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
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)
Renal failure20.01.03.005--Not Available
Second primary malignancy16.16.01.014--
Skin papilloma23.10.01.002; 16.26.01.002; 11.05.07.001--
Squamous cell carcinoma16.16.01.002--Not Available
Squamous cell carcinoma of skin16.03.02.005; 23.08.02.005--Not Available
Stomatitis07.05.06.005--
Thrombocytopenia01.08.01.002--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Uveitis10.02.01.023; 06.04.03.003--
Vaginal haemorrhage21.08.01.001; 24.07.03.005--
Vision blurred17.17.01.010; 06.02.06.007--
Vitreous haemorrhage24.07.05.005; 06.10.03.001--
Vomiting07.01.07.003--
Tubulointerstitial nephritis20.05.02.002--Not Available
Deep vein thrombosis24.01.02.003--Not Available
Adenocarcinoma pancreas16.13.10.002; 07.21.09.003--Not Available
Haemorrhage24.07.01.002--Not Available
Skin toxicity23.03.03.032; 12.03.01.020--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Ocular toxicity12.03.01.031; 06.11.01.006--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Colorectal cancer16.13.01.002; 07.21.01.002--Not Available
Retinal pigment epithelial tear06.09.03.016--Not Available
Head and neck cancer16.16.01.003--Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Acute kidney injury20.01.03.016--
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