Compound monograph · §4

Lixisenatide — safety

Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.

Document identifier: CEI-MN-010/4
Series: Compound monograph
Version: 3.1
Published: 12 Oct 2024
Last reviewed: 12 Apr 2025
Next review: 12 Apr 2027
Identifier: 10.71829/cei.mono.10
Certainty: Moderate
Cycle: 2024 Q4

§4Safety

§4.1Adverse events reported in controlled trials

Table 4. Adverse events for Lixisenatide 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	25.0	7.0	+18.0	GetGoal pooled
Vomiting	10.0	2.0	+8.0	GetGoal pooled
Headache	8.0	6.0	+2.0	GetGoal pooled
Symptomatic hypoglycaemia (with sulfonylurea)	22.0	13.0	+9.0	GetGoal pooled
Antibody formation	70.0	—	—	GetGoal pooled — high incidence; efficacy attenuated only at very high titre
Discontinuation for adverse events	7.0	3.0	+4.0	GetGoal 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

Known hypersensitivity
End-stage renal disease

§4.3Warnings and precautions

Acute pancreatitis
Hypoglycaemia with sulfonylurea or basal insulin
Immunogenicity is high in incidence though usually not neutralising
Severe gastrointestinal disease including gastroparesis — not recommended

§4.4What this section does not establish

What this document does not establish

Rare events. A trial programme of the size available for this compound could not detect an event occurring at a rate below approximately one in several hundred exposed participants. The absence of such an event in the tables above is uninformative, not reassuring.
Long-latency events. The longest randomised exposure in the contributing evidence is measured in months to a small number of years. Outcomes with a longer latency are outside what any contributing trial could observe.
Harms of the supplied material as distinct from the compound. Every incidence above was measured in a trial using material manufactured under a regulated quality system. Harms attributable to impurities, counter-ion load, endotoxin or incorrect content in research-supply material are not represented in any of these figures.

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.

Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. New England Journal of Medicine 2015;373(23):2247–2257. doi:10.1056/NEJMoa1509225 · PMID 26630143
Drucker DJ. Mechanisms of action and therapeutic application of glucagon-like peptide-1. Cell Metabolism 2018;27(4):740–756. doi:10.1016/j.cmet.2018.03.001 · PMID 29617641

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.

Compound Evidence Institute · CEI-MN-010/4 · https://compoundevidence.com/monographs/lixisenatide/safety/ · retrieved 30 July 2026