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 Tafinlar is a kinase inhibitor that was initially indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test [FDA label]. Tafinlar in combination with [DB08911] is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. The use in combination is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for Tafinlar in combination with trametinib [FDA label]. In May 2018, Tafinlar (dabrafenib) and Mekinist ([DB08911]) have been approved in combination to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene [L2712].
Marketing Status approved; investigational
ATC Code L01EC02
DrugBank ID DB08912
KEGG ID D10064
MeSH ID C561627
PubChem ID 44462760
TTD Drug ID D05ROI
NDC Product Code 0078-0681; 0078-0682; 0078-1154; 52482-007
UNII QGP4HA4G1B
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Metastases to central nervous system17.02.10.013; 16.22.02.0040.001198%Not Available
Skin toxicity23.03.03.032; 12.03.01.0200.000336%Not Available
Blood alkaline phosphatase increased13.04.02.004--
Drug resistance08.06.01.0050.000112%Not Available
Adverse event08.06.01.010--Not Available
Brain neoplasm16.30.01.003; 17.20.01.0030.000437%Not Available
Connective tissue disorder15.06.01.006; 10.04.04.026--Not Available
Ocular toxicity06.11.01.006; 12.03.01.031--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.0070.000168%Not Available
Iris disorder06.06.06.0050.000112%Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.0020.000437%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.002138%
Ill-defined disorder08.01.03.049--Not Available
Polyp16.02.02.005; 08.01.06.010--Not Available
Adverse drug reaction08.06.01.009--Not Available
Disease progression08.01.03.0380.002697%
Disease recurrence08.01.03.0500.000224%Not Available
Non-small cell lung cancer22.08.01.002; 16.19.01.0010.000112%Not Available
Metastasis16.22.01.0010.000112%Not Available
Hypophagia07.01.06.010; 19.09.01.004; 14.03.01.0060.000112%Not Available
Keratosis pilaris23.01.01.0020.000246%Not Available
Thyroid cancer16.24.03.001; 05.02.05.0010.000302%Not Available
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Acute kidney injury20.01.03.0160.000616%
Langerhans' cell histiocytosis01.13.04.003; 09.01.08.018; 22.01.01.016; 15.09.03.008; 16.21.04.0030.000448%Not Available
Drug reaction with eosinophilia and systemic symptoms12.03.01.064; 23.03.05.005; 10.01.01.0210.000224%Not Available
Palmoplantar keratoderma23.01.01.0070.000414%Not Available
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