Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Vemurafenib
Drug ID BADD_D02344
Description Vemurafenib is a competitive kinase inhibitor with activity against BRAF kinase with mutations like V600E.[A31269] It exerts its function by binding to the ATP-binding domain of the mutant BRAF.[A31270] Vemurafenib was co-developed by Roche and Plexxikon and it obtained its FDA approval on August 17, 2011, under the company Hoffmann La Roche. After approval, Roche in collaboration with Genentech launched a broad development program. [L1012]
Indications and Usage Vemurafenib is approved since 2011 for the treatment of metastatic melanoma with a mutation on BRAF in the valine located in the exon 15 at codon 600, this mutation is denominated as V600E.[A31270] The V600E mutation, a substitution of glutamic acid for valine, accounts for 54% of the cases of cutaneous melanoma.[A31271] Vemurafenib approval was extended in 2017, for its use as a treatment of adult patients with Erdheim-Chester Disease whose cancer cells present BRAF V600 mutation.[L1013] Erdheim-Chester disease is an extremely rare histiocyte cell disorder that affects large bones, large vessels, central nervous system, as well as, skin and lungs. It is reported an association of Erdheim-Chester disease and V600E mutation.[A31272]
Marketing Status approved
ATC Code L01EC01
DrugBank ID DB08881
KEGG ID D09996
MeSH ID D000077484
PubChem ID 42611257
TTD Drug ID D0Y9EW
NDC Product Code 50242-090
UNII 207SMY3FQT
Synonyms Vemurafenib | PLX4032 | PLX 4032 | RG7204 | RG-7204 | RG 7204 | Zelboraf | R05185426
Chemical Information
Molecular Formula C23H18ClF2N3O3S
CAS Registry Number 918504-65-1
SMILES CCCS(=O)(=O)NC1=C(C(=C(C=C1)F)C(=O)C2=CNC3=C2C=C(C=N3)C4=CC=C(C=C4)Cl)F
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)
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.021; 12.03.01.0640.001231%Not Available
Diffuse alopecia23.02.02.0070.000112%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000560%
Acanthosis23.01.04.0030.000224%Not Available
Adenocarcinoma of colon07.21.01.008; 16.13.01.0100.000112%Not Available
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000224%Not Available
Intracranial tumour haemorrhage24.07.04.028; 17.08.01.052; 16.32.03.0230.000112%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000112%Not Available
Malignant melanoma in situ23.08.01.004; 16.03.01.0040.000839%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.000112%Not Available
Palmoplantar keratoderma23.01.01.0070.000806%Not Available
Panniculitis lobular23.07.02.0050.000224%Not Available
Superficial spreading melanoma stage unspecified16.03.01.010; 23.08.01.0100.000280%Not Available
Transient acantholytic dermatosis23.03.03.0690.000716%Not Available
Metastases to meninges17.02.10.012; 16.22.02.0030.000448%Not Available
Fibrous histiocytoma23.10.01.012; 16.26.01.0120.000112%Not Available
Cell death14.11.02.005; 08.03.03.0030.000112%Not Available
Acantholysis23.03.03.0620.000358%Not Available
Acanthoma23.10.01.010; 16.26.01.0100.000112%Not Available
Dysplastic naevus23.10.01.011; 16.26.01.0110.000246%Not Available
Lip squamous cell carcinoma16.13.07.005; 07.21.07.0070.000168%Not Available
Neutrophilic panniculitis23.07.02.0040.001019%Not Available
Prerenal failure24.06.02.025; 20.01.03.0220.000112%Not Available
Cutaneous T-cell lymphoma01.11.03.002; 23.07.04.029; 16.17.03.0020.000168%Not Available
Eccrine squamous syringometaplasia23.02.03.0150.000437%Not Available
Limb mass15.03.05.0190.000246%Not Available
Metastases to ovary21.11.01.019; 16.22.02.0370.000112%Not Available
Myelosuppression01.03.03.0150.000168%Not Available
Septal panniculitis23.07.02.008; 10.01.03.0630.000302%Not Available
Taste disorder17.02.07.029; 07.14.03.004--Not Available
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