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Foundayo side effects, as its own label reports them
Foundayo’s label reports nausea most often: 35 in every 100 adults at 17.2 mg, against 10 in every 100 on placebo.
Source: Read from the Foundayo label, revision 07/2026, published by DailyMed on 2026-08-13
What matters first
Reviewed 2026-09-06every number here is sourced
The three Foundayo doses in two placebo-controlled weight-management trials
Read the placebo column first. Nearly everything below also happened to some people on placebo. The gap between columns is the part linked to the drug in these trials.
Trial armsPlacebo: n = 1,576Foundayo 5.5 mg: n = 1,051Foundayo 9 mg: n = 1,055Foundayo 17.2 mg: n = 1,049
| Side effect | Placebo | Foundayo 5.5 mg | Foundayo 9 mg | Foundayo 17.2 mg |
|---|---|---|---|---|
| Nausea | 10% | 26% | 34% | 35% |
| Constipation | 9% | 20% | 27% | 24% |
| Diarrhea | 11% | 21% | 23% | 25% |
| Vomiting | 4% | 13% | 21% | 24% |
| Dyspepsia | 4% | 12% | 16% | 13% |
| Abdominal painThe label groups related terms under this heading | 7% | 13% | 14% | 14% |
| Headache | 7% | 8% | 9% | 9% |
| Abdominal distension | 3% | 7% | 9% | 8% |
| FatigueThe label groups related terms under this heading | 4% | 6% | 7% | 9% |
| Eructation | 1% | 6% | 8% | 8% |
| Gastroesophageal reflux disease | 2% | 6% | 6% | 7% |
| Flatulence | 2% | 5% | 6% | 6% |
| Hair lossThe label groups related terms under this heading | 2% | 4% | 4% | 5% |
The boxed warning: risk of thyroid C-cell tumors
Orforglipron is not active in rats or mice, and Foundayo did not cause tumors in them. The label says the human meaning of rodent thyroid C-cell tumors is unknown. It says people with medullary thyroid carcinoma (MTC), MEN 2, or a family history of MTC must not use Foundayo.
What does the label tell prescribers to watch for?
These warnings sit above the table in the label. They cover uncommon problems that matter most.
| Warning | What this label says about it |
|---|---|
| Thyroid C-cell tumors | The human relevance of the rodent class finding has not been determined; the label carries a boxed warning and a contraindication for MTC or MEN 2. |
| Acute pancreatitis | The label says it has been observed in people treated with GLP-1 receptor agonists or Foundayo. |
| Severe stomach and gut reactions | Severe reactions occurred in about 3 in 100 Foundayo-treated adults, against 1 in 100 on placebo. The label does not recommend Foundayo in severe gastroparesis. |
| Acute kidney injury from fluid loss | The label links most reports to dehydration after nausea, vomiting or diarrhea and tells prescribers to monitor kidney function in that setting. |
| Low blood sugar | The risk rises when Foundayo is used with insulin or a medicine that makes the pancreas release insulin. |
| Serious allergic reactions | The label names serious hypersensitivity, including anaphylaxis and angioedema. |
| Diabetic eye disease | Rapid improvement in blood sugar has been associated with temporary worsening of diabetic retinopathy. |
| Acute gallbladder disease | The label reports gallstones and gallbladder inflammation in the weight-management trials. |
| Breathing in stomach contents under anesthesia | The label says delayed stomach emptying creates a rare aspiration risk during general anesthesia or deep sedation. |
3Interpret the page
The label reports the same dose pattern across the main gut reactions
Nausea, diarrhea and vomiting rose from 5.5 mg to 17.2 mg. Constipation was highest at 9 mg, so one highest-dose summary would miss it.
These three reactions were more common while doses increased. The label says they became less common over time. That trial pattern cannot predict one person’s experience.
Stopping treatment also differed by dose
At 5.5, 9 and 17.2 mg, 6, 9 and 10 in 100 adults stopped because of a reaction. Three in 100 stopped on placebo.
Across the Foundayo groups, 5 in 100 adults stopped because of a stomach or gut reaction. The label does not split that figure by symptom.
Where to read next
Two pages carry the parts this one leaves out.
- The Foundayo dose schedule has the step pattern these percentages are attached to.
- How oral GLP-1 tablets differ from injections keeps the tablet comparison on the existing oral GLP-1 route.