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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 injection site reactions associated with Mounjaro® (tirzepatide) use in adults with type 2 diabetes?
In the placebo-controlled phase 3 studies, injection site reactions were reported in 3.2% of tirzepatide-treated patients compared with 0.4% of placebo-treated patients.
See important safety information, including boxed warning, in the attached prescribing information.
Injection Site Reactions
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
The SURPASS clinical trial program assessed the efficacy and safety of tirzepatide as a treatment to improve glycemic control in people with T2D. Global registration trials include 5 registered clinical trials which compared tirzepatide with placebo, semaglutide, insulin degludec, and insulin glargine.2-6 SURPASS-6 compared tirzepatide with 3-times daily insulin lispro, both as add-on therapy in patients inadequately controlled with basal insulin.7
In placebo-controlled trials, injection site reactions were reported in 3.2% of tirzepatide-treated patients compared with 0.4% of placebo-treated patients.1 Injection site reactions ranged from <1% to 7% in the SURPASS-1 to -6 studies and occurred at least as or more commonly than active comparator as shown in Injection Site Reactions in SURPASS-1 to -6 Studies.2-7
No severe injection site reactions were reported in the SURPASS-1 to -6 clinical trial program.2-6,8
Parameter, n (%)a |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Tirzepatide 15 mg |
Comparatorb |
SURPASS-1 |
4 (3) |
4 (3) |
3 (2) |
0 |
SURPASS-2 |
9 (2) |
13 (3) |
21 (5) |
1 (<1) |
SURPASS-3 |
1 (<1) |
6 (2) |
8 (2) |
6 (2) |
SURPASS-4 |
1 (<1) |
2 (<1) |
1 (<1) |
4 (<1) |
SURPASS-5 |
4 (3) |
3 (3) |
8 (7) |
1 (1) |
SURPASS-6 |
1 (0.4) |
3 (1.3) |
4 (1.7) |
1 (0.1) |
aSafety analysis set: safety analysis set included all randomly assigned participants who took at least 1 dose of study drug with data from the start of the treatment to end of safety follow-up period.
bComparator was placebo in SURPASS-1 and SURPASS-5 for 40 weeks. Comparator was semaglutide 1 mg once weekly in SURPASS-2 for 40 weeks. Comparator was titrated insulin degludec in SURPASS-3 for 52 weeks. Comparator was titrated insulin glargine in SURPASS-4 for 52 weeks. Comparator was titrated insulin lispro in SURPASS-6 for 52 weeks.
Injection Site Reactions in Participants With Anti-Tirzepatide Antibodies
In a pool of seven clinical trials, injection site reactions occurred in 119/2,570 (4.6%) of tirzepatide-treated patients with anti-tirzepatide antibodies and in 18/2,455 (0.7%) of tirzepatide-treated patients who did not develop anti-tirzepatide antibodies.1
Management of Injection Site Reactions
The SURPASS-1 to -6 study protocols did not provide guidance about the management of injection site reactions. During the trials, investigators used local standards of care to make treatment recommendations.3-5,7-9
Eli Lilly and Company cannot provide treatment recommendations for injection site reactions.
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2Rosenstock 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
3Frías 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
4Ludvik 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
5Del 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
6Dahl 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
7Rosenstock 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
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
9Dahl D, Onishi Y, Norwood P, et al. Tirzepatide, a dual GIP/GLP-1 receptor agonist, is effective and safe when added to basal insulin for treatment of type 2 diabetes (SURPASS-5). Diabetes. 2021;70(suppl 1):80-LB. American Diabetes Association abstract 80-LB. https://doi.org/10.2337/db21-80-LB
Date of Last Review: September 05, 2023