Common side effects
Gastrointestinal symptoms were the most frequent label-reported reactions
The current DailyMed prescribing label pools two placebo-controlled weight-management trials lasting up to 72 weeks. Depending on the Foundayo maintenance group, nausea was reported in 26% to 35% of participants, constipation in 20% to 27%, diarrhea in 21% to 25%, and vomiting in 13% to 24%, compared with 10%, 9%, 11%, and 4% on placebo. Indigestion and abdominal pain were also common. These are trial rates, not a personal forecast, and they should not be compared directly with rates from another drug trial. The label reports that nausea, vomiting, and diarrhea were more frequent during dosage escalation and decreased over time, but persistent or severe symptoms still require clinician review.
- Other reactions reported in at least 5% of at least one Foundayo group included headache, abdominal distension, fatigue, burping, reflux, flatulence, and hair loss.
- Across the pooled trials, gastrointestinal reactions led some participants to discontinue treatment; severe gastrointestinal reactions occurred in about 3% of orforglipron-treated participants versus 1% on placebo.
- Foundayo is not recommended in patients with severe gastroparesis according to the current label.