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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

Highest listed reaction
Nausea: 35% in Foundayo 17.2 mg
Distinct reactions listed
13
Warnings to watch
9
Boxed warning
The boxed warning: risk of thyroid C-cell tumors

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

The three Foundayo doses in two placebo-controlled weight-management trials
Side effectPlaceboFoundayo 5.5 mgFoundayo 9 mgFoundayo 17.2 mg
Nausea10%26%34%35%
Constipation9%20%27%24%
Diarrhea11%21%23%25%
Vomiting4%13%21%24%
Dyspepsia4%12%16%13%
Abdominal painThe label groups related terms under this heading7%13%14%14%
Headache7%8%9%9%
Abdominal distension3%7%9%8%
FatigueThe label groups related terms under this heading4%6%7%9%
Eructation1%6%8%8%
Gastroesophageal reflux disease2%6%6%7%
Flatulence2%5%6%6%
Hair lossThe label groups related terms under this heading2%4%4%5%
Who was in the trials
The pooled trials included 3,155 adults with obesity or overweight who took Foundayo once daily and 1,576 adults who took placebo. The average age was 49; 31% had type 2 diabetes.
How long
Up to 72 weeks, followed by 2 weeks off the drug
What made the table
Reactions reported by at least 5 in 100 Foundayo-treated adults, and more often than on placebo
Who stopped
8 in every 100 Foundayo-treated adults stopped permanently because of a reaction, against 3 on placebo. By dose, the figures were 6, 9 and 10 in every 100 at 5.5, 9 and 17.2 mg.

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.

Warnings and precautions from the Foundayo FDA label
WarningWhat this label says about it
Thyroid C-cell tumorsThe 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 pancreatitisThe label says it has been observed in people treated with GLP-1 receptor agonists or Foundayo.
Severe stomach and gut reactionsSevere 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 lossThe label links most reports to dehydration after nausea, vomiting or diarrhea and tells prescribers to monitor kidney function in that setting.
Low blood sugarThe risk rises when Foundayo is used with insulin or a medicine that makes the pancreas release insulin.
Serious allergic reactionsThe label names serious hypersensitivity, including anaphylaxis and angioedema.
Diabetic eye diseaseRapid improvement in blood sugar has been associated with temporary worsening of diabetic retinopathy.
Acute gallbladder diseaseThe label reports gallstones and gallbladder inflammation in the weight-management trials.
Breathing in stomach contents under anesthesiaThe label says delayed stomach emptying creates a rare aspiration risk during general anesthesia or deep sedation.
3Interpret the pageDose patterns, same-drug context, and where the evidence continues

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.

1primary source, each with the day we read it — open the documents used on this page

Foundayo is a registered trademark of its maker. The maker did not write, review or endorse this page. We report figures from a public FDA label. This is not medical advice.

Beyond the Foundayo reaction table