Prescription medicine
Exenatide Brand names: Byetta
Exenatide (Byetta) is a prescription medicine. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $300.17 per mL (Exenatide 10 mcg dose pen injection) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the exenatide FDA label on DailyMed (effective September 2, 2025); every exenatide label on DailyMed.
Highlights of the record
FDA label of September 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $300.17 per mL Exenatide 10 mcg dose pen injection
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 0 Class I among all firms' recalls; latest August 28, 2026
- FAERS reports
- 52,313 through July 30, 2026
What is exenatide used for?
From the label: indications and usageBYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use
BYETTA contains exenatide. Coadministration with other exenatide-containing products is not recommended. BYETTA (exenatide) is 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 , 14 ) Limitations of Use
Coadministration with other exenatide-containing products is not recommended ( 1 ).
Conditions named in the indications of exenatide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: GLP-1 Receptor Agonist.
Source: FDA drug label (Byetta), AstraZeneca Pharmaceuticals LP, effective September 2, 2025 (SPL set 53d03c03-ebf7-418d-88a8-533eabd2ee4f), via openFDA; the full label on DailyMed
What does the patient leaflet for exenatide 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 BYETTA?Serious side effects can happen in people who take BYETTA, including inflammation of your pancreas (pancreatitis). Stop using BYETTA 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 vomiting. You may feel the pain from your abdomen to your back.
From the patient leaflet: How should I store BYETTA?Store your new, unused BYETTA Pen in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C). • After first use, keep your BYETTA Pen at a temperature cooler than 77°F (25°C). • Do not freeze your BYETTA Pen. Do not use BYETTA if it has been frozen. • Protect BYETTA from light. • Use a BYETTA Pen for only 30 days. Throw away a used BYETTA Pen after 30 days, even if there is some medicine left in the pen. • Do not use BYETTA after the expiration date printed on the label. • Keep your BYETTA Pen, pen needles, and all medicines out of the reach of children.
Source: FDA drug label (Byetta), AstraZeneca Pharmaceuticals LP, effective September 2, 2025 (SPL set 53d03c03-ebf7-418d-88a8-533eabd2ee4f), via openFDA; the full label on DailyMed
Is there a generic for exenatide (Byetta)?
No generic exenatide is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists exenatide 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.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for exenatide (Byetta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $300.17 per mL (Exenatide 10 mcg dose pen injection), up 8% from $277.52 on October 22, 2025. 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.
- Exenatide 10 mcg dose pen injection (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Exenatide 10 mcg dose pen injection | Generic | $300.17 per mL | n/a | +8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has exenatide been recalled?
The FDA's Enforcement Report lists 1 recall naming exenatide since 2026: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 28, 2026 | Class II | Amneal Pharmaceuticals of New York, LLC | Defective Delivery System: Possibility of no medication in the prefilled pen. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the exenatide label say about other medicines?
The exenatide label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name exenatide. 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 | Orally Administered Drugs (e.g., acetaminophen) Clinical Impact Exenatide slows gastric emptying. Therefore, BYETTA has the potential to reduce the rate of absorption of orally administered drugs [see Clinical Pharmacology (12.3) ]. … |
| Warfarin | drug interactions | Clinical Impact; In a drug interaction study, BYETTA did not have a significant effect on INR [see ]. There have been postmarketing reports for BYETTA of increased INR with concomitant use of warfarin, sometimes associated with bleeding [see ]. |
Source: FDA drug label (Byetta), AstraZeneca Pharmaceuticals LP, effective September 2, 2025 (SPL set 53d03c03-ebf7-418d-88a8-533eabd2ee4f), via openFDA; the full label on DailyMed
What do FAERS reports show for exenatide?
The FDA Adverse Event Reporting System holds 52,313 reports that list exenatide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,763 are coded as a death and 7,535 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 rose sharply in 2016 (1,149, against a median of 274 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 exenatide?
14 other medicines are given the same way (subcutaneous) and in the same FDA class as exenatide 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 |
| 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 and liraglutide | Type 2 diabetes | none listed | $85.89 per mL 100 unit-3.6 mg/mL pen | No current entry |
| Insulin glargine and lixisenatide | Type 2 diabetes | none listed | $57.06 per mL 100 unit-33 mcg/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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to exenatide
- 14 medicines for the same use
- Other GLP-1 receptor agonists
- the pharmacologic class, with prices and generics
- Exenatide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other