Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cetuximab
Drug ID BADD_D00422
Description Cetuximab is a recombinant chimeric human/mouse IgG1 monoclonal antibody that competitively binds to epidermal growth factor receptor (EGFR) and competitively inhibits the binding of epidermal growth factor (EGF).[A227973] EGFR is a member of the ErbB family of receptor tyrosine kinases found in both normal and tumour cells; it is responsible for regulating epithelial tissue development and homeostasis.[A228083] EGFR has been implicated in various types of cancer, as it is often overexpressed in malignant cells [A227973] and EGFR overexpression has been linked to more advanced disease and poor prognosis.[A227963] EGFR is often mutated in certain types of cancer and serves as a driver of tumorigenesis.[A228083] _In vitro_, cetuximab was shown to mediate anti-tumour effects in numerous cancer cell lines and human tumour xenografts.[A227963] Approved by the FDA in February 2004 under the brand name ERBITUX, cetuximab is used for the treatment of head and neck cancer and metastatic, KRAS wild-type colorectal cancer, and metastatic colorectal cancer with a BRAF V600E mutation.[A227963,L39045] It has also been investigated in advanced colorectal cancer, EGFR-expressing non-small cell lung cancer (NSCLC), and unresectable squamous cell skin cancer.[L31418] Cetuximab is administered via intravenous infusion and is used as monotherapy or in combination with other chemotherapies, including platinum agents, radiation therapy, [leucovorin], [fluorouracil], and [irinotecan].[L30448]
Indications and Usage Cetuximab indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. It is indicated for treating a recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. It is indicated for recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.[L30448] Cetuximab is also indicated for K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI, a chemotherapy combination that includes [leucovorin], [fluorouracil], and [irinotecan]; in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy; or as monotherapy in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.[L30448] Additionally, cetuximab is also indicated for metastatic colorectal cancer that is BRAF V600E mutation-positive (as determined by an FDA-approved test) in combination with [encorafenib] but only after prior therapy.[L39045] Cetuximab is not indicated for the treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.[L30448]
Marketing Status approved
ATC Code L01FE01
DrugBank ID DB00002
KEGG ID D03455
MeSH ID D000068818
PubChem ID Not Available
TTD Drug ID D0N5OV
NDC Product Code 66733-948; 66733-958; 73424-0561
UNII PQX0D8J21J
Synonyms Cetuximab | Erbitux | IMC C225 | IMC-C225 | MAb C225 | C225
Chemical Information
Molecular Formula Not Available
CAS Registry Number 205923-56-4
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hypomagnesaemia14.04.02.001--
Infection11.01.08.002--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Leukopenia01.02.02.001--Not Available
Malaise08.01.01.003--
Meningitis aseptic17.06.03.002; 11.01.03.002--Not Available
Mucosal inflammation08.01.06.002--Not Available
Nail disorder23.02.05.002--
Nausea07.01.07.001--
Neuropathy peripheral17.09.03.003--Not Available
Neutropenia01.02.03.004--Not Available
Pain08.01.08.004--
Palmar-plantar erythrodysaesthesia syndrome17.02.07.009; 23.03.05.009--
Paronychia23.11.04.006; 11.02.01.054--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.003--Not Available
Skin fissures23.03.03.008--Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
Toxic epidermal necrolysis10.01.01.006; 23.03.01.008; 12.03.01.015; 11.07.01.006--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Infusion related reaction12.02.05.009; 10.01.01.017; 08.01.03.002--
Blood alkaline phosphatase increased13.04.02.004--
Decreased appetite14.03.01.005; 08.01.09.028--
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ADReCS-Target
Drug Name ADR Term Target
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