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Avelumab Side Effects

The most commonly reported side effects of avelumab include death, disease progression, and off label use, based on 3,888 FDA adverse event reports from 2016 to 2025.

Avelumab side effects

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

1
Death9.5%370
2
Disease Progression9.4%366
3
Off Label Use5.7%221
4
Diarrhoea4.3%166
5
Pyrexia3.8%147
6
Infusion Related Reaction3.7%144
7
Fatigue3.3%130
8
Neoplasm Progression3.2%125
9
Nausea2.7%106
10
Dyspnoea2.7%105
11
Interstitial Lung Disease2.6%101
12
Chills2.6%101
13
Hypertension2.6%100
14
Rash2.5%98
15
Acute Kidney Injury2.2%85

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

Report severity

90.9%Serious3,533 reports
44.2%Hospitalizations1,717 reports
23.4%Fatal908 reports

Seriousness is determined by the reporter, not by OpenClaim.

Avelumab drug interactions

Other drugs that appear in adverse event reports alongside avelumab. 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
Axitinib19.7%765
2
Carboplatin6.2%241
3
Gemcitabine5.0%196
4
Cisplatin4.8%185
5
Oxaliplatin3.5%138
6
Paclitaxel3.3%127
7
Pembrolizumab3.1%120
8
Atezolizumab3.0%115
9
Fluorouracil2.9%112
10
Nivolumab2.7%105
11
Enfortumab-vedotin-ejfv2.6%103
12
Cetuximab2.6%101
13
Durvalumab2.5%99
14
Docetaxel2.2%86
15
Ipilimumab2.1%81

Taken alongside

1
Acetaminophen12.7%494
2
Amlodipine4.6%178
3
Diphenhydramine4.4%171
4
Levothyroxine-sodium3.7%145
5
Omeprazole3.7%142
6
Ondansetron3.3%129
7
Atorvastatin-calcium3.2%125
8
Aspirin3.1%122
9
Oxycodone2.5%98
10
Pantoprazole-sodium2.5%97
11
Metformin2.3%91
12
Dexamethasone2.3%89
13
Axitinib2.1%82
14
Insulin1.9%74
15
Bisoprolol-fumarate1.8%71

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 avelumab side effects

26.9% of avelumab adverse event reports involve female patients and 61.1% involve male patients. The largest age group is elderly at 66%. These figures reflect who reports side effects, not underlying risk.

Sex

Female26.9%
Male61.1%
Unknown12.0%

Age group

< 20.0%
2–110.0%
12–17<0.1%
18–6434.0%
65+65.9%

What is avelumab used for

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

Acute Myeloid LeukaemiaAcute Myeloid Leukaemia RefractoryAdenocarcinoma GastricAdenocarcinoma Of ColonAdenoid Cystic CarcinomaAdrenocortical CarcinomaAnal Cancer MetastaticAnal Squamous Cell CarcinomaAngiocentric LymphomaAngiosarcomaAdenocarcinoma GastricAdenocarcinoma Of ColonAdenocarcinoma PancreasAdenoid Cystic CarcinomaAdrenocortical Carcinoma

Showing 15 of 267 indications

Avelumab brand names and reporting trend

Avelumab is sold under the brand name Bavencio.

Brand names

Bavencio2,795

Quarterly reports (20162025)

2016202020242025

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

Taking avelumab with another medication?

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