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Foundayo (Orforglipron): What the Label Says

November 1, 2026

Educational only. Not medical advice. Talk to your doctor.

Short answer: Foundayo® (orforglipron) is a once-daily GLP-1 tablet from Eli Lilly; the FDA announced its approval on April 1, 2026, for weight reduction in adults with obesity, or adults with overweight and at least one weight-related condition. Its label says to take it by mouth once a day, with or without food, and to swallow it whole. This page summarizes what the label and Medication Guide say, without strengths or how a prescriber adjusts them.

What is Foundayo?

The Foundayo label on DailyMed (effective July 29, 2026) says the tablets contain orforglipron, “a GLP-1 receptor agonist.” Section 12.1 adds that Foundayo “binds to and activates the human GLP-1 receptor.” The FDA’s approval announcement describes it as a tablet taken by mouth once daily that “does not need to be taken on an empty stomach.” For what the GLP-1 class does, see What is a GLP-1?.

Who is Foundayo for?

Section 1 lists one use: “in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.”

  • Not with another GLP-1. The label says: “Concomitant use with another GLP-1 receptor agonist is not recommended.”
  • Adults only. Section 8.4 says safety and effectiveness “have not been established in pediatric patients.”
  • Who should not take it. Section 4 says Foundayo is contraindicated in people with a personal or family history of medullary thyroid carcinoma (MTC), in people with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and in people with a known serious allergic reaction to orforglipron or any of the tablet’s ingredients.

The label does not list a blood sugar use for type 2 diabetes, although one of its two trials (Trial 2) enrolled adults with type 2 diabetes. Section 8.6 says Foundayo is not recommended for people with severe liver impairment, and Section 5.3 says it is not recommended for people with severe gastroparesis.

How is Foundayo taken?

Section 2.1 says:

  • “Take FOUNDAYO orally once daily, with or without food.”
  • “Swallow tablets whole. Do not break, crush, or chew.”
  • “Do not take more than one tablet per day.”

The label sets a stepwise schedule of tablet strengths, which it says is meant to reduce the risk of stomach and bowel side effects. Your prescriber manages that schedule, so it is not covered here. For what to do about a missed tablet, follow your Medication Guide and your prescriber.

Section 12.3 reports “no clinically relevant food effect on orforglipron exposure” and says steady levels are reached after about 1 week of daily use. It gives an elimination half-life of about 29 to 49 hours; see how long GLP-1 medicines stay in your system.

How is Foundayo different from semaglutide tablets?

Three GLP-1 tablet labels are on DailyMed. Their instructions differ most around food and water.

Foundayo tabletsWegovy tabletsRybelsus and Ozempic tablets
MedicineOrforglipronSemaglutideSemaglutide
How oftenOnce dailyOnce dailyOnce daily
Food and waterWith or without foodEmpty stomach in the morning, with up to 4 ounces of plain water; wait at least 30 minutes before eating, drinking or other oral medicinesSame steps as Wegovy tablets
Uses in Section 1Weight reduction in adultsHeart-risk reduction and weight reduction in adultsBlood sugar control in adults with type 2 diabetes; heart-risk reduction in adults with type 2 diabetes at high risk
Storage68°F to 77°F, in a bottle with a desiccant68°F to 77°F, in the original bottle, away from moisture68°F to 77°F, in the original bottle, away from moisture

The semaglutide tablet labels list an absorption ingredient called SNAC, and the Wegovy label says absorption from the tablet happens mainly in the stomach and was higher after a longer fast. The Foundayo label lists no such ingredient and reports no clinically relevant food effect. These are different medicines tested in different trials, so the table compares instructions, not results. For more on the Wegovy tablet, see Wegovy pill: what the label says, and for pills next to injections, see GLP-1 pills vs shots.

What side effects does the Foundayo label report?

Section 6.1 pools two placebo-controlled trials (Trials 1 and 2): 3,155 adults with obesity or overweight took Foundayo once daily for up to 72 weeks, and 1,576 took placebo. Table 1 reports three strengths separately; the range below covers all three.

Reported in at least 5% of patients on FoundayoPlaceboFoundayo (range across the three strengths)
Nausea10%26% to 35%
Constipation9%20% to 27%
Diarrhea11%21% to 25%
Vomiting4%13% to 24%
Indigestion (dyspepsia)4%12% to 16%
Stomach (abdominal) pain7%13% to 14%
Headache7%8% to 9%
Swollen belly (abdominal distension)3%7% to 9%
Fatigue4%6% to 9%
Belching1%6% to 8%
Reflux (GERD)2%6% to 7%
Gas2%5% to 6%
Hair loss2%4% to 5%
  • Stopping treatment. 8% of people on Foundayo stopped permanently because of side effects, compared with 3% on placebo; most of them (5%) stopped because of stomach and bowel side effects.
  • How severe. Of the people on Foundayo who had stomach and bowel side effects, 60% reported them as mild, 36% as moderate and 4% as severe. The label says nausea, vomiting and diarrhea were more common while the strength was being increased “and decreased over time.”
  • Low blood sugar. In Trial 2 (adults with type 2 diabetes), low blood sugar was reported in 2% on Foundayo vs 0.2% on placebo, and in 7% of those also taking a sulfonylurea.

