FDA-filed SPL labeling · retrieved through openFDA

Glyburide and Metformin

Glyburide and metformin is a combination oral tablet used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Drug class ⓘ Sulfonylurea
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 12 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 →

At a glance
Linked label effectiveJun 12, 2024
Clinical labels in scope ⓘ12
AvailabilityRx
Earliest approval/marketing year ⓘ2007
FDA-listed product records ⓘ76
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 23, 2026
⭐ Glyburide and Metformin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Glyburide and metformin hydrochloride is an effective combination tablet for managing blood sugar in type 2 diabetes, used alongside diet and exercise. It carries an important warning about a rare but serious condition called lactic acidosis, as well as a real risk of low blood sugar — so kidney function monitoring and recognizing early warning signs are key parts of staying safe on this medication. Always keep your healthcare team informed about any other medications, health changes, or upcoming procedures.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

This medication carries a serious warning about a rare but potentially fatal condition called lactic acidosis — a dangerous buildup of lactic acid in the blood, caused by the metformin component. It has caused deaths in postmarketing reports. The early warning signs are often vague: unusual tiredness, muscle aches, difficulty breathing, stomach pain, feeling cold, or excessive drowsiness. You might not realize something is seriously wrong at first.

People at highest risk include those with kidney disease, liver problems, heart failure, those aged 65 or older, people who drink alcohol heavily, and those having surgery or a procedure using contrast dye. If lactic acidosis is suspected, stop the medication immediately and go to the emergency room — treatment in a hospital setting, and sometimes dialysis, may be needed.

Read the full warning on DailyMed →

📖 Glyburide and Metformin: Patient Information Guide

A plain-language walkthrough of Glyburide and Metformin — 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▾

Glyburide and metformin hydrochloride is a combination oral tablet approved to help control blood sugar in adults with type 2 diabetes.

  • Used as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults with type 2 diabetes
  • May be used as initial therapy when diet and exercise alone aren't enough
  • May be used when either a sulfonylurea or metformin alone hasn't provided adequate blood sugar control
  • Can also be combined with a thiazolidinedione (another class of diabetes medication) when additional blood sugar control is needed
⚙️How it works▾

This tablet combines two medicines with different but complementary mechanisms. Glyburide (a sulfonylurea) stimulates the insulin-producing beta cells in the pancreas to release more insulin — lowering blood sugar relatively quickly. Metformin works outside the pancreas: it tells the liver to produce less glucose, slows how fast sugar is absorbed from the intestines, and helps the body's cells use insulin more effectively. Together, they lower both fasting blood sugar and blood sugar after meals more effectively than either drug alone.

With long-term use, glyburide's ability to stimulate insulin release may gradually decline, but its blood-sugar-lowering effect can persist — possibly through additional mechanisms outside the pancreas. Metformin does not cause the pancreas to release insulin on its own, which is one reason it carries a lower risk of low blood sugar when used alone.

💊How it's taken▾

Glyburide and metformin hydrochloride tablets are taken by mouth with meals, typically twice a day. Your doctor will start you on a low dose and increase it gradually — every couple of weeks — until your blood sugar is well controlled or the maximum recommended daily dose is reached. How you dose it depends on whether you are new to diabetes medication or are switching from another regimen.

  • Take with meals to reduce stomach upset and lower the risk of low blood sugar
  • If you take colesevelam, take this tablet at least 4 hours before your colesevelam dose
  • If you need imaging with contrast dye, your doctor may ask you to stop this medication beforehand and restart it 48 hours later if your kidney function is stable
  • Follow your prescriber's instructions closely — do not adjust your dose on your own
🤒Side effects — in detail▾

The most common side effects are stomach-related and tend to improve as your body adjusts to the medication.

  • Diarrhea
  • Nausea or vomiting
  • Stomach pain
  • Headache
  • Dizziness
  • Upper respiratory infection (common cold symptoms)
  • Low blood sugar symptoms: shakiness, sweating, hunger, dizziness

Seek immediate medical care if you experience signs of lactic acidosis (muscle pain, trouble breathing, stomach pain, extreme weakness, or feeling very cold) or severe low blood sugar (loss of consciousness or seizures) — these are emergencies.

