Glimepiride / Pioglitazone
Glimepiride/pioglitazone is a two-in-one oral tablet combination used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Pioglitazone, one of the ingredients in this combination tablet, can cause or worsen heart failure in some people. Heart failure means the heart cannot pump blood as well as it should, leading to fluid buildup in the body. After you start this medicine or your dose goes up, watch for warning signs like sudden weight gain, swelling in your legs or feet, or feeling short of breath. If any of these happen, contact your doctor immediately. This medicine is not recommended if you already have symptoms of heart failure, and it must not be started if you have been diagnosed with moderate to severe heart failure (NYHA Class III or IV).
📖 Glimepiride / Pioglitazone: Patient Information Guide
A plain-language walkthrough of Glimepiride / Pioglitazone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Glimepiride/pioglitazone is a combination oral tablet used to improve blood sugar control in adults with type 2 diabetes, always alongside diet and exercise.
- Duetact (oral tablet) is indicated for adults with type 2 diabetes when treatment with both pioglitazone and glimepiride is appropriate — including those not adequately controlled on a thiazolidinedione or sulfonylurea alone, or those already on both types as separate pills.
- Pioglitazone and glimepiride tablets (oral tablet) are indicated for adults with type 2 diabetes who are already treated with a thiazolidinedione and sulfonylurea, or who have inadequate control on either one alone.
- Neither product is approved for type 1 diabetes or diabetic ketoacidosis.
- Use with caution if you have liver disease — liver tests should be checked before starting.
⚙️How it works▾
This tablet combines two medicines that lower blood sugar in different ways. Pioglitazone is an insulin sensitizer — it activates a receptor in fat, muscle, and liver cells (called PPARγ) that makes those cells respond better to insulin, so they take up more glucose and the liver releases less sugar into the bloodstream. Glimepiride is an insulin releaser — it stimulates the pancreas to produce and release more insulin by closing a specific potassium channel in pancreatic beta cells. Together, they address two of the main problems that drive high blood sugar in type 2 diabetes.
Because pioglitazone works by enhancing the effect of existing insulin rather than releasing new insulin, it requires some insulin to be present in the body to work — which is why this combination is not effective in type 1 diabetes.
💊How it's taken▾
Both Duetact and the generic pioglitazone/glimepiride tablet are taken once a day by mouth, with your first main meal. Your starting dose is based on what diabetes medicines you've taken before, and your doctor will adjust it over time based on how well your blood sugar is controlled and how you tolerate the medicine.
- Take with your first main meal each day — this helps reduce the risk of low blood sugar.
- If you take colesevelam (a cholesterol medicine), take this tablet at least 4 hours before your colesevelam dose.
- If you take a strong CYP2C8-inhibiting drug like gemfibrozil, you may need to switch to separate pills — talk to your doctor.
- Always follow your prescriber's guidance and do not exceed the maximum daily dose they set for you.
🤒Side effects — in detail▾
The most commonly reported side effects include:
- Upper respiratory tract infections (cold symptoms)
- Swelling in the lower legs or feet (edema)
- Low blood sugar (hypoglycemia) — more likely if you take other diabetes medicines or insulin
- Weight gain
- Headache
- Urinary tract infection
- Diarrhea or nausea
- Muscle pain (myalgia) or limb pain
Serious reactions to act on quickly include signs of heart failure (sudden weight gain, shortness of breath, swelling), severe low blood sugar (confusion, seizures, fainting), liver injury (jaundice, dark urine, upper belly pain), serious allergic reactions (hives, throat swelling), and sudden changes in vision.
⚠️Warnings & precautions▾
- Heart failure: Pioglitazone causes fluid retention that can lead to or worsen heart failure — especially when combined with insulin. Watch for rapid weight gain, swelling, or difficulty breathing. Do not start this medicine if you have moderate to severe heart failure (NYHA Class III or IV).
- Severe low blood sugar (hypoglycemia): Glimepiride can cause dangerous drops in blood sugar, especially in older adults, people with kidney problems, and those on other blood sugar–lowering medicines. Severe episodes can cause unconsciousness, seizures, or brain injury.
- Bladder cancer: Pioglitazone may be associated with an increased risk of urinary bladder tumors. Do not use this medicine if you have active bladder cancer.
- Liver injury: Rare but serious cases of liver failure have been reported with pioglitazone. Get liver tests before starting and seek care if you develop fatigue, loss of appetite, dark urine, or yellowing of the skin.
- Bone fractures: Female patients treated with pioglitazone have a higher rate of bone fractures, particularly in the arms and legs.
