FDA-filed SPL labeling · retrieved through openFDA

Orforglipron

Orforglipron is a GLP-1 receptor agonist taken by mouth to help adults with obesity or overweight lose weight and keep it off long term.

Brand name Foundayo
Rx Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 19, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 29, 2026
AvailabilityRx
Earliest approval/marketing year ⓘ2024
FDA-listed product records ⓘ57
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 18, 2026
⭐ Orforglipron at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Foundayo is an oral, once-daily GLP-1 receptor agonist that helps adults with obesity or overweight lose meaningful weight when combined with diet and exercise. It is generally well tolerated, but stomach side effects are common — especially early on — and the dose is increased slowly to manage them. People with a personal or family history of medullary thyroid carcinoma or MEN 2 cannot take it, and several important drug interactions require attention before starting.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Foundayo carries a boxed warning — the FDA's most serious label alert — about a possible risk of medullary thyroid carcinoma (MTC), a type of thyroid cancer. Other GLP-1 medicines have caused thyroid tumors in rodents, but orforglipron did not cause tumors in those animal studies. Whether there is a risk in humans is still not known.

Because of this uncertainty, Foundayo is completely off-limits if you or a blood relative has ever had MTC, or if you have a genetic condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your doctor immediately if you notice a lump or swelling in your neck, trouble swallowing, difficulty breathing, or hoarseness that won't go away — these can be signs of a thyroid tumor.

Read the full warning on DailyMed →

📖 Orforglipron: Patient Information Guide

A plain-language walkthrough of Orforglipron — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Orforglipron is approved for use in adults to support long-term weight management. All current FDA-approved uses are through Foundayo tablets.

  • Foundayo is indicated — alongside a reduced-calorie diet and increased physical activity — to reduce excess body weight and maintain that weight loss long term in adults who have obesity, or in adults who are overweight and have at least one weight-related health condition (such as high blood pressure, type 2 diabetes, or high cholesterol).
  • Using Foundayo at the same time as another GLP-1 receptor agonist is not recommended.
⚙️How it works▾

Foundayo works by binding to and activating GLP-1 receptors — natural receptors found in areas of the brain that regulate appetite and food intake. GLP-1 is a hormone the body normally releases after eating to signal fullness and curb hunger. By mimicking and amplifying that signal, Foundayo helps reduce appetite, lowers how much food you eat, and slows the rate at which the stomach empties — all of which contribute to weight loss over time.

💊How it's taken▾

Foundayo tablets are taken once a day by mouth, with or without food. Your prescriber starts you on a low dose and increases it gradually — at least 30 days at each level — to help your body adjust and reduce the chance of stomach side effects. The dose can be escalated up to a maximum level based on how well you tolerate it and how you respond to treatment.

  • Swallow Foundayo tablets whole — never break, crush, or chew them.
  • Take only one tablet per day.
  • If you miss a dose, take it as soon as you remember — but do not double up the next day's dose. If you miss 7 or more days in a row, talk to your prescriber before restarting, as you may need to go back to a lower dose to avoid GI side effects.
🤒Side effects — in detail▾

The most common side effects of Foundayo — especially early in treatment or after a dose increase — are stomach-related:

  • Nausea
  • Constipation
  • Diarrhea
  • Vomiting
  • Indigestion (dyspepsia)
  • Stomach pain or bloating
  • Burping (eructation) or gas
  • Acid reflux (gastroesophageal reflux disease)
  • Headache
  • Fatigue
  • Hair loss

These effects often ease up over time and are most noticeable during dose escalation. However, if you develop severe stomach pain (especially radiating to the back), signs of dehydration, or signs of a serious allergic reaction, seek medical attention right away.

⚠️Warnings & precautions▾
  • Thyroid cancer risk: Foundayo cannot be used if you or a close relative has had medullary thyroid carcinoma (MTC) or if you have MEN 2. Watch for a neck lump, difficulty swallowing, shortness of breath, or persistent hoarseness — report these immediately.
  • Pancreatitis: Foundayo has been associated with acute pancreatitis (sudden inflammation of the pancreas). Severe abdominal pain — especially pain that spreads to the back — needs prompt medical evaluation.
  • Kidney injury: Severe vomiting or diarrhea can lead to dehydration and, in some cases, acute kidney injury. Stay hydrated and tell your doctor if you have prolonged GI symptoms.
  • Low blood sugar (hypoglycemia): If you also take insulin or a sulfonylurea, your blood sugar may drop too low. Know the signs — shakiness, sweating, confusion — and ask your prescriber if your other diabetes medicine needs to be adjusted.
  • Gallbladder disease: Cases of gallbladder inflammation (cholecystitis) have been reported. Tell your doctor if you have sudden severe upper-right belly pain or fever.
  • Surgery/anesthesia risk: Foundayo slows stomach emptying, which raises the risk of inhaling stomach contents during anesthesia. Tell your surgical team you take Foundayo before any planned procedure.
  • Serious allergic reactions: Stop Foundayo and seek emergency help if you have swelling of the face or throat, trouble breathing, or a rapid heartbeat.
🔀What it interacts with▾

