Prescription medicine
Insulin degludec and liraglutide Brand names: Xultophy; first approved as Xultophy 100/3.6
Insulin degludec and liraglutide (Xultophy) is a prescription medicine with an FDA approval on record since 2016. No generic is listed; pharmacies paid $85.89 per mL (Xultophy 100 unit-3.6 mg/mL pen) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the insulin degludec and liraglutide FDA label on DailyMed (effective October 14, 2025, Novo Nordisk); the BLA 208583 record on Drugs@FDA; every insulin degludec and liraglutide label on DailyMed.
Highlights of the record
FDA label of October 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF THYROID C-CELL TUMORS •.
Liraglutide, one of the components of XULTOPHY 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13 )].
XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of XULTOPHY 100/3.6 and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with XULTOPHY 100/3.6 [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning.
Liraglutide, one of the components of XULTOPHY 100/3.6, causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. […]
Used for
From the label: indications and usageXULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 3.6 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- November 21, 2016 Xultophy 100/3.6, Novo; 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
Supply and safety
- Pharmacy cost (NADAC)
- $85.89 per mL Xultophy 100 unit-3.6 mg/mL pen
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 1 Class I among all firms' recalls; latest March 22, 2021
- FAERS reports
- 1,628 through July 30, 2026
What is insulin degludec and liraglutide used for?
From the label: indications and usageXULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:
XULTOPHY 100/3.6 contains liraglutide. Coadministration with any other product containing liraglutide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended [see Warnings and Precautions ( 5.5 )].
XULTOPHY 100/3.6 is not recommended for the treatment of diabetic ketoacidosis.
XULTOPHY 100/3.6 has not been studied in combination with prandial insulin. […]
Conditions named in the indications of insulin degludec and liraglutide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: GLP-1 Receptor Agonist and Insulin Analog.
Source: FDA drug label (Xultophy 100/3.6), Novo Nordisk, effective October 14, 2025 (SPL set 21335fe4-d395-4501-ac2a-2f20d7520da9), via openFDA; the full label on DailyMed
What does the patient leaflet for insulin degludec and liraglutide 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 XULTOPHY 100/3.6?XULTOPHY 100/3.6 may cause serious side effects, including: • Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide, one of the components of XULTOPHY 100/3.6, and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer. It is not known if XULTOPHY 100/3.6 will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. • Do not use XULTOPHY 100/3.6 if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
From the patient leaflet: What should I avoid while taking XULTOPHY 100/3.6?While taking XULTOPHY 100/3.6 do not: • drive or operate heavy machinery, until you know how XULTOPHY 100/3.6 affects you. • drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
From the patient leaflet: How should I store my XULTOPHY 100/3.6 pen?Before use: • Store unused XULTOPHY 100/3.6 pens in the refrigerator at 36°F to 46°F (2°C to 8°C). • Do not freeze XULTOPHY 100/3.6. Do not use XULTOPHY 100/3.6 if it has been frozen. • Unused pens may be used until the expiration date printed on the label, if kept in the refrigerator. • If XULTOPHY 100/3.6 is stored outside of refrigeration prior to first use, it should be used or thrown away within 21 days. • Store the pens in the carton they come in to keep them clean and protected from light. Pen in use: • Store the pen you are currently using at room temperature at 59°F to 86°F (15°C to 30°C) or in a refrigerator at 36°F to 46°F (2°C to 8°C). • Do not freeze XULTOPHY 100/3.6. Do not use XULTOPHY 100/3.6 if it has been frozen. • Keep XULTOPHY 100/3.6 away from heat and light. […]
Source: FDA drug label (Xultophy 100/3.6), Novo Nordisk, effective October 14, 2025 (SPL set 21335fe4-d395-4501-ac2a-2f20d7520da9), via openFDA; the full label on DailyMed
Is there a generic for insulin degludec and liraglutide (Xultophy)?
No generic insulin degludec and liraglutide is approved (Drugs@FDA, October 8, 2026).
- 2016 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for insulin degludec and liraglutide (Xultophy)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $85.89 per mL (Xultophy 100 unit-3.6 mg/mL pen), 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.
- Xultophy 100 unit-3.6 mg/mL pen (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Xultophy 100 unit-3.6 mg/mL pen | Brand | $85.89 per mL | n/a | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has insulin degludec and liraglutide been recalled?
The FDA's Enforcement Report lists 1 recall naming insulin degludec and liraglutide since 2021: 1 Class I (the most serious), 0 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 22, 2021 | Class I | Novo Nordisk Inc | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the insulin degludec and liraglutide label say about other medicines?
The insulin degludec and liraglutide 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 |
|---|---|---|
| Albuterol | drug interactions | … progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dosage increases and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs. |
| Clonidine | drug interactions | Anti-Adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Hypoglycemia signs and symptoms may be reduced or absent. |
| Clozapine | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of XULTOPHY 100/3.6 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Danazol | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of XULTOPHY 100/3.6 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Disopyramide | drug interactions | Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics … |
| Epinephrine | drug interactions | … (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dosage increases and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs. |
| Fluoxetine | drug interactions | Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics … |
| Glucagon | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of XULTOPHY 100/3.6 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Isoniazid | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of XULTOPHY 100/3.6 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Lithium | drug interactions | Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of XULTOPHY 100/3.6 Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. |
| Niacin | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of XULTOPHY 100/3.6 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Octreotide | drug interactions | Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics … |
| Olanzapine | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of XULTOPHY 100/3.6 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Pentoxifylline | drug interactions | Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics … |
Every other medicine the insulin degludec and liraglutide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Pramlintide | drug interactions | … fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics Intervention: Dosage reductions and … |
| Somatropin | drug interactions | … progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. … |
| Terbutaline | drug interactions | … somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dosage increases and increased frequency of glucose monitoring may be required when … |
Check insulin degludec and liraglutide against other medicines
Source: FDA drug label (Xultophy 100/3.6), Novo Nordisk, effective October 14, 2025 (SPL set 21335fe4-d395-4501-ac2a-2f20d7520da9), via openFDA; the full label on DailyMed
What do FAERS reports show for insulin degludec and liraglutide?
The FDA Adverse Event Reporting System holds 1,628 reports that list insulin degludec and liraglutide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 90 are coded as a death and 630 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 insulin degludec and liraglutide?
12 other medicines are given the same way (subcutaneous) and in the same FDA class as insulin degludec and liraglutide 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 (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tirzepatide | Type 2 diabetes | none listed | $538.68 per mL 10 mg/0.5 mL pen | No current entry |
| Insulin glargine | Type 2 diabetes | none listed | $2.90 per mL 100 pen | A presentation being discontinued |
| Insulin aspart | Type 2 diabetes | none listed | $6.95 per mL 100 unit/mL vial | No current entry |
| Insulin lispro | Type 2 diabetes | none listed | $10.19 per mL 100 unit/mL kwikpen | A presentation being discontinued |
| Semaglutide | Type 2 diabetes | none listed | $331.99 per mL 0.25-0.5 mg/dose (2 mg/3 mL) pen | A presentation being discontinued |
| Dulaglutide | Type 2 diabetes | none listed | $487.57 per mL 0.75 mg/0.5 mL pen | No current entry |
| Exenatide | Type 2 diabetes | 1 labeler | $300.17 per mL 10 mcg dose pen injection | No current entry |
| Insulin detemir | Type 2 diabetes | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as insulin degludec and liraglutide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to insulin degludec and liraglutide
- 12 medicines for the same use
- Other GLP-1 receptor agonists
- the pharmacologic class, with prices and generics
- Insulin degludec and liraglutide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other