Prescription medicine
Cetuximab Brand names: Erbitux
Cetuximab (Erbitux) is a prescription medicine with an FDA approval on record since 2004. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the cetuximab FDA label on DailyMed (effective April 16, 2026, ImClone LLC); the BLA 125084 record on Drugs@FDA; every cetuximab label on DailyMed.
Highlights of the record
FDA label of April 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 )]. Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration [see Warnings and Precautions ( 5.2 , 5.6 )]. WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST See full prescribing information for complete boxed warning. ERBITUX can cause serious and fatal infusion reactions. ( 5.1 , 6 ) Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions. ( 2.5 ) Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration.
Used for
From the label: indications and usageERBITUX ® 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.
Forms and strengths
- 2 mg/ml
Solution.
On the market
- Earliest approval on file
- February 12, 2004 Erbitux, Imclone; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2018 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 31,149 through July 30, 2026
What is cetuximab used for?
From the label: indications and usageERBITUX ® 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. ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. […]
Conditions named in the indications of cetuximab's FDA labels, with every medicine labeled for each:
From other cetuximab labelsColorectal cancer: Cancer (CRC) ERBITUX is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test [see Dosage and Administration ( 2.2 )] …
FDA pharmacologic class: Epidermal Growth Factor Receptor Antagonist.
Source: FDA drug label (ERBITUX), ImClone LLC, effective April 16, 2026 (SPL set 8bc6397e-4bd8-4d37-a007-a327e4da34d9), via openFDA; the full label on DailyMed
Is there a generic for cetuximab (Erbitux)?
No generic cetuximab is approved (Drugs@FDA, October 8, 2026).
- 2004 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has cetuximab been recalled?
The FDA's Enforcement Report lists 2 recalls naming cetuximab since 2018: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| November 8, 2018 | Class III | Eli Lilly & Co | Labeling: Missing label; potential for missing primary container label on the vial. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cetuximab label say about other medicines?
The cetuximab label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name cetuximab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carboplatin | warnings and precautions | Hypomagnesemia of any grade occurred in 4% of patients who received cetuximab, carboplatin, and fluorouracil. |
| Cisplatin | warnings and precautions | The addition of ERBITUX resulted in an increase in the incidence of Grade 3 and 4 mucositis, radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances compared to radiation and cisplatin alone. |
| Fluorouracil | boxed warning | … neck receiving ERBITUX with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration. |
Other labels that name cetuximab
Source: FDA drug label (ERBITUX), ImClone LLC, effective April 16, 2026 (SPL set 8bc6397e-4bd8-4d37-a007-a327e4da34d9), via openFDA; the full label on DailyMed
What do FAERS reports show for cetuximab?
The FDA Adverse Event Reporting System holds 31,149 reports that list cetuximab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,217 are coded as a death and 12,520 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cetuximab?
8 other medicines are given the same way (intravenous) and in the same FDA class as cetuximab or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Panitumumab | Colorectal cancer | none listed | n/a | No current entry |
| Oxaliplatin | Colorectal cancer | 17 labelers | n/a | A presentation being discontinued |
| Fluorouracil | Colorectal cancer | 12 labelers | n/a | No current entry |
| Irinotecan | Colorectal cancer | 12 labelers | n/a | A presentation being discontinued |
| Levoleucovorin | Colorectal cancer | 8 labelers | n/a | No current entry |
| Bevacizumab | Colorectal cancer | none listed | n/a | No current entry |
| Aflibercept | Colorectal cancer | none listed | n/a | No current entry |
| Bevacizumab-maly | Colorectal cancer | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cetuximab
- 8 medicines for the same use
- Other epidermal growth factor receptor antagonists
- the pharmacologic class, with prices and generics
- Cetuximab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other