GLP-1 pills are here100% online, with options that ship to your door 

Important safety information

Foundayo (orforglipron)

Important Safety Information for Foundayo (orforglipron) tablet

Warning: Risk of Thyroid C-Cell Tumors

  • In rats and mice, certain GLP-1 medications caused thyroid C-cell tumors. Foundayo did not produce these tumors in rats and mice. However, it is unknown whether Foundayo causes these tumors in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. 

  • Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is the FDA-approved use of Foundayo?

  • Foundayo is used along with a reduced-calorie diet and increased physical activity to reduce and maintain weight in adults with obesity or with overweight plus a weight-related condition.

Limitations of Use:

  • Foundayo should not be used in combination with other GLP-1 receptor agonists.

Who should not use Foundayo?

Do not use Foundayo if:

  • You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

  • You have a known allergic reaction to Foundayo.

How should I take Foundayo?

Take one Foundayo tablet by mouth every day. Swallow the tablet whole and don’t cut, crush, or chew the tablet.

You can take Foundayo with or without food. There are no restrictions on water or other liquid intake. You should not change your dosing regimen or stop taking Foundayo as prescribed without discussing with your provider first. Your provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

What should I tell my provider before using Foundayo?

  • Foundayo has certain drug interactions. It’s important to tell your provider all of the medications you are currently taking, including prescription or over-the-counter medications, vitamins, and herbal and dietary supplements. 

Foundayo may interact with other medicines, affecting how they or Foundayo work.  Your provider can guide you on how to take your medications.

Some medications to watch out for include:

  • Zocor (simvastatin): If you are taking Zocor while taking Foundayo, do not take more than 20 mg a day.

  • Medications for diabetes: Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL). Foundayo may increase the risk of low blood sugar if taken together.

  • Other oral medications: Foundayo causes a delay in gastric emptying, so it has the potential to impact the absorption of medications. 

    • Hormonal birth control: If you are using an oral hormonal contraceptive (birth control pills), Foundayo may decrease its efficacy, especially after the first dose. Switch to a non-oral contraceptive method or use a barrier method of contraception for 4 weeks after starting Foundayo and for 4 weeks after each dose escalation, until you reach the maintenance dose.

  • Other GLP-1 medications: Including Mounjaro, Zepbound, Wegovy, Ozempic, or Saxenda. These medications should not be taken with Foundayo.

  • Other products for weight loss: Including dietary supplements

  • It’s important to share your entire medical history with your provider. In particular, tell your provider if you have or have a past history of:

    • Thyroid cancer

    • Type 1 or type 2 diabetes

    • Gastrointestinal disease

    • Pancreatitis

    • Liver disease

    • Kidney disease

    • Diabetic retinopathy

  • Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. 

    • If you are pregnant: Foundayo should not be used during pregnancy. Based on animal studies, there may be potential risks to the unborn baby from exposure to Foundayo during pregnancy. Intentional weight loss is not recommended during pregnancy and it may cause harm to the unborn baby.

    • If you are a female of reproductive potential: Foundayo may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.

    • If you are breastfeeding: Foundayo is not recommended for breastfeeding women. Talk to your provider first about the benefits and risks of using Foundayo while breastfeeding.

  • Pregnancy registry: Pregnant patients exposed to Foundayo and healthcare providers are encouraged to contact the manufacturer at 1-800-LillyRx (1-800-545-5979).

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking Foundayo?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rarer, but can occur with Foundayo. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • Thyroid C-Cell Tumors: In rats and mice, certain GLP-1 medications caused thyroid C-cell tumors. Foundayo did not produce these tumors in rats and mice. However, it is unknown whether Foundayo causes these tumors in people. Foundayo is contraindicated in patients with a family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. 

  • Inflammation of Pancreas (Acute Pancreatitis): Acute pancreatitis has been reported in patients using Foundayo. Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.

  • Severe Gastrointestinal Disease: Foundayo is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain and they can sometimes be severe. Foundayo isn’t recommended in patients with severe gastroparesis.

  • Acute Kidney Injury: Gastrointestinal side effects of Foundayo like diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems if dehydration is severe. Drink plenty of water to help reduce the chance of dehydration.

  • Low Blood Sugar (Hypoglycemia): Foundayo lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.

  • Allergic Reactions: Stop using Foundayo right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.

  • Diabetic Retinopathy Complications: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.

  • Acute Gallbladder Disease: Foundayo and other GLP-1 receptor agonists are associated with an increased chance of acute gallbladder disease. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.

  • Pulmonary Aspiration During General Anesthesia or Deep Sedation: Foundayo causes a delay in gastric emptying. There have been reports of pulmonary aspiration (when food or liquid from the stomach enters the lungs) in people taking GLP-1 medication while undergoing surgery requiring sedation, even when instructed to fast before the surgery. If you have a planned major surgery requiring sedation, reach out to your provider for instructions on how to prepare.

What are the most common side effects of Foundayo?

  • Nausea

  • Constipation

  • Diarrhea

  • Vomiting

  • Indigestion

  • Stomach pain

  • Headache

  • Bloating of stomach

  • Fatigue

  • Belching

  • Gastroesophageal reflux disease

  • Flatulence

  • Hair loss

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.