Prescription medicine
Linagliptin and metformin Brand names: Jentadueto
Linagliptin and metformin (Jentadueto) is a prescription medicine with an FDA approval on record since 2012. A generic is approved and listed by 1 labeler, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $8.44 per Jentadueto 2.5 mg-1,000 mg tablet.
- Generic approved
- Boxed warning
Check it at the source: the linagliptin and metformin FDA label on DailyMed (effective August 19, 2026, Boehringer Ingelheim Pharmaceuticals, Inc.); the NDA 201281 record on Drugs@FDA; every linagliptin and metformin label on DailyMed.
Highlights of the record
FDA label of August 19, 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 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) ]. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7), and Use in Specific Populations (8.6 , 8.7) ]. […]
Used for
From the label: indications and usageJENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 2.5 mg / 1000 mg
- 2.5 mg / 500 mg
- 2.5 mg / 850 mg
- 5 mg / 1000 mg
Film-coated tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- January 30, 2012 Jentadueto, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first August 30, 2021; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 8, 2037 Jentadueto tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $8.44 per tablet Jentadueto 2.5 mg-1,000 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 1,262 through July 30, 2026
What is linagliptin and metformin used for?
From the label: indications and usageJENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2) ]. […]
Conditions named in the indications of linagliptin and metformin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Biguanide and Dipeptidyl Peptidase 4 Inhibitor.
Source: FDA drug label (Jentadueto), Boehringer Ingelheim Pharmaceuticals, Inc., effective August 19, 2026 (SPL set f6dd9b86-0d18-95d4-2bc7-05591bfdd597), via openFDA; the full label on DailyMed
What does the patient leaflet for linagliptin 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 JENTADUETO?JENTADUETO can cause serious side effects, including: 1. Lactic acidosis. Metformin hydrochloride (HCl), one of the medicines in JENTADUETO, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking JENTADUETO and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms of lactic acidosis: feel very weak and tired have unusual (not normal) muscle pain have trouble breathing have unexplained stomach or intestinal problems with nausea and 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 You have a higher chance of getting lactic acidosis with JENTADUETO if you: have severe kidney problems. have liver problems. drink a lot of alcohol (very often or 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: What should I avoid while taking JENTADUETO?Avoid drinking alcohol very often or drinking a lot of alcohol in a short period of time ("binge" drinking). It can increase your chances of getting serious side effects.
From the patient leaflet: How should I store JENTADUETO?Store JENTADUETO at room temperature between 68°F and 77°F (20°C and 25°C). Keep tablets dry. Keep JENTADUETO and all medicines out of the reach of children.
Source: FDA drug label (Jentadueto), Boehringer Ingelheim Pharmaceuticals, Inc., effective August 19, 2026 (SPL set f6dd9b86-0d18-95d4-2bc7-05591bfdd597), via openFDA; the full label on DailyMed
Is there a generic for linagliptin and metformin (Jentadueto)?
The FDA approved the first generic linagliptin and metformin on August 30, 2021. 4 generic applications are approved; 4 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 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists linagliptin and metformin from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
The Orange Book lists 10 patents for Jentadueto tablets, the last expiring on December 8, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2021 first generic approved
- 2037 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for linagliptin and metformin (Jentadueto)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $8.44 per Jentadueto 2.5 mg-1,000 mg tablet, about the same as a year earlier. 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.
- Jentadueto 2.5 mg-1,000 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Jentadueto 2.5 mg-1,000 mg tablet | Brand | $8.44 per tablet | $253.16 | no change |
| Jentadueto 2.5 mg-500 mg tablet | Brand | $8.44 per tablet | $253.29 | +0.1% |
| Jentadueto 2.5 mg-850 mg tablet | Brand | $8.45 per tablet | $253.63 | no change |
| Jentadueto XR 2.5 mg-1,000 mg | Brand | $8.47 per unit | n/a | +0.3% |
| Jentadueto XR 5 mg-1,000 mg tablet | Brand | $16.95 per tablet | $508.41 | +0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has linagliptin and metformin been recalled?
The FDA's Enforcement Report lists 1 recall naming linagliptin and metformin since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the linagliptin and metformin label say about other medicines?
The linagliptin and metformin label names 11 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; Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with JENTADUETO may increase the risk of lactic acidosis. |
| Cimetidine | 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 acidosis [see ]. |
| Dichlorphenamide | drug interactions | Clinical Impact; Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with JENTADUETO may increase the risk of lactic 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 ]. |
| Isoniazid | drug interactions | … estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| Phenytoin | drug interactions | … thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| Ranolazine | drug interactions | Clinical Impact; 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 cimetidine) could increase … |
| Rifampin | drug interactions | Clinical Impact; Rifampin decreased linagliptin exposure, suggesting that the efficacy of linagliptin may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. |
| 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 | Clinical Impact; 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 cimetidine) could increase … |
| Zonisamide | drug interactions | Clinical Impact; Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with JENTADUETO may increase the risk of lactic acidosis. |
Source: FDA drug label (Jentadueto), Boehringer Ingelheim Pharmaceuticals, Inc., effective August 19, 2026 (SPL set f6dd9b86-0d18-95d4-2bc7-05591bfdd597), via openFDA; the full label on DailyMed
What do FAERS reports show for linagliptin and metformin?
The FDA Adverse Event Reporting System holds 1,262 reports that list linagliptin and metformin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 53 are coded as a death and 351 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 linagliptin and metformin?
19 other medicines are given the same way (oral) and in the same FDA class as linagliptin 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 |
| 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 |
| Saxagliptin | Type 2 diabetes | 3 labelers | $1.04 per tablet 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 linagliptin and metformin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to linagliptin and metformin
- 19 medicines for the same use
- Other biguanides
- the pharmacologic class, with prices and generics
- Linagliptin and metformin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other