Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sunitinib
Drug ID BADD_D02100
Description Sunitinib is a small-molecule multi-targeted receptor tyrosine kinase (RTK) inhibitor. On January 26, 2006, the agent was formally approved by the US FDA for the indications of treating renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST). For these purposes, sunitinib is generally available as an orally administered formulation. Sunitinib inhibits cellular signaling by targeting multiple RTKs. These include all platelet-derived growth factor receptors (PDGF-R) and vascular endothelial growth factor receptors (VEGF-R). Sunitinib also inhibits KIT (CD117), the RTK that drives the majority of GISTs. In addition, sunitinib inhibits other RTKs including RET, CSF-1R, and flt3.
Indications and Usage For the treatment of advanced renal cell carcinoma as well as the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.
Marketing Status Prescription
ATC Code L01EX01
DrugBank ID DB01268
KEGG ID D08552
MeSH ID D000077210
PubChem ID 5329102
TTD Drug ID D0R0MW
NDC Product Code Not Available
Synonyms Sunitinib | 5-(5-Fluoro-2-oxo-1,2-dihydroindolylidenemethyl)-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylaminoethyl)amide | Sunitinib Malate | Sutent | SU 11248 | SU011248 | SU 011248 | SU-011248 | SU11248 | SU-11248
Chemical Information
Molecular Formula C22H27FN4O2
CAS Registry Number 557795-19-4
SMILES CCN(CC)CCNC(=O)C1=C(NC(=C1C)C=C2C3=C(C=CC(=C3)F)NC2=O)C
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
DiarrhoeaBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
DiarrhoeaBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
HypertensionBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
HypertensionBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
Palmar-plantar erythrodysaesthesia syndromeBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
Palmar-plantar erythrodysaesthesia syndromeBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
VomitingBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
VomitingBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Dehydration14.05.05.0010.033568%
Delirium19.13.02.001--
Dementia19.20.02.001; 17.03.01.001--Not Available
Demyelination17.16.02.0010.000533%Not Available
Dental caries07.09.01.001--
Depressed level of consciousness17.02.04.002--
Depressed mood19.15.02.001--Not Available
Depression19.15.01.001--
Dermatitis23.03.04.0020.001865%Not Available
Dermatitis allergic10.01.03.014; 23.03.04.003--Not Available
Dermatitis bullous23.03.01.0020.003730%
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.003--Not Available
Dermatitis exfoliative23.03.07.001; 10.01.01.0040.001332%
Diabetes mellitus14.06.01.001; 05.06.01.0010.006127%Not Available
Diabetes mellitus inadequate control14.06.01.004; 05.06.01.0040.001332%Not Available
Diarrhoea07.02.01.0010.234974%
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.001332%Not Available
Dilatation ventricular02.04.02.0260.000533%Not Available
Diplopia17.17.01.005; 06.02.06.002--Not Available
Discomfort08.01.08.003--Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Disseminated intravascular coagulation24.01.01.010; 01.01.02.0020.002502%
Disturbance in attention17.03.03.001; 19.21.02.002--
Diverticulitis11.01.07.003; 07.10.02.0010.004529%Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Drug dependence19.07.02.009--Not Available
Drug hypersensitivity10.01.01.001--Not Available
Dry eye06.08.02.001--
Dry mouth07.06.01.0020.017050%
Dry skin23.03.03.0010.026375%
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