Foundayo has several important drug interactions to be aware of before you start:

  • Strong CYP3A4 inhibitors (e.g., clarithromycin): raise Foundayo levels significantly — your prescriber will limit your dose. Combinations that also block OATP1B (e.g., ritonavir) should be avoided entirely.
  • Strong CYP3A4 inducers (e.g., carbamazepine): sharply reduce Foundayo levels, making it less effective — avoid this combination.
  • Moderate CYP3A4 inducers (e.g., efavirenz): also reduce Foundayo levels — your prescriber may need to adjust your dose.
  • Simvastatin: Foundayo raises simvastatin levels in the blood. Do not take more than 20 mg of simvastatin per day while using Foundayo.
  • Insulin or sulfonylureas: Adding Foundayo increases the risk of low blood sugar — a dose reduction of your insulin or sulfonylurea may be needed.
  • Oral contraceptives (birth control pills): Foundayo slows stomach emptying and may reduce how well the pill is absorbed. Switch to or add a non-oral birth control method for 30 days after starting Foundayo and for 30 days after each dose increase.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do NOT take Foundayo if you or a close blood relative has a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do NOT take Foundayo if you have had a serious allergic reaction to orforglipron or any ingredient in Foundayo.
  • Tell your doctor if you have a history of pancreatitis, gallbladder problems, or severely slow stomach emptying (gastroparesis) — Foundayo is not recommended with severe gastroparesis.
  • Tell your doctor if you have significant liver disease — Foundayo is not recommended in severe hepatic (liver) impairment.
  • Kidney disease alone does not require a dose adjustment, but let your doctor know and report any GI side effects that could lead to dehydration.
  • If you are pregnant or trying to become pregnant, tell your doctor right away — Foundayo should be stopped when pregnancy is confirmed, as weight loss during pregnancy is not recommended and the medicine may harm the fetus.
  • Do not breastfeed while using Foundayo — it is unknown whether it passes into human breast milk.
  • If you use oral birth control pills, discuss switching to or adding a non-oral contraceptive method while on Foundayo.
  • Safety and effectiveness in children have not been established.
  • Adults 65 and older have been studied and no overall differences in safety or effectiveness were found compared to younger adults.
🚑If you take too much▾

If you think you or someone else has taken too much Foundayo, call Poison Control at 1-800-222-1222 or seek emergency medical care right away. Treatment is supportive — meaning medical staff will watch for and manage any symptoms that arise. Because orforglipron stays in the body for an extended period, a longer observation time may be needed.

📡Pharmacodynamics — effects in the body▾

Foundayo reduces body weight primarily by decreasing appetite and lowering food intake. It produces greater loss of fat mass than lean (muscle) mass. It also slows gastric emptying — the rate at which food leaves the stomach — which is most pronounced after the first dose and diminishes over time. At the doses used clinically, Foundayo did not cause meaningful changes in heart rhythm (QTc interval prolongation).

🔬Pharmacokinetics — how your body processes it▾

After a Foundayo tablet is swallowed, orforglipron reaches its peak concentration in the blood roughly 4 to 8 hours later. The drug can be taken with or without food, as food has no clinically meaningful effect on overall exposure. Orforglipron is extensively bound to proteins in the blood (more than 99%) and is broken down mainly by the liver enzyme CYP3A4; most of the drug and its breakdown products leave the body through the stool. The elimination half-life — how long it takes the body to clear half the drug — is approximately 29 to 49 hours, meaning it takes about a week of once-daily dosing to reach steady levels in the body. Liver impairment can raise orforglipron levels significantly, but kidney disease does not meaningfully affect how the body handles the drug.

📦How to store it▾

Store FOUNDAYO 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) .