⚠️Warnings & precautions▾
  • Lactic acidosis — the most serious risk, caused by metformin. Rare but potentially fatal. Early symptoms are vague (fatigue, muscle aches, belly pain, trouble breathing). Risk is highest in people with kidney disease, liver disease, heart failure, heavy alcohol use, or those over 65. Stop the medication and seek emergency care if suspected.
  • Low blood sugar (hypoglycemia) — glyburide can cause significant drops in blood sugar, especially if you skip meals, exercise heavily, drink alcohol, or take other diabetes medications. Severe cases can cause seizures or loss of consciousness.
  • Cardiovascular risk — sulfonylurea-class drugs have been associated with increased cardiovascular mortality in older research. Discuss the risks and benefits with your doctor.
  • Hemolytic anemia — people with G6PD deficiency (a genetic enzyme condition) may develop breakdown of red blood cells. A non-sulfonylurea alternative may be preferred.
  • Vitamin B12 deficiency — metformin can lower B12 levels over time, which may lead to anemia or nerve symptoms. Your doctor should check B12 levels every 2 to 3 years.
  • Contrast dye procedures — this medication must often be stopped before imaging with iodinated contrast because it can increase the risk of kidney problems and lactic acidosis.
🔀What it interacts with▾

Several medications and substances can interact with glyburide and metformin hydrochloride, either making it less effective or increasing the risk of side effects.

  • Bosentan — strictly contraindicated; increases liver enzyme abnormalities when combined with glyburide
  • Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide) — raise the risk of lactic acidosis
  • Drugs that raise blood sugar (thiazide diuretics, corticosteroids, estrogens, oral contraceptives, phenytoin, niacin, calcium channel blockers, sympathomimetics) — may reduce blood sugar control
  • Drugs that increase low blood sugar risk (NSAIDs, sulfonamides, warfarin, MAO inhibitors, beta-blockers, chloramphenicol, probenecid) — may intensify glyburide's blood-sugar-lowering effect
  • Colesevelam — reduces glyburide absorption; take at least 4 hours before colesevelam
  • Ciprofloxacin — may potentiate glyburide's hypoglycemic effect
  • Oral miconazole — may cause severe low blood sugar
  • Alcohol — worsens metformin's effect on lactate metabolism, raising the lactic acidosis risk; avoid excessive intake

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 severe kidney impairment (eGFR below 30 mL/min/1.73 m²) — it is contraindicated
  • Do not take if you have diabetic ketoacidosis or other serious metabolic acidosis
  • Do not take if you are allergic to glyburide or metformin
  • Avoid if you have liver disease — associated with increased lactic acidosis risk
  • Use with caution if you are 65 or older — higher risk of low blood sugar and lactic acidosis; kidney function should be monitored more frequently
  • Tell your doctor if you have G6PD deficiency — risk of hemolytic anemia
  • Tell your doctor if you have a mitochondrial disease (e.g., MELAS syndrome) — metformin is not recommended
  • If pregnant: the medication should be stopped at least two weeks before your due date; poorly controlled diabetes in pregnancy also carries serious risks — discuss with your doctor
  • If breastfeeding: metformin passes into breast milk; monitor your baby for signs of low blood sugar
  • Not approved or studied for use in children
  • If you are a premenopausal woman who is not using contraception, be aware that this medication may trigger ovulation in some women who previously were not ovulating
🚑If you take too much▾

Taking too much glyburide can cause severe low blood sugar, including loss of consciousness or seizures — this is a medical emergency requiring immediate hospital care and glucose treatment. Metformin overdose has been associated with lactic acidosis in a significant portion of reported cases. Hemodialysis (a type of blood-filtering treatment) can help remove excess metformin from the body and may be recommended in serious overdose situations.

📡Pharmacodynamics — effects in the body▾

Glyburide lowers blood sugar by prompting the pancreas to release more insulin — an effect that depends on having working insulin-producing (beta) cells. Metformin lowers both fasting blood sugar and blood sugar after meals by reducing how much glucose the liver releases, slowing glucose absorption from the intestines, and improving how efficiently the body's cells take up and use glucose. Together, the two drugs address high blood sugar through multiple pathways, producing a more complete glucose-lowering effect than either agent alone.

🔬Pharmacokinetics — how your body processes it▾

Glyburide is absorbed within about an hour of taking a dose, with peak blood levels around 4 hours, and remains detectable for up to 24 hours. Importantly, the glyburide in this combination tablet is not bioequivalent to some single-ingredient glyburide products — your doctor should not assume they are interchangeable. Metformin is about 50–60% absorbed under fasting conditions; food reduces its absorption somewhat but does not change the clinical approach to dosing. Metformin is not significantly bound to plasma proteins, is not metabolized by the liver, and is cleared almost entirely by the kidneys — which is why kidney function is so important to monitor. Steady-state blood levels of metformin are generally reached within 24 to 48 hours of consistent dosing.

