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)
Melanocytic naevus23.10.01.007; 16.26.01.0070.001865%Not Available
Memory impairment19.20.01.003; 17.03.02.003--
Metastases to liver16.22.02.001; 09.04.02.0040.000347%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.000347%Not Available
Metastatic malignant melanoma23.08.01.002; 16.03.01.0020.000903%Not Available
Muscle spasms15.05.03.004--
Muscular weakness17.05.03.005; 15.05.06.001--
Musculoskeletal pain15.03.04.0070.000799%
Myalgia15.05.02.0010.005861%
Mydriasis17.02.11.003; 06.05.03.0040.000533%Not Available
Myocardial infarction24.04.04.009; 02.02.02.007--
Myocardial ischaemia24.04.04.010; 02.02.02.0080.000533%Not Available
Nasopharyngitis22.07.03.002; 11.01.13.0020.001332%Not Available
Nausea07.01.07.0010.012521%
Neck pain15.03.04.0090.000533%
Neoplasm16.16.02.001--Not Available
Neoplasm malignant16.16.01.001--Not Available
Nephritis20.05.02.001--Not Available
Nephropathy20.05.03.001--Not Available
Nervous system disorder17.02.10.0010.000533%Not Available
Neuropathy peripheral17.09.03.0030.001066%Not Available
Neutropenia01.02.03.004--Not Available
Neutrophil count increased13.01.06.0110.000533%Not Available
Night sweats23.02.03.006; 08.01.03.0310.000799%Not Available
Ocular hyperaemia06.04.05.0040.000533%Not Available
Oedema14.05.06.010; 08.01.07.0060.000799%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.001332%
Pain08.01.08.0040.004795%
Pain in extremity15.03.04.0100.004263%
Palmar-plantar erythrodysaesthesia syndrome23.07.04.001; 17.02.07.0090.002664%
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