Cetuximab: uses, dosing, side effects & brands
Cetuximab is a medicine sold in the U.S. under one brand, for squamous cell carcinoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Squamous Cell Carcinoma
- Available as
- Solution
- Sold as
- Erbitux
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How cetuximab is dosed
From the FDA label for Erbitux (application BLA125084). Other cetuximab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Premedicate with an H 1 receptor antagonist. ( 2.4 ) In Combination With Radiation Therapy: Initial dose: 400 mg/m 2 administered as a 120-minute intravenous infusion one week prior to initiating a course of radiation therapy. ( 2.2 ) Subsequent doses: 250 mg/m 2 administered as a 60-minute infusion every week for the duration of radiation therapy (6–7 weeks). ( 2.2 ) Complete ERBITUX administration 1 hour prior to radiation therapy. ( 2.2 ) As Single-Agent or in Combination With Chemotherapy: Weekly: Administer initial dose of 400 mg/m 2 as a 120-minute intravenous infusion, and subsequent doses of 250 mg/m 2 infused over 60 minutes once weekly. ( 2.2 , 2.3 ) Biweekly: Administer 500 mg/m 2 as a 120-minute intravenous infusion every two weeks. ( 2.2 , 2.3 ) Complete ERBITUX administration 1 hour prior to chemotherapy. Continue treatment until disease progression or unacceptable toxicity. ( 2.2 , 2.3 ) See full prescribing information for dosage adjustments for adverse reactions. ( 2.5 ) 2.1 Patient Selection Select patients with metastatic colorectal cancer (CRC) for treatment with ERBITUX based on the presence of: Ras wild-type, EGFR-expressing CRC [see Clinical Studies ( 14.2 )], or BRAF V600E mutation-positive metastatic CRC [see Clinical Studies ( 14.3 )] Information on FDA-approved tests for the detection of K-Ras or BRAF V600E mutations in CRC in patients with…
Cetuximab side effects
The following adverse reactions are discussed in greater detail in other sections of the label: Infusion reactions [see Warnings and Precautions ( 5.1 )] . Cardiopulmonary arrest [see Warnings and Precautions ( 5.2 )] . Pulmonary toxicity [see Warnings and Precautions ( 5.3 )] . Dermatologic toxicity [see Warnings and Precautions ( 5.4 )] . Hypomagnesemia and Electrolyte Abnormalities [see Warnings and Precautions ( 5.6 )] . The most common adverse reactions (incidence ≥25%) with Erbitux as a single-agent or in combination with radiotherapy or chemotherapy (FOLFIRI, Irinotecan and 5-Fluorouracil/Platinum) are: cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, diarrhea, and infection. ( 6 ) The most common adverse reactions (>25%) for ERBITUX, in combination with encorafenib, are fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash. ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data…
Who shouldn’t take cetuximab
None. None. ( 4 )
Every cetuximab product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Erbitux.
Cetuximab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for cetuximab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of cetuximab during breastfeeding. Because cetuximab is a large protein molecule with a molecular weight of 145,782 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, cetuximab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during cetuximab therapy and for 2 months after the last dose.
National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about cetuximab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 12,879 reports naming cetuximab, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- diarrhoea1,177 reports
- nausea940 reports
- vomiting799 reports
- neutropenia739 reports
- dehydration723 reports
- fatigue664 reports
- pyrexia617 reports
- malignant neoplasm progression551 reports
Read these as a signal, not a rate. A report does not mean cetuximab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is cetuximab?
Erbitux (Cetuximab) is a medication used to treat Squamous Cell Carcinoma.
Can you take cetuximab with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run cetuximab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does cetuximab come in?
Across the brands we track, cetuximab is currently marketed as solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic cetuximab?
We do not currently list a generic-labelled cetuximab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Cetuximab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/cetuximab
- MLA
- “Cetuximab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/cetuximab.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for cetuximab on DailyMed (NIH) ↗ — including its boxed warning in full.