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Foundayo ™ (orforglipron) tablet
0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What are the common adverse events with Foundayo™ (orforglipron) use in adults?
Adverse reactions reported in ≥5% of patients receiving orforglipron are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss.
See important safety information, including boxed warning, in the attached prescribing information.
Orforglipron Common Adverse Events in Clinical Trials in Adults
Adverse Reactions Reported in ≥5% of Orforglipron-treated Adult Patients with Obesity or Overweight (With or Without Type 2 Diabetes) in Pool of Placebo-Controlled Trials (ATTAIN-1 and ATTAIN-2) shows common adverse reactions associated with the use of once daily orforglipron in the pool of two placebo-controlled trials for weight management (ATTAIN-1 and ATTAIN-2). These adverse reactions occurred more commonly with once daily orforglipron than with placebo and occurred in at least 5% of patients treated with orforglipron.1
Adverse Reaction, % | Placebo | Orforglipron 5.5 mg once daily | Orforglipron 9 mg once daily | Orforglipron 17.2 mg once daily |
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 paina | 7 | 13 | 14 | 14 |
Headache | 7 | 8 | 9 | 9 |
Abdominal distension | 3 | 7 | 9 | 8 |
Fatiguea | 4 | 6 | 7 | 9 |
Eructation | 1 | 6 | 8 | 8 |
Gastroesophageal reflux disease | 2 | 6 | 6 | 7 |
Flatulence | 2 | 5 | 6 | 6 |
Hair lossa | 2 | 4 | 4 | 5 |
aIncludes other related terms.
Gastrointestinal Adverse Reactions
In a pool of ATTAIN-1 and ATTAIN-2, gastrointestinal (GI) adverse reactions occurred more frequently among patients treated with once daily orforglipron 5.5 mg (60%), 9 mg (68%), and 17.2 mg (69%) than placebo (37%). More patients treated with once daily orforglipron 5.5 mg (3%), 9 mg (6%), and 17.2 mg (6%) discontinued treatment due to GI adverse reactions than patients receiving placebo (0.7%).1
Of the orforglipron-treated patients who reported GI adverse reactions, 60%, 36%, and 4% reported mild or moderate or severe adverse reactions, respectively. The incidence of nausea, vomiting, and diarrhea was higher during the orforglipron dosage escalation period and decreased over time.1
Hypoglycemia
In ATTAIN-2, a trial of patients with type 2 diabetes (T2D) and body mass index (BMI) ≥27 kg/m2, hypoglycemia (glucose <54 mg/dL) was reported in 2% of orforglipron-treated patients versus 0.2% of placebo-treated patients.1
One patient treated with orforglipron 5.5 mg once daily, and no patients receiving placebo reported severe hypoglycemia in ATTAIN-2.1
In this trial, 7% of patients taking orforglipron in combination with sulfonylurea reported hypoglycemia compared with 0.5% of patients not taking sulfonylurea.1
Enclosed Prescribing Information
References
1Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: June 23, 2026