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)
Gastric haemorrhage24.07.02.007; 07.12.01.001--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.0040.000533%
Gingival bleeding24.07.02.010; 07.09.07.001--Not Available
Glaucoma06.03.01.0020.000533%
Haematuria24.07.01.047; 20.02.01.006--
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemorrhage intracranial24.07.04.003; 17.08.01.008--
Hair texture abnormal23.02.06.0040.000799%
Headache17.14.01.0010.008259%
Heart rate increased13.14.04.002--Not Available
Hemiparesis17.01.04.0010.000533%
Hepatic failure09.01.03.0020.000278%
Hepatitis C11.05.06.004; 09.01.09.0050.000208%Not Available
Hepatocellular injury09.01.07.0080.001066%Not Available
Hepatomegaly09.01.05.0010.000799%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.000799%Not Available
Hidradenitis23.02.03.0130.000799%Not Available
Hyperbilirubinaemia09.01.01.003; 01.06.04.003; 14.11.01.010--Not Available
Hypercalcaemia14.04.01.003; 05.04.01.002--
Hyperglycaemia14.06.02.002; 05.06.02.0020.001332%
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkalaemia14.05.03.001--
Hyperkeratosis23.01.01.0010.004529%
Hyperpyrexia08.05.02.0020.000533%Not Available
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.0230.001332%Not Available
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