📦How to store it▾

Store at temperatures up to 25°C (77°F). Dispense in light-resistant containers.

📄 Written from Glyburide and Metformin’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 Glyburide and Metformin — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does this medication do for my diabetes? ▾
It helps bring your blood sugar down using two medicines in one tablet. Glyburide nudges your pancreas to release more insulin, while metformin works on your liver and body cells to reduce how much sugar gets into your bloodstream in the first place. Think of it as two tools working together. It won't cure diabetes, but along with eating well and staying active, it can help keep your blood sugar in a healthier range.
Should I take it with food or on an empty stomach? ▾
Always take it with a meal — your morning and evening meals, typically. Food helps reduce the stomach upset that metformin can cause, and it also helps prevent your blood sugar from dropping too low too fast. Skipping a meal after taking it — especially the glyburide part — can increase your risk of low blood sugar, so try to keep your eating schedule consistent.
What does low blood sugar feel like, and what should I do? ▾
Low blood sugar can feel like shakiness, sweating, dizziness, hunger, or a racing heart. If you catch it early, a small amount of fast-acting sugar — like juice or glucose tablets — can usually bring you back up. If it becomes severe — confusion, seizures, or passing out — that's an emergency and someone should call 911. Older adults and people on certain other medications sometimes don't feel the early warning signs, so extra monitoring is important.
I've heard about something called lactic acidosis — should I be worried? ▾
It's a serious but rare risk from the metformin in this tablet. Lactic acid can build up in the blood, and in severe cases it can be life-threatening. The warning signs can be easy to miss at first — unusual tiredness, muscle aches, trouble breathing, or belly pain. You're at higher risk if you have kidney or liver problems, drink heavily, or are over 65. If you ever notice those symptoms together, stop the medication and go to the emergency room. For most healthy people, the risk is very low when the medication is used as directed.
Do I need to stop this medication before a CT scan or MRI with dye? ▾
Yes — if your scan uses iodinated contrast dye (the kind injected into a vein or artery), you may need to stop this tablet before the procedure. The dye can temporarily affect your kidneys, and since metformin is cleared by the kidneys, it can build up and increase the risk of lactic acidosis. Your doctor will tell you when to stop and when it's safe to restart — usually after checking your kidney function 48 hours later. Always mention this medication when scheduling any imaging procedure.
Is it safe to drink alcohol while taking this? ▾
You don't have to avoid alcohol entirely, but heavy or binge drinking is a real concern with this medication. Alcohol makes it harder for your liver to clear lactic acid, which increases the risk of lactic acidosis. It can also make low blood sugar worse and harder to recognize. An occasional drink with a meal is generally considered lower risk, but talk to your doctor about what's appropriate for you personally.
Is Glyburide and Metformin available over the counter? ▾
Glyburide and Metformin is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Glyburide and Metformin first available? ▾
Glyburide and Metformin has been available in the United States since at least 2007, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Glyburide and Metformin? ▾
Glyburide and Metformin is supplied by 18 manufacturers listed in the FDA NDC Directory, including Aurobindo Pharma Limited, A-S Medication Solutions, Bryant Ranch Prepack.

💬 Answers drafted from Glyburide and Metformin’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

🌿Drug & Supplement CheckerGlyburide and Metformin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Glyburide and Metformin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Glyburide and Metformin comes

Glyburide and Metformin 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

By mouth
How this form is used
What it may be used for
  • Glyburide and metformin hydrochloride tablets are used to improve blood sugar control in adults with type 2 diabetes, as an adjunct to diet and exercise
  • Glyburide and metformin hydrochloride tablets may be used as initial therapy in patients whose blood sugar is not controlled by diet and exercise alone
  • Glyburide and metformin hydrochloride tablets may be used in patients not adequately controlled on a sulfonylurea or metformin alone
Important instructions
  • Glyburide and metformin hydrochloride tablets should be taken by mouth with meals, generally twice daily
  • Glyburide and metformin hydrochloride tablets should be started at a low dose and gradually increased based on blood sugar response and tolerability
  • If you also take colesevelam, take glyburide and metformin hydrochloride tablets at least 4 hours before your colesevelam dose
  • Glyburide and metformin hydrochloride tablets may need to be temporarily stopped before imaging procedures that use contrast dye — ask your doctor
Available strengths 3 strengths
1.25 mg / 250 mg 2.5 mg / 500 mg 5 mg / 500 mg
76 FDA-listed product records ⓘ

📊 Glyburide and Metformin across the U.S. market

How Glyburide and Metformin 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.

