Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dabrafenib mesylate
Drug ID BADD_D00567
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 D10104
MeSH ID C561627
PubChem ID 44516822
TTD Drug ID D05ROI
NDC Product Code 81719-015; 54893-0052; 81719-016
Synonyms dabrafenib | GSK 2118436 | GSK2118436 | GSK-2118436
Chemical Information
Molecular Formula C24H24F3N5O5S3
CAS Registry Number 1195768-06-9
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.CS( =O)(=O)O
Chemical Structure
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--
Actinic keratosis23.01.06.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Basal cell carcinoma16.03.02.001; 23.08.02.001--Not Available
Blindness transient06.02.02.002; 17.17.01.004--Not Available
Blood creatinine increased13.13.01.004--
Brain stem haemorrhage17.08.01.031; 24.07.04.015--Not Available
Cardiomyopathy02.04.01.001--Not Available
Cellulitis11.02.01.001; 23.09.01.001--Not Available
Cerebral haemorrhage17.08.01.003; 24.07.04.001--Not Available
Chills08.01.09.001; 15.05.03.016--
Constipation07.02.02.001--
Cough22.02.03.001--
Dehydration14.05.05.001--
Dermatitis acneiform23.02.01.004--
Dermatitis bullous23.03.01.002--
Diarrhoea07.02.01.001--
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Dry mouth07.06.01.002--
Dry skin23.03.03.001--
Embolism venous24.01.01.003--Not Available
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