- Serious allergic reactions: Glimepiride has been linked to anaphylaxis, severe skin reactions (Stevens-Johnson Syndrome), and angioedema — stop the medicine and seek emergency care immediately.
- Cardiovascular mortality: Sulfonylurea-class medicines (like glimepiride) have been associated with a possible increase in cardiovascular death risk compared to diet alone — discuss risks and benefits with your doctor.
🔀What it interacts with▾
Several medicines and substances can affect how this combination works or increase your risk of side effects:
- Gemfibrozil and other strong CYP2C8 inhibitors — can triple pioglitazone levels in your blood, raising side effect risk; a switch to separate pills at lower doses may be required.
- Rifampin and other CYP2C8 inducers — can lower pioglitazone levels, weakening blood sugar control.
- Topiramate (seizure/migraine medicine) — may reduce pioglitazone and its active metabolite levels; monitor blood sugar closely.
- Oral miconazole (antifungal) — can cause dangerously low blood sugar when combined with glimepiride.
- Colesevelam (cholesterol medicine) — reduces glimepiride absorption; take this tablet at least 4 hours before colesevelam.
- Fluconazole (CYP2C9 inhibitor) — may raise glimepiride levels, increasing low blood sugar risk.
- Many other medicines including steroids, diuretics, thyroid hormones, some antibiotics, ACE inhibitors, NSAIDs, and insulin can raise or lower blood sugar — always share your full medicine list with your doctor or pharmacist.
- Alcohol — can unpredictably raise or lower blood sugar and may mask warning signs of hypoglycemia.
- Beta-blockers and other sympatholytic drugs — can hide the early warning signs of low blood sugar such as rapid heartbeat and shakiness.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not take if you have NYHA Class III or IV heart failure (moderate to severe).
- Do not take if you are allergic to pioglitazone, glimepiride, sulfonamide-type medicines, or any component of this tablet — serious reactions including anaphylaxis have been reported.
- Liver disease: Get liver tests before starting. If results are abnormal, use with caution and under close medical supervision.
- Bladder cancer: Do not use if you have active bladder cancer. Use with caution if you have a prior history of bladder cancer.
- Older adults and people with kidney impairment are at higher risk for severe low blood sugar and need careful dose selection and monitoring.
- Children: Not recommended — safety and effectiveness have not been established in pediatric patients.
- Pregnancy: Limited safety data are available. Glimepiride should be stopped at least 2 weeks before the expected delivery date to reduce the risk of prolonged low blood sugar in the newborn. Talk to your doctor if you are pregnant or planning to become pregnant.
- Breastfeeding: It is not known whether these medicines pass into human breast milk. Discuss the risks and benefits with your doctor.
- Premenopausal women not using contraception: Pioglitazone may trigger ovulation in women who don't normally ovulate, increasing the risk of unintended pregnancy.
- G6PD deficiency (a genetic enzyme deficiency): Glimepiride can cause hemolytic anemia (breakdown of red blood cells) in people with this condition — a different medicine may be preferred.
🚑If you take too much▾
Taking too much glimepiride can cause severe low blood sugar, which may lead to seizures, loss of consciousness, or coma — this is a medical emergency. Mild low blood sugar from an overdose can be treated with oral glucose (sugar), but severe cases require emergency care with glucagon or intravenous glucose. Even after initial recovery, blood sugar should be monitored closely because low blood sugar can return.
📡Pharmacodynamics — effects in the body▾
In clinical studies, pioglitazone improved how well cells respond to insulin, lowered fasting blood glucose, reduced insulin levels in the blood, and lowered HbA1c (a measure of long-term blood sugar control). It also tended to decrease triglyceride levels and increase HDL ("good") cholesterol, though it had no consistent effect on LDL or total cholesterol. There is no conclusive evidence that pioglitazone reduces the risk of heart attacks, strokes, or other major cardiovascular events. Weight gain is a recognized pharmacodynamic effect of pioglitazone and is dose-related.
🔬Pharmacokinetics — how your body processes it▾
When taken with food, the combined tablet delivers the same total amount of both medicines as taking the two pills separately — food does not meaningfully change how much of either drug is absorbed overall. Pioglitazone is broken down mainly by the liver enzyme CYP2C8 into active metabolites (M-III and M-IV) that contribute meaningfully to its blood sugar–lowering effect; steady blood levels are reached within about a week of daily dosing. Glimepiride reaches peak blood levels within 2 to 3 hours of taking it, is almost completely broken down by the liver (via CYP2C9), and is cleared from the body through both urine and bile. Both pioglitazone and glimepiride are very heavily bound to blood proteins (over 99%), which is why interactions with other highly protein-bound medicines matter.
📦How to store it▾
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . protect from moisture and humidity.
