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Cetuximab Side Effects

The most commonly reported side effects of cetuximab include off label use, rash, and diarrhoea, based on 31,104 FDA adverse event reports from 2004 to 2025.

Cetuximab side effects

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

1
Off Label Use5.8%1,801
2
Rash4.5%1,385
3
Diarrhoea3.9%1,219
4
Nausea3.0%931
5
Rash2.8%886
6
Neutropenia2.8%879
7
Death2.8%861
8
Malignant Neoplasm Progression2.8%856
9
Diarrhoea2.7%833
10
Nausea2.4%750
11
Dehydration2.4%742
12
Vomiting2.4%742
13
Dyspnoea2.3%726
14
Fatigue2.3%711
15
Vomiting2.2%684

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

Report severity

85.1%Serious26,462 reports
40.7%Hospitalizations12,658 reports
13.7%Fatal4,263 reports

Seriousness is determined by the reporter, not by OpenClaim.

Cetuximab drug interactions

Other drugs that appear in adverse event reports alongside cetuximab. 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
Fluorouracil17.6%5,467
2
Irinotecan-hydrochloride13.4%4,182
3
Oxaliplatin11.8%3,673
4
Cisplatin10.5%3,276
5
Carboplatin7.8%2,420
6
Paclitaxel5.5%1,708
7
Bevacizumab5.3%1,649
8
Encorafenib4.9%1,515
9
Capecitabine4.8%1,489
10
Docetaxel3.8%1,176
11
Levoleucovorin2.8%872
12
Gemcitabine2.7%825
13
Leucovorin-calcium2.5%793
14
Binimetinib1.9%602
15
Panitumumab1.4%440

Taken alongside

1
Dexamethasone6.6%2,040
2
Diphenhydramine6.4%1,987
3
Irinotecan-hydrochloride5.5%1,711
4
Fluorouracil5.3%1,656
5
Acetaminophen4.7%1,472
6
Ondansetron3.8%1,172
7
Oxaliplatin3.2%991
8
Oxycodone2.5%777
9
Aspirin2.2%673
10
Omeprazole1.8%563
11
Sodium-chloride1.8%554
12
Prochlorperazine1.7%543
13
Lorazepam1.7%528
14
Levoleucovorin1.7%523
15
Cisplatin1.7%523

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 cetuximab side effects

28.7% of cetuximab adverse event reports involve female patients and 56.7% involve male patients. The largest age group is adult at 54%. These figures reflect who reports side effects, not underlying risk.

Sex

Female28.7%
Male56.7%
Unknown14.6%

Age group

< 2<0.1%
2–110.1%
12–170.1%
18–6454.1%
65+45.7%

What is cetuximab used for

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

Accidental ExposureAcinar Cell Carcinoma Of PancreasAcinic Cell Carcinoma Of Salivary GlandAcneAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma MetastaticAdenocarcinoma Of AppendixAdenocarcinoma Of ColonAdenocarcinoma Of Colon Stage IvAdenocarcinoma Of The CervixAdenocarcinoma Of The Gastroesophageal JunctionAdenocarcinoma PancreasAdenoid Cystic Carcinoma

Showing 15 of 620 indications

Cetuximab brand names and reporting trend

Cetuximab is sold under the brand name Erbitux.

Brand names

Erbitux15,729

Quarterly reports (20042025)

20052010201520202025

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

Taking cetuximab with another medication?

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