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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.
Has pancreatitis been reported with Mounjaro® (tirzepatide)?
Pancreatitis has been reported in patients treated with tirzepatide. Patients should be informed of the symptoms of pancreatitis. If pancreatitis is suspected, tirzepatide should be discontinued and appropriate management should be initiated.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
What is the Incidence of Pancreatitis with Tirzepatide?
- Observations in Clinical Studies for Glycemic Control (SURPASS)
- Observations in Cardiovascular Outcomes Trial (SURPASS-CVOT) With a Median of 4 Years of Follow-up
- Postmarketing Data for Pancreatitis
Additional Prescribing Information Related to Acute Pancreatitis
Can Tirzepatide be used in Patients with a History of Pancreatitis?
Additional Prescribing Information Related to Acute Pancreatitis
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with glucagon-like peptide-1 (GLP-1) receptor agonists or tirzepatide.1
Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting.1
Instruct patients to discontinue tirzepatide promptly and contact their physician if pancreatitis is suspected.1
After initiation of tirzepatide, observe patients carefully for signs and symptoms of pancreatitis.1
If pancreatitis is suspected,
- discontinue tirzepatide, and
- initiate appropriate management.1
Amylase and Lipase Increases
The clinical significance of elevations in lipase or amylase with tirzepatide is unknown in the absence of other signs and symptoms of pancreatitis. In the pool of placebo-controlled clinical trials, treatment with tirzepatide resulted in mean increases from baseline in serum pancreatic amylase concentrations of 33% to 38% and serum lipase concentrations of 31% to 42%. Placebo-treated patients had a mean increase from baseline in pancreatic amylase of 4% and no changes were observed in lipase.1
What is the Incidence of Pancreatitis with Tirzepatide?
Observations in Clinical Studies for Glycemic Control (SURPASS)
The SURPASS clinical trial program assessed the efficacy and safety of tirzepatide as a treatment to improve glycemic control in people with type 2 diabetes. Confirmed adjudicated pancreatitis events from the SURPASS-1 to -6 clinical trials are summarized in Adjudication-Confirmed Pancreatitis in Phase 3 SURPASS-1 to -6 Studies.2-7
Event, n (%)a |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Tirzepatide 15 mg |
Comparatorb |
SURPASS-1 |
0 |
0 |
0 |
0 |
SURPASS-2 |
0 |
2 (0.4) |
2 (0.4) |
3 (0.6) |
SURPASS-3 |
0 |
0 |
0 |
0 |
SURPASS-4 |
3 (<1) |
2 (<1) |
1 (<1) |
1 (<1) |
SURPASS-5 |
0 |
0 |
0 |
0 |
SURPASS-6 |
0 |
0 |
0 |
0 |
aData are n (%); Safety analyses 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 as add-on to insulin glargine in SURPASS-6 for 52 weeks.
Observations in Cardiovascular Outcomes Trial (SURPASS-CVOT) With a Median of 4 Years of Follow-up
SURPASS-CVOT was an event-driven, randomized, double-blind, active comparator, parallel-group phase 3 study assessing the efficacy and safety of tirzepatide, up to 15 mg versus dulaglutide 1.5 mg on composite 3-point major adverse cardiovascular event (MACE-3) when added to standard of care in participants with T2D with established atherosclerotic cardiovascular disease.8
SURPASS-CVOT is the largest and longest study of tirzepatide to date, with a median follow-up of 4 years.8
Confirmed adjudicated pancreatitis events from the SURPASS-CVOT clinical trial are summarized in Adjudication-Confirmed Pancreatitis in Phase 3 SURPASS-CVOT Study.9
Event, n (%)a |
Tirzepatide |
Dulaglutide |
Pancreatitis |
41 (0.6) |
39 (0.6) |
Abbreviation: MedDRA = Medical Dictionary for Regulatory Activities.
aAdverse events are defined according to preferred terms in the MedDRA, version 28.0.
Postmarketing Data for Pancreatitis
The preferred terms pancreatitis and pancreatitis acute have been very rarely reported in the Global Patient Safety (GPS) spontaneous database.10
Very rarely is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the GPS database.10
These data do not represent the rate of occurrence of an adverse event in the treated population; they merely represent the rate of reporting of a particular adverse event to the company.10
Spontaneous reporting of adverse events can be highly variable and is not controlled clinical information on which to base an assessment of whether a particular drug product caused an event.10
Spontaneous reporting is also limited in usage due to a bias in reporting, including
- incomplete information concerning the patient as with an unknown medical history
- unknown concomitant medications and disease states, and
- under reporting.10
The GPS database may also include reports of adverse events for products that may be available from Eli Lilly and Company and from other manufacturers. Although verification of product manufacturer is sought, this verification is not always obtainable. The default for these cases is to include them in the GPS database.10
Due to the dynamic nature of the GPS database, this information is valid for data received through May 13, 2025.10
Can Tirzepatide be used in Patients with a History of Pancreatitis?
Tirzepatide has not been studied in people with a prior history of chronic or acute pancreatitis as these participants were excluded from the tirzepatide phase 3 type 2 diabetes (T2D) studies.2-7,9,11,12
Eli Lilly and Company cannot provide a recommendation on whether to use tirzepatide in a patient with a history of pancreatitis. The healthcare practitioner may use the information provided, the patient’s prior medical history and concomitant medications, and other individual factors in developing a treatment plan. The healthcare practitioner should consider the potential risks and benefits of treatment options and monitor appropriately.
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; 2026.
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
8Nicholls SJ, Bhatt DL, Buse JB, et al. Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease: SURPASS-CVOT design and baseline characteristics. Am Heart J. 2024;267:1-11. https://doi.org/10.1016/j.ahj.2023.09.007
9Nicholls SJ, Pavo I, Bhatt DL, et al; SURPASS-CVOT Investigators. Cardiovascular outcomes with tirzepatide versus dulaglutide in type 2 diabetes. N Engl J Med. 2025;393(24):2409-2420. https://doi.org/10.1056/NEJMoa2505928
10Data on file, Eli Lilly and Company and/or one of its subsidiaries.
11Inagaki 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
12Gao L, Lee BW, Chawla M, et al. Tirzepatide versus insulin glargine as second-line or third-line therapy in type 2 diabetes in the Asia-Pacific region: the SURPASS-AP-Combo trial. Nat Med. 2023;29(6):1500-1510. https://doi.org/10.1038/s41591-023-02344-1
Date of Last Review: January 21, 2026