Foundayo prescribing information describes a daily orforglipron pill for long-term weight management. Its doses rise gradually. Its warnings cover thyroid tumors, digestive problems and medicine interactions.
Which Foundayo prescribing information is current?
As of October 1, 2026, the day this article was written, DailyMed's current version prints “Revised: 7/2026.” Its posting history lists August 13, 2026, a different date from the revision. The FDA PDF uses “07/2026” for that same month.
The April 1 FDA announcement describes a faster review under its national priority voucher program. Foundayo's background covers that story.
Section 1: what Foundayo is labeled to treat
An indication is a use listed on the label. Foundayo's is long-term weight management in adults with obesity, or overweight with a weight-related condition. The label pairs it with reduced-calorie eating and increased physical activity.
Foundayo activates GLP-1 receptors, cell switches for a gut-hormone signal involved in appetite. Combining it with another GLP-1 receptor agonist, a medicine activating those switches, is “not recommended.”
As of October 1, 2026, the day this article was written, Lilly's October 1 report adds predicted heart and diabetes risks. These models don't count prevented illnesses or expand the U.S. label's uses. The ACHIEVE-4 heart-safety guide covers the separate trial results.
Sections 2–3: doses and missed days
Section 2.1 describes one whole tablet daily, “with or without food.” It sets no fasting interval or water-volume limit. It excludes splitting, crushing and chewing.
| Label stage | Daily amount | Timing in the label |
|---|---|---|
| Starting level | 0.8 mg | At least 30 days |
| Second level | 2.5 mg | At least 30 days |
| Next level | 5.5 mg | At least 30 days before further increase |
| Optional higher levels | 9 mg, 14.5 mg, 17.2 mg | At least 30 days between increases; response and side effects guide decisions |
The usual maximum is 17.2 mg daily. The prescriber sets the actual dose.
Section 2.3 describes a missed dose being taken when remembered, without doubling the next dose. After “7 or more consecutive doses” are missed, it calls for restarting gradual dose increases from a lower dose through the prescriber.
Branded tirzepatide follows the Zepbound label's weekly injection schedule. Foundayo's amounts don't convert to it. The pills-versus-injections guide explains the comparison.
Boxed warning and section 4: who cannot use it
A boxed warning is the label's most prominent safety warning. Foundayo's concerns thyroid C-cells, one type of thyroid cell.
Orforglipron didn't produce tumors in rodents and doesn't activate their GLP-1 receptors. Other medicines activating those receptors produced thyroid C-cell tumors in rodents. Human relevance remains unknown. Kawai and colleagues' 2020 PNAS study described different activity at human and mouse receptors.
A contraindication is a reason the medicine must not be used. Section 4 lists personal or family history of medullary thyroid carcinoma, a rare thyroid cancer. It also lists MEN 2, an inherited condition causing tumors, and previous serious allergy to orforglipron or a tablet ingredient.
Section 5: the other warnings
- Pancreatitis: inflammation of the pancreas, which can cause persistent or severe belly pain, sometimes reaching the back.
- Severe digestive reactions: Foundayo isn't recommended with severe gastroparesis, a stomach that empties very slowly.
- Kidney injury from fluid loss: vomiting or diarrhea can cause dehydration severe enough to affect kidney function.
- Hypoglycemia: low blood sugar, with greater risk alongside insulin or sulfonylureas, diabetes pills that increase insulin release. It can also occur without them.
- Serious allergy: reactions can include dangerous swelling or breathing problems.
- Diabetic retinopathy: diabetes-related eye damage can worsen during rapid blood-sugar improvement.
- Gallbladder disease: gallstones or gallbladder inflammation.
- Pulmonary aspiration: stomach contents entering the lungs during procedures involving medicines that cause unconsciousness or deep sleepiness.
Breathing difficulty, persistent or severe belly pain, or ongoing severe vomiting warrants prompt medical assessment. Planned procedures belong in the medical team's review.
