Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dabrafenib
Drug ID BADD_D00566
Description Dabrafenib mesylate (Tafinlar) is a reversible ATP-competitive kinase inhibitor and targets the MAPK pathway. It was approved on May 29, 2013 for the treatment of melanoma [L2718]. In May 2018, Tafinlar (dabrafenib) and Mekinist ([DB08911]) in combination have been approved to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene [L2714].
Indications and Usage Dabrafenib is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
Marketing Status Not Available
ATC Code L01EC02
DrugBank ID DB08912
KEGG ID D10064
MeSH ID C561627
PubChem ID 44462760
TTD Drug ID D05ROI
NDC Product Code 0078-0682; 0078-0681; 52482-007
Synonyms dabrafenib | GSK 2118436 | GSK2118436 | GSK-2118436
Chemical Information
Molecular Formula C23H20F3N5O2S2
CAS Registry Number 1195765-45-7
SMILES CC(C)(C)C1=NC(=C(S1)C2=NC(=NC=C2)N)C3=C(C(=CC=C3)NS(=O)(=O)C4=C(C=CC=C4F)F)F
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal infection11.01.07.014; 07.19.02.0070.000139%
Staphylococcal infection11.02.05.0020.000533%Not Available
Angiopathy24.03.02.007--Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.001112%Not Available
Skin toxicity12.03.01.020; 23.03.03.0320.001066%Not Available
Blood alkaline phosphatase increased13.04.02.0040.000533%
Urine output decreased13.13.03.0010.000533%
Hepatic enzyme increased13.03.01.0190.001066%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000208%Not Available
Cardiac disorder02.01.01.003--Not Available
Connective tissue disorder15.06.01.006--Not Available
Ocular toxicity06.11.01.006; 12.03.01.031--Not Available
Infestation23.09.05.001; 11.09.01.001--Not Available
Inflammation08.01.05.0070.000799%Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.004529%
Polyp16.02.02.005; 08.01.06.010--Not Available
Disease progression08.01.03.0380.001807%
Drug intolerance08.06.01.013--Not Available
Investigation13.18.01.0040.000208%Not Available
Metastasis16.22.01.0010.000139%Not Available
Respiratory tract infection22.07.07.001; 11.01.08.0170.001598%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000533%Not Available
Thyroid cancer16.24.03.001; 05.02.05.0010.000139%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Acute kidney injury20.01.03.0160.002131%
Langerhans' cell histiocytosis22.01.01.016; 16.21.04.003; 15.09.03.008; 01.13.04.0030.001332%Not Available
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.0210.001066%Not Available
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