Medication safetyLast medically sourced: 21 July 2026

Foundayo™: Important safety information

Read this information before starting Foundayo and keep the patient leaflet supplied with your medicine. This page does not replace advice from your doctor or pharmacist.

Read this information before starting Foundayo and keep the patient leaflet supplied with your medicine. This page does not replace advice from your doctor or pharmacist.

Foundayo is a prescription-only medicine. It is not suitable for everyone. Completing a DarDoc assessment does not guarantee a prescription.

Warning: possible risk of thyroid C-cell tumours

Medicines with GLP-1 receptor agonist activity that work in rats and mice have caused thyroid C-cell tumours in those animals. Orforglipron is not pharmacologically active in rats or mice and did not produce tumours in those animals. It is not known whether GLP-1 receptor agonist activity can cause thyroid C-cell tumours, including medullary thyroid carcinoma, in people.

Do not take Foundayo if you or a family member has had medullary thyroid carcinoma, or if you have multiple endocrine neoplasia syndrome type 2. Tell your clinician promptly if you develop a lump or swelling in your neck, persistent hoarseness, difficulty swallowing, or difficulty breathing.

Using Foundayo with another orforglipron-containing product or another GLP-1 receptor agonist is not recommended.

Do not take Foundayo if

You or a family member has had medullary thyroid carcinoma, or MTC.
You have multiple endocrine neoplasia syndrome type 2, or MEN 2.
You have had a serious allergic reaction to orforglipron or any other ingredient in Foundayo.

Tell your clinician before taking Foundayo

Tell your doctor or pharmacist about every health condition and all prescription medicines, over-the-counter medicines, vitamins, and supplements you use. In particular, tell them if you:

Have or have previously had pancreatitis.
Have severe delayed stomach emptying, or gastroparesis, or other severe digestive problems.
Have kidney problems or are at increased risk of dehydration.
Have type 2 diabetes, diabetic retinopathy, macular oedema, or changes in your vision.
Take insulin or a sulfonylurea. The combination can increase the risk of low blood sugar.
Have severe liver impairment. Foundayo is not recommended for people with severe liver impairment.
Take simvastatin.
Take a medicine that strongly affects CYP3A4, including some medicines for infections, seizures, or HIV. Some combinations must be avoided and others may require a lower maximum Foundayo dose.
Take any oral medicine that requires careful absorption. Foundayo delays stomach emptying and may affect the absorption of oral medicines.
Use an oral hormonal contraceptive.
Are pregnant, think you may be pregnant, are planning pregnancy, or are breastfeeding.
Are planning surgery or another procedure involving general anaesthesia or deep sedation. Delayed stomach emptying may increase the risk of stomach contents entering the lungs.

Pregnancy, contraception, and breastfeeding

Weight loss offers no benefit during pregnancy and may harm an unborn baby. Stop Foundayo and contact your clinician promptly if you become pregnant. If you could become pregnant, use effective contraception during treatment.

Foundayo may reduce the effectiveness of oral hormonal contraceptives because it delays stomach emptying. Switch to a non-oral contraceptive method or add a barrier method, such as a condom, for 30 days after starting Foundayo and for 30 days after every dose increase.

There are no human data showing whether orforglipron passes into breast milk or affects a breastfed baby or milk production. Foundayo is not recommended while breastfeeding. Discuss feeding and treatment options with your clinician.

Stop taking Foundayo and seek urgent medical help if you experience

Possible pancreatitis

Persistent or severe pain in the stomach area, sometimes moving to the back, with or without nausea or vomiting. Pancreatitis can be serious and may be life-threatening.

A serious allergic reaction

Swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; severe rash or itching; fainting; or a very fast heartbeat. Serious reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists.

Contact your clinician promptly if you experience

Severe or persistent nausea, vomiting, diarrhoea, constipation, stomach pain, or other digestive symptoms.
Difficulty drinking enough fluid, reduced urination, dark urine, persistent dizziness, or other signs of dehydration. Dehydration can cause acute kidney injury and has sometimes required dialysis.
New or worsening vision problems, especially if you have type 2 diabetes or diabetic retinopathy.
Persistent upper abdominal pain, fever, or yellowing of the skin or eyes, which may indicate gallstones or gallbladder inflammation.
Symptoms of a thyroid tumour, including a neck lump, difficulty swallowing, difficulty breathing, or persistent hoarseness.
Any side effect that is severe, does not improve, or makes it difficult to eat, drink, or take other medicines.

Low blood sugar

Foundayo lowers blood glucose and can cause low blood sugar. The risk is higher if you take insulin or a sulfonylurea. Your clinician may reduce the dose of those medicines and ask you to monitor your blood sugar.

Warning signs may include:

Headache
Drowsiness or weakness
Dizziness
Hunger
Confusion or irritability
Fast heartbeat
Sweating
Shaking

Ask your clinician how to recognise and treat low blood sugar. Avoid driving or using machinery if symptoms affect your concentration.

