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 discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Acne23.02.01.0010.001332%Not Available
Acrochordon23.10.01.005; 16.26.01.0050.000799%Not Available
Actinic keratosis23.01.06.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.01.0030.001865%
Alopecia23.02.02.0010.003197%
Anaemia01.03.02.001--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Aphasia17.02.03.001; 19.21.01.0010.001066%
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.0010.008525%
Arthritis15.01.01.0010.001066%
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000799%
Aspartate aminotransferase increased13.03.01.0060.001066%
Asthenia08.01.01.0010.004529%Not Available
Atrial fibrillation02.03.03.0020.001332%
Azotaemia20.01.01.001--Not Available
Back pain15.03.04.005--
Basal cell carcinoma16.03.02.001; 23.08.02.0010.007992%Not Available
Blindness17.17.01.003; 06.02.02.0010.000533%Not Available
Blindness transient17.17.01.004; 06.02.02.002--Not Available
Blood albumin decreased13.09.01.0010.000533%Not Available
Blood creatinine increased13.13.01.004--
Blood culture positive13.08.02.0020.000533%Not Available
Blood glucose increased13.02.02.002--Not Available
Blood lactate dehydrogenase increased13.04.02.0020.000533%
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