What the label lists and what reports show
Nivolumab side effects
Nivolumab's FDA label: “Most common adverse reactions (incidence ≥20%) in patients were: • As a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract …” FAERS holds 96,109 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 (9,844 reports).
- No generic listed
Check it at the source: the nivolumab FDA label on DailyMed (effective August 12, 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 OPDIVO?OPDIVO can cause serious side effects, including: • See “What is the most important information I should know about OPDIVO?” • Severe infusion reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of OPDIVO: ∘ chills or shaking ∘ itching or rash ∘ flushing ∘ shortness of breath or wheezing ∘ dizziness ∘ feel like passing out ∘ fever ∘ back or neck pain • Complications of stem cell transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant. […]
Source: FDA drug label, E.R. Squibb & Sons, L.L.C., effective August 12, 2026 (SPL set f570b9c4-6846-4de2-abfa-4d0a4ae4e394), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥20%) in patients were: • As a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, vomiting, and urinary tract infection.
Table 9: Adverse Reactions Occurring in ≥10% of Patients on the OPDIVO and Ipilimumab Arm or the OPDIVO Arm and at a Higher Incidence than in the Ipilimumab Arm (Between Arm Difference of ≥5% All Grades or ≥2% Grades…
| 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 | 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 | 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) ] • Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥20%) in patients were: • As a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, vomiting, and urinary tract infection. (6.1) • In combination with ipilimumab: 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) • In combination with platinum-doublet chemotherapy: nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, vomiting, and peripheral neuropathy. (6.1) • In combination with ipilimumab and platinum-doublet chemotherapy: fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.
Source: FDA drug label, E.R. Squibb & Sons, L.L.C., effective August 12, 2026 (SPL set f570b9c4-6846-4de2-abfa-4d0a4ae4e394), via openFDA; the full label on DailyMed
What do FAERS reports show?
96,109 reports list nivolumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 24,663 are coded as a death and 39,168 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 21 reactions below, 15 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?
- Nivolumab: 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