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)
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000168%
Unresponsive to stimuli17.02.05.0310.000246%Not Available
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.000246%
Urinary retention20.02.02.0110.000112%
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Uveitis10.02.01.023; 06.04.03.0030.001075%
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vasculitis10.02.02.006; 24.12.04.0270.000112%
Vision blurred17.17.01.010; 06.02.06.0070.001612%
Visual acuity reduced06.02.10.012; 17.17.01.0110.000112%
Visual impairment06.02.10.0130.003380%Not Available
Vitreous haemorrhage06.10.03.001; 24.07.05.005--
Vomiting07.01.07.0030.003929%
Tubulointerstitial nephritis20.05.02.002--Not Available
Mobility decreased17.02.05.018; 08.01.03.030; 15.03.05.0230.000168%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.001198%Not Available
General physical health deterioration08.01.03.0180.000672%Not Available
Tumour haemorrhage24.07.01.028; 16.32.03.0080.000224%
Ejection fraction decreased13.14.02.003--
Madarosis23.02.02.004; 06.06.04.0100.000381%Not Available
Malignant neoplasm progression16.16.01.0050.003123%Not Available
Metastases to peritoneum16.22.02.008; 07.21.03.0030.000112%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.000112%Not Available
Nodule08.03.05.0020.000168%Not Available
Haemorrhage24.07.01.002--Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.000112%Not Available
Angiopathy24.03.02.007--Not Available
The 8th Page    First    Pre   8 9 10    Next   Last    Total 10 Pages