📄 Written from Orforglipron’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Orforglipron — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Foundayo, and how is it different from injectable weight-loss medicines? ▾
Foundayo contains orforglipron, which works the same way as other GLP-1 receptor agonist medicines — it activates receptors in your brain that control hunger, so you feel less hungry and eat less. What makes it different is that it comes as a pill you swallow once a day, rather than a weekly injection. It's still a prescription medicine that works best alongside a healthy diet and more physical activity.
What side effects should I expect when I first start taking it? ▾
The most common ones are stomach-related — nausea, constipation, diarrhea, and sometimes vomiting. These tend to be worst early on and after each dose increase, but they usually ease up as your body adjusts. That's actually why the dose is started low and increased slowly over several months. Taking it at a consistent time each day and sticking to smaller meals can help. If the nausea becomes severe or you can't keep fluids down, call your doctor.
Is there anything in my medicine cabinet that could interact with Foundayo? ▾
Yes, a few things are worth discussing with your pharmacist or doctor. If you take simvastatin (a cholesterol medicine), your dose of simvastatin will need to stay low while you're on Foundayo because Foundayo raises simvastatin levels in your blood. If you take antibiotics like clarithromycin, seizure medicines like carbamazepine, or HIV medicines, those can affect how much Foundayo is in your system. And if you take insulin or a sulfonylurea for diabetes, there's a higher risk of low blood sugar — your prescriber may lower those doses when you start Foundayo.
Can I take Foundayo if I'm pregnant or trying to get pregnant? ▾
No — Foundayo should be stopped as soon as you find out you're pregnant. Weight loss during pregnancy is not recommended, and animal studies suggest the medicine may potentially harm a developing baby. If you're using birth control pills, be aware that Foundayo can interfere with how well the pill is absorbed, so your doctor may recommend switching to a non-oral method or adding a barrier method like a condom for at least 30 days after you start Foundayo and after each dose increase. Definitely have a conversation with your doctor about birth control before you begin.
What warning signs mean I should call my doctor or go to the ER right away? ▾
A few things need prompt attention. Severe stomach pain — especially if it radiates to your back — could be a sign of pancreatitis, which is a medical emergency. A lump in your neck, trouble swallowing, shortness of breath, or a persistent hoarse voice could be signs of a thyroid problem and need to be evaluated. Signs of a severe allergic reaction — swelling of your face or throat, or trouble breathing — mean call 911 immediately. And if you become very dehydrated from vomiting or diarrhea and notice your urine output drops dramatically, get medical help, because that can lead to kidney injury.
What happens if I miss a few doses in a row? ▾
If you just miss one dose, take it as soon as you remember — but skip it if it's almost time for your next dose, and never take two doses to catch up. If you miss 7 or more days in a row, don't just jump back to where you left off. Contact your prescriber, because you may need to restart at a lower dose and work back up slowly — this helps avoid a fresh wave of stomach side effects.
Is Orforglipron available over the counter? ▾
Orforglipron is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Orforglipron first available? ▾
Orforglipron has been available in the United States since at least 2024, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Orforglipron? ▾
Orforglipron is supplied by 14 manufacturers listed in the FDA NDC Directory, including Eli Lilly and Company, Lilly del Caribe, Inc., Shanghai SynTheAll Pharmaceutical Co., Ltd..

💬 Answers drafted from Orforglipron’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerOrforglipron vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Orforglipron NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Orforglipron comes

Orforglipron is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Foundayo
How this form is used
What it may be used for
  • Foundayo tablets are used with a reduced-calorie diet and exercise to reduce excess body weight and maintain weight loss long term in adults with obesity or overweight with at least one weight-related health condition
Important instructions
  • Foundayo tablets are taken by mouth once daily, with or without food
  • Swallow Foundayo tablets whole — do not break, crush, or chew them
  • Do not take more than one Foundayo tablet per day
  • If you miss 7 or more consecutive Foundayo doses, contact your prescriber — the dose escalation schedule may need to be restarted at a lower level to reduce stomach side effects
Available strengths 6 strengths
0.8 mg 2.5 mg 5.5 mg 9 mg 14.5 mg 17.2 mg
26 FDA-listed product records ⓘ

📊 Orforglipron across the U.S. market

How Orforglipron appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms ⓘ
14
Manufacturers
1
Brand names
57
FDA-listed product records ⓘ
2024
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (25) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Eli Lilly and Company21%
Lilly del Caribe, Inc.21%
Shanghai SynTheAll Pharmaceutical Co., Ltd.18%
Pfizer Italia S.r.l.14%
Chonqing Sintaho Pharmaceutical Co., Ltd.4%
Eternal Wealth(china)limited4%
Other makers19%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

🔍 Compare Orforglipron products

A representative set of FDA-listed product records for Orforglipron — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 57 of 57 products — FDA National Drug Code Directory. See every product, package size and price: browse all 57 Orforglipron NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Orforglipron RxCUI 2739838 1 dose form · 6 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 2739843 In current FDA listings
    Clinical drug / strength (SCD) 0.8 MG RxCUI 2739844 2.5 MG RxCUI 2739852 5.5 MG RxCUI 2739856 9 MG RxCUI 2739860 14.5 MG RxCUI 2739864 17.2 MG RxCUI 2739868

Look up RxCUI 2739838 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Foundayo

🏭 Manufacturers & labelers

Eli Lilly and Company 12 Lilly del Caribe, Inc. 12 Shanghai SynTheAll Pharmaceutical Co., Ltd. 10 Pfizer Italia S.r.l. 8 Chonqing Sintaho Pharmaceutical Co., Ltd. 2 Eternal Wealth(china)limited 2 Hovione Farmaciencia Sa 2 Hovione Limited 2 Nanjing Chengong Pharmaceutical Co., Ltd. 2 Eli Lilly Kinsale Limited 1 Nanjing Hanxin Pharmaceutical Technology Co., Ltd. 1 Porton Pharma Solutions Ltd 1 Qingdao Biopeptek Co., Ltd. 1 Sterling Spa 1

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 29, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Orforglipron.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Orforglipron after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
57
Distinct labelers/manufacturers represented
14
Linked representative label ⓘ
Eli Lilly and Company
Linked label effective
Jul 29, 2026
Composite sections available
24
Linked SPL Set ID
8ac446c5-feba-474f-a103-23facb9b5c62
Linked SPL Document ID
ebe44919-a00d-4ea1-a511-18e6a87da34c
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Eli Lilly and Company is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.