Possible side effects

Like all medicines, Foundayo can cause side effects, although not everybody gets them.

Most common side effects

The following were reported in at least 5% of Foundayo-treated adults in clinical trials:

Nausea
Constipation
Diarrhoea
Vomiting
Indigestion
Stomach pain
Headache
Abdominal bloating
Tiredness
Burping
Reflux or heartburn
Gas
Hair loss

Digestive side effects were more common during dose escalation and generally decreased over time. They should not be described as proof that treatment is working. Severe gastrointestinal reactions occurred in approximately 3% of orforglipron-treated trial participants compared with 1% receiving placebo.

Other important adverse effects

Acute pancreatitis
Acute kidney injury caused by dehydration
Low blood pressure and dizziness
Low blood sugar, including severe low blood sugar
Serious allergic reactions
Worsening diabetic retinopathy in people with type 2 diabetes
Gallstones or gallbladder inflammation
Severe constipation, bowel blockage, or faecal impaction reported after approval with the GLP-1 class
Pulmonary aspiration during procedures involving general anaesthesia or deep sedation reported with the GLP-1 class

Read the leaflet supplied with your medicine for the complete current list.

Important medicine interactions

Foundayo can interact with other medicines. Do not alter any medicine yourself.

Avoid strong CYP3A4 inhibitors that also inhibit OATP1B, such as ritonavir.
When used with another strong CYP3A4 inhibitor, the maximum Foundayo dose is 9 mg once daily.
Avoid strong CYP3A4 inducers. Moderate CYP3A4 inducers may reduce Foundayo exposure and require clinical monitoring.
Do not exceed simvastatin 20 mg once daily while using Foundayo.
Insulin or sulfonylurea doses may need to be reduced to lower the risk of hypoglycaemia.
Because Foundayo delays stomach emptying, it may affect the absorption of other oral medicines, including oral hormonal contraceptives.

Give your clinician and pharmacist a complete medicine list before starting treatment and whenever another medicine is added or stopped.

How to take Foundayo safely

Take Foundayo exactly as prescribed. Do not change your dose yourself.

Take one tablet by mouth once daily, with or without food.
Swallow it whole. Do not break, crush, or chew the tablet.
Do not take more than one tablet in a day.
Treatment starts at 0.8 mg once daily for at least 30 days, then increases to 2.5 mg once daily for at least 30 days, and then to 5.5 mg once daily.
If needed, the prescriber may increase the dose to the next level,9 mg, 14.5 mg, or 17.2 mg,after at least 30 days at the current dose, based on response and tolerability.
The maximum dose is 17.2 mg once daily.

The gradual increase is intended to reduce gastrointestinal adverse effects. Follow your prescription and the leaflet supplied with your medicine.

If you miss a dose

Take a missed dose as soon as possible after you remember. Do not take two doses on the same day or double the next dose.

If you miss seven or more consecutive doses, contact your clinician before restarting. You may need to restart at a lower dose to reduce gastrointestinal effects.

If you take more than prescribed

Seek urgent medical advice. Treatment depends on your symptoms and may require observation because orforglipron remains in the body for some time. Do not take another tablet until a clinician advises you.

Children and adolescents

Safety and effectiveness have not been established in people under 18 years.

Storage and disposal

Keep Foundayo out of the sight and reach of children.
Store at room temperature, normally 20°C to 25°C. Short periods between 15°C and 30°C are permitted.
Protect Foundayo from light by keeping it in its original bottle and carton and replacing the cap after opening.
Do not use it after the expiry date shown on the pack.
Ask your pharmacist how to dispose of unused or expired medicine. Do not dispose of it in wastewater or household waste.

Report a suspected side effect in the UAE

Tell your doctor or pharmacist about any suspected side effect.

Lilly UAE pharmacovigilance: pv-mea@lilly.com · +971 55 432 5014
Emirates Drug Establishment: pv@ede.gov.ae · EDRUG call centre 800 33784

Seek emergency care first for severe or life-threatening symptoms.

Sources

Last medically sourced: 21 July 2026.

UAE approval, chronic-weight-management use, once-daily administration, and lack of food or water restrictions were checked against the EDE approval announcement dated 3 April 2026. UAE prescription status, form, 30-tablet bottle, and strengths were checked against the EDE registered medical product directory, including the Foundayo 0.8 mg product record.

Detailed safety, interaction, administration, and storage wording was cross-checked against Lilly's current April 2026 full Foundayo prescribing information, Medication Guide, and official dosing information. The same six strengths are registered in the UAE. Lilly's Gulf portal lists the product but does not expose the detailed local document publicly.

U.S.-only services, FDA reporting details, insurance claims, and pregnancy-registry contacts are excluded.

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