Compound monograph · §4

Dulaglutide — safety

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

Document identifier: CEI-MN-008/4
Series: Compound monograph
Version: 3.1
Published: 23 Jul 2024
Last reviewed: 23 Sep 2025
Next review: 23 Sep 2027
Identifier: 10.71829/cei.mono.8
Certainty: High
Cycle: 2024 Q3

§4Safety

§4.1Adverse events reported in controlled trials

Table 4. Adverse events for Dulaglutide 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	12.4	5.3	+7.1	AWARD programme pooled (1.5 mg)
Diarrhoea	8.9	5.0	+3.9	AWARD pooled
Vomiting	6.0	2.3	+3.7	AWARD pooled
Abdominal pain	6.5	4.7	+1.8	AWARD pooled
Decreased appetite	4.9	1.6	+3.3	AWARD pooled
Acute pancreatitis	0.1	0.1	0.0	REWIND
Discontinuation for adverse events	5.1	2.9	+2.2	AWARD pooled
Antibody formation	1.6	—	—	AWARD pooled; neutralising antibodies rare
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.

Figure 4. Gastrointestinal adverse events for Dulaglutide as reported in the contributing safety tables. Incidences of this kind are dose- and titration-rate-dependent and attenuate with continued exposure in most but not all participants.

§4.2Contraindications

Personal or family history of medullary thyroid carcinoma
Multiple endocrine neoplasia syndrome type 2
Known hypersensitivity

§4.3Warnings and precautions

Boxed warning for thyroid C-cell tumours
Acute pancreatitis
Hypoglycaemia with insulin or secretagogues
Hypersensitivity including anaphylaxis
Diabetic retinopathy complications
Acute kidney injury from volume depletion

§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.

Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The Lancet 2019;394(10193):121–130. doi:10.1016/S0140-6736(19)31149-3 · PMID 31189511
Pratley RE, Aroda VR, Lingvay I, Lüdemann J, Andreassen C, Navarria A, Viljoen A. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. The Lancet Diabetes & Endocrinology 2018;6(4):275–286. doi:10.1016/S2213-8587(18)30024-X · PMID 29397376

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-008/4 · https://compoundevidence.com/monographs/dulaglutide/safety/ · retrieved 30 July 2026