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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.
Can people with gallbladder disease or gallbladder removal take Zepbound® (tirzepatide)?
Lilly cannot provide treatment recommendations on the use of tirzepatide in people with a history of gallbladder disease or removal. These participants were not excluded from tirzepatide trials, but no subgroup analysis was completed in this population.
See important safety information, including boxed warning, in the attached prescribing information.
Tirzepatide Use in Patients With Gallbladder Disease or Prior Gallbladder Removal
The use of tirzepatide in people with gallbladder disease or prior gallbladder removal is not listed as a contraindication.1
Participants with gallbladder disease or prior gallbladder removal were not explicitly excluded from the tirzepatide clinical trial programs for weight management.2-5
Eli Lilly and Company has not sponsored a subgroup analysis in participants with a preexisting condition of gallbladder disease or prior gallbladder removal in the tirzepatide weight management clinical studies.
Clinical Considerations
Treatment with tirzepatide and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease.1
In a pool of 2 tirzepatide weight management clinical trials (SURMOUNT-1 and SURMOUNT-2),
- cholelithiasis was reported in 1.1% of tirzepatide-treated patients and 1% of placebo-treated patients
- cholecystitis was reported in 0.7% of tirzepatide-treated patients and 0.2% of placebo-treated patients, and
- cholecystectomy was reported in 0.2% of tirzepatide-treated patients and no placebo-treated patients.1
Acute gallbladder events were associated with weight reduction. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.1
Eli Lilly and Company cannot provide treatment recommendations on the use of tirzepatide in people who have a history of gallbladder disease or prior gallbladder removal. In formulating an assessment and approach, the health care practitioner may consider
- the information provided
- the patient’s prior medical history and concomitant medications, and
- other individual factors.
The health care professional should consider potential risks and benefits of tirzepatide use in these patients
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; 2024.
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 28, 2025