What the label lists and what reports show
Ipilimumab side effects
Ipilimumab's FDA label: “Most common adverse reactions (≥20%) with YERVOY as a single agent are fatigue, diarrhea, pruritus, rash, nausea, and headache.” FAERS holds 42,912 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 malignant neoplasm progression (3,782 reports).
- No generic listed
Check it at the source: the ipilimumab FDA label on DailyMed (effective August 20, 2026, E.R. Squibb & Sons, L.L.C.); 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 YERVOY?YERVOY can cause serious side effects, including: • See “ What is the most important information I should know about YERVOY? ” • Severe infusion-related reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of YERVOY: o chills or shaking o itching or rash o flushing o shortness of breath or wheezing o dizziness o feel like passing out o fever o back or neck pain • Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with YERVOY. Your healthcare provider will monitor you for these complications. […]
Source: FDA drug label, E.R. Squibb & Sons, L.L.C., effective August 20, 2026 (SPL set 2265ef30-253e-11df-8a39-0800200c9a66), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥20%) with YERVOY as a single agent are fatigue, diarrhea, pruritus, rash, nausea, and headache.
Table 5: Adverse Reactions Occurring in ≥10% of Patients on the YERVOY and Nivolumab Arm or the Nivolumab Arm and at a Higher Incidence than in the YERVOY Arm (Between Arm Difference of ≥5% All Grades or ≥2% Grades 3-4)…
| Reaction | All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) |
|---|---|---|---|---|---|---|
| Fatigue a | 62 | 7 | 59 | 1.6 | 51 | 4.2 |
| Pyrexia | 40 | 1.6 | 16 | 0 | 18 | 0.6 |
| Diarrhea | 54 | 11 | 36 | 5 | 47 | 7 |
| Nausea | 44 | 3.8 | 30 | 0.6 | 31 | 1.9 |
| Vomiting | 31 | 3.8 | 20 | 1.0 | 17 | 1.6 |
| Rash b | 53 | 6 | 40 | 1.9 | 42 | 3.5 |
| Vitiligo | 9 | 0 | 10 | 0.3 | 5 | 0 |
| Musculoskeletal pain c | 32 | 2.6 | 42 | 3.8 | 36 | 1.9 |
| Arthralgia | 21 | 0.3 | 21 | 1.0 | 16 | 0.3 |
| Decreased appetite | 29 | 1.9 | 22 | 0 | 24 | 1.3 |
| Cough/productive cough | 27 | 0.3 | 28 | 0.6 | 22 | 0 |
| Dyspnea/exertional dyspnea | 24 | 2.9 | 18 | 1.3 | 17 | 0.6 |
| Upper respiratory tract infection d | 23 | 0 | 22 | 0.3 | 17 | 0 |
| Hypothyroidism | 19 | 0.6 | 11 | 0 | 5 | 0 |
| Hyperthyroidism | 11 | 1.3 | 6 | 0 | 1 | 0 |
| Decreased weight | 12 | 0 | 7 | 0 | 7 | 0.3 |
| Hypertension e | 7 | 2.2 | 11 | 5 | 9 | 2.3 |
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 clinically significant adverse reactions are described elsewhere in the labeling: • Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ]. • Infusion-related reactions [see Warnings and Precautions (5.2) ]. Most common adverse reactions (≥20%) with YERVOY as a single agent are fatigue, diarrhea, pruritus, rash, nausea, and headache. (6.1) Most common adverse reactions (≥20%) with YERVOY in combination with nivolumab are fatigue, diarrhea, rash, pruritus, nausea, musculoskeletal pain, pyrexia, cough, decreased appetite, vomiting, abdominal pain, dyspnea, upper respiratory tract infection, arthralgia, headache, hypothyroidism, constipation, decreased weight, and dizziness. (6.1) Most common adverse reactions (≥20%) with YERVOY in combination with nivolumab and platinum-doublet chemotherapy are fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, E.R. Squibb & Sons, L.L.C., effective August 20, 2026 (SPL set 2265ef30-253e-11df-8a39-0800200c9a66), via openFDA; the full label on DailyMed
What do FAERS reports show?
42,912 reports list ipilimumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 9,586 are coded as a death and 19,401 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 22 reactions below, 20 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?
- Ipilimumab: 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