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Cetuximab side effects: what 31,149 FDA adverse event reports show

Cetuximab · Erbitux · 1,074 reaction terms · 85,215 drug–reaction co-reports · data 2026-09-14
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Drug class

Epidermal Growth Factor Receptor Antagonist

FDA label (Established Pharmacologic Class)

Brand names

Erbitux

openFDA label

Who reports

31,149 reports · 85% serious · 4,217 with death outcome · 34% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.

FDA label, Indications and Usage

What it is

Cetuximab is an epidermal growth factor receptor (EGFR) antagonist. It is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR).

FDA label, Description section

Boxed warning

INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration ( 2.5 )] .

FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 3Labeled (related wording) 6Likely indication confounding 6Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 20
What the badges mean

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,034 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Radiation skin injury213151.4
130.5–175.7ROR 152.5 · χ² 25,792 / p <1e-300
122.1 EB05 109.0 · IC025 +6.4
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=198not reported in cached trials
Trichomegaly16139.6
81.5–239.4ROR 139.7 · χ² 1,706 / p <1e-300
101.8 EB05 66.5 · IC025 +3.8
3/3 methods agree
Not in label — unassessedserious n=15not reported in cached trials
Dermatitis acneiform852110.4
102.7–118.6ROR 113.5 · χ² 79,099 / p <1e-300
94.6 EB05 89.4 · IC025 +6.4
3/3 methods agree
Labeled adverse reaction
exact term
serious n=612not reported in cached trials
Serous retinal detachment105102.4
83.4–125.8ROR 102.8 · χ² 9,047 / p <1e-300
87.5 EB05 74.3 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious n=105 · 92% cliniciannot reported in cached trials
Squamous cell carcinoma of head and neck2580.9
53.4–122.5ROR 81.0 · χ² 1,688 / p <1e-300
68.6 EB05 48.9 · IC025 +4.2
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=24 · 100% cliniciannot reported in cached trials
Portal venous gas2449.1
32.5–74.4ROR 49.2 · χ² 1,009 / p 9e-222
44.3 EB05 31.3 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=24 · ♀ 0% (drug 34%)not reported in cached trials
Pharyngeal inflammation7745.8
36.3–57.6ROR 45.9 · χ² 3,112 / p <1e-300
42.5 EB05 35.1 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=76 · ♀ 10% (drug 34%)not reported in cached trials
Paronychia26243.3
38.3–49.1ROR 43.7 · χ² 10,137 / p <1e-300
40.6 EB05 36.7 · IC025 +5.0
3/3 methods agree
Labeled adverse reaction
exact term
serious n=234not reported in cached trials
Osteoradionecrosis1341.1
23.5–71.9ROR 41.1 · χ² 441 / p 3e-98
36.8 EB05 22.9 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=10not reported in cached trials
Granulocyte count decreased9839.1
31.9–48.0ROR 39.3 · χ² 3,403 / p <1e-300
36.8 EB05 31.1 · IC025 +4.6
3/3 methods agree
Lab value / disease markerserious n=98 · 82% consumernot reported in cached trials
Colorectal cancer metastatic12338.2
31.9–45.8ROR 38.4 · χ² 4,180 / p <1e-300
36.0 EB05 31.0 · IC025 +4.7
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=123 · ♀ 56% (drug 34%) · 93% cliniciannot reported in cached trials
Haemoglobin1035.5
18.8–67.0ROR 35.5 · χ² 286 / p 2e-64
31.8 EB05 18.4 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious n=10NCT00079274: 1/1,326 (0.1%) on Cetuximab (serious AE)
Hepatectomy1432.4
18.9–55.3ROR 32.4 · χ² 376 / p 4e-84
29.8 EB05 18.8 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=14not reported in cached trials
Hypomagnesaemia59630.2
27.8–32.7ROR 30.8 · χ² 16,069 / p <1e-300
