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Nivolumab Side Effects

The most commonly reported side effects of nivolumab include death, malignant neoplasm progression, and off label use, based on 93,285 FDA adverse event reports from 2012 to 2025.

Nivolumab side effects

Percentages show how often each reaction appears relative to total reports for nivolumab.

1
Death12.4%11,587
2
Malignant Neoplasm Progression10.4%9,656
3
Off Label Use6.4%5,952
4
Diarrhoea5.4%5,059
5
Fatigue4.3%4,047
6
Pyrexia3.9%3,637
7
Intentional Product Use Issue3.6%3,330
8
Nausea3.3%3,083
9
Rash3.2%2,988
10
Decreased Appetite3.0%2,811
11
Dyspnoea2.8%2,651
12
Pneumonia2.6%2,411
13
Colitis2.4%2,226
14
Pneumonitis2.3%2,144
15
Asthenia2.2%2,048

These are voluntary reports and do not establish that nivolumab caused these reactions.

Report severity

89.5%Serious83,533 reports
41.1%Hospitalizations38,321 reports
25.8%Fatal24,113 reports

Seriousness is determined by the reporter, not by OpenClaim.

Nivolumab drug interactions

Other drugs that appear in adverse event reports alongside nivolumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Ipilimumab30.5%28,497
2
Cabozantinib6.7%6,218
3
Carboplatin3.9%3,631
4
Paclitaxel2.5%2,312
5
Oxaliplatin2.1%1,963
6
Pemetrexed1.7%1,602
7
Fluorouracil1.7%1,541
8
Cisplatin1.5%1,416
9
Pembrolizumab1.2%1,116
10
Gemcitabine1.0%927
11
Prednisone0.9%820
12
Bevacizumab0.8%751
13
Docetaxel0.7%663
14
Prednisolone0.7%642
15
Methylprednisolone0.7%615

Taken alongside

1
Acetaminophen4.9%4,572
2
Levothyroxine-sodium4.0%3,703
3
Amlodipine3.4%3,191
4
Ondansetron3.3%3,115
5
Oxycodone3.0%2,812
6
Aspirin3.0%2,781
7
Pantoprazole-sodium2.9%2,750
8
Omeprazole2.8%2,636
9
Atorvastatin-calcium2.6%2,468
10
Prednisone2.6%2,453
11
Dexamethasone2.4%2,232
12
Metformin1.9%1,770
13
Metoprolol1.9%1,750
14
Furosemide1.8%1,724
15
Ergocalciferol1.7%1,622

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports nivolumab side effects

30.1% of nivolumab adverse event reports involve female patients and 56.3% involve male patients. The largest age group is elderly at 54%. These figures reflect who reports side effects, not underlying risk.

Sex

Female30.1%
Male56.3%
Unknown13.6%

Age group

< 2<0.1%
2–110.2%
12–170.4%
18–6444.9%
65+54.5%

What is nivolumab used for

Conditions and purposes for which patients were taking nivolumab when the adverse event was reported.

Abdominal NeoplasmAcral Lentiginous MelanomaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RecurrentAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma MetastaticAdenocarcinoma Of AppendixAdenocarcinoma Of ColonAdenocarcinoma Of Salivary GlandAdenocarcinoma Of The CervixAdenocarcinoma PancreasAdenoid Cystic Carcinoma

Showing 15 of 1,450 indications

Nivolumab brand names and reporting trend

Nivolumab is sold under the brand name Opdualag.

Brand names

Opdualag62,422

Quarterly reports (20122025)

20122016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking nivolumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.