Orforglipron, like other GLP-1 receptor agonists, has shown thyroid C-cell tumors in rodent studies at clinically relevant exposures. It is unknown whether orforglipron causes such tumors, including medullary thyroid carcinoma, in humans. Foundayo is contraindicated in patients with a personal or family history of MTC and in patients with MEN 2.
About this product
Foundayo (orforglipron) is a once-daily oral GLP-1 receptor agonist indicated for chronic weight management in adults with obesity, or overweight with at least one weight-related condition, as an adjunct to a reduced-calorie diet and increased physical activity.
Important safety information
Orforglipron may cause serious side effects, including:
Possible thyroid tumors, including medullary thyroid carcinoma (MTC). Tell your provider about any neck lump, hoarseness, trouble swallowing, or shortness of breath.
Inflammation of the pancreas (pancreatitis). Stop and call your provider for severe abdominal pain that does not go away.
Gallbladder problems, including gallstones.
Low blood sugar (hypoglycemia), especially with insulin or sulfonylureas.
Acute kidney injury from dehydration related to nausea, vomiting, or diarrhea.
Serious allergic reactions, including anaphylaxis.
Increased heart rate.
Depression or thoughts of suicide.
Possible delayed gastric emptying — tell anesthesia providers about Foundayo use before surgery or sedation.
Do not use Foundayo if you
Or any of your family members have ever had medullary thyroid carcinoma (MTC).
Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Have had a serious allergic reaction to orforglipron or any of the ingredients.
Most common side effects
Nausea, vomiting, diarrhea, constipation
Indigestion, abdominal pain, decreased appetite
Belching, eructation
Headache, fatigue
Before starting Foundayo, tell your provider if you
Have or have had pancreatitis, gallbladder, kidney, or severe stomach problems
Have a history of diabetic retinopathy
Have a history of depression or suicidal thoughts
Are pregnant, plan to become pregnant, or are breastfeeding
Are taking other prescription, over-the-counter, vitamin, or herbal products
Reporting side effects
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to the manufacturer or to your NowYou care team.
Important
This summary does not include all information about this medication. It is not a substitute for the full Prescribing Information or for talking with your healthcare provider. Please read the full Prescribing Information and Medication Guide before starting treatment, and discuss any questions with your provider.
This safety summary is provided for educational purposes and does not replace the full Prescribing Information, Medication Guide, or professional medical advice. Always discuss benefits, risks, and alternatives with your licensed provider.