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)
Dermatitis bullous23.03.01.002--
Diarrhoea07.02.01.001--
Diplopia17.17.01.005; 06.02.06.0020.000533%Not Available
Discomfort08.01.08.0030.000799%Not Available
Disseminated intravascular coagulation24.01.01.010; 01.01.02.0020.000139%
Dizziness17.02.05.003; 02.01.02.004; 24.06.02.007--
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.0150.000533%Not Available
Dry mouth07.06.01.002--
Dry skin23.03.03.0010.001865%
Dysgeusia17.02.07.003; 07.14.03.0010.000799%
Dysphagia07.01.06.0030.005062%
Dyspnoea22.02.01.004; 02.01.03.002--
Eczema23.03.04.0060.001066%
Electrocardiogram QT prolonged13.14.05.0040.001066%
Embolism venous24.01.01.003--Not Available
Epistaxis24.07.01.005; 22.04.03.001--
Erythema23.03.06.0010.002131%Not Available
Erythema nodosum23.07.02.001; 10.02.01.0200.001332%Not Available
Eye disorder06.08.03.001--Not Available
Eye haemorrhage24.07.05.002; 06.07.02.001--Not Available
Eye pain06.08.03.0020.000799%
Fatigue08.01.01.0020.012255%
Febrile neutropenia08.05.02.004; 01.02.03.0020.001865%
Feeling abnormal08.01.09.014--Not Available
Femur fracture15.08.03.003; 12.04.01.003--Not Available
Flushing24.03.01.002; 08.01.03.025; 23.06.05.003--
Folliculitis23.09.04.007; 11.01.12.018--
Furuncle11.02.05.008; 23.09.01.0040.000533%Not Available
Gait disturbance17.02.05.016; 08.01.02.002--
Gamma-glutamyltransferase increased13.03.01.011--
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