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)
Brain oedema17.07.02.003; 12.01.10.0100.000280%
Lip blister23.03.01.016; 07.05.01.0070.000381%Not Available
Precancerous skin lesion23.01.06.0040.000112%Not Available
General physical health deterioration08.01.03.0180.002071%Not Available
Left ventricular dysfunction02.04.02.0110.000168%
Tumour haemorrhage24.07.01.028; 16.32.03.0080.000582%
Musculoskeletal chest pain15.03.04.012; 22.09.01.0010.000168%
Madarosis23.02.02.004; 06.06.04.0100.000437%Not Available
Photodermatosis23.03.09.0040.000112%Not Available
Facial paresis17.04.03.0020.000112%
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000112%Not Available
Malignant neoplasm progression16.16.01.0050.001623%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.000112%Not Available
Metastases to peritoneum16.22.02.008; 07.21.03.0030.000224%Not Available
Eye pruritus06.04.05.0060.000302%Not Available
Ocular discomfort06.08.03.0080.000112%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Nodule08.03.05.0020.000246%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.000492%Not Available
Cerebral disorder17.02.10.0170.000112%Not Available
Haemorrhage24.07.01.002--Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.001063%Not Available
Neutrophilic dermatosis01.02.01.013; 23.03.03.0590.000627%Not Available
Cystoid macular oedema12.02.02.005; 06.04.06.0100.000168%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.000168%Not Available
Intestinal haemorrhage24.07.02.031; 07.12.03.0050.000112%Not Available
Angiopathy24.03.02.007--Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.008361%Not Available
Skin toxicity23.03.03.032; 12.03.01.0200.003403%Not Available
Neurological symptom17.02.05.0100.000168%Not Available
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