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Exenatide Synthetic: uses, dosing, side effects & brands

Exenatide Synthetic is a medicine sold in the U.S. under 4 brand and generic names, for type 2 diabetes mellitus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Treats (across its forms)
Type 2 Diabetes Mellitus
Available as
Suspension, extended release · Injectable
Sold as
4 products — Bydureon, Bydureon Bcise and Bydureon Pen, and others
Prescription?
Prescription only
Generic available?
Not in our catalog

How Byetta is dosed

From the FDA label for Byetta (application NDA021773). Other exenatide synthetic products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Inject subcutaneously within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). ( 2.1 ) • Initiate at 5 mcg per dose twice daily; increase to 10 mcg twice daily after 1 month based on clinical response. ( 2.1 ) 2.1 Recommended Dosing • Initiate BYETTA at 5 mcg administered subcutaneously twice daily at any time within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). Do not administer after a meal. • Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily which is recommended after 1 month of therapy, in order to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ] . • Administer as a subcutaneous injection in the thigh, abdomen, or upper arm. • Rotate injections sites with each dose. Do not use the same site for each injection. • Inspect visually for particulate matter and discoloration. Only use BYETTA if the solution appears clear, colorless, and contains no particles. • When using BYETTA with insulin, administer as separate injections and never mix. It is acceptable to inject BYETTA and insulin in the same body region, but the injections should not be adjacent to each other. • If a dose is missed, resume the treatment…

Everything below is the FDA label for Byetta (injectable). Exenatide Synthetic is also sold as suspension, extended release, and those are different medicines to take — follow the label for the one you were prescribed.

Byetta side effects

The following serious adverse reactions are described below or elsewhere in the prescribing information: • Acute Pancreatitis [see Warnings and Precautions (5.1) ] • Never Share a BYETTA Pen Between Patients [see Warnings and Precautions (5.2) ] • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions (5.3) ] • Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions (5.4) ] • Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.5) ] • Immunogenicity [see Warnings and Precautions (5.6) ] • Hypersensitivity [see Warnings and Precautions (5.7) ] • Drug-Induced Thrombocytopenia [see Warnings and Precautions (5.8) ] • Acute Gallbladder Disease [see Warnings and Precautions (5.9) ] • Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.10) ] • Most common (≥5%) and occurring more frequently than placebo in clinical trials: nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, dyspepsia, constipation, asthenia. Nausea usually decreases over time. ( 5.3 , 6 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical…

Who shouldn’t take Byetta

BYETTA is contraindicated in patients with: • A prior severe hypersensitivity reaction to exenatide or to any of the excipients in BYETTA. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with BYETTA [see Warnings and Precautions (5.7) ]. • A history of drug-induced immune-mediated thrombocytopenia from exenatide products. Serious bleeding, which may be fatal, from drug-induced immune-mediated thrombocytopenia has been reported with exenatide use [see Warnings and Precautions (5.8) ] . • History of severe hypersensitivity to exenatide or any of the excipients in BYETTA. (4) • History of drug-induced immune-mediated thrombocytopenia from exenatide products. ( 4 )

Byetta drug interactions

May impact absorption of orally administered medications. ( 7 ) • Warfarin: Postmarketing reports of increased INR sometimes associated with bleeding. Monitor INR frequently until stable upon initiation or alteration of BYETTA therapy. ( 7 ) Generic Section Table 6: Clinically Relevant Interactions with BYETTA Concomitant Use of Insulin Secretagogues or Insulin Clinical Impact Exenatide promotes insulin release from pancreatic beta-cells in the presence of elevated glucose concentrations. The risk of hypoglycemia is increased when exenatide is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin [see Warnings and Precautions (5.3) and Adverse Reactions (6) ] . Intervention When initiating BYETTA, consider reducing the dose of concomitantly administered insulin secretagogue or insulin to reduce the risk of hypoglycemia. Warfarin Clinical Impact In a drug interaction study, BYETTA did not have a significant effect on INR [see Clinical Pharmacology (12.3) ] . There have been postmarketing reports for BYETTA of increased INR with concomitant use of warfarin, sometimes associated with bleeding [see Adverse Reactions (6.2) ] . Intervention In patients taking warfarin, the prothrombin time should be monitored more frequently after initiation or alteration of BYETTA therapy. Once a stable prothrombin time has been documented, the prothrombin time can be monitored at the intervals recommended for patients taking warfarin. 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) ]. Intervention Use caution when administering oral medications with BYETTA where a slower rate of oral absorption may be clinically meaningful. For oral medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics, patients should be advised to take those drugs at least 1 hour before BYETTA injection. If such drugs are to be administered with food, patients should be advised to take them with a meal or snack when BYETTA is not administered [see Clinical Pharmacology (12.3) ] .

Every exenatide synthetic product we track (4)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Exenatide Synthetic products
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What people report to the FDA about exenatide synthetic

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1 reports naming exenatide synthetic, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • cataract1 reports
  • chest pain1 reports
  • coronary artery occlusion1 reports
  • eye haemorrhage1 reports
  • retinopathy1 reports

Read these as a signal, not a rate. A report does not mean exenatide synthetic caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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Frequently asked questions

What is Byetta?

Byetta (Exenatide Synthetic) is a medication used to treat Type 2 Diabetes Mellitus.

Can you take exenatide synthetic with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run exenatide synthetic against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is exenatide synthetic sold under?

We track 4 exenatide synthetic-containing products in the U.S.: Bydureon, Bydureon Bcise, Bydureon Pen and Byetta. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does exenatide synthetic come in?

Across the brands we track, exenatide synthetic is currently marketed as suspension, extended release and injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic exenatide synthetic?

We do not currently list a generic-labelled exenatide synthetic product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Exenatide Synthetic: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/exenatide-synthetic
MLA
“Exenatide Synthetic: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/exenatide-synthetic.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for exenatide synthetic on DailyMed (NIH) ↗.