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Foundayo ™ (orforglipron) tablet
0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 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 dysesthesia with Foundayo™ (orforglipron)?
In the pool of ATTAIN-1 and ATTAIN-2, dysesthesia was reported in 0.4% of participants treated with orforglipron and 0.1% of participants receiving placebo.
See important safety information, including boxed warning, in the attached prescribing information.
Were Dysesthesia Adverse Events Reported With Orforglipron in Phase 3 Weight Management Studies?
ATTAIN-1 and ATTAIN-2 were randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety of orforglipron in adults with obesity or overweight. ATTAIN-1 enrolled participants without type 2 diabetes (T2D) and ATTAIN-2 enrolled participants with T2D1,2
Dysesthesia is a touch-based disorder that can result in feelings of pain, itchiness, tingling, shock, burning, and other uncomfortable sensations in the skin.3
In the pool of ATTAIN-1 and ATTAIN-2, dysesthesia was reported in
- 0.3% of participants treated with orforglipron 9 mg
- 1.0% of participants treated with orforglipron 17.2 mg, and
- 0.1% of participants receiving placebo.4
No participants taking orforglipron 5.5 mg reported dysesthesia.4
These studies were conducted with an investigational orforglipron capsule formulation at doses equivalent to the once-daily tablet dosages approved in the United States.4
In the ATTAIN-1 and ATTAIN-2 studies, events of dysesthesia were identified using the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of
- allodynia
- burning sensation
- dysesthesia
- hyperesthesia
- hyperpathia
- pain of skin
- paresthesia
- sensitive skin
- skin burning sensation, and
- skin discomfort.1,2,5
What Is Known About Dysesthesia With GLP-1 Receptor Agonist Use?
Dysesthesia has recently been described for some marketed and investigational molecules with glucagon-like peptide- 1 (GLP-1) receptor agonism.5-8
The etiology is not well understood, but it is thought to be an error in the long-term potentiation of sensory nerves.6
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Wharton S, Aronne LJ, Stefanski A, et al; ATTAIN-1 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist for obesity treatment. N Engl J Med. 2025;393(18):1796-1806. https://doi.org/10.1056/NEJMoa2511774
- Horn DB, Ryan DH, Giljanovic Kis S, et al; ATTAIN-2 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial. Lancet. 2025;406(10522):2927-2944. https://doi.org/10.1016/S0140-6736(25)02165-8.
- Labib A, Burke O, Nichols A, Maderal AD. Approach to diagnosis, evaluation, and treatment of generalized and nonlocal dysesthesia: a review. J Am Acad Dermatol. 2023;89(6):1192-1200. https://doi.org/10.1016/j.jaad.2023.06.063
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- Ahern S. Allodynia and dysesthesia associated with semaglutide and tirzepatide. Cureus. 2025;17(10):e94126. https://doi.org/10.7759/cureus.94126
- Stark J, Klass MJ, Owen L. Allodynia (skin tenderness) associated with semaglutide: a case series. Am J Health Syst Pharm. 2025;82(9):e426-e430. https://doi.org/10.1093/ajhp/zxaf008
- Tran MM, Mirza FN, Lee AC, et al. Dermatologic findings associated with semaglutide use: a scoping review. J Am Acad Dermatol. 2024;91(1):166-168. https://doi.org/10.1016/j.jaad.2024.03.021
Date of Last Review: April 03, 2026