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, used in combination with irinotecan, is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. Cetuximab administered as a single agent is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy.
Marketing Status Prescription
ATC Code L01FE01
DrugBank ID DB00002
KEGG ID D03455
MeSH ID D000068818
PubChem ID Not Available
TTD Drug ID D0N5OV
NDC Product Code 52203-0000; 66733-958; 66733-948; 73424-0561
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Neoplasm related morbiditiesEpidermal growth factor receptorP00533T5932814993230; 15821783; 15309512
ADRs Induced by Drug
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 syndrome23.07.04.001; 17.02.07.009--
Paronychia23.09.04.001; 11.01.12.001--
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 syndrome23.03.01.007; 12.03.01.014; 11.07.01.005; 10.01.03.020--
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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