Prescription medicine
Insulin glargine and lixisenatide Brand names: Soliqua; first approved as Soliqua 100/33
Insulin glargine and lixisenatide (Soliqua) is a prescription medicine with an FDA approval on record since 2016. No generic is listed; pharmacies paid $57.06 per mL (Soliqua 100 unit-33 mcg/mL pen) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the insulin glargine and lixisenatide FDA label on DailyMed (effective March 18, 2026, Sanofi-Aventis U.S. LLC); the BLA 208673 record on Drugs@FDA; every insulin glargine and lixisenatide label on DailyMed.
Highlights of the record
FDA label of March 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
Injection (solution).
On the market
- Earliest approval on file
- November 21, 2016 Soliqua 100/33, Sanofi-Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing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)
- $57.06 per mL Soliqua 100 unit-33 mcg/mL pen
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,552 through July 30, 2026
What is insulin glargine and lixisenatide used for?
From the label: indications and usageSOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use ( 1 ): Concomitant use in combination with any other product containing a GLP-1 receptor agonist is not recommended. Not recommended for the treatment of diabetic ketoacidosis. […]
Conditions named in the indications of insulin glargine and lixisenatide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: GLP-1 Receptor Agonist and Insulin Analog.
Source: FDA drug label (Soliqua 100/33), Sanofi-Aventis U.S. LLC, effective March 18, 2026 (SPL set 4bba538b-cf7c-4310-ae8f-cb711ed21bcc), via openFDA; the full label on DailyMed
What does the patient leaflet for insulin glargine and lixisenatide 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 SOLIQUA 100/33?SOLIQUA 100/33 can cause serious side effects including inflammation of the pancreas (pancreatitis). Stop using SOLIQUA 100/33 and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.
From the patient leaflet: What should I avoid while taking SOLIQUA 100/33?While taking SOLIQUA 100/33 do not: drive or operate heavy machinery, until you know how SOLIQUA 100/33 affects you. drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
From the patient leaflet: How should I store SOLIQUA 100/33?Store your new, unused SOLIQUA 100/33 pen in the refrigerator at 36°F to 46°F (2°C to 8°C). Protect the pen from light. After first use, store your SOLIQUA 100/33 pen at room temperature no higher than 77°F (25°C). Do not freeze SOLIQUA 100/33 pens and do not use SOLIQUA 100/33 if it has been frozen. Replace the pen cap after each use to protect from light. After first use, use the SOLIQUA 100/33 pen for up to 28 days. Throw away the used SOLIQUA 100/33 pen after 28 days, even if there is some medicine left in the pen. Do not use SOLIQUA 100/33 past the expiration date printed on the carton and pen label. Do not store the SOLIQUA 100/33 pen with the needle attached. If the needle is left on, this might lead to contamination and cause air bubbles which might affect your dose of medicine. See the Instructions for Use about the right way to throw away the SOLIQUA 100/33 pen. […]
Source: FDA drug label (Soliqua 100/33), Sanofi-Aventis U.S. LLC, effective March 18, 2026 (SPL set 4bba538b-cf7c-4310-ae8f-cb711ed21bcc), via openFDA; the full label on DailyMed
Is there a generic for insulin glargine and lixisenatide (Soliqua)?
No generic insulin glargine and lixisenatide is approved (Drugs@FDA, October 8, 2026).
- 2016 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for insulin glargine and lixisenatide (Soliqua)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $57.06 per mL (Soliqua 100 unit-33 mcg/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.
- Soliqua 100 unit-33 mcg/mL pen (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Soliqua 100 unit-33 mcg/mL pen | Brand | $57.06 per mL | n/a | no change |
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 insulin glargine and lixisenatide label say about other medicines?
The insulin glargine and lixisenatide label names 18 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 |
|---|---|---|
| Acetaminophen | drug interactions | Oral contraceptives and other medications such as antibiotics and acetaminophen should be taken at least 1 hour prior to SOLIQUA 100/33 administration or 11 hours after. |
| Albuterol | drug interactions | … progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dose increases and increased frequency of glucose monitoring may be required when SOLIQUA 100/33 is coadministered with these drugs. |
| Clonidine | drug interactions | DRUG INTERACTIONS Drugs that affect glucose metabolism: Adjustment of SOLIQUA 100/33 dosage may be needed; closely monitor blood glucose. ( 7.1 ) Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): |
| Clozapine | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of SOLIQUA 100/33 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 SOLIQUA 100/33 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: Dose increases and increased frequency of glucose monitoring may be required when SOLIQUA 100/33 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 SOLIQUA 100/33 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 SOLIQUA 100/33 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 SOLIQUA 100/33 Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. |
| Niacin | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of SOLIQUA 100/33 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 SOLIQUA 100/33 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 … |
Every other medicine the insulin glargine and lixisenatide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Pentoxifylline | drug interactions | … disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. … |
| Pramlintide | drug interactions | … fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. … |
| 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: Dose increases and increased frequency of glucose monitoring may be required when … |
Check insulin glargine and lixisenatide against other medicines
Source: FDA drug label (Soliqua 100/33), Sanofi-Aventis U.S. LLC, effective March 18, 2026 (SPL set 4bba538b-cf7c-4310-ae8f-cb711ed21bcc), via openFDA; the full label on DailyMed
What do FAERS reports show for insulin glargine and lixisenatide?
The FDA Adverse Event Reporting System holds 3,552 reports that list insulin glargine and lixisenatide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 41 are coded as a death and 244 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 glargine and lixisenatide?
13 other medicines are given the same way (subcutaneous) and in the same FDA class as insulin glargine and lixisenatide 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 |
| Liraglutide | Type 2 diabetes | 9 labelers | $31.41 per mL 2-pak 18 mg/3 mL | In shortage |
| 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 |
| Insulin degludec | Type 2 diabetes | none listed | $11.39 per mL 100 unit/mL pen | No current entry |
| Exenatide | Type 2 diabetes | 1 labeler | $300.17 per mL 10 mcg dose pen injection | No current entry |
Every medicine labeled for the same conditions as insulin glargine and lixisenatide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to insulin glargine and lixisenatide
- 13 medicines for the same use
- Other GLP-1 receptor agonists
- the pharmacologic class, with prices and generics
- Insulin glargine and lixisenatide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other