Tirzepatide — 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 Tirzepatide 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 | 29.0 | 9.5 | +19.5 | SURMOUNT-1 (15 mg, 72 weeks) |
| Diarrhoea | 23.4 | 7.3 | +16.1 | SURMOUNT-1 |
| Constipation | 11.7 | 5.8 | +5.9 | SURMOUNT-1 |
| Vomiting | 12.8 | 2.6 | +10.2 | SURMOUNT-1 |
| Dyspepsia | 9.1 | 2.9 | +6.2 | SURMOUNT-1 |
| Injection-site reaction | 5.6 | 0.9 | +4.7 | SURMOUNT-1 |
| Alopecia | 5.4 | 1.0 | +4.4 | SURMOUNT-1 |
| Cholelithiasis | 1.6 | 0.4 | +1.2 | SURMOUNT-1 |
| Acute pancreatitis | 0.2 | 0.1 | +0.1 | SURPASS programme pooled |
| Discontinuation for adverse events | 4.3 | 2.6 | +1.7 | SURMOUNT-1 |
| Serious adverse events | 6.3 | 6.2 | +0.1 | SURMOUNT-1 |
| Hypoglycaemia (<54 mg/dL) | 0.2 | 0.2 | 0.0 | SURMOUNT-1 (non-diabetic population) |
| 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 to tirzepatide or any excipient
- Pregnancy
§4.3Warnings and precautions
- Boxed warning for thyroid C-cell tumours based on rodent data
- Acute pancreatitis
- Acute gallbladder disease
- Hypoglycaemia with insulin or secretagogues
- Diabetic retinopathy in participants with pre-existing retinopathy
- Delayed gastric emptying with anaesthetic implications
- Reduced efficacy of combined oral contraceptives after initiation and dose escalation — a non-oral method or barrier method is advised for four weeks after each escalation
- Acute kidney injury from volume depletion
§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.
- Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A. Tirzepatide once weekly for the treatment of obesity. New England Journal of Medicine 2022;387(3):205–216. doi:10.1056/NEJMoa2206038 · PMID 35658024
- Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. The Lancet 2023;402(10402):613–626. doi:10.1016/S0140-6736(23)01200-X · PMID 37385275
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.