What the label lists and what reports show
Exenatide side effects
Exenatide's FDA label: “Most common (≥5%) and occurring more frequently than placebo in clinical trials: nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, dyspepsia, constipation, asthenia.” FAERS holds 52,313 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood glucose increased (15,473 reports).
- Generic listed
Check it at the source: the exenatide FDA label on DailyMed (effective September 2, 2025); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of BYETTA?BYETTA may cause serious side effects, including: • See "What is the most important information I should know about BYETTA?" • low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take BYETTA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. • Signs and symptoms of low blood sugar may include: ∘ dizziness or light-headedness ∘ sweating ∘ confusion or drowsiness ∘ headache ∘ blurred vision ∘ slurred speech ∘ shakiness ∘ fast heartbeat ∘ anxiety, irritability, or mood changes ∘ hunger ∘ weakness • feeling jittery • dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. […]
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective September 2, 2025 (SPL set 53d03c03-ebf7-418d-88a8-533eabd2ee4f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common (≥5%) and occurring more frequently than placebo in clinical trials: nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, dyspepsia, constipation, asthenia.
Table 1: Incidence (%) and Rate of Hypoglycemia when BYETTA was used as Monotherapy or with Concomitant Antidiabetic Therapy in Six Placebo-Controlled Clinical Trials A hypoglycemic episode was recorded if a patient…
| N | Placebo BID 77 | BYETTA 5 mcg BID 77 | BYETTA 10 mcg BID 78 |
|---|---|---|---|
| % Overall | 1.3% | 5.2% | 3.8% |
| Rate (episodes/patient-year) | 0.03 | 0.21 | 0.52 |
| % Severe | 0.0% | 0.0% | 0.0% |
| % Overall | 5.3% | 4.5% | 5.3% |
| Rate (episodes/patient-year) | 0.12 | 0.13 | 0.12 |
| % Severe | 0.0% | 0.0% | 0.0% |
| % Overall | 3.3% | 14.4% | 35.7% |
| Rate (episodes/patient-year) | 0.07 | 0.64 | 1.61 |
| % Severe | 0.0% | 0.0% | 0.0% |
| % Overall | 12.6% | 19.2% | 27.8% |
| Rate (episodes/patient-year) | 0.58 | 0.78 | 1.71 |
| % Severe | 0.0% | 0.4% | 0.0% |
| % Overall | 7.1% | not evaluated | 10.7% |
| Rate (episodes/patient-years) | 0.56 | not evaluated | 0.98 |
| % Severe | 0.0% | not evaluated | 0.0% |
| % Overall | 29.5% | not evaluated | 24.8% |
| Rate (episodes/patient-years) | 1.58 | not evaluated | 1.61 |
| % Severe | 0.8% | not evaluated | 0.0% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, 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?
52,313 reports list exenatide among the medicines taken, 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. Of the 23 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Exenatide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions