Orforglipron Side Effects: What Studies and Users Report
What FDA labels and clinical studies report for Orforglipron, how strong that evidence is, and what is still unknown.
Side effects reported in studies
Adverse reactions from the FDA label come first, then side effects reported in individual studies. Frequencies are quoted as the source gives them; animal results are labelled.
| Side effect | How common | Study type | Source |
|---|---|---|---|
| Most common adverse reactions (5% or more) | 5% or more of patients | FDA label | FDA label (Foundayo) |
| Nausea (placebo, 5.5 mg, 9 mg, 17.2 mg) | placebo 10%; 5.5 mg 26%; 9 mg 34%; 17.2 mg 35% | FDA label | FDA label (Foundayo) |
| Vomiting (placebo, 5.5 mg, 9 mg, 17.2 mg) | placebo 4%; 5.5 mg 13%; 9 mg 21%; 17.2 mg 24% | FDA label | FDA label (Foundayo) |
| Discontinuation due to adverse reactions | 8% overall (6%, 9%, 10% by dose) vs 3% placebo | FDA label | FDA label (Foundayo) |
| Discontinuation due to adverse events | 6·1-9·9% vs 4·1% placebo | Human RCTn = 1613 | Lancet 2026, PMID 41275875 |
| Gastrointestinal events and discontinuation | 59% and 58% (orforglipron) vs 37% and 45% (oral semaglutide) | Human controlled trialn = 1698 | Lancet 2026, PMID 41765029 |
| Gastrointestinal events | 47%, 46%, 54% (3, 12, 36 mg) vs 12% dapagliflozin | Human controlled trialn = 962 | Lancet 2026, PMID 42259339 |
| Gastrointestinal events | most common | Human RCTn = 376 | Nature medicine 2026, PMID 42120723 |
| Gastrointestinal events | most common | Human RCTn = 616 | Obesity pillars 2026, PMID 42577069 |
| Discontinuation due to adverse events | 5.3 to 10.3% vs 2.7% placebo | Human RCTn = 3127 | The New England journal of medicine 2025, PMID 40960239 |
| Gastrointestinal events | most common | Human RCTn = 3127 | The New England journal of medicine 2025, PMID 40960239 |
| Discontinuation due to adverse events | 4.4 to 7.8% vs 1.4% placebo | Human RCTn = 559 | The New England journal of medicine 2025, PMID 40544435 |
| Severe hypoglycemia | none reported | Human RCTn = 559 | The New England journal of medicine 2025, PMID 40544435 |
| Gastrointestinal events | discontinuation in 10 to 17% of participants | Human RCTn = 272 | The New England journal of medicine 2023, PMID 37351564 |
| Gastrointestinal events | 44·1% to 70·4% (orforglipron) vs 18·2% (placebo) | Human RCTn = 383 | Lancet 2023, PMID 37369232 |
| Gastrointestinal events | most common | Human RCTn = 92 | Diabetes, obesity & metabolism 2023, PMID 37344954 |
| Gastrointestinal events | most common | Human RCTn = 68 | Diabetes, obesity & metabolism 2023, PMID 37264711 |
| Gastrointestinal events | most common | Meta-analysisn = 815 | Archives of endocrinology and metabolism 2024, PMID 39420937 |
What is not known
- How common each effect is at the doses people use outside of studies.
- Effects that take longer to appear than the length of the published studies.
- How Orforglipron interacts with other medicines and supplements.
- Whether research-grade products, which are not checked by the FDA, behave like the material used in studies.
When to get medical help
Get urgent care for: trouble breathing, swelling of the face or throat, a widespread rash, severe or lasting stomach pain, fainting, or an injection site that becomes hot, red and spreading.
This is not a complete list. A doctor or pharmacist can help you judge whether a symptom is related.
Common questions
What are the side effects of Orforglipron?
The FDA label lists most common adverse reactions (5% or more), nausea (placebo, 5.5 mg, 9 mg, 17.2 mg), vomiting (placebo, 5.5 mg, 9 mg, 17.2 mg) among others. The table on this page gives how often each happened and links each source.
Is Orforglipron safe?
Orforglipron has an FDA-approved label that lists its known risks. That label covers the approved product used as prescribed, not compounded or research-chemical versions.
More on Orforglipron
DosageDoses used in published studies, with the source for each.ResultsStudy outcomes and when they were measured.PricePrice per mg and per week from dated listings. No vendor links.Legal statusFDA, compounding and WADA status with dates.For weight lossWhat research says about Orforglipron for weight loss.
Sources
- 1These highlights do not include all the information needed to use FOUNDAYO safely and effectively. See full prescribing information for FOUNDAYO. FOUNDAYO (orforglipron) tablets, for oral use Initial FDA label (Foundayo), DailyMed · current labeldailymed.nlm.nih.govAccessed 2 Oct 2026
- 2Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial.Lancet (London, England) · 2026PMID 41275875Accessed 2 Oct 2026
- 3Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (ACHIEVE-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial.Lancet (London, England) · 2026PMID 41765029Accessed 2 Oct 2026
- 4Orforglipron compared with dapagliflozin in adults with type 2 diabetes and inadequate glycaemic control with metformin (ACHIEVE-2): a multicentre, randomised, non-inferiority, open-label, phase 3 trial.Lancet (London, England) · 2026PMID 42259339Accessed 2 Oct 2026
- 5Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trial.Nature medicine · 2026PMID 42120723Accessed 2 Oct 2026
- 6Orforglipron for obesity treatment in older patients ≥65 years with or without type 2 diabetes: A post hoc subgroup analysis of the ATTAIN-1 and ATTAIN-2 trials.Obesity pillars · 2026PMID 42577069Accessed 2 Oct 2026
- 7Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment.The New England journal of medicine · 2025PMID 40960239Accessed 2 Oct 2026
- 8Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes.The New England journal of medicine · 2025PMID 40544435Accessed 2 Oct 2026
- 9Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity.The New England journal of medicine · 2023PMID 37351564Accessed 2 Oct 2026
- 10Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study.Lancet (London, England) · 2023PMID 37369232Accessed 2 Oct 2026
- 11Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1a, blinded, placebo-controlled, randomized, single- and multiple-ascending-dose study in healthy participants.Diabetes, obesity & metabolism · 2023PMID 37344954Accessed 2 Oct 2026
- 12Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1b, multicentre, blinded, placebo-controlled, randomized, multiple-ascending-dose study in people with type 2 diabetes.Diabetes, obesity & metabolism · 2023PMID 37264711Accessed 2 Oct 2026
- 13Effects of once-daily oral orforglipron on weight and metabolic markers: a systematic review and meta-analysis of randomized controlled trials.Archives of endocrinology and metabolism · 2024PMID 39420937Accessed 2 Oct 2026
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