Liraglutide — 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 Liraglutide 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 | 39.3 | 13.8 | +25.5 | SCALE Obesity (3.0 mg, 56 weeks) |
| Diarrhoea | 20.9 | 9.3 | +11.6 | SCALE Obesity |
| Constipation | 19.4 | 8.5 | +10.9 | SCALE Obesity |
| Vomiting | 15.7 | 3.9 | +11.8 | SCALE Obesity |
| Headache | 13.6 | 12.6 | +1.0 | SCALE Obesity |
| Cholelithiasis | 1.5 | 0.5 | +1.0 | SCALE Obesity |
| Acute pancreatitis | 0.3 | 0.1 | +0.2 | SCALE programme pooled |
| Discontinuation for adverse events | 9.9 | 3.8 | +6.1 | SCALE Obesity |
| Injection-site reaction | 13.9 | 10.5 | +3.4 | SCALE Obesity |
| 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
- Personal or family history of medullary thyroid carcinoma
- Multiple endocrine neoplasia syndrome type 2
- Known hypersensitivity
- Pregnancy
§4.3Warnings and precautions
- Boxed warning for thyroid C-cell tumours
- Acute pancreatitis
- Acute gallbladder disease
- Hypoglycaemia with insulin or secretagogues
- Renal impairment secondary to volume depletion
- Suicidal ideation reported in the SCALE programme at low incidence and monitored in post-marketing surveillance
§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.
- Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DCW, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JPH. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. New England Journal of Medicine 2015;373(1):11–22. doi:10.1056/NEJMoa1411892 · PMID 26132939
- Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JFE, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB. Liraglutide and cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine 2016;375(4):311–322. doi:10.1056/NEJMoa1603827 · PMID 27295427
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.