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)
Sunburn23.03.09.007; 12.05.02.001--Not Available
Supraventricular tachycardia02.03.03.0120.000112%
Swelling08.01.03.0150.002227%Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.001679%Not Available
Synovitis15.04.02.0010.000168%Not Available
Tendonitis15.07.01.003; 12.01.07.0070.000168%Not Available
Thrombocytopenic purpura23.06.01.007; 01.08.01.0030.000112%Not Available
Tooth loss12.01.17.026; 07.09.09.0010.000112%Not Available
Toxic epidermal necrolysis10.01.01.006; 23.03.01.008; 12.03.01.015; 11.07.01.0060.001007%
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000336%
Tumour pain16.32.03.0030.000112%
Ulcer08.03.06.0010.000224%Not Available
Uterine leiomyoma21.07.02.004; 16.04.02.0010.000381%Not Available
Uveitis10.02.01.023; 06.04.03.0030.002787%
Vasculitis10.02.02.006; 24.12.04.0270.000660%
Vision blurred17.17.01.010; 06.02.06.0070.002709%
Visual acuity reduced06.02.10.012; 17.17.01.0110.000392%
Visual impairment06.02.10.0130.001869%Not Available
Vitiligo23.05.02.004; 10.04.02.0040.000112%Not Available
Vitreous floaters06.09.01.0050.000112%
Vomiting07.01.07.0030.005943%
Weight decreased13.15.01.005--
Xeroderma23.01.02.0030.000112%Not Available
Xerosis08.01.03.0160.000772%Not Available
Yellow skin23.03.03.042; 09.01.01.009; 08.01.03.0460.000302%Not Available
Musculoskeletal disorder15.03.05.0250.000112%Not Available
Cardiotoxicity02.11.01.009; 12.03.01.0070.000392%Not Available
Acute generalised exanthematous pustulosis12.03.01.005; 11.07.01.018; 10.01.01.034; 23.03.10.0020.000302%Not Available
Performance status decreased08.01.03.0420.000358%Not Available
Peripheral swelling08.01.03.053; 02.05.04.015--Not Available
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