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Tremelimumab Side Effects

The most commonly reported side effects of tremelimumab include death, diarrhoea, and pyrexia, based on 3,662 FDA adverse event reports from 2008 to 2025.

Tremelimumab side effects

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

1
Death7.6%279
2
Diarrhoea7.0%256
3
Pyrexia5.7%207
4
Malignant Neoplasm Progression5.3%193
5
Colitis4.5%164
6
Cytokine Release Syndrome4.2%152
7
Immune-mediated Enterocolitis3.4%126
8
Rash3.4%123
9
Liver Disorder3.1%112
10
Pneumonia2.9%106
11
Myocarditis2.4%89
12
Pneumonitis2.4%89
13
Hepatic Function Abnormal2.4%87
14
Sepsis2.3%85
15
Interstitial Lung Disease2.2%82

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

Report severity

96.9%Serious3,548 reports
50.7%Hospitalizations1,857 reports
27.4%Fatal1,005 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tremelimumab drug interactions

Other drugs that appear in adverse event reports alongside tremelimumab. 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
Durvalumab77.5%2,839
2
Paclitaxel15.0%549
3
Gemcitabine11.7%429
4
Carboplatin10.0%366
5
Pemetrexed4.4%162
6
Cisplatin2.8%102
7
Atezolizumab2.3%85
8
Etoposide2.2%79
9
Bevacizumab1.9%69
10
Lenvatinib-mesylate1.6%60
11
Nivolumab1.1%42
12
Pembrolizumab1.1%40
13
Enfortumab-vedotin-ejfv0.9%34
14
Ipilimumab0.8%30
15
Prednisone0.7%27

Taken alongside

1
Acetaminophen10.1%371
2
Carboplatin6.4%233
3
Dexamethasone6.1%224
4
Pantoprazole-sodium5.6%206
5
Levothyroxine-sodium4.5%166
6
Metoclopramide-hydrochloride4.5%165
7
Ondansetron4.5%163
8
Amlodipine4.4%160
9
Atorvastatin-calcium4.0%145
10
Prednisone3.8%138
11
Hydromorphone-hydrochloride3.7%136
12
Paclitaxel3.7%135
13
Aspirin3.7%134
14
Omeprazole3.7%134
15
Ergocalciferol3.5%128

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 tremelimumab side effects

23.6% of tremelimumab adverse event reports involve female patients and 62.2% involve male patients. The largest age group is elderly at 63%. These figures reflect who reports side effects, not underlying risk.

Sex

Female23.6%
Male62.2%
Unknown14.1%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6437.2%
65+62.6%

What is tremelimumab used for

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

AdenocarcinomaAdenocarcinoma GastricAdenocarcinoma PancreasAnal Squamous Cell CarcinomaAnaplastic Thyroid CancerAnticoagulant TherapyAdenocarcinoma Of ColonAdenocarcinoma PancreasAdenoid Cystic CarcinomaAsthmaBile Duct CancerBiliary Cancer MetastaticBiliary NeoplasmBladder CancerBladder Transitional Cell Carcinoma

Showing 15 of 176 indications

Tremelimumab brand names and reporting trend

Tremelimumab is sold under the brand name Imjudo.

Brand names

Imjudo3,461

Quarterly reports (20082025)

2010201520202025

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

Taking tremelimumab with another medication?

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