Prescription medicine
Glyburide and metformin Brand names: Glyburide-Metformin; first approved as Glucovance
Glyburide and metformin (Glucovance) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $0.171 per unit (Glyburide-metformin 2.5-500 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the glyburide and metformin FDA label on DailyMed (effective June 30, 2026, Aurobindo Pharma Limited); the NDA 21178 record on Drugs@FDA; every glyburide and metformin label on DailyMed.
Highlights of the record
FDA label of June 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
LACTIC ACIDOSIS.
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., a cu te congestive heart failure), excessive alcohol intake, hepatic impairment, and mitochondrial diseases [see Warnings and Precautions (5.1) ]. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see Dosage and Administration (2.3), Contraindications (4) and Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageGlyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 1.25 mg / 250 mg
- 2.5 mg / 500 mg
- 5 mg / 500 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- July 31, 2000 Glucovance, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first February 18, 2004; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 11 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.171 per unit Glyburide-metformin 2.5-500 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2014 0 Class I among all firms' recalls; latest March 24, 2014
- FAERS reports
- 216 through July 30, 2026
What is glyburide and metformin used for?
From the label: indications and usageGlyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Conditions named in the indications of glyburide and metformin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Biguanide and Sulfonylurea.
Source: FDA drug label (Glyburide and Metformin Hydrochloride), Aurobindo Pharma Limited, effective June 30, 2026 (SPL set 7010b662-8b34-49ce-8e5b-73dee0821a60), via openFDA; the full label on DailyMed
What does the patient leaflet for glyburide and metformin 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 glyburide and metformin hydrochloride tablets?Glyburide and metformin hydrochloride tablets can cause serious side effects, including: Lactic Acidosis. Metformin hydrochloride, a medicine in glyburide and metformin hydrochloride tablets, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking glyburide and metformin hydrochloride tablets and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis: feel very weak and tired have unusual sleepiness or sleep longer than usual have unusual (not normal) muscle pain feel cold, especially in your arms and legs have trouble breathing feel dizzy or lightheaded have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea have a slow or irregular heartbeat You have a higher chance of getting lactic acidosis if you: have severe kidney problems. “See “Do not take glyburide and metformin hydrochloride tablets if you:” have liver problems. drink a lot of alcohol (very often or short-term “binge” drinking). get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. […]
From the patient leaflet: What should I avoid while taking glyburide and metformin hydrochloride tablets?Do not drink a lot of alcoholic drinks while taking glyburide and metformin hydrochloride tablets. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis. Do not drive, operate machinery, or do other dangerous activities until you know how glyburide and metformin hydrochloride tablets affects you.
From the patient leaflet: How should I store glyburide and metformin hydrochloride tablets?Store glyburide and metformin hydrochloride tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep glyburide and metformin hydrochloride tablets and all medicines out of the reach of children.
Source: FDA drug label (Glyburide and Metformin Hydrochloride), Aurobindo Pharma Limited, effective June 30, 2026 (SPL set 7010b662-8b34-49ce-8e5b-73dee0821a60), via openFDA; the full label on DailyMed
Is there a generic for glyburide and metformin (Glucovance)?
The FDA approved the first generic glyburide and metformin on February 18, 2004. 7 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists glyburide and metformin from 11 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2000 earliest approval on file
- 2004 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for glyburide and metformin (Glucovance)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.171 per unit (Glyburide-metformin 2.5-500 mg), down 4% from $0.180 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.
- Glyburide-metformin 2.5-500 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Glyburide-metformin 2.5-500 mg | Generic | $0.171 per unit | n/a | -4% |
| Glyburide-metformin 5-500 mg | Generic | $0.190 per unit | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has glyburide and metformin been recalled?
The FDA's Enforcement Report lists 1 recall naming glyburide and metformin since 2014: 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 |
|---|---|---|---|
| March 24, 2014 | Class II | Teva Pharmaceuticals USA | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the glyburide and metformin label say about other medicines?