The boxed warning reads differently from the injection labels. It says orforglipron “is not pharmacologically active in rats or mice and did not produce tumors in rodents,” but also that the human relevance of the thyroid C-cell tumors seen in rodents with other GLP-1 medicines “has not been determined.” Foundayo is still contraindicated in people with a personal or family history of MTC or with MEN 2. For each effect in more depth, see GLP-1 side effects, nausea and vomiting and constipation and diarrhea.

Does Foundayo interact with other medicines?

Section 12.3 says orforglipron is broken down mainly by a liver enzyme called CYP3A4, so Section 7 includes interactions that the semaglutide tablet labels do not list.

Taken withWhat the label says
Strong CYP3A4 inhibitorsThey raise Foundayo levels. The label limits the Foundayo strength when one is used, and says to avoid strong CYP3A4 inhibitors that also block OATP1B (it names ritonavir)
Strong CYP3A4 inducersThey lower Foundayo levels, which “may reduce the effectiveness.” The label says to avoid using them together
SimvastatinFoundayo doubled exposure to simvastatin’s active form, and the label sets a limit on the simvastatin dose
Insulin or a sulfonylureaHigher risk of low blood sugar; the label says prescribers may consider lowering those medicines
Other medicines taken by mouthFoundayo slows stomach emptying, which can affect how they are absorbed

The Medication Guide says: “Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.” Include over-the-counter medicines, vitamins and herbal supplements, which the Medication Guide also asks you to mention.

What does the label say about birth control pills?

The Medication Guide says: “Birth control pills by mouth may not work as well while taking FOUNDAYO. If you take birth control pills by mouth, your healthcare provider may recommend another type of birth control for 30 days after you start FOUNDAYO and for 30 days after each increase in your dose of FOUNDAYO.” Section 7.3 says hormonal birth control that is not taken by mouth should not be affected, and Section 8.3 advises effective contraception during treatment.

The label says to stop Foundayo when a pregnancy is recognized, and that there will be a pregnancy exposure registry run through Eli Lilly (1-800-545-5979). It says Foundayo “is not recommended for nursing women.”

How should Foundayo be stored?

Section 16 says to store the tablets “at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).” They come in bottles with a desiccant and a child-resistant cap. That differs from GLP-1 pens, which are kept in the refrigerator before first use; see storing and traveling with GLP-1 pens.

Does Medicare cover Foundayo?

Medicare.gov lists “Foundayo® (tablet)” among the GLP-1 drugs Medicare covers starting July 1, 2026, under the temporary Medicare GLP-1 Bridge, with a $50 copayment to the pharmacy for a one-month supply. The rules are dated and have eligibility criteria, so see Does Medicare cover GLP-1 drugs? and check Medicare.gov.

How can you keep track?

A daily tablet is easy to forget and easy to doubt later. A short note of the day you took it, and how you felt, helps at appointments, especially after a strength change. Weeko, a shot tracker coming to iPhone and Android, is being built around this kind of simple log. It is a logbook, not medical guidance.

When to call your doctor

Before you start, the Medication Guide asks you to tell your healthcare provider if you have or have had problems with your pancreas or kidneys, severe liver problems, severe stomach problems such as slowed stomach emptying (gastroparesis), or diabetic retinopathy; if you are scheduled for surgery or a procedure with anesthesia or deep sedation; or if you are pregnant, plan to become pregnant or are breastfeeding.

Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area that will not go away, with or without nausea or vomiting. Call right away for nausea, vomiting or diarrhea that does not go away, for gallbladder symptoms (upper stomach pain, fever, yellowing of the skin or eyes, clay-colored stools), for vision changes if you have type 2 diabetes, or for a lump or swelling in your neck, hoarseness, trouble swallowing or shortness of breath. Get medical help right away for signs of a serious allergic reaction. If you take too much, call Poison Help at 1-800-222-1222 or go to the nearest emergency room.

Related guides

Sources

  1. Foundayo (orforglipron) tablets prescribing information and Medication Guide, DailyMed
  2. FDA news release on the approval of Foundayo (April 1, 2026)
  3. Wegovy (semaglutide) injection and tablets prescribing information, DailyMed
  4. Rybelsus and Ozempic (semaglutide) tablets prescribing information, DailyMed
  5. Weight loss drugs, Medicare.gov

Ozempic®, Wegovy®, Rybelsus® are trademarks of Novo Nordisk A/S; Mounjaro®, Zepbound®, Foundayo® are trademarks of Eli Lilly and Company. Weeko is not affiliated with or endorsed by these companies.