Prescription medicine
Acarbose First approved as Precose
Acarbose (Precose) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.274 per acarbose 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the acarbose FDA label on DailyMed (effective July 15, 2026, Strides Pharma Science Limited); the NDA 20482 record on Drugs@FDA; every acarbose label on DailyMed.
Highlights of the record
FDA label of July 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAcarbose 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
Tablet.
On the market
- Earliest approval on file
- September 6, 1995 Precose, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first May 7, 2008; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.274 per tablet Acarbose 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest September 5, 2017; 2 more by firms not listed as its makers
- FAERS reports
- 3,847 through July 30, 2026
What is acarbose used for?
From the label: indications and usageAcarbose 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 acarbose's FDA labels, with every medicine labeled for each:
From other acarbose labelsType 2 diabetes: INDICATIONS AND USAGE Acarbose 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 (Acarbose), Strides Pharma Science Limited, effective July 15, 2026 (SPL set 656769ee-e292-4950-83df-a38e6b1a9d6e), via openFDA; the full label on DailyMed
Is there a generic for acarbose (Precose)?
The FDA approved the first generic acarbose on May 7, 2008. 8 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 acarbose from 6 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
- 2008 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 acarbose (Precose)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.274 per Acarbose 100 mg tablet, up 8% from $0.253 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.
- Acarbose 50 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acarbose 100 mg tablet | Generic | $0.274 per tablet | $8.22 | +8% |
| Acarbose 25 mg tablet | Generic | $0.180 per tablet | $5.39 | +16% |
| Acarbose 50 mg tablet | Generic | $0.169 per tablet | $5.07 | +1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has acarbose been recalled?
The FDA's Enforcement Report lists 4 recalls naming acarbose since 2013: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of acarbose and that hold 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 |
|---|---|---|---|
| September 5, 2017 | Class II | Teva Pharmaceuticals USA | Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct … |
| April 2, 2015 | Class II | Boehringer Ingelheim Roxane Inc | Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; ACARBOSE Tablet, 25 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD39588_4, EXP: 5/13/2014. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: ACARBOSE, Tablet, 25 mg may be potentially mislabeled as one of the following drugs: ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the acarbose label say about other medicines?
The acarbose label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name acarbose. 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 | Acarbose Tablets have been shown to change the bioavailability of digoxin when they are coadministered, which may require digoxin dose adjustment. (See CLINICAL PHARMACOLOGY, Drug-Drug Interactions. ) |
| Isoniazid | drug interactions | These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicolinic acid, sympathomimetics, calcium channel-blocking drugs, and isoniazid. |
| Phenytoin | drug interactions | These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicolinic acid, sympathomimetics, calcium channel-blocking drugs, and isoniazid. |
Other labels that name acarbose
Source: FDA drug label (Acarbose), Strides Pharma Science Limited, effective July 15, 2026 (SPL set 656769ee-e292-4950-83df-a38e6b1a9d6e), via openFDA; the full label on DailyMed
What do FAERS reports show for acarbose?
The FDA Adverse Event Reporting System holds 3,847 reports that list acarbose among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 316 are coded as a death and 2,096 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 acarbose?
33 other medicines are given the same way (oral) and in the same FDA class as acarbose 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 |
|---|---|---|---|---|
| Miglitol | Type 2 diabetes | 2 labelers | n/a | 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)
How does acarbose compare with medicines for the same use?
3 side-by-side pages set acarbose beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to acarbose
- 33 medicines for the same use
- Other alpha-glucosidase inhibitors
- the pharmacologic class, with prices and generics
- Acarbose side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other