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Mounjaro ® (tirzepatide) injection
2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the incidence of nausea in adults with type 2 diabetes taking Mounjaro® (tirzepatide)?
Gastrointestinal adverse events, including nausea, were the most frequently reported adverse reactions in clinical trials with tirzepatide. Incidence decreased over time and was comparable to the GLP-1 receptor agonist class.
See important safety information, including boxed warning, in the attached prescribing information.
Nausea
Mounjaro (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) for once-weekly, subcutaneous administration.1
Reported gastrointestinal (GI) adverse events (AEs), including nausea, were the most frequently reported adverse reactions in clinical trials with tirzepatide. The majority of the reported GI AEs occurred during dose escalation and decreased over time.1
In pooled data derived from 2 placebo-controlled trials with a mean treatment duration of 36.6 weeks, nausea was reported in
18% of patients receiving tirzepatide 15 mg
15% of patients receiving tirzepatide 10 mg
12% of patients receiving tirzepatide 5 mg, and
4% of patients receiving placebo.1
Across 5 clinical studies, SURPASS-1, 2, 3, 4, and 5, the percent of patients experiencing nausea ranged between
18% to 24% for tirzepatide 15 mg
13% to 23% for tirzepatide 10 mg, and
12% to 17% for tirzepatide 5 mg.2-6
The SURPASS clinical trial program in adults with type 2 diabetes had a 20-week dose escalation phase. The starting dose of tirzepatide was 2.5 mg once weekly for 4 weeks, escalated in 2.5 mg increments every 4 weeks until the assigned dose of 5, 10, or 15 mg was achieved. 2-9
The slow dose escalation scheme used in the SURPASS clinical trial program was conducted to improve tolerability of treatment and was associated with a better gastrointestinal adverse event profile than the rapid dose escalation scheme used in the phase 2 trial.3
The incidence of nausea with tirzepatide, which refers to the proportion of participants who experienced a new event during a specified time interval, decreased over time during clinical trials and was comparable to the GLP-1 receptor agonist class.1,10
The incidence of nausea over time in SURPASS-2, which compared tirzepatide with semaglutide 1 mg, is shown in Figure 1.3
Figure . Incidence of Nausea Over Time Through 40 Weeks in SURPASS-23
Figure 1 description: In SURPASS-2, tirzepatide 5 mg, 10 mg, and 15 mg, and semaglutide 1 mg each demonstrated similar rates of nausea during initiation but decreased over time.
Abbreviations: mITT = modified intention-to-treat; SEMA = semaglutide; TZP = tirzepatide.
Data are percent of participants who reported a new event relative to participants at risk during a time interval; mITT population (safety analysis set). Shaded areas indicate the period of time before reaching the maintenance dose of the study treatments. Incidence refers to the proportion of participants who have a new event during a time interval.
Use of Antiemetic Medication in SURPASS-1 to -5
The clinical trial protocols for SURPASS-1 to -5 provided information on the management of patients with GI symptoms. Among other options to mitigate GI symptoms and manage patients with intolerable GI AEs, the investigator was asked to
advise patients to eat smaller meals and to stop eating when they feel full, and
prescribe symptomatic medication (eg, antiemetic medication) per local country availability and individual patient needs.11
Use of symptomatic medication was captured as concomitant medication in the study record.11
In the SURPASS-1 to -5 trials, the proportion of tirzepatide-treated patients who received antiemetic medications during the course of the trial is shown in (Table 1).11
Table . Proportion of Patients Taking 1 or More Antiemetic Medication During the Study Treatment Period in SURPASS-1 to -511
|
Trial |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Tirzepatide 15 mg |
|
SURPASS-1 |
10/121 (8.3) |
9/121 (7.4) |
11/121 (9.1) |
|
SURPASS-2 |
67/470 (14.3) |
71/469 (15.1) |
101/470 (21.5) |
|
SURPASS-3 |
22/358 (6.1) |
36/360 (10.0) |
52/359 (14.5) |
|
SURPASS-4 |
33/329 (10.0) |
47/328 (14.3) |
63/338 (18.6) |
|
SURPASS-5 |
7/116 (6.0) |
13/119 (10.9) |
12/120 (10.0) |
Abbreviation: mITT = modified intention-to-treat.
Note: Data is n/N (%) from the mITT population (full analysis set), defined as the number of patients who were randomized and received at least 1 dose of study drug per the assigned treatment group.
n = number of patients in the assigned treatment group that reported taking ≥1 antiemetic medication during the study treatment period.
N = number of patients in the assigned treatment group who were randomized and received at least 1 dose of study drug.
Enclosed Prescribing Information
MOUNJARO® (tirzepatide) injection, for subcutaneous use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1. Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
2. Rosenstock J, Wysham C, Frías JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. https://doi.org/10.1016/S0140-6736%2821%2901324-6
3. Frías JP, Davies MJ, Rosenstock J, et al; SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503-515. https://doi.org/10.1056/NEJMoa2107519
4. Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598. https://doi.org/10.1016/S0140-6736(21)01443-4
5. Del Prato S, Kahn SE, Pavo I, et al; SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824. https://doi.org/10.1016/S0140-6736(21)02188-7
6. Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. https://doi.org/10.1001/jama.2022.0078
7. Rosenstock J, Frías JP, Rodbard HW, et al. Tirzepatide vs insulin lispro added to basal insulin in type 2 diabetes: the SURPASS-6 randomized clinical trial. JAMA. 2023;330(17):1631-1640. https://doi.org/10.1001/jama.2023.20294
8. Inagaki N, Takeuchi M, Oura T, et al. Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial. Lancet. 2022;10(9):623-633. https://doi.org/10.1016/S2213-8587(22)00188-7
9. Kadowaki T, Chin R, Ozeki A, et al. Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial. Lancet. 2022;10(9):634-644. https://doi.org/10.1016/S2213-8587(22)00187-5
10. Karagiannis T, Avgerinos I, Liakos A, et al. Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. Diabetologia. 2022;65(8):1251-1261. https://doi.org/10.1007/s00125-022-05715-4
11. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: January 26, 2026