Quick answers
- What is Empagliflozin and linagliptin used for?
- The FDA-approved label (Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., January 20, 2026) says: “GLYXAMBI is a combination of empagliflozin and linagliptin 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 […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Empagliflozin and linagliptin?
- The “Adverse Reactions” section of the FDA label (Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., January 20, 2026) begins: “The following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1)] Pancreatitis [see Warnings and Precautions (5.2)] Volume Depletion [see Warnings and Precautions (5.3)] Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections …” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Empagliflozin and linagliptin?
- The “Drug Interactions” section of the FDA label (Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., January 20, 2026) begins: “Table 3 describes clinically relevant interactions with GLYXAMBI. Table 3 Clinically Relevant Interactions with GLYXAMBI Diuretics Clinical Impact Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Intervention Before initiating GLYXAMBI, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating GLYXAMBI.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Empagliflozin and linagliptin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Empagliflozin and linagliptin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Empagliflozin and linagliptin been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Empagliflozin and linagliptin?
- 1 company lists prescription products of Empagliflozin and linagliptin in the FDA NDC Directory, including Boehringer Ingelheim Pharmaceuticals, Inc.
What Empagliflozin and linagliptin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
GLYXAMBI is a combination of empagliflozin and linagliptin 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 […]. …
— FDA label: Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Empagliflozin and linagliptin side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1)] Pancreatitis [see Warnings and Precautions (5.2)] Volume Depletion [see Warnings and Precautions (5.3)] Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections …
— FDA label: Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026. This is part of the section. Read the full label on DailyMed →
Empagliflozin and linagliptin drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Table 3 describes clinically relevant interactions with GLYXAMBI. Table 3 Clinically Relevant Interactions with GLYXAMBI Diuretics Clinical Impact Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Intervention Before initiating GLYXAMBI, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating GLYXAMBI.
Read more of this section
Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy. Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia is increased when GLYXAMBI is used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin. Intervention Coadministration of GLYXAMBI with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower dosages of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during GLYXAMBI initiation and dosage changes. Inducers of P-glycoprotein or CYP3A4 Enzymes 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. Intervention Use of alternative treatments is strongly recommended when linagliptin is to be administered with a strong P-gp or CYP3A4 inducer. Positive Urine Glucose Test Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Intervention Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) Assay Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Intervention Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control. See full prescribing information for information on drug interactions and interference of GLYXAMBI with laboratory tests. (7)
— FDA label: Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026. This is part of the section. Read the full label on DailyMed →
Empagliflozin and linagliptin dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating. (2.1) The recommended dosage of GLYXAMBI is 10 mg empagliflozin and 5 mg linagliptin once daily, taken in the morning, with or without food. (2.2) Dosage may be increased to 25 mg empagliflozin and 5 mg linagliptin once daily.
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(2.2) Withhold GLYXAMBI for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. (2.4) 2.1 Testing Prior to Initiation of GLYXAMBI Assess renal function before initiating GLYXAMBI and as clinically indicated [see Warnings and Precautions (5.3)]. Assess volume status. In patients with volume depletion, correct this condition before initiating GLYXAMBI [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5, 8.6)]. 2.2 Recommended Dosage and Administration The recommended dosage of GLYXAMBI is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food. GLYXAMBI may be increased to 25 mg empagliflozin/5 mg linagliptin once daily for additional glycemic control. 2.3 Dosage Recommendations in Patients with Renal Impairment GLYXAMBI is not recommended for use in patients with an eGFR less than 30 mL/min/1.73 m 2 [see Indications and Usage (1), Warnings and Precautions (5.3), and Use in Specific Populations (8.6)]. 2.4 Temporary Interruption for Surgery Withhold GLYXAMBI for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. Resume GLYXAMBI when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)]. 2.5 Recommendations Regarding Missed Dose If a dose is missed, instruct patients to take the dose as soon as possible. Advise patients not to double up the next dose.
— FDA label: Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026. Read the full label on DailyMed →
Empagliflozin and linagliptin in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary Based on animal data showing adverse renal effects from empagliflozin, GLYXAMBI is not recommended during the second and third trimesters of pregnancy. The limited available data with GLYXAMBI, linagliptin, or empagliflozin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations).
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In animal studies, empagliflozin, a component of GLYXAMBI, resulted in adverse renal changes in rats when administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible. No adverse developmental effects were observed when the combination of linagliptin and empagliflozin was administered to pregnant rats (see Data). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal Data The combined components administered during the period of organogenesis were not teratogenic in rats up to and including a combined dose of 700 mg/kg/day empagliflozin and 140 mg/kg/day linagliptin, which is 253- and 353-times the clinical exposure. A pre- and postnatal development study was not conducted with the combined components of GLYXAMBI. Empagliflozin: Empagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 1, 10, 30, and 100 mg/kg/day caused increased kidney weights and renal tubular and pelvic dilatation at 100 mg/kg/day, which approximates 13-times the maximum clinical dose of 25 mg, based on AUC. These findings were not observed after a 13-week, drug-free recovery period. These outcomes occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimester of human renal development. In embryo-fetal development studies in rats and rabbits, empagliflozin was administered for intervals coinciding with the first trimester period of organogenesis in humans. Doses up to 300 mg/kg/day, which approximates 48-times (rats) and 128-times (rabbits) the maximum clinical dose of 25 mg (based on AUC), did not result in adverse developmental effects.
— FDA label: Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026. This is part of the section. Read the full label on DailyMed →
When Empagliflozin and linagliptin should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
GLYXAMBI is contraindicated in patients: with a hypersensitivity to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see Warnings and Precautions (5.7) and Adverse Reactions (6)]. Hypersensitivity to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI. (4)
— FDA label: Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026. Read the full label on DailyMed →
Empagliflozin and linagliptin overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
In the event of an overdose with GLYXAMBI, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Removal of empagliflozin by hemodialysis has not been studied, and removal of linagliptin by hemodialysis or peritoneal dialysis is unlikely.
— FDA label: Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Glyxambi |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| empagliflozin 10 mg · linagliptin 5 mg tablet, film coated | Brand: Glyxambi | $11.24 per tablet |
| empagliflozin 25 mg · linagliptin 5 mg tablet, film coated | Brand: Glyxambi | $11.19 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA206073 GLYXAMBI | Boehringer Ingelheim | January 30, 2015 | 20, latest October 24, 2025 2025: Labeling · 2023: Labeling · 2022: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 15, 2021 · Class II · Terminated · D-0455-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1602109, 1602115, 1602118, 1602120 |
|---|---|
| SPL set ID of the quoted label | ddbab689-f76c-488c-9613-4168d41dd730 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA206073 |
| Active ingredients (FDA) | EMPAGLIFLOZIN / LINAGLIPTIN |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- DiabetesCondition named on the label: hospitals that treat it
- Boehringer Ingelheim Pharmaceuticals, Inc.Maker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Glyxambi, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →