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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.
Are there any warnings or precautions with the use of Foundayo™ (orforglipron)?
Warnings and precautions associated with the use of orforglipron are presented below.
Boxed Warning: Risk of Thyroid C-Cell Tumors
See important safety information, including boxed warning, in the attached prescribing information.
In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents. While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined.1
Orforglipron is contraindicated in patients with a personal or family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.1
Orforglipron Warnings and Precautions
Risk of Thyroid C-Cell Tumors
In products with GLP-1 receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents. While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined.1
Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.1
Orforglipron is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of orforglipron and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, hyspnea, or persistent hoarseness).1
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with orforglipron. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.1
Acute Pancreatitis
Acute pancreatitis has been reported in patients treated with orforglipron. Fatal and non-fatal hemorrhagic or necrotizing pancreatitis have been observed in patients treated with GLP-1 receptor agonists.1
After initiation of orforglipron, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue orforglipron and initiate appropriate management.1
Severe Gastrointestinal Reactions
Use of orforglipron has been associated with gastrointestinal (GI) adverse reactions, sometimes severe. In clinical trials (ATTAIN-1 and ATTAIN-2), severe GI adverse reactions were reported more frequently among patients treated with orforglipron (approximately 3%) than patients who received placebo (1%). Severe GI adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.1
Orforglipron is not recommended in patients with severe gastroparesis.1
Acute Kidney Injury Due to Volume Depletion
There have been reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists or orforglipron. The majority of the reported events occurred in patients who experienced GI adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea.1
Monitor renal function in patients reporting adverse reactions to orforglipron that could lead to volume depletion, especially during dosage initiation and escalation of orforglipron.1
Hypoglycemia
Orforglipron lowers blood glucose and can cause hypoglycemia.1
In a trial of adults with type 2 diabetes (T2D) and body mass index (BMI) ≥27 kg/m2 (ATTAIN-2), hypoglycemia (plasma glucose <54 mg/dL) was reported in 2% of patients treated with orforglipron versus 0.2% of patients receiving placebo. One patient treated with orforglipron and no patients receiving placebo reported severe hypoglycemia in ATTAIN-2. In ATTAIN-2, 7% of patients treated with orforglipron in combination with sulfonylurea reported hypoglycemia compared with 0.5% of patients not taking a sulfonylurea.1
There is also increased risk of hypoglycemia in patients treated with orforglipron in combination with insulin. Hypoglycemia has also been associated with orforglipron and GLP-1 receptor agonists in adults without T2D.1
Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes, monitor blood glucose prior to starting orforglipron and during orforglipron treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea (or other concomitantly administered insulin secretagogue).1
Hypersensitivity Reactions
Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists. If hypersensitivity reactions occur, advise the patient to promptly seek medical attention and discontinue use of orforglipron.1
Orforglipron is contraindicated in patients with a prior serious hypersensitivity reaction to orforglipron or to any of the excipients in orforglipron. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with orforglipron.1
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes
Temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control. Orforglipron has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment. Monitor patients with a history of diabetic retinopathy for progression of diabetic retinopathy.1
Acute Gallbladder Disease
Treatment with orforglipron and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease.1
In a pool of two clinical trials for weight reduction (ATTAIN-1 and ATTAIN-2), cholelithiasis was reported in 1% of patients treated with orforglipron once daily and 0.7% of placebo-treated patients, and acute cholecystitis was reported in 0.4% of patients treated with orforglipron once daily and 0.3% of 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
Pulmonary Aspiration During General Anesthesia or Deep Sedation
Orforglipron delays gastric emptying.1
There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.1
Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking orforglipron, including whether modifying preoperative fasting recommendations or temporarily discontinuing orforglipron could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking orforglipron.1
Enclosed Prescribing Information
References
1Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: June 23, 2026