Prescription medicine
Miglitol First approved as Glyset
Miglitol (Glyset) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the miglitol FDA label on DailyMed (effective April 1, 2022, Proficient Rx LP); the NDA 20682 record on Drugs@FDA; every miglitol label on DailyMed.
Highlights of the record
FDA label of April 1, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMiglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 25 mg
- 50 mg
- 100 mg
Coated tablet.
On the market
- Earliest approval on file
- December 18, 1996 Glyset, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first February 24, 2015; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 947 through July 30, 2026
What is miglitol used for?
From the label: indications and usageMiglitol tablets are 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 miglitol's FDA labels, with every medicine labeled for each:
From other miglitol labelsType 2 diabetes: INDICATIONS AND USAGE Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FDA pharmacologic class: alpha-Glucosidase Inhibitor.
Source: FDA drug label (Miglitol), ANDA203965 (Orient Pharma), as published by Proficient Rx LP, effective April 1, 2022 (SPL set f16ecb50-e54e-43e1-8789-eaf5bc94f332), via openFDA; the full label on DailyMed
Is there a generic for miglitol (Glyset)?
The FDA approved the first generic miglitol on February 24, 2015. 1 generic application is approved; 1 of it carries 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 miglitol from 2 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.
- 1996 earliest approval on file
- 2015 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the miglitol label say about other medicines?
The miglitol label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name miglitol. 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 |
|---|---|---|
| Digoxin | drug interactions | In a study with healthy volunteers, co-administration of either 50 mg or 100 mg miglitol 3 times daily together with digoxin reduced the average plasma concentrations of digoxin by 19% and 28%, respectively. |
| Glyburide | drug interactions | In a study in diabetic patients in which the effects of adding miglitol 100 mg 3 times daily for 7 days or placebo to a background regimen of 3.5 mg glyburide daily were investigated, the mean AUC value for glyburide was 18% lower in the group treated with miglitol, although this difference was not statistically … |
| Metformin | drug interactions | Mean AUC and C max values for metformin were 12% to 13% lower when the volunteers were given miglitol as compared with placebo, but this difference was not statistically significant. |
| Nifedipine | drug interactions | No effect of miglitol was observed on the pharmacokinetics or pharmacodynamics of either warfarin or nifedipine. |
| Propranolol | drug interactions | Other healthy volunteer studies have demonstrated that miglitol may significantly reduce the bioavailability of ranitidine and propranolol by 60% and 40%, respectively. |
| Ranitidine | drug interactions | Other healthy volunteer studies have demonstrated that miglitol may significantly reduce the bioavailability of ranitidine and propranolol by 60% and 40%, respectively. |
| Warfarin | drug interactions | No effect of miglitol was observed on the pharmacokinetics or pharmacodynamics of either warfarin or nifedipine. |
Source: FDA drug label (Miglitol), ANDA203965 (Orient Pharma), as published by Proficient Rx LP, effective April 1, 2022 (SPL set f16ecb50-e54e-43e1-8789-eaf5bc94f332), via openFDA; the full label on DailyMed
What do FAERS reports show for miglitol?
The FDA Adverse Event Reporting System holds 947 reports that list miglitol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 106 are coded as a death and 560 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 miglitol?
33 other medicines are given the same way (oral) and in the same FDA class as miglitol 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 |
|---|---|---|---|---|
| Acarbose | Type 2 diabetes | 6 labelers | $0.274 per tablet 100 mg tablet | No current entry |
| Metformin | Type 2 diabetes | 83 labelers | $0.0145 per tablet 500 mg tablet | No current entry |
| 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 |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
| Glyburide | Type 2 diabetes | 16 labelers | $0.0643 per tablet 5 mg tablet | A presentation being discontinued |
| 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to miglitol
- 33 medicines for the same use
- Other alpha-glucosidase inhibitors
- the pharmacologic class, with prices and generics
- Miglitol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other