Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Encorafenib
Drug ID BADD_D02552
Description Encorafenib, also known as _BRAFTOVI_, is a kinase inhibitor. Encorafenib inhibits BRAF gene, which encodes for B-raf protein, which is a proto-oncogene involved in various genetic mutations [FDA label]. This protein plays a role in regulating the MAP kinase/ERK signaling pathway, which impacts cell division, differentiation, and secretion. Mutations in this gene, most frequently the V600E mutation, are the most commonly identified cancer-causing mutations in melanoma, and have been isolated in various other cancers as well, including non-Hodgkin lymphoma, colorectal cancer, thyroid carcinoma, non-small cell lung carcinoma, hairy cell leukemia and adenocarcinoma of the lung [L3344]. On June 27, 2018, the Food and Drug Administration approved encorafenib and [Binimetinib] (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test [FDA label].
Indications and Usage Used in combination with [Binimetinib] in metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test [L3335].
Marketing Status approved; investigational
ATC Code L01EC03
DrugBank ID DB11718
KEGG ID D11053
MeSH ID C000601108
PubChem ID 50922675
TTD Drug ID D0TK7R
NDC Product Code 59651-641; 11014-0345; 62009-1913; 54893-0114; 70255-025; 11014-0344
UNII 8L7891MRB6
Synonyms encorafenib | LGX818 | Braftovi
Chemical Information
Molecular Formula C22H27ClFN7O4S
CAS Registry Number 1269440-17-6
SMILES CC(C)N1C=C(C(=N1)C2=C(C(=CC(=C2)Cl)NS(=O)(=O)C)F)C3=NC(=NC=C3)NCC(C)NC(=O)OC
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)
Abdominal pain07.01.05.0020.000358%
Arthralgia15.01.02.0010.001063%
Asthenia08.01.01.0010.000358%-
Atrial fibrillation02.03.03.0020.000112%
Back pain15.03.04.0050.000381%
Cerebrovascular accident17.08.01.007; 24.03.05.0010.000112%
Constipation07.02.02.0010.000381%
Death08.04.01.0010.003078%
Dehydration14.05.05.001--
Diarrhoea07.02.01.0010.001287%
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dysphagia07.01.06.0030.003727%
Dysuria20.02.02.0020.000112%
Erythema23.03.06.0010.000381%-
Eye disorder06.08.03.0010.000246%-
Facial paralysis17.04.03.0080.000168%-
Fatigue08.01.01.0020.001556%
Feeling abnormal08.01.09.014---
Haematochezia07.12.02.003; 24.07.02.0120.000112%-
Headache17.14.01.0010.001007%
Hepatotoxicity09.01.07.009; 12.03.01.008---
Hypersensitivity10.01.03.0030.000381%
Hypotension24.06.03.002--
Insomnia17.15.03.002; 19.02.01.002--
Lentigo23.05.01.0110.000112%-
Malaise08.01.01.0030.000548%
Malignant melanoma16.03.01.001; 23.08.01.0010.000112%-
Musculoskeletal pain15.03.04.0070.000381%
Myalgia15.05.02.0010.000302%
Myocardial infarction02.02.02.007; 24.04.04.0090.000112%
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