📄 Written from Glimepiride / Pioglitazone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Glimepiride / Pioglitazone — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this combination tablet supposed to do for my diabetes? ▾
When should I take it — does it matter if I take it with food? ▾
What does low blood sugar feel like, and what should I do if it happens? ▾
I heard pioglitazone can affect the heart — should I be worried? ▾
Are there medicines, supplements, or foods I should avoid while taking this? ▾
Is it safe to take this if I'm pregnant or thinking about getting pregnant? ▾
Is Glimepiride / Pioglitazone available over the counter? ▾
When was Glimepiride / Pioglitazone first available? ▾
Who makes Glimepiride / Pioglitazone? ▾
💬 Answers drafted from Glimepiride / Pioglitazone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Glimepiride / Pioglitazone comes
Glimepiride / Pioglitazone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Duetact is used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes who need both pioglitazone and glimepiride
- Pioglitazone and glimepiride tablets are used for adults with type 2 diabetes who have inadequate control on a thiazolidinedione or a sulfonylurea alone, or who are already on both drug types separately
- Neither Duetact nor pioglitazone and glimepiride tablets are for type 1 diabetes or diabetic ketoacidosis
- Duetact should be taken once daily with the first main meal of the day
- Pioglitazone and glimepiride tablets should be taken once daily with the first main meal of the day
- If you also take colesevelam, take Duetact or pioglitazone and glimepiride tablets at least 4 hours before the colesevelam dose
- Your doctor will individualize your starting dose based on your current diabetes regimen and adjust it based on your response and tolerability
📊 Glimepiride / Pioglitazone across the U.S. market
How Glimepiride / Pioglitazone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Glimepiride / Pioglitazone is used
A general measure of how commonly Glimepiride / Pioglitazone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Glimepiride / Pioglitazone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Glimepiride / Pioglitazone prescribed? Of the 1,596 medications we measure, Glimepiride / Pioglitazone ranks #1,312 by Medicaid prescriptions — more than 18% of them.
Utilization by Glimepiride / Pioglitazone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
glimepiride 4 MG / pioglitazone 30 MG Oral Tablet Most dispensed
Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 647239
glimepiride 2 MG / pioglitazone 30 MG Oral Tablet
Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 647237
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Glimepiride / Pioglitazone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 14 listed Glimepiride / Pioglitazone NDCs with Medicaid activity.
🔍 Compare Glimepiride / Pioglitazone products
A representative set of FDA-listed product records for Glimepiride / Pioglitazone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| PIOGLITAZONE HYDROCHLORIDE 30 mg/1; GLIMEPIRIDE 2 mg | Oral | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| PIOGLITAZONE HYDROCHLORIDE 30 mg/1; GLIMEPIRIDE 4 mg | Oral | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| 2; 30 mg/1; mg | Oral | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| 4; 30 mg/1; mg | Oral | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| 2; 30 mg/1; mg | Oral | Sandoz Inc | ANDA | View NDC → |
| 4; 30 mg/1; mg | Oral | Sandoz Inc | ANDA | View NDC → |
| PIOGLITAZONE HYDROCHLORIDE 30 mg/1; GLIMEPIRIDE 2 mg | — | Takeda GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
| PIOGLITAZONE HYDROCHLORIDE 30 mg/1; GLIMEPIRIDE 4 mg | — | Takeda GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
| PIOGLITAZONE HYDROCHLORIDE 30 mg/1; GLIMEPIRIDE 2 mg | — | Takeda Pharmaceutical Company LTD | DRUG FOR FURTHER PROCESSING | View NDC → |
| PIOGLITAZONE HYDROCHLORIDE 30 mg/1; GLIMEPIRIDE 4 mg | — | Takeda Pharmaceutical Company LTD | DRUG FOR FURTHER PROCESSING | View NDC → |
| PIOGLITAZONE HYDROCHLORIDE 30 mg/1; GLIMEPIRIDE 2 mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| PIOGLITAZONE HYDROCHLORIDE 30 mg/1; GLIMEPIRIDE 4 mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| 2; 30 mg/1; mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| 4; 30 mg/1; mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Glimepiride / Pioglitazone NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Glimepiride / Pioglitazone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Glimepiride / Pioglitazone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Glimepiride / Pioglitazone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 647235 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 647236In current FDA listingsClinical drug / strength (SCD) glimepiride 2 MG / pioglitazone 30 MGRxCUI 647237glimepiride 4 MG / pioglitazone 30 MGRxCUI 647239
Look up RxCUI 647235 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Glimepiride / Pioglitazone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Glimepiride / Pioglitazone belongs to the Sulfonylurea class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Takeda Pharmaceuticals America, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.