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)
Pancreatitis07.18.01.0010.000533%
Panniculitis23.07.02.002; 10.01.03.0240.001066%Not Available
Papillary thyroid cancer16.24.03.002; 05.02.05.0050.000799%Not Available
Papilloma16.02.02.004--Not Available
Paraesthesia17.02.06.0050.002131%
Paronychia23.09.04.001; 11.01.12.001--
Pericardial effusion02.06.01.0020.000533%
Peritoneal haemorrhage24.07.02.016; 07.07.02.0010.000533%Not Available
Peritonitis11.01.07.007; 07.19.05.0040.000533%
Pharyngeal oedema22.04.05.003; 10.01.05.016; 23.04.01.0160.000533%Not Available
Photophobia17.17.02.006; 06.01.01.0040.000533%
Photosensitivity reaction23.03.09.0030.000533%
Platelet count decreased13.01.04.001--
Pleural effusion22.05.02.002--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Productive cough22.02.03.0050.000799%
Prurigo23.03.04.017--Not Available
Pruritus23.03.12.001--
Pyrexia08.05.02.0030.033568%
Rash23.03.13.0010.012255%Not Available
Rash erythematous23.03.06.0030.001332%Not Available
Rash generalised23.03.13.0020.001332%Not Available
Rash macular23.03.13.003--Not Available
Rash maculo-papular23.03.13.0040.001865%
Rash papular23.03.13.017--Not Available
Rash pruritic23.03.12.0020.000799%Not Available
Rash pustular11.01.12.002; 23.03.10.0030.000533%
Rash vesicular23.03.13.009--Not Available
Renal failure20.01.03.005--Not Available
Respiratory distress22.02.01.0120.000139%Not Available
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