28.9 EB05 27.0 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious PRR 17.4not reported in cached trials
Skin chapped1729.1
17.9–47.4ROR 29.2 · χ² 416 / p 1e-92
27.2 EB05 17.9 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=10not reported in cached trials
Catheter related infection3825.9
18.7–35.8ROR 25.9 · χ² 851 / p 2e-187
24.7 EB05 18.8 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=38NCT00079274: 1/1,378 (0.1%) on Cetuximab (serious AE)
Feeding tube complication1124.3
13.3–44.4ROR 24.3 · χ² 215 / p 5e-49
22.5 EB05 13.0 · IC025 +2.5
3/3 methods agree
Reporting / coding artifactserious n=10not reported in cached trials
Rectal cancer metastatic1224.1
13.6–42.9ROR 24.1 · χ² 235 / p 3e-53
22.4 EB05 13.4 · IC025 +2.6
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=12not reported in cached trials
Mucosal inflammation82522.0
20.5–23.5ROR 22.6 · χ² 15,991 / p <1e-300
21.3 EB05 20.1 · IC025 +4.3
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 14.1not reported in cached trials
Oncologic complication2920.6
14.3–29.9ROR 20.7 · χ² 507 / p 2e-112
19.8 EB05 14.4 · IC025 +3.3
3/3 methods agree
Reporting / coding artifactserious n=29 · ♀ 0% (drug 34%) · 100% consumernot reported in cached trials
Mesenteric artery thrombosis1119.8
10.9–36.0ROR 19.8 · χ² 173 / p 1e-39
18.2 EB05 10.0 · IC025 +2.4
3/3 methods agree
Not in label — unassessedserious n=11not reported in cached trials
Pneumatosis intestinalis8119.7
15.8–24.6ROR 19.8 · χ² 1,382 / p <1e-300
19.1 EB05 15.9 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=81not reported in cached trials
Necrotising oesophagitis1419.7
11.6–33.5ROR 19.7 · χ² 224 / p 7e-51
18.5 EB05 11.2 · IC025 +2.7
3/3 methods agree
Not in label — unassessedserious n=14not reported in cached trials
Rectal adenocarcinoma1719.7
12.1–31.9ROR 19.7 · χ² 275 / p 5e-62
18.6 EB05 12.0 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Blood pressure immeasurable4118.4
13.5–25.1ROR 18.4 · χ² 639 / p 3e-141
17.8 EB05 13.6 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=39not reported in cached trials
Carcinoembryonic antigen increased5118.2
13.8–24.1ROR 18.3 · χ² 792 / p 2e-174
17.7 EB05 13.9 · IC025 +3.5
3/3 methods agree
Lab value / disease markerserious n=44not reported in cached trials
Radiation oesophagitis1018.2
9.7–34.1ROR 18.2 · χ² 142 / p 6e-33
16.3 EB05 8.4 · IC025 +2.2
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=10not reported in cached trials
Proteus infection1918.2
11.5–28.6ROR 18.2 · χ² 283 / p 7e-64
17.2 EB05 11.4 · IC025 +2.9
3/3 methods agree
Not in label — unassessedserious n=19not reported in cached trials
Metastatic squamous cell carcinoma1317.5
10.1–30.4ROR 17.5 · χ² 182 / p 1e-41
16.2 EB05 9.3 · IC025 +2.5
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=13not reported in cached trials
Nail dystrophy1417.4
10.2–29.6ROR 17.4 · χ² 195 / p 1e-44
16.2 EB05 9.6 · IC025 +2.5
3/3 methods agree
Not in label — unassessedserious n=14not reported in cached trials
Metastases to the mediastinum1016.6
8.9–31.1ROR 16.6 · χ² 128 / p 6e-30
14.7 EB05 7.3 · IC025 +2.2
3/3 methods agree
Not in label — unassessedserious n=10not reported in cached trials
Colon cancer metastatic3816.3
11.8–22.5ROR 16.3 · χ² 518 / p 7e-115
15.7 EB05 11.9 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=37 · 100% cliniciannot reported in cached trials
Blood magnesium abnormal1316.2
9.4–28.1ROR 16.2 · χ² 167 / p 2e-38
14.8 EB05 8.4 · IC025 +2.4
3/3 methods agree
Lab value / disease marker–NCT00079274: 1/1,378 (0.1%) on Cetuximab (serious AE)
Abdominal compartment syndrome1415.5
9.1–26.2ROR 15.5 · χ² 171 / p 2e-39
14.1 EB05 8.2 · IC025 +2.4
3/3 methods agree
