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Zepbound ® (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 Zepbound® (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?
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
In clinical studies of tirzepatide for a different indication, 14 events of acute pancreatitis were confirmed by adjudication in 13 tirzepatide-treated patients (0.23 patients per 100 years of exposure) versus 3 events in 3 comparator-treated patients (0.11 patients per 100 years of exposure).1
In pool of SURMOUNT-1 and -2, 0.2% of tirzepatide-treated patients had acute pancreatitis confirmed by adjudication (0.14 patients per 100 years of exposure) versus 0.2% of placebo-treated patients (0.15 patients per 100 years of exposure).1
In the pooled clinical studies of tirzepatide for obstructive sleep apnea (OSA), the exposure-adjusted incidence rate for treatment-emergent adjudication-confirmed pancreatitis was 0.84 patients per 100 years for tirzepatide and 0 for placebo-treated patients.1
Clinical Considerations for Acute Pancreatitis Risk and Patient Monitoring
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 healthcare provider if pancreatitis is suspected.1
After initiation of tirzepatide, observe patients carefully for signs and symptoms of acute pancreatitis.1
Observations in Individual Clinical Studies for Weight‑Management (SURMOUNT)
The SURMOUNT clinical trial program assessed the efficacy and safety of tirzepatide as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with obesity or overweight in the presence of at least one weight-related comorbid condition (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, prediabetes, or T2D). Confirmed adjudicated pancreatitis events from the SURMOUNT-1 to -4 clinical trials are summarized in Adjudication-Confirmed Pancreatitis in Phase 3 SURMOUNT-1 to -4 Studies.2-5
Event, n (%)a | Tirzepatide 5 mg | Tirzepatide 10 mg | Tirzepatide 15 mg | Tirzepatide MTD | Placebo |
SURMOUNT-1 | 1 (0.2) | 1 (0.2) | 1 (0.2) | NA | 1 (0.2) |
SURMOUNT-2 | NA | 0 | 2 (1%) | NA | 1 (<1%) |
SURMOUNT-3 | NA | 1 (0.3) | 1 (0.3) | ||
SURMOUNT-4b | NA | 0 | 0c | ||
Abbreviations: MTD = maximum tolerated dose (10 or 15 mg); NA = not applicable.
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.
bData is for the randomized treatment period week 36-88. There were no reported cases of adjudicated pancreatitis in the open label period (Week 0-36) for participants receiving tirzepatide.
cPatients in this group received tirzepatide in the open-label lead-in period.
Postmarketing Data for Pancreatitis
Acute pancreatitis, including hemorrhagic and necrotizing pancreatitis sometimes resulting in death have been reported during post-approval use of tirzepatide.1
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to
- reliably estimate their frequency, or
- establish a causal relationship to drug exposure.1
Can Tirzepatide be used in Patients with a History of Pancreatitis?
Tirzepatide has not been studied in patients with a history of pancreatitis and should be used with caution in these patients.2-5
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).
1Zepbound [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
2Jastreboff AM, Aronne LJ, Ahmad NN, et al; SURMOUNT-1 Investigators. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205-216. https://doi.org/10.1056/NEJMoa2206038
3Garvey WT, Frias JP, Jastreboff AM, et al; SURMOUNT-2 investigators. 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. Lancet. 2023;402(10402):613-626. https://doi.org/10.1016/S0140-6736(23)01200-X
4Wadden TA, Chao AM, Machineni S, et al. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023;29(11):2909-2918. https://doi.org/10.1038/s41591-023-02597-w
5Aronne LJ, Sattar N, Horn DB, et al; SURMOUNT-4 Investigators. Continued treatment with tirzepatide for maintenance of weight reduction in adults with obesity: the SURMOUNT-4 randomized clinical trial. JAMA. 2024;331(1):38-48. https://doi.org/10.1001/jama.2023.24945
Date of Last Review: January 21, 2026