Patient safety
Contraindications, warnings, precautions for use and reported adverse effects are available in the summary of product characteristics for tirzepatide.
Adverse effects
In SURMOUNT‑1 and SURMOUNT‑2, 2,519 people had tirzepatide alone or in combination with other glucose-lowering medicines. The most frequently reported adverse reactions were gastrointestinal disorders, including nausea, diarrhoea, constipation and vomiting (see table 3). In general, these reactions were mostly mild or moderate in severity and occurred more often during dose escalation and decreased over time.
| Adverse effect | Tirzepatide (no type 2 diabetes) | Placebo (no type 2 diabetes) | Tirzepatide (with type 2 diabetes) | Placebo (with type 2 diabetes) |
|---|---|---|---|---|
|
Nausea |
30% |
9% |
21% |
6% |
|
Vomiting |
10% |
2% |
12% |
3% |
|
Diarrhoea |
21% |
7% |
21% |
9% |
|
Constipation |
15% |
6% |
9% |
4% |
|
Dyspepsia |
10% |
4% |
7% |
3% |
|
Abdominal pain |
5% |
3% |
6% |
2% |
|
Eructation |
5% |
1% |
5% |
1% |
Pancreatitis has been reported with tirzepatide and other GLP‑1 agonists. In SURMOUNT‑1 and SURMOUNT‑2 pancreatitis was reported in only a small number of people. However, the trials were not powered to detect a difference between the tirzepatide and placebo groups and are unlikely to give reliable estimates of absolute or comparative risks. In people who did not have diabetes, hypoglycaemia was reported more frequently with tirzepatide than with placebo.
Pregnancy and contraception
Tirzepatide is not recommended during pregnancy or in people who can become pregnant and who are not using contraception. If the person wishes to become pregnant, tirzepatide should be stopped at least 1 month before a planned pregnancy because of its long half-life.
There is limited information about the effect of tirzepatide on the pharmacokinetics and efficacy of oral contraceptives in people with overweight or obesity. Since reduced efficacy of oral contraceptives cannot be excluded, switching to a non-oral contraceptive method, or adding a barrier method of contraception, is advised for 4 weeks after starting treatment and after each dose escalation (see the summary of product characteristics for tirzepatide).