Prescription medicine
Glimepiride First approved as Amaryl
Glimepiride (Amaryl) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $0.0507 per glimepiride 4 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the glimepiride FDA label on DailyMed (effective May 12, 2025, Micro Labs Limited); the NDA 20496 record on Drugs@FDA; every glimepiride label on DailyMed.
Highlights of the record
FDA label of May 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGlimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1) ].
Forms and strengths
- 1 mg
- 2 mg
- 3 mg
- 4 mg
- 6 mg
- 8 mg
Tablet.
On the market
- Earliest approval on file
- November 30, 1995 Amaryl, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first October 6, 2005; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 27 of which 27 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0507 per tablet Glimepiride 4 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 19 since 2013 0 Class I among all firms' recalls; latest January 18, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 38,737 through July 30, 2026
What is glimepiride used for?
From the label: indications and usageGlimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1) ]. Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ). Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).
Conditions named in the indications of glimepiride's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sulfonylurea.
Source: FDA drug label (Glimepiride), Micro Labs Limited, effective May 12, 2025 (SPL set 60e9397e-83b9-489e-9683-6f87e458bbaa), via openFDA; the full label on DailyMed
Is there a generic for glimepiride (Amaryl)?
The FDA approved the first generic glimepiride on October 6, 2005. 16 generic applications are approved; 8 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 glimepiride from 27 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.
- 1995 earliest approval on file
- 2005 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 glimepiride (Amaryl)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0507 per Glimepiride 4 mg tablet, up 4% from $0.0485 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.
- Glimepiride 4 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Glimepiride 1 mg tablet | Generic | $0.0243 per tablet | $0.730 | -4% |
| Glimepiride 2 mg tablet | Generic | $0.0375 per tablet | $1.13 | +6% |
| Glimepiride 4 mg tablet | Generic | $0.0507 per tablet | $1.52 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has glimepiride been recalled?
The FDA's Enforcement Report lists 20 recalls naming glimepiride since 2013: 0 Class I (the most serious), 18 Class II, 2 Class III; 6 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of glimepiride and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 18, 2024 | Class III | Dr. Reddy's Laboratories, Inc. | Misprint on tablet |
| April 6, 2023 | Class II | PD-Rx Pharmaceuticals, Inc. | CGMP deviations. |
| March 23, 2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| March 20, 2023 | Class II | RemedyRepack Inc. | cGMP Deviations |
| March 17, 2023 | Class II | Amerisource Health Services LLC | CGMP Deviations: recalling drug products following an FDA inspection. |
| March 16, 2023 | Class II | Northwind Pharmaceuticals LLC | CGMP Deviations |
| March 13, 2023 | Class II | Direct Rx | cGMP deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the glimepiride label say about other medicines?
The glimepiride label names 24 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name glimepiride. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | drug interactions | … hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. |
| Chloramphenicol | drug interactions | … highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid and monoamine oxidase inhibitors. |
| Clarithromycin | drug interactions | … steroids and androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins … |
| Clonidine | drug interactions | Beta-blockers, clonidine, and reserpine may lead to either potentiation or weakening of glimepiride’s glucose-lowering effect. |
| Clozapine | drug interactions | … danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids, phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid … |
| Colesevelam | drug interactions | Glimepiride should be administered at least 4 hours prior to colesevelam. |
| Cyclophosphamide | drug interactions | … antagonists, fibrates, propoxyphene, pentoxifylline, somatostatin analogs, anabolic steroids and androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal … |
| Danazol | drug interactions | The following are examples of medications that may reduce the glucose-lowering effect of sulfonylureas including glimepiride, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide … |
| Diazoxide | drug interactions | … somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids, phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e.g. … |
| Disopyramide | drug interactions | … cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid and monoamine … |
| Epinephrine | drug interactions | … phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. |
| Fluconazole | drug interactions | … pentoxifylline, somatostatin analogs, anabolic steroids and androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs … |
| Fluoxetine | drug interactions | … tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid and monoamine oxidase inhibitors. |
| Glucagon | drug interactions | The following are examples of medications that may reduce the glucose-lowering effect of sulfonylureas including glimepiride, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide … |
Every other medicine the glimepiride label names
| Medicine named | Section | What the label says |
|---|---|---|
| Isoniazid | drug interactions | … sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. |
| Miconazole | drug interactions | Severe hypoglycemia can occur when glimepiride and oral miconazole are used concomitantly. ( 7.2 ) Cytochrome P450 2C9 interactions: |
| Olanzapine | drug interactions | … somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids … |
| Pentoxifylline | drug interactions | … (ACE) inhibitors, H 2 receptor antagonists, fibrates, propoxyphene, pentoxifylline, somatostatin analogs, anabolic steroids and androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole … |
| Phenytoin | drug interactions | … phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. |
| Pramlintide | drug interactions | … and/or intensity of hypoglycemia: oral anti-diabetic medications, pramlintide acetate, insulin, angiotensin converting enzyme (ACE) inhibitors, H 2 receptor antagonists, fibrates, propoxyphene … |
| Probenecid | drug interactions | … anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid and monoamine oxidase inhibitors. |
| Rifampin | drug interactions | … (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids, phenothiazines, thyroid hormones, estrogens, oral contraceptives … |
| Somatropin | drug interactions | … glimepiride, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide … |
| Terbutaline | drug interactions | … phenytoin, nicotinic acid, sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. |
Other labels that name glimepiride
Source: FDA drug label (Glimepiride), Micro Labs Limited, effective May 12, 2025 (SPL set 60e9397e-83b9-489e-9683-6f87e458bbaa), via openFDA; the full label on DailyMed
What do FAERS reports show for glimepiride?
The FDA Adverse Event Reporting System holds 38,737 reports that list glimepiride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,272 are coded as a death and 13,866 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as glimepiride?
32 other medicines are given the same way (oral) and in the same FDA class as glimepiride or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Glipizide | Type 2 diabetes | 31 labelers | $0.0339 per tablet 5 mg tablet | No current entry |
| Glyburide | Type 2 diabetes | 16 labelers | $0.0643 per tablet 5 mg tablet | A presentation being discontinued |
| Glyburide and metformin | Type 2 diabetes | 11 labelers | $0.171 per unit 2.5-500 mg | No current entry |
| Glipizide and metformin | Type 2 diabetes | 9 labelers | $0.242 per unit 2.5-250 mg | No current entry |
| Metformin | Type 2 diabetes | 83 labelers | $0.0145 per tablet 500 mg tablet | No current entry |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
| Dapagliflozin and metformin | Type 2 diabetes | 8 labelers | $0.720 per tablet 10-1,000 mg tablet | No current entry |
| Metformin and sitagliptin | Type 2 diabetes | 4 labelers | $1.76 per tablet 50 mg-1,000 mg tablet | No current entry |
Every medicine labeled for the same conditions as glimepiride
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does glimepiride compare with medicines for the same use?
8 side-by-side pages set glimepiride beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to glimepiride
- 32 medicines for the same use
- Other sulfonylureas
- the pharmacologic class, with prices and generics
- Glimepiride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other