Prescription medicine
Alogliptin and metformin Brand names: Kazano
Alogliptin and metformin (Kazano) is a prescription medicine with an FDA approval on record since 2013. No generic is listed; pharmacies paid $2.46 per unit (Alogliptin-metformin 12.5-1000) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the alogliptin and metformin FDA label on DailyMed (effective August 17, 2026, Takeda Pharmaceuticals America, Inc.); the NDA 203414 record on Drugs@FDA; every alogliptin and metformin label on DailyMed.
Highlights of the record
FDA label of August 17, 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 bradyarrhythmia's. 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 (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 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 usageKAZANO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 12.5 mg / 1000 mg
- 12.5 mg / 500 mg
Film-coated tablet.
On the market
- Earliest approval on file
- January 25, 2013 Kazano, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 24, 2029 Kazano tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2.46 per unit Alogliptin-metformin 12.5-1000
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 138 through July 30, 2026
What is alogliptin and metformin used for?
From the label: indications and usageKAZANO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. KAZANO is a combination of alogliptin, a dipeptidyl-peptidase-4 (DPP-4) 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: Should not be used in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use KAZANO is not recommended for use in patients with type 1 diabetes mellitus.
Conditions named in the indications of alogliptin and metformin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Biguanide and Dipeptidyl Peptidase 4 Inhibitor.
Source: FDA drug label (KAZANO), Takeda Pharmaceuticals America, Inc., effective August 17, 2026 (SPL set 83cb7914-a683-47bb-a713-f2bc6a596bd2), via openFDA; the full label on DailyMed
What does the patient leaflet for alogliptin 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 KAZANO?KAZANO can cause serious side effects, including: 1. Lactic Acidosis. Metformin, one of the medicines in KAZANO, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis: you feel cold in your hands or feet you feel dizzy or lightheaded you have a slow or irregular heartbeat you feel very weak or tired you have unusual (not normal) muscle pain you have trouble breathing you feel sleepy or drowsy you have stomach pains, nausea or vomiting Most people who have had lactic acidosis with metformin have other things that, combined with metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance of getting lactic acidosis with KAZANO 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 KAZANO?Store KAZANO at room temperature between 68°F to 77°F (20°C to 25°C). Keep the container of KAZANO tightly closed. Keep KAZANO and all medicines out of the reach of children.
Source: FDA drug label (KAZANO), Takeda Pharmaceuticals America, Inc., effective August 17, 2026 (SPL set 83cb7914-a683-47bb-a713-f2bc6a596bd2), via openFDA; the full label on DailyMed
Is there a generic for alogliptin and metformin (Kazano)?
No generic alogliptin and metformin is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 2 patents for Kazano tablets: the compound patent runs to June 27, 2028, and the last listed entry to May 24, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for alogliptin and metformin (Kazano)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.46 per unit (Alogliptin-metformin 12.5-1000), up 6% from $2.32 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.
- Alogliptin-metformin 12.5-500 (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Alogliptin-metformin 12.5-1000 | Generic | $2.46 per unit | n/a | +6% |
| Alogliptin-metformin 12.5-500 | Generic | $2.32 per unit | n/a | -0.5% |
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 alogliptin and metformin label say about other medicines?
The alogliptin and metformin label names 10 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 | 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 KAZANO may increase the risk of lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Topiramate, zonisamide, acetazolamide or dichlorphenamide Drugs that Reduce Metformin Clearance |
| Cimetidine | drug interactions | Consider more frequent monitoring. ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. |
| Dichlorphenamide | drug interactions | 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 KAZANO may increase the risk of lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Topiramate, zonisamide, acetazolamide or dichlorphenamide Drugs that Reduce Metformin Clearance |
| Dolutegravir | drug interactions | Consider more frequent monitoring. ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. |
| 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 blocking drugs and isoniazid Alogliptin Cytochrome (CYP) P450, CYP-Substrates or Inhibitors |
| 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 blocking drugs and isoniazid Alogliptin Cytochrome (CYP) P450 … |
| Ranolazine | drug interactions | Consider more frequent monitoring. ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. |
| 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., acute congestive heart … |
| Vandetanib | drug interactions | Consider more frequent monitoring. ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. |
| Zonisamide | drug interactions | 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 KAZANO may increase the risk of lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Topiramate, zonisamide, acetazolamide or dichlorphenamide Drugs that Reduce Metformin Clearance |
Source: FDA drug label (KAZANO), Takeda Pharmaceuticals America, Inc., effective August 17, 2026 (SPL set 83cb7914-a683-47bb-a713-f2bc6a596bd2), via openFDA; the full label on DailyMed
What do FAERS reports show for alogliptin and metformin?
The FDA Adverse Event Reporting System holds 138 reports that list alogliptin and metformin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 25 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 alogliptin and metformin?
19 other medicines are given the same way (oral) and in the same FDA class as alogliptin 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 |
|---|---|---|---|---|
| Sitagliptin | Type 2 diabetes | 4 labelers | $3.77 per tablet 100 mg tablet | No current entry |
| Saxagliptin | Type 2 diabetes | 3 labelers | $1.04 per tablet 5 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 |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
Every medicine labeled for the same conditions as alogliptin and metformin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to alogliptin and metformin
- 19 medicines for the same use
- Other biguanides
- the pharmacologic class, with prices and generics
- Alogliptin and metformin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other