1
Dose forms ⓘ
18
Manufacturers
1
Brand names
76
FDA-listed product records ⓘ
2007
First marketed ⓘ
Aurobindo Pharma Limited16%
A-S Medication Solutions13%
Bryant Ranch Prepack11%
Rising Pharma Holdings, Inc.8%
Preferred Pharmaceuticals Inc.8%
Zydus Pharmaceuticals (USA) Inc.8%
Other makers37%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Glyburide and Metformin is used

A general measure of how commonly Glyburide and Metformin 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 Glyburide and Metformin 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.

16,761
Medicaid prescriptions filled (Q1–Q4 2025)
$421,627 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Glyburide and Metformin prescribed? Of the 1,596 medications we measure, Glyburide and Metformin ranks #832 by Medicaid prescriptions — more than 48% of them.

Where Glyburide and Metformin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #832 of 1,596
#827 Colesevelam 17,250 Rx #828 Itraconazole 17,092 Rx #829 Potassium Acetate 16,989 Rx #830 Theophylline 16,886 Rx #831 Raltegravir 16,834 Rx #832 Glyburide and Metformi... 16,761 Rx #833 Travoprost Ophthalmic 16,632 Rx #834 Bromocriptine 16,540 Rx #835 Ketoprofen 16,480 Rx #836 Bicalutamide 16,214 Rx #837 Sodium Polystyrene Sul... 16,195 Rx

Utilization by Glyburide and Metformin 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.

The 5 mg / 500 mg oral tablet is the most-dispensed Glyburide and Metformin product — about 80% of these Medicaid prescriptions.

glyburide 5 MG / metformin hydrochloride 500 MG Oral Tablet Most dispensed

13,423 Medicaid prescriptions (Q1–Q4 2025) 80% of Glyburide and Metformin prescriptions shown $359,171 gross reimbursement (before rebates) ≈ $27 per prescription (gross)

Summed across the 5 of 101 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861753

glyburide 2.5 MG / metformin hydrochloride 500 MG Oral Tablet

3,267 Medicaid prescriptions (Q1–Q4 2025) 19% of Glyburide and Metformin prescriptions shown $61,304 gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 5 of 60 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861748

glyburide 1.25 MG / metformin hydrochloride 250 MG Oral Tablet

71 Medicaid prescriptions (Q1–Q4 2025) <1% of Glyburide and Metformin prescriptions shown $1,152 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 1 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861743

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 Glyburide and Metformin, 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 11 of 191 listed Glyburide and Metformin NDCs with Medicaid activity.

🔍 Compare Glyburide and Metformin products

A representative set of FDA-listed product records for Glyburide and Metformin — 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.)

Showing 76 of 76 products — FDA National Drug Code Directory. See every product, package size and price: browse all 76 Glyburide and Metformin NDCs →

🏭 Manufacturers & labelers

Aurobindo Pharma Limited 12 A-S Medication Solutions 10 Bryant Ranch Prepack 8 Rising Pharma Holdings, Inc. 6 Preferred Pharmaceuticals Inc. 6 Zydus Pharmaceuticals (USA) Inc. 6 Zydus Lifesciences Limited 6 NuCare Pharmaceuticals,Inc. 4 Denton Pharma, Inc. dba Northwind Pharmaceuticals 4 Rising Health, LLC 3 AvPAK 3 PD-Rx Pharmaceuticals, Inc. 2 DirectRX 1 NuCare Pharmaceuticals, Inc. 1 Northwind Pharmaceuticals 1 Northwind Pharmaceuticals, LLC 1 Northwind Health Company, LLC 1 Actavis Pharma, Inc. 1

RxNorm drug class

Glyburide and Metformin belongs to the Sulfonylurea class.

Pharmacologic class Sulfonylurea
Drug family (ATC) Sulfonylureas

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 12, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Glyburide and Metformin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Glyburide and Metformin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
12
NDC products indexed
76
Distinct labelers/manufacturers represented
18
Linked representative label ⓘ
NuCare Pharmaceuticals,Inc.
Linked label effective
Jun 12, 2024
Composite sections available
23
Linked SPL Set ID
7facb5ac-c1d5-43b4-e053-2991aa0a2a7b
Linked SPL Document ID
1ab9df7f-6510-2ace-e063-6394a90a3bde
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 12 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. NuCare Pharmaceuticals,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.