What the label lists and what reports show
Orforglipron side effects
Orforglipron's FDA label: “Most common adverse reactions, reported in ≥5% of patients treated with FOUNDAYO, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and …” FAERS holds 726 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (179 reports).
- No generic listed
- Boxed warning
Check it at the source: the orforglipron FDA label on DailyMed (effective July 29, 2026, Eli Lilly and Company); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of FOUNDAYO?FOUNDAYO may cause serious side effects, including: See “ What is the most important information I should know about FOUNDAYO? ” inflammation of the pancreas (pancreatitis). Stop taking FOUNDAYO and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use FOUNDAYO. Tell your healthcare provider if you have stomach problems that are severe or will not go away. dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. […]
Source: FDA drug label, Eli Lilly and Company, effective July 29, 2026 (SPL set 8ac446c5-feba-474f-a103-23facb9b5c62), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions, reported in ≥5% of patients treated with FOUNDAYO, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss.
Table 1: Adverse Reactions Reported in ≥5% of FOUNDAYO-treated Adult Patients with Obesity or Overweight (With or Without Type 2 Diabetes) in Pool of Placebo-Controlled Trials (Trials 1 and 2)
| Adverse Reaction | Placebo (N=1,576) % | FOUNDAYO 5.5 mg once daily (N=1,051) % | FOUNDAYO 9 mg once daily (N=1,055) % | FOUNDAYO 17.2 mg once daily (N=1,049) % |
|---|---|---|---|---|
| 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 pain a | 7 | 13 | 14 | 14 |
| Headache | 7 | 8 | 9 | 9 |
| Abdominal distension | 3 | 7 | 9 | 8 |
| Fatigue a | 4 | 6 | 7 | 9 |
| Eructation | 1 | 6 | 8 | 8 |
| Gastroesophageal reflux disease | 2 | 6 | 6 | 7 |
| Flatulence | 2 | 5 | 6 | 6 |
| Hair loss a | 2 | 4 | 4 | 5 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-Cell Tumors [see Warnings and Precautions ( 5.1 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] Severe Gastrointestinal Reactions [see Warnings and Precautions ( 5.3 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.4 )] Hypoglycemia [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes [see Warnings and Precautions ( 5.7 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] Most common adverse reactions, reported in ≥5% of patients treated with FOUNDAYO, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Eli Lilly and Company, effective July 29, 2026 (SPL set 8ac446c5-feba-474f-a103-23facb9b5c62), via openFDA; the full label on DailyMed
What do FAERS reports show?
726 reports list orforglipron among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 10 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 24 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Orforglipron: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions