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)
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.000533%
Urinary retention20.02.02.0110.000533%
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.0040.001598%
Urticaria23.04.02.001; 10.01.06.001--
Uveitis10.02.01.023; 06.04.03.0030.001332%
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vasculitis24.05.02.001; 10.02.02.0060.000533%
Vertigo17.02.12.002; 04.04.01.003--
Viral infection11.05.04.0010.001066%Not Available
Vision blurred06.02.06.007; 17.17.01.0100.001865%
Visual impairment06.02.06.0080.003197%Not Available
Vitreous haemorrhage24.07.05.005; 06.10.03.001--
Vomiting07.01.07.0030.008792%
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Tubulointerstitial nephritis20.05.02.002--Not Available
Mobility decreased17.02.05.018; 15.03.01.003; 08.01.03.0300.000799%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.001332%Not Available
Abasia17.02.05.035; 08.01.02.0070.000533%Not Available
Tumour haemorrhage24.07.01.028; 16.32.03.0080.000799%
Ejection fraction decreased13.14.02.0030.001598%
Madarosis23.02.02.004; 06.06.04.0100.000533%Not Available
Malignant neoplasm progression16.16.01.0050.002780%Not Available
Metastases to peritoneum16.22.02.008; 07.21.03.0030.000139%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Nodule08.03.05.0020.000799%Not Available
Transaminases increased13.03.01.0150.000799%Not Available
Haemorrhage24.07.01.002--Not Available
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