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)
Acne23.02.01.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Anxiety19.06.02.002--
Application site reaction12.07.01.006; 08.02.01.006--Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Bone pain15.02.01.001--
Chills15.05.03.016; 08.01.09.001--
Confusional state19.13.01.001; 17.02.03.005--
Conjunctivitis06.04.01.002; 11.01.06.012--
Constipation07.02.02.001--
Cough22.02.03.001--
Death08.04.01.001--
Dehydration14.05.05.001--
Depression19.15.01.001--
Dermatitis acneiform23.02.01.004--
Dermatitis bullous23.03.01.002--
Diarrhoea07.02.01.001--
Dry mouth07.06.01.002--
Dry skin23.03.03.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dyspnoea02.01.03.002; 22.02.01.004--
Fatigue08.01.01.002--
Gastrointestinal disorder07.11.01.001--Not Available
Headache17.14.01.001--
Hypocalcaemia14.04.01.004--
Hypokalaemia14.05.03.002--
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