Not in label — unassessedserious n=14not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Cetuximab as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Rash2,2733.5
3.4–3.7ROR 3.7 · χ² 4,210 / p <1e-300
3.5 EB05 3.4 · IC025 +1.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.7NCT00079274: 1/1,326 (0.1%) on Cetuximab (serious AE)
Diarrhoea (diarrhea)2,0232.1
2.0–2.2ROR 2.2 · χ² 1,231 / p 5e-270
2.1 EB05 2.0 · IC025 +1.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.3NCT00079274: 15/1,378 (1.1%) on Cetuximab (serious AE)
Off label use (used outside approved label)1,8901.5
1.4–1.5ROR 1.5 · χ² 292 / p 9e-66
1.5 EB05 1.4 · IC025 +0.5Reporting / coding artifactserious PRR 1.8not reported in cached trials
Nausea1,6451.4
1.3–1.5ROR 1.4 · χ² 198 / p 2e-45
1.4 EB05 1.3 · IC025 +0.4Labeled adverse reaction
exact term
serious PRR 1.7NCT00079274: 5/1,378 (0.4%) on Cetuximab (serious AE)
Vomiting1,3942.0
1.9–2.1ROR 2.1 · χ² 715 / p 1e-157
2.0 EB05 1.9 · IC025 +0.9Labeled adverse reaction
exact term
serious PRR 1.9NCT00079274: 3/1,378 (0.2%) on Cetuximab (serious AE)
Dyspnoea (shortness of breath)1,3851.7
1.6–1.7ROR 1.7 · χ² 363 / p 3e-81
1.6 EB05 1.6 · IC025 +0.6Labeled adverse reaction
exact term
serious PRR 1.4NCT00079274: 2/1,378 (0.1%) on Cetuximab (serious AE)
Neutropenia (low neutrophils (infection-fighting cells))1,2256.1
5.8–6.5ROR 6.3 · χ² 5,244 / p <1e-300
6.1 EB05 5.8 · IC025 +2.5
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.2NCT00079274: 2/1,326 (0.2%) on Cetuximab (serious AE)
Pyrexia (fever)1,1242.2
2.1–2.3ROR 2.2 · χ² 735 / p 4e-162
2.2 EB05 2.1 · IC025 +1.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 1.7not reported in cached trials
Dehydration1,1045.6
5.3–5.9ROR 5.8 · χ² 4,169 / p <1e-300
5.6 EB05 5.3 · IC025 +2.4
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.3NCT00079274: 7/1,378 (0.5%) on Cetuximab (serious AE)
Infusion related reaction (reaction during infusion)1,10411.4
10.8–12.1ROR 11.8 · χ² 10,349 / p <1e-300
11.2 EB05 10.7 · IC025 +3.4
3/3 methods agree
Labeled — boxed warning
synonym match
serious PRR 8.1not reported in cached trials
Malignant neoplasm progression1,1037.4
6.9–7.8ROR 7.6 · χ² 6,017 / p <1e-300
7.3 EB05 6.9 · IC025 +2.8
3/3 methods agree
Reporting / coding artifactserious PRR 5.0not reported in cached trials
Fatigue (tiredness)1,0760.9
0.9–1.0ROR 0.9 · χ² 5 / p 0.010
0.9 EB05 0.9 · IC025 -0.2
PRR-only: not supported by EBGM or IC
Labeled adverse reaction
exact term
serious PRR 1.0NCT00079274: 3/1,378 (0.2%) on Cetuximab (serious AE)
Death1,0730.8
0.8–0.9ROR 0.8 · χ² 35 / p 2e-9
0.8 EB05 0.8 · IC025 -0.4
PRR-only: not supported by EBGM or IC
Outcome field, not a reaction
boxed warning mentions mortality
serious PRR 0.6NCT00079274: 2/1,326 (0.2%) on Cetuximab (serious AE)
Anaemia (low red blood cells)9263.3
3.1–3.5ROR 3.3 · χ² 1,469 / p <1e-300
3.3 EB05 3.1 · IC025 +1.6
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.4not reported in cached trials
Hypotension (low blood pressure)9233.1
2.9–3.3ROR 3.2 · χ² 1,327 / p 6e-291
3.1 EB05 2.9 · IC025 +1.5
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 2.3NCT00079274: 3/1,378 (0.2%) on Cetuximab (serious AE)

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Cetuximab ↔ Hypomagnesaemia.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Cetuximab?

In FDA FAERS, the most frequently co-reported reaction terms for Cetuximab are rash, diarrhoea, nausea, vomiting, dyspnoea, neutropenia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Cetuximab have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration ( 2.5 )] .

Do FAERS signals prove that Cetuximab causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.