What the label lists and what reports show
Nivolumab and relatlimab side effects
Nivolumab and relatlimab's FDA label: “The most common adverse reactions (≥20%) are musculoskeletal pain, fatigue, rash, pruritus, and diarrhea.” FAERS holds 472 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 (34 reports).
- No generic listed
Check it at the source: the nivolumab and relatlimab FDA label on DailyMed (effective June 8, 2026); 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 OPDUALAG?OPDUALAG can cause serious side effects, including: • See “What is the most important information I should know about OPDUALAG?” • Severe infusion reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of OPDUALAG: o chills or shaking o itching or rash o flushing o shortness of breath o dizziness o feel like passing out o fever o back or neck pain • Complications of 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 OPDUALAG. 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 June 8, 2026 (SPL set b22c9d83-3256-4e17-85f7-f331a504adc6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) are musculoskeletal pain, fatigue, rash, pruritus, and diarrhea.
Table 3: Adverse Reactions in ≥15% of Patients - RELATIVITY-047
| Reaction | All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) |
|---|---|---|---|---|
| Musculoskeletal pain a | 45 | 4.2 | 31 | 1.7 |
| Fatigue a | 39 | 2 | 29 | 0.6 |
| Rash a | 28 | 1.4 | 21 | 1.9 |
| Pruritus | 25 | 0 | 17 | 0.6 |
| Diarrhea a | 24 | 2 | 17 | 1.4 |
| Nausea | 17 | 0.6 | 14 | 0 |
| Headache a | 18 | 0.3 | 12 | 0.3 |
| Hypothyroidism a | 17 | 0 | 14 | 0 |
| Decreased appetite | 15 | 0.6 | 7 | 0.3 |
| Cough a | 15 | 0.3 | 11 | 0 |
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 discussed in greater detail in other sections of the labeling. • Severe and Fatal IMARs [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) ] The most common adverse reactions (≥20%) are musculoskeletal pain, fatigue, rash, pruritus, and diarrhea. (6.1) The most common laboratory abnormalities (≥20%) are decreased hemoglobin, decreased lymphocytes, increased AST, increased ALT, and decreased sodium. (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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of OPDUALAG was evaluated in RELATIVITY-047, a randomized (1:1), double-blinded trial in 714 patients with previously untreated metastatic or unresectable melanoma [see Clinical Studies (14) ]. Patients received intravenous OPDUALAG (nivolumab 480 mg and relatlimab 160 mg) every 4 weeks (n=355) or nivolumab 480 mg by intravenous infusion every 4 weeks (n=359). …
Source: FDA drug label, E.R. Squibb & Sons, L.L.C., effective June 8, 2026 (SPL set b22c9d83-3256-4e17-85f7-f331a504adc6), via openFDA; the full label on DailyMed
What do FAERS reports show?
472 reports list nivolumab and relatlimab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 95 are coded as a death and 103 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, 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.
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 and relatlimab: 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