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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.
Can Mounjaro® (tirzepatide) cause or worsen preexisting anxiety, panic, manic, or bipolar disorder?
There is no information about tirzepatide causing or worsening anxiety, panic, manic, or bipolar disorders because this has not been studied.
See important safety information, including boxed warning, in the attached prescribing information.
Tirzepatide and Anxiety, Panic, Manic, or Bipolar Disorders
No information about new or worsening anxiety, panic, manic, or bipolar disorders is included in the current US Mounjaro (tirzepatide) prescribing information.1 At the time of review, to the extent there was data available on new or worsening anxiety, panic, manic, or bipolar disorders from the tirzepatide clinical trials and postmarketing experience, it did not meet Food and Drug Administration's criteria for clinical significance, causality to the drug, or relevance to patient safety and treatment decisions.2
Patient safety is Eli Lilly and Company’s top priority, and we actively engage in evaluating, monitoring, and reporting safety information for all our medicines. If new information indicates a new safety concern or signal for the product or the class, including postmarketing experience, the prescribing information will be properly updated in alignment with regulatory authorities.2
The efficacy and safety of tirzepatide in patients with anxiety, panic, manic, or bipolar disorders have not been evaluated.
Relevant SURPASS Clinical Trial Exclusion Criteria
In the SURPASS clinical trial program, participants were excluded if they had a history of any condition that, in the opinion of the investigator, may preclude the patient from following and completing the protocol. Examples of exclusionary conditions include history of known drug abuse, alcohol abuse, or psychiatric disorder.3-9
Clinical Recommendations
Eli Lilly and Company cannot provide treatment recommendations on the use of tirzepatide in people with comorbid anxiety, panic, manic, or bipolar disorders. The health care practitioner should consider potential risks and benefits of treatment options and monitor appropriately.
Enclosed Prescribing Information
References
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2US Food and Drug Administration. Frequently asked questions about labeling for prescription medicines for healthcare professionals. Updated April 1, 2024. Accessed August 19, 2024. https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/frequently-asked-questions-about-labeling-prescription-medicines
3Rosenstock 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
4Frías 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
5Ludvik 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
6Del 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
7Dahl 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
8Inagaki 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
9Kadowaki 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
Date of Last Review: May 29, 2025