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)
Respiratory failure22.02.06.002; 14.01.04.003--
Rhabdomyolysis15.05.05.0020.000799%
Seborrhoeic keratosis23.10.01.008; 16.26.01.008--Not Available
Second primary malignancy16.16.01.0140.000347%
Seizure17.12.03.001--
Sensory loss17.02.07.0070.000533%Not Available
Sepsis11.01.11.0030.001332%
Skin cancer23.08.02.002; 16.03.02.0020.000799%Not Available
Skin discolouration23.03.03.0050.000533%Not Available
Skin disorder23.03.03.0070.001066%Not Available
Skin exfoliation23.03.07.0030.001066%Not Available
Skin hypertrophy23.01.04.0020.000799%Not Available
Skin lesion23.03.03.0100.001332%Not Available
Skin papilloma23.10.01.002; 11.05.07.001; 16.26.01.0020.001332%
Somnolence19.02.05.003; 17.02.04.006--
Splenomegaly01.09.02.0010.000533%Not Available
Squamous cell carcinoma16.16.01.0020.002131%Not Available
Squamous cell carcinoma of skin23.08.02.005; 16.03.02.0050.001598%Not Available
Stomatitis07.05.06.005--
Stridor22.04.02.0030.000533%
Swelling08.01.03.0150.000799%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.000533%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Tachycardia02.03.02.007--Not Available
Thirst14.03.02.007; 08.01.09.0210.000533%Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombosis24.01.01.006--Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tremor17.01.06.0020.002131%
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000208%
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