tablets or with dose increase, monitor patients carefully for hypoglycemia and adverse reactions related to fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure [see Boxed Warning and Warnings and Precautions (5.7)]. Liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) should be obtained prior to initiating pioglitazone and glimepiride tablets. Routine periodic monitoring of liver tests during treatment with pioglitazone and glimepiride tablets is not recommended in patients without liver disease.
— FDA label: Pioglitazone and Glimepiride, Prasco Laboratories, effective December 12, 2025. This is part of the section. Read the full label on DailyMed →
Pioglitazone and glimepiride in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary Limited data with pioglitazone and glimepiride tablets or pioglitazone in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are clinical considerations related to fetal and neonatal adverse reactions and drug discontinuation if glimepiride is used during pregnancy. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations].
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No adverse developmental effects were observed when pioglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 5 and 35 times the 45 mg clinical dose, respectively, based on the body surface area. Administration of glimepiride to pregnant rats and rabbits during organogenesis induced maternal hypoglycemia and also increased fetal mortality at doses 50 (rats) and 0.1 times (rabbits) the 8 mg clinical dose, respectively, based on body surface area [see Data]. The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20% respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. Fetal/Neonatal Adverse Reaction Neonates of women with gestational diabetes, who are treated with sulfonylureas during pregnancy, may be at increased risk for neonatal intensive care unit admission, and may develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age. Prolonged severe hypoglycemia, lasting 4-10 days, has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery and has been reported with the use of agents with a prolonged half-life. Observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly. Dose adjustments during pregnancy and the postpartum period Due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, pioglitazone and glimepiride should be discontinued at least two weeks before expected delivery [see Fetal/Neonatal Adverse Reaction]. Data Animal Data Pioglitazone and Glimepiride Animal reproduction studies were not conducted with the combined products in pioglitazone and glimepiride tablets. The following data are based on studies conducted with the individual components of pioglitazone and glimepiride tablets.
— FDA label: Pioglitazone and Glimepiride, Prasco Laboratories, effective December 12, 2025. This is part of the section. Read the full label on DailyMed →
When Pioglitazone and glimepiride should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning]. Use in patients with known hypersensitivity to pioglitazone, glimepiride or any other component of pioglitazone and glimepiride tablets [see Warnings and Precautions (5.3)]. Use in patients with known history of an allergic reaction to sulfonamide derivatives.
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Reported hypersensitivity reactions with glimepiride include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g., anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea) [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)] Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure [see Boxed Warning]. (4) Use in patients with known hypersensitivity to pioglitazone, glimepiride or any other component of pioglitazone and glimepiride tablets. (4) Hypersensitivity to sulfonamide derivatives. (4)
— FDA label: Pioglitazone and Glimepiride, Prasco Laboratories, effective December 12, 2025. Read the full label on DailyMed →
Pioglitazone and glimepiride overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Pioglitazone During controlled clinical trials, one case of overdose with pioglitazone was reported. A male patient took 120 mg per day for four days, then 180 mg per day for seven days. The patient denied any clinical symptoms during this period. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
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Glimepiride An overdosage of glimepiride, as with other sulfonylureas, can produce severe hypoglycemia. Mild episodes of hypoglycemia can be treated with oral glucose. Severe hypoglycemic reactions constitute medical emergencies requiring immediate treatment. Severe hypoglycemia with coma, seizure, or neurological impairment can be treated with glucagon or intravenous glucose. Continued observation and additional carbohydrate intake may be necessary because hypoglycemia may recur after apparent clinical recovery [see Warnings and Precautions (5.2)].
— FDA label: Pioglitazone and Glimepiride, Prasco Laboratories, effective December 12, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Duetact |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| glimepiride 2 mg · pioglitazone hydrochloride 30 mg tablet | Generic | $9.60 per tablet |
| glimepiride 4 mg · pioglitazone hydrochloride 30 mg tablet | Generic | $10.32 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Takeda Pharmaceuticals America, Inc.2 products
- Prasco Laboratories2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021925 DUETACT | Takeda Pharms USA | July 28, 2006 | 16, latest December 21, 2017 2017: Labeling · 2016: Efficacy · 2015: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 647237, 647239, 731457, 731463 |
|---|---|
| SPL set ID of the quoted label | ea385b3d-cb4c-4550-97b0-93a86533f6dc |
| FDA labels (SPL) | 2 |
| FDA applications | NDA021925 |
| Active ingredients (FDA) | GLIMEPIRIDE / PIOGLITAZONE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- DuetactBrand page: products, maker and price
- DiabetesCondition named on the label: hospitals that treat it
- Takeda Pharmaceuticals America, Inc.Maker or distributor
- Prasco LaboratoriesMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pioglitazone and Glimepiride, Prasco Laboratories, effective December 12, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →