Label for oral GLP-1 Foundayo sets 30-day dose steps and no food timing rules

The full US prescribing information for Foundayo (orforglipron) has been published on DailyMed, laying out the labeled use, the step-by-step dose schedule and the safety warnings for Eli Lilly's once-daily oral GLP-1 tablet ^[1].

The label covers adults with obesity, or with overweight plus at least one weight-related health condition. It is intended for use along with a lower-calorie diet and more physical activity, to reduce excess weight and keep it off long term ^[1]. Taking it with another GLP-1 receptor agonist is not recommended ^[1]. The document was revised in July 2026 and updated on DailyMed on July 29, 2026. Eli Lilly and Company is listed as the packager, the marketing status is a New Drug Application, and the initial US approval year is 2026 ^[1].

How the label says to take it

Foundayo is a tablet swallowed whole — not split, crushed or chewed — once a day. The instructions say to take it with or without food and never to take more than one tablet in a day ^[1].

Six strengths appear in the label: 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg. Treatment begins at 0.8 mg. Each increase follows at least 30 days at the current level — first to 2.5 mg, then to 5.5 mg, then to 9 mg, 14.5 mg or 17.2 mg depending on response and tolerability. The ceiling is 17.2 mg daily. On the minimum timeline, that is roughly five months from first dose to top dose ^[1].

Safety information

A boxed warning covers thyroid C-cell tumors. Foundayo is contraindicated for people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[1]. The label states that orforglipron is not pharmacologically active in rats or mice and produced no tumors in rodents, and that the human relevance of GLP-1 receptor-dependent rodent thyroid tumors has not been determined ^[1].

Warnings also cover pancreatitis; severe gastrointestinal reactions, with the drug not recommended for people who have severe gastroparesis; acute kidney injury from fluid loss; low blood sugar when used with insulin or an insulin secretagogue; serious allergic reactions; diabetic retinopathy complications in type 2 diabetes; gallbladder disease; and pulmonary aspiration during general anesthesia or deep sedation ^[1].

Adverse reactions reported in 5% or more of patients include nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence and hair loss ^[1].

On interactions, the label sets a 9 mg daily maximum alongside a strong CYP3A4 inhibitor and says to avoid strong CYP3A4 inhibitors that also inhibit OATP1B. Strong CYP3A4 inducers should be avoided; with moderate inducers, effectiveness should be monitored and the dose raised if needed. Simvastatin should not exceed 20 mg daily. Foundayo delays stomach emptying and can change how other oral medicines are absorbed ^[1].

The drug may cause fetal harm and should be discontinued when pregnancy is recognized. People using oral contraceptives are advised to switch to a non-oral method or add a barrier method for 30 days after starting and for 30 days after each dose escalation. It is not recommended in severe hepatic impairment ^[1].

Why it matters for patients

The administration section contains no water limit and no waiting period before or after the dose — the instructions are one tablet daily, with or without food, swallowed whole ^[1]. For people whose schedule made a timed oral GLP-1 hard to keep up with, that removes one routine to remember.

The titration is deliberately slow. Thirty-day minimums at each step mean the maximum is not reached quickly, and months pass before the top dose ^[1].

The label includes no head-to-head weight-loss comparison with other GLP-1 medicines, so how Foundayo stacks up against injectables or other oral options is not established in this document ^[1]. Price and insurance coverage are also not addressed ^[1].