Exenatide — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for Exenatide as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Nausea | 44.0 | 18.0 | +26.0 | AMIGO pooled (immediate release) |
| Vomiting | 13.0 | 4.0 | +9.0 | AMIGO pooled |
| Diarrhoea | 13.0 | 6.0 | +7.0 | AMIGO pooled |
| Injection-site nodule | — | — | — | A characteristic finding with the microsphere extended-release product, reported in up to 17 % and generally resolving over weeks to months |
| Acute pancreatitis | 0.2 | 0.1 | +0.1 | EXSCEL |
| Antibody formation | — | — | — | Higher than for human-sequence analogues, reflecting the non-human origin; high-titre antibodies attenuate efficacy in a minority |
| Discontinuation for adverse events | 8.0 | 3.0 | +5.0 | AMIGO pooled |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Severe renal impairment or end-stage renal disease (eGFR below 30 mL/min/1.73 m²)
- Personal or family history of medullary thyroid carcinoma (extended-release product)
- Known hypersensitivity
§4.3Warnings and precautions
- Boxed warning for thyroid C-cell tumours applies to the extended-release presentation
- Acute pancreatitis
- Renal impairment and reports of acute renal failure
- Hypoglycaemia with secretagogues
- Immunogenicity with efficacy attenuation at high antibody titre
- Injection-site nodules with the microsphere product
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Holman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, Chan JC, Choi J, Gustavson SM, Iqbal N, Maggioni AP, Marso SP, Öhman P, Pagidipati NJ, Poulter N, Ramachandran A, Zinman B, Hernandez AF. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine 2017;377(13):1228–1239. doi:10.1056/NEJMoa1612917 · PMID 28910237
- Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). The Lancet 2009;374(9683):39–47. doi:10.1016/S0140-6736(09)60659-0 · PMID 19515413
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