Prescription medicine
Metformin and saxagliptin First approved as Kombiglyze Xr
Metformin and saxagliptin (Kombiglyze Xr) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $9.65 per saxagliptin-metformin ER 5-1,000 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the metformin and saxagliptin FDA label on DailyMed (effective August 21, 2026, Mylan Pharmaceuticals Inc.); the NDA 200678 record on Drugs@FDA; every metformin and saxagliptin label on DailyMed.
Highlights of the record
FDA label of August 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
LACTIC ACIDOSIS •.
Post-marketing 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., acute congestive heart failure ), excessive alcohol intake, hepatic impairment, and mitochondrial diseases [ see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageSaxagliptin and metformin hydrochloride extended-release 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) ].
Forms and strengths
- 2.5 mg / 1000 mg
- 5 mg / 1000 mg
- 5 mg / 500 mg
Film-coated extended-release tablet.
On the market
- Earliest approval on file
- November 5, 2010 Kombiglyze Xr, Astrazeneca Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first July 31, 2023; 2 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)
- $9.65 per tablet Saxagliptin-metformin ER 5-1,000 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4 through July 30, 2026
What is metformin and saxagliptin used for?
From the label: indications and usageSaxagliptin and metformin hydrochloride extended-release 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) ]. Saxagliptin and metformin hydrochloride extended-release tablets are a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor, 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. ( 1 ) Limitations of Use:
Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. […]
Conditions named in the indications of metformin and saxagliptin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Biguanide and Dipeptidyl Peptidase 4 Inhibitor.
Source: FDA drug label (Saxagliptin and Metformin), Mylan Pharmaceuticals Inc., effective August 21, 2026 (SPL set cbf8677c-cafe-48bc-8844-0cc6547886bd), via openFDA; the full label on DailyMed
What does the patient leaflet for metformin and saxagliptin 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 saxagliptin and metformin hydrochloride extended-release tablets?Serious side effects can happen in people taking saxagliptin and metformin hydrochloride extended-release tablets, including: 1. Lactic acidosis. Metformin, one of the medicines in saxagliptin and metformin hydrochloride extended-release tablets, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking saxagliptin and metformin hydrochloride extended-release tablets and call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following symptoms of lactic acidosis: • feel very weak or tired • you have unusual (not normal) muscle pain • you have trouble breathing • you have stomach pains, nausea, vomiting or diarrhea • have unusual sleepiness or sleep longer than usual • feel cold, especially in your arms and legs • feel dizzy or lightheaded • have a slow or irregular heartbeat Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with saxagliptin and metformin hydrochloride extended-release tablets if you: • have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye • have liver problems • drink alcohol very often, or drink a lot of alcohol in 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: How should I store saxagliptin and metformin hydrochloride extended-release tablets?Store saxagliptin and metformin hydrochloride extended-release tablets between 20° to 25°C (68° to 77°F). Keep saxagliptin and metformin hydrochloride extended-release tablets and all medicines out of the reach of children.
Source: FDA drug label (Saxagliptin and Metformin), Mylan Pharmaceuticals Inc., effective August 21, 2026 (SPL set cbf8677c-cafe-48bc-8844-0cc6547886bd), via openFDA; the full label on DailyMed
Is there a generic for metformin and saxagliptin (Kombiglyze Xr)?
The FDA approved the first generic metformin and saxagliptin on July 31, 2023. 3 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists metformin and saxagliptin 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.
- 2010 earliest approval on file
- 2023 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for metformin and saxagliptin (Kombiglyze Xr)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $9.65 per Saxagliptin-metformin ER 5-1,000 mg tablet, down 2% from $9.87 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.
- Saxagliptin-metformin ER 2.5-1,000 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Saxagliptin-metformin ER 2.5-1,000 mg tablet | Generic | $5.01 per tablet | $150.21 | -0.5% |
| Saxagliptin-metformin ER 5-1,000 mg tablet | Generic | $9.65 per tablet | $289.41 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the metformin and saxagliptin label say about other medicines?
The metformin and saxagliptin label names 17 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 | Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. |
| Atazanavir | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
| Cimetidine | drug interactions | … transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [ see Clinical Pharmacology (12.3) ]. Consider the benefits and risks of concomitant use. |
| Clarithromycin | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
| Dichlorphenamide | drug interactions | Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. |
| Dolutegravir | drug interactions | … cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [ see Clinical Pharmacology (12.3) ]. … |
| Isoniazid | drug interactions | These medications include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| Itraconazole | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
| Ketoconazole | drug interactions | Strong CYP3A4/5 inhibitors (e.g., ketoconazole): Coadministration with saxagliptin and metformin hydrochloride extended-release tablets significantly increases saxagliptin concentrations. |
| Nefazodone | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
| Nelfinavir | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
| Phenytoin | drug interactions | These medications include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| Ranolazine | drug interactions | Drugs that Reduce Metformin Clearance Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and … |
| Ritonavir | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
Every other medicine the metformin and saxagliptin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Topiramate | boxed warning | … 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 … |
| Vandetanib | drug interactions | … [OCT2]/multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic … |
| Zonisamide | drug interactions | Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic … |
Source: FDA drug label (Saxagliptin and Metformin), Mylan Pharmaceuticals Inc., effective August 21, 2026 (SPL set cbf8677c-cafe-48bc-8844-0cc6547886bd), via openFDA; the full label on DailyMed
What do FAERS reports show for metformin and saxagliptin?
The FDA Adverse Event Reporting System holds 4 reports that list metformin and saxagliptin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 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 metformin and saxagliptin?
19 other medicines are given the same way (oral) and in the same FDA class as metformin and saxagliptin 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 |
|---|---|---|---|---|
| Sitagliptin | Type 2 diabetes | 4 labelers | $3.77 per tablet 100 mg tablet | No current entry |
| Alogliptin | Type 2 diabetes | none listed | $4.96 per tablet 12.5 mg tablet | No current entry |
| Alogliptin and pioglitazone | Type 2 diabetes | none listed | $4.73 per tablet 25-15 mg tablet | No current entry |
| Linagliptin | Type 2 diabetes | none listed | $16.80 per tablet 5 mg tablet | No current entry |
| Empagliflozin and linagliptin | Type 2 diabetes | none listed | $11.24 per tablet 10 mg-5 mg tablet | No current entry |
| Ertugliflozin and sitagliptin | Type 2 diabetes | none listed | $17.59 per tablet 15-100 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 |
Every medicine labeled for the same conditions as metformin and saxagliptin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to metformin and saxagliptin
- 19 medicines for the same use
- Other biguanides
- the pharmacologic class, with prices and generics
- Metformin and saxagliptin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other