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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.
Is Foundayo™ (orforglipron) associated with gastroparesis?
Use of orforglipron has been associated with gastrointestinal adverse reactions, sometimes severe. Orforglipron is not recommended in patients with severe gastroparesis.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Warnings and Precautions Related to Orforglipron and Severe Gastrointestinal Reactions
- Were Gastroparesis Events Reported With Orforglipron in Phase 3 Studies for Weight Management?
- Enclosed Prescribing Information
- References
Warnings and Precautions Related to Orforglipron and Severe Gastrointestinal Reactions
Orforglipron delays gastric emptying. The delay is largest after the first dose and diminishes over time.1
Use of orforglipron has been associated with gastrointestinal adverse reactions, sometimes severe. In clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients treated with orforglipron (approximately 3%) than patients who received placebo (1%).1
Severe gastrointestinal adverse reactions have also been reported postmarketing with glucagon-like peptide-1 (GLP-1) receptor agonists.1
Orforglipron is not recommended in patients with severe gastroparesis.1
Were Gastroparesis Events Reported With Orforglipron in Phase 3 Studies for Weight Management?
In 2 completed phase 3 placebo-controlled studies for weight management, ATTAIN-1 and ATTAIN-2, potential gastroparesis events were reported by
- 31 (0.99%) out of 3155 participants receiving orforglipron, and
- 5 (0.33%) out of 1576 participants receiving placebo.2
None of the events were reported as serious.2
In this analysis, "potential gastroparesis events" refer to any of the events that met the search criteria for gastroparesis events as defined by the following Medical Dictionary for Regulatory Activities (MedDRA) preferred terms:
- bezoar
- diabetic gastroparesis
- diabetic gastropathy
- endoscopy upper gastrointestinal tract
- endoscopy upper gastrointestinal tract abnormal
- gastric atony
- gastric emptying study
- gastric hypomotility
- gastric residual increased
- gastrointestinal hypomotility
- gastrointestinal motility disorder
- gastroparesis postoperative
- impaired gastric emptying, or
- regurgitation.2
To identify potential events of gastroparesis, an intentionally broad search strategy was utilized that included diagnostic tests, symptoms, and sequelae that may be associated with gastroparesis. As a result, some adverse events may be included that are not gastroparesis.2
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: April 01, 2026