Section 6: the side-effect table
Label Table 1 combines two studies in people, called Trials 1 and 2, lasting up to 72 weeks. Placebo means a look-alike treatment without active medicine.
| Reaction | Placebo | 5.5 mg | 9 mg | 17.2 mg |
|---|---|---|---|---|
| Nausea | 10% | 26% | 34% | 35% |
| Constipation | 9% | 20% | 27% | 24% |
| Diarrhea | 11% | 21% | 23% | 25% |
| Vomiting | 4% | 13% | 21% | 24% |
| Indigestion | 4% | 12% | 16% | 13% |
| Belly pain | 7% | 13% | 14% | 14% |
| Headache | 7% | 8% | 9% | 9% |
| Bloating | 3% | 7% | 9% | 8% |
| Fatigue | 4% | 6% | 7% | 9% |
| Belching | 1% | 6% | 8% | 8% |
| Acid reflux | 2% | 6% | 6% | 7% |
| Gas | 2% | 5% | 6% | 6% |
| Hair loss | 2% | 4% | 4% | 5% |
At 17.2 mg, about 35 in 100 reported nausea, versus 10 in 100 on placebo. Reactions led 6%, 9% and 10% to stop at the respective doses, versus 3% on placebo. These rates aren't a direct comparison with another medicine's trials.
Branded semaglutide injections also have digestive side effects, described in the Ozempic label.
Sections 2.2 and 7: Foundayo drug interactions
CYP3A4 is a liver enzyme that breaks down orforglipron. Medicines slowing it can raise blood levels; medicines speeding it up can lower them.
The label caps Foundayo at 9 mg daily with strong enzyme blockers. It avoids strong blockers that also inhibit OATP1B, a protein that moves medicines into liver cells; ritonavir is one such blocker. Strong enzyme inducers, medicines speeding that enzyme up, are also avoided. Moderate inducers prompt review and possible dose adjustment.
As of October 1, 2026, the day this article was written, Morse and colleagues' July 3 paper in Clinical Pharmacology & Therapeutics adds interaction data from six early studies in healthy volunteers. Clarithromycin, an antibiotic, raised orforglipron levels; carbamazepine, a seizure medicine, lowered them. That's why the medication list matters.
Section 7.2 limits accompanying simvastatin, a cholesterol medicine, to 20 mg daily. Section 7.3 addresses pills affected by slower stomach emptying. For birth-control pills, it specifies a method that isn't swallowed or added barrier protection, such as condoms, for 30 days after starting. That precaution also lasts “30 days after each dose escalation,” meaning each increase. No study in people measured Foundayo's effect on birth-control absorption, the amount reaching the bloodstream.
Section 8: pregnancy, age, liver and kidneys
The label calls for stopping Foundayo when pregnancy is recognized. Breastfeeding isn't recommended, and children's safety and effectiveness aren't established. Older and younger adults showed no overall difference.
Severely reduced liver function makes use not recommended. Mild or moderately reduced liver function and reduced kidney function don't require a labeled dose adjustment. Kidney monitoring still matters during fluid loss.
Section 16: supply and storage
Branded bottles contain 30 tablets, a drying insert and child-resistant closure. Storage is 68°F–77°F, with brief periods permitted at 59°F–86°F.
Tirzepatide and other prescriptions have their own storage requirements.
What the label says about compounded medicines
Foundayo's label doesn't establish doses, absorption, storage or outcomes for compounded semaglutide or tirzepatide.
Through Promise, semaglutide and tirzepatide are dispensed as compounded medications, which are different from FDA-approved products: the formulations offered here are not FDA-approved. FDA explains that it doesn't verify compounded drugs' safety, effectiveness or quality before marketing. A licensed provider may still prescribe — that decision is between you and your doctor.
At Promise, a licensed provider reviews every request, and not everyone qualifies. The prescription and pharmacy label identify the preparation actually dispensed.
