Important Safety Information: Foundayo™ Pill

Important Safety Information — Foundayo™ Pill (orforglipron tablets)

This summary is drawn from the FDA-approved Prescribing Information for Foundayo™ (orforglipron), revised April 2026. It does not replace the full Prescribing Information and Medication Guide. Review the complete Prescribing Information before starting treatment.

Foundayo™ contains orforglipron, a small-molecule (non-peptide) GLP-1 receptor agonist taken as a once-daily tablet. It can be taken at any time of day, with or without food.

Boxed Warning: Risk of Thyroid C-Cell Tumors
Certain GLP-1 medicines that are active in rats and mice have caused thyroid C-cell tumors in those animals. Orforglipron is not active in rats and mice and did not cause these tumors in animal studies. Because orforglipron is active at the human GLP-1 receptor and the human relevance of these rodent findings has not been determined, this warning still applies. It is unknown whether Foundayo™ causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in people.

Do not use the Foundayo™ Pill if:

  • You or any family member has ever had medullary thyroid carcinoma (MTC), or
  • You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).


Tell your provider right away if you notice any of these symptoms of a possible thyroid tumor:

  • A lump or swelling in the neck
  • Hoarseness that does not go away
  • Trouble swallowing
  • Shortness of breath


What the Foundayo™ Pill Is Used For
The Foundayo™ Pill is a prescription medicine used along with a reduced-calorie diet and increased physical activity to reduce excess body weight and help maintain weight reduction long term in adults with:

  • Obesity (BMI ≥ 30 kg/m²), or
  • Overweight (BMI ≥ 27 kg/m²) with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol).

The Foundayo™ Pill should not be used together with another GLP-1 receptor agonist medicine.

Who Should Not Use the Foundayo™ Pill
Do not use the Foundayo™ Pill if you:

  • Have a personal or family history of medullary thyroid carcinoma (MTC);
  • Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); or
  • Have had a serious allergic reaction to orforglipron or any of the ingredients in the Foundayo™ Pill.

Before Taking the Foundayo™ Pill, Tell Your Provider If You

  • Have type 1 or type 2 diabetes;
  • Have a history of pancreatitis;
  • Have kidney problems;
  • Have a history of diabetic retinopathy;
  • Have severe problems with your stomach emptying (severe gastroparesis);
  • Have liver problems;
  • Have ever had a serious allergic reaction (such as anaphylaxis or angioedema) to a GLP-1 medicine; or
  • Are pregnant, planning to become pregnant, or breastfeeding.

The Foundayo™ Pill is not recommended for people with severe liver problems. Give your provider a complete and accurate medical history.

Drug Interactions
The Foundayo™ Pill can interact with other medicines. Tell your provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and supplements. In particular:

  • Certain medicines that affect the CYP3A4 enzyme: With a strong CYP3A4 inhibitor, the maximum Foundayo™ dose is 9 mg once daily; strong CYP3A4 inhibitors that also inhibit OATP1B should be avoided. Strong CYP3A4 inducers should be avoided; with moderate inducers, your provider will monitor whether Foundayo™ is still working and may adjust your dose.
  • Simvastatin: Do not exceed 20 mg of simvastatin once daily while taking the Foundayo™ Pill.
  • Insulin or insulin secretagogues (such as sulfonylureas): These can raise the risk of low blood sugar when combined with the Foundayo™ Pill. Your provider may lower their dose.
  • Other oral medicines: The Foundayo™ Pill slows stomach emptying, which can affect how other oral medications are absorbed.


Pregnancy and Reproductive Planning

  • The Foundayo™ Pill may cause harm to an unborn baby and should not be used during pregnancy. If you become pregnant while taking it, stop and tell your provider.
  • Oral birth control: Because the Foundayo™ Pill can affect how oral medications are absorbed, if you use oral contraceptives, switch to a non-oral method or add a barrier method of contraception for 30 days after starting the Foundayo™ Pill and for 30 days after each dose increase.
  • Tell your provider if you are breastfeeding or planning to breastfeed.


Serious Side Effects
Seek medical attention right away if you have symptoms of any of the following:

  • Thyroid tumors — a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath.
  • Inflammation of the pancreas (pancreatitis) — severe and persistent abdominal pain that may spread to the back, with or without nausea or vomiting.
  • Gallbladder problems — upper-stomach pain, fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.
  • Low blood sugar (hypoglycemia) — especially if you also take insulin or a sulfonylurea. Know the signs (dizziness, shakiness, sweating, confusion).
  • Kidney problems (acute kidney injury) — particularly if nausea, vomiting, or diarrhea leads to dehydration.
  • Serious allergic reactions — swelling of the face, lips, tongue, or throat, or trouble breathing.
  • Diabetic retinopathy complications — vision changes, particularly in people with type 2 diabetes.
  • Risk during anesthesia or deep sedation — because the medicine slows stomach emptying, food may remain in the stomach. Tell your surgical or procedure team that you take the Foundayo™ Pill ahead of any planned surgery or procedure.


The Foundayo™ Pill may also raise your heart rate and, in some people, lower blood pressure (more likely if you take blood-pressure medicine).

Most Common Side Effects

  • Nausea
  • Constipation
  • Diarrhea
  • Vomiting
  • Indigestion (dyspepsia)
  • Abdominal (stomach) pain
  • Headache
  • Abdominal bloating
  • Fatigue
  • Belching
  • Acid reflux (GERD)
  • Gas (flatulence)
  • Hair loss

Side effects are most common during dose escalation, and nausea, vomiting, and diarrhea tend to decrease over time.

How the Foundayo™ Pill Is Taken

  • Take one tablet by mouth once daily, at any time of day, with or without food.
  • Swallow the tablet whole. Do not break, crush, or chew it.
  • Take only one tablet per day.
  • The starting dose is 0.8 mg once daily, increased gradually under your provider's guidance (typically to 2.5 mg, then 5.5 mg, and potentially 9 mg, 14.5 mg, or up to a maximum of 17.2 mg), about every 30 days, to help reduce gastrointestinal side effects.
  • If you miss a dose, take it as soon as possible, but do not take two doses to make up for it. If you miss 7 or more days in a row, your provider may restart you at a lower dose.
  • Do not change your dose without speaking to your provider.
  • Store tablets in the original bottle and carton to protect them from light.


Reporting Side Effects
You are encouraged to report side effects of prescription drugs:

  • Eli Lilly and Company: 1-800-LillyRx (1-800-545-5979)
  • FDA MedWatch: 1-800-FDA-1088 or www.fda.gov/medwatch


This summary does not replace the full Prescribing Information and Medication Guide. Review the complete Prescribing Information before initiating treatment.

Foundayo™ is a trademark of Eli Lilly and Company. Naky Health LLC is not affiliated with, endorsed by, or sponsored by Eli Lilly and Company, and does not manufacture these medications. All referenced medications are FDA-approved prescription drugs available only when prescribed by a licensed healthcare provider. Individual eligibility, including eligibility for any specific medication or formulation, is determined at the sole discretion of your provider. Naky Health LLC does not guarantee access to any specific medication.