Prescription medicine
Empagliflozin and linagliptin and metformin Brand names: Trijardy; first approved as Trijardy Xr
Empagliflozin and linagliptin and metformin (Trijardy) is a prescription medicine with an FDA approval on record since 2020. No generic is listed; pharmacies paid $11.28 per Trijardy XR 10-5-1,000 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the empagliflozin and linagliptin and metformin FDA label on DailyMed (effective August 24, 2026, Boehringer Ingelheim Pharmaceuticals, Inc.); the NDA 212614 record on Drugs@FDA; every empagliflozin and linagliptin and metformin label on DailyMed.
Highlights of the record
FDA label of August 24, 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 (2.3), 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 usageTRIJARDY XR is a combination of empagliflozin, linagliptin, and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 5 mg / 2.5 mg / 1000 mg
- 10 mg / 5 mg / 1000 mg
- 12.5 mg / 2.5 mg / 1000 mg
- 25 mg / 5 mg / 1000 mg
Extended-release tablet.
On the market
- Earliest approval on file
- January 27, 2020 Trijardy Xr, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 8, 2037 Trijardy XR tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $11.28 per tablet Trijardy XR 10-5-1,000 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 118 through July 30, 2026
What is empagliflozin and linagliptin and metformin used for?
From the label: indications and usageTRIJARDY XR is a combination of empagliflozin, linagliptin, and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease [see Clinical Studies (14.2) ]. TRIJARDY XR is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, linagliptin, 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. […]
Conditions named in the indications of empagliflozin and linagliptin and metformin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Biguanide, Dipeptidyl Peptidase 4 Inhibitor and Sodium-Glucose Cotransporter 2 Inhibitor.
Source: FDA drug label (Trijardy XR), Boehringer Ingelheim Pharmaceuticals, Inc., effective August 24, 2026 (SPL set 71873567-9594-452a-bb92-34a129adecac), via openFDA; the full label on DailyMed
What does the patient leaflet for empagliflozin and 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 TRIJARDY XR?TRIJARDY XR can cause serious side effects, including: Lactic Acidosis. Metformin hydrochloride (HCl), one of the medicines in TRIJARDY XR, 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. […] Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness swelling redness of skin (erythema) Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections: Urinary tract infection: burning feeling when you urinate need to urinate often or right away pain in the lower part of your stomach (pelvis) blood in your urine You may also have a fever, back pain, nausea, or vomiting. […]
From the patient leaflet: What should I avoid while taking TRIJARDY XR?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 TRIJARDY XR?Store TRIJARDY XR at room temperature between 68°F to 77°F (20°C to 25°C). Keep TRIJARDY XR tablets dry. Keep TRIJARDY XR and all medicines out of the reach of children.
Source: FDA drug label (Trijardy XR), Boehringer Ingelheim Pharmaceuticals, Inc., effective August 24, 2026 (SPL set 71873567-9594-452a-bb92-34a129adecac), via openFDA; the full label on DailyMed
Is there a generic for empagliflozin and linagliptin and metformin (Trijardy)?
No generic empagliflozin and linagliptin 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 17 patents for Trijardy XR tablets: the compound patent runs to August 1, 2028 (pediatric exclusivity to February 1, 2029), and the last listed entry to 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.
- 2020 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for empagliflozin and linagliptin and metformin (Trijardy)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.28 per Trijardy XR 10-5-1,000 mg tablet, down 44% from $20.20 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Trijardy XR 12.5-2.5-1,000 mg (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Trijardy XR 10-5-1,000 mg tablet | Brand | $11.28 per tablet | $338.32 | -44% |
| Trijardy XR 12.5-2.5-1,000 mg | Brand | $5.63 per unit | n/a | -44% |
| Trijardy XR 25-5-1,000 mg tablet | Brand | $11.24 per tablet | $337.16 | -44% |
| Trijardy XR 5-2.5-1,000 mg tablet | Brand | $5.67 per tablet | $170.06 | -44% |
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 empagliflozin and linagliptin and metformin label say about other medicines?
The empagliflozin and linagliptin and metformin label names 12 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 causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic 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 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 ]. |
| Isoniazid | drug interactions | … estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| Lithium | drug interactions | Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during TRIJARDY XR initiation and dosage changes. |
| 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 causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. … |
Check empagliflozin and linagliptin and metformin against other medicines
Source: FDA drug label (Trijardy XR), Boehringer Ingelheim Pharmaceuticals, Inc., effective August 24, 2026 (SPL set 71873567-9594-452a-bb92-34a129adecac), via openFDA; the full label on DailyMed
What do FAERS reports show for empagliflozin and linagliptin and metformin?
The FDA Adverse Event Reporting System holds 118 reports that list empagliflozin and linagliptin and metformin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 23 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 empagliflozin and linagliptin and metformin?
21 other medicines are given the same way (oral) and in the same FDA class as empagliflozin and 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 |
|---|---|---|---|---|
| Dapagliflozin | Type 2 diabetes | 22 labelers | $0.184 per tablet 10 mg tablet | No current entry |
| 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 |
| Canagliflozin | Type 2 diabetes | none listed | $19.13 per tablet 100 mg tablet | No current entry |
| Saxagliptin | Type 2 diabetes | 3 labelers | $1.04 per tablet 5 mg tablet | No current entry |
| Bexagliflozin | Type 2 diabetes | none listed | n/a | No current entry |
| Ertugliflozin and sitagliptin | Type 2 diabetes | none listed | $17.59 per tablet 15-100 mg tablet | No current entry |
Every medicine labeled for the same conditions as empagliflozin and linagliptin and metformin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to empagliflozin and linagliptin and metformin
- 21 medicines for the same use
- Other biguanides
- the pharmacologic class, with prices and generics
- Empagliflozin and linagliptin and metformin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other