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)
Blood pressure decreased13.14.03.0020.000533%Not Available
Blood sodium decreased13.11.01.0120.000533%Not Available
Body temperature increased13.15.01.0010.000799%Not Available
Bone disorder15.02.04.0040.000533%Not Available
Bowen's disease23.08.02.004; 16.03.02.004--Not Available
Brain stem haemorrhage24.07.04.015; 17.08.01.031--Not Available
Breast cancer21.05.01.003; 16.10.01.0010.000533%Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.0010.000347%
Cardiac failure congestive02.05.01.002--Not Available
Cardiomyopathy02.04.01.001--Not Available
Carpal tunnel syndrome17.09.02.0010.000533%Not Available
Cellulitis11.02.01.001; 23.09.01.0010.000533%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.003--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest discomfort22.02.08.001; 08.01.08.019; 02.02.02.009--Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.0010.009857%
Cholecystitis09.03.01.0010.000533%
Circulatory collapse24.06.02.0010.000799%Not Available
Coagulation factor decreased13.01.02.0160.000533%Not Available
Confusional state19.13.01.001; 17.02.03.0050.002398%
Constipation07.02.02.001--
Cough22.02.03.0010.002664%
Cyst16.02.02.002; 08.03.05.001--Not Available
Death08.04.01.0010.007158%
Dehydration14.05.05.0010.003463%
Depressed level of consciousness17.02.04.0020.000533%
Dermatitis23.03.04.002--Not Available
Dermatitis acneiform23.02.01.0040.000533%
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