The glyburide and metformin label names 15 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetazolamide | drug interactions | Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with glyburide and metformin hydrochloride may increase the risk for … Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide and dichlorphenamide. |
| Bosentan | contraindications | Concomitant administration of bosentan [see Drug Interactions (7) ]. |
| Chloramphenicol | drug interactions | Clinical Impact: Certain drugs may potentiate the hypoglycemic action of sulfonylureas, one of the components of glyburide and metformin hydrochloride. … agents and other highly protein-boind drugs, salicylcates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, beta-adrenergic blocking agents; potentially with ciprofloxacin, micronazole. |
| Cimetidine | drug interactions | Drugs that Reduce Metformin Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (…) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [ see ]. Intervention: Consider the benefits and risks of concomitant use with glyburide and metformin hydrochloride. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. |
| Ciprofloxacin | drug interactions | Clinical Impact: Certain drugs may potentiate the hypoglycemic action of sulfonylureas, one of the components of glyburide and metformin hydrochloride. … monoamine oxidase inhibitors, beta-adrenergic blocking agents; potentially with ciprofloxacin, micronazole. |
| Colesevelam | drug interactions | Clinical Impact: Concomitant administration may led to reduced glyburide absorption (…). Intervention: Glyburide and metformin hydrochloride should be administered at least 4 hours prior to colesevelam. |
| Dichlorphenamide | drug interactions | Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with glyburide and metformin hydrochloride may increase the risk for … Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide and dichlorphenamide. |
| Dolutegravir | drug interactions | Drugs that Reduce Metformin Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (…) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [ see ]. Intervention: Consider the benefits and risks of concomitant use with glyburide and metformin hydrochloride. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. |
| Isoniazid | drug interactions | Clinical Impact: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. … phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. |
| Phenytoin | drug interactions | Clinical Impact: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. … corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. |
| Probenecid | drug interactions | Clinical Impact: Certain drugs may potentiate the hypoglycemic action of sulfonylureas, one of the components of glyburide and metformin hydrochloride. … highly protein-boind drugs, salicylcates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, beta-adrenergic blocking agents; potentially with ciprofloxacin, micronazole. |
| Ranolazine | drug interactions | Drugs that Reduce Metformin Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (…) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [ see ]. Intervention: Consider the benefits and risks of concomitant use with glyburide and metformin hydrochloride. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. |
| Topiramate | boxed warning | Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., a cu te congestive heart … |
| Vandetanib | drug interactions | Drugs that Reduce Metformin Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (…) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [ see ]. Intervention: Consider the benefits and risks of concomitant use with glyburide and metformin hydrochloride. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. |
Every other medicine the glyburide and metformin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Zonisamide | drug interactions | Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with glyburide and metformin hydrochloride may increase the risk for … Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide and dichlorphenamide. |
Source: FDA drug label (Glyburide and Metformin Hydrochloride), Aurobindo Pharma Limited, effective June 30, 2026 (SPL set 7010b662-8b34-49ce-8e5b-73dee0821a60), via openFDA; the full label on DailyMed
What do FAERS reports show for glyburide and metformin?
The FDA Adverse Event Reporting System holds 216 reports that list glyburide and metformin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 16 are coded as a death and 85 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 glyburide and metformin?
20 other medicines are given the same way (oral) and in the same FDA class as glyburide and metformin or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Glipizide | Type 2 diabetes | 31 labelers | $0.0339 per tablet 5 mg tablet | No current entry |
| Glimepiride | Type 2 diabetes | 29 labelers | $0.0507 per tablet 4 mg tablet | No current entry |
| Glimepiride and pioglitazone | Type 2 diabetes | none listed | $10.52 per unit 30-4 | No current entry |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
| Sitagliptin | Type 2 diabetes | 4 labelers | $3.77 per tablet 100 mg tablet | No current entry |
| Repaglinide | Type 2 diabetes | 7 labelers | $0.0987 per tablet 1 mg tablet | No current entry |
| Nateglinide | Type 2 diabetes | 9 labelers | $0.179 per tablet 60 mg tablet | No current entry |
| Acarbose | Type 2 diabetes | 6 labelers | $0.274 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as glyburide and metformin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to glyburide and metformin
- 20 medicines for the same use
- Other biguanides
- the pharmacologic class, with prices and generics
- Glyburide and metformin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other