Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sunitinib malate
Drug ID BADD_D02101
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 D06402
MeSH ID D000077210
PubChem ID 6456015
TTD Drug ID D0R0MW
NDC Product Code 0093-8224; 0093-8199; 16714-679; 63539-019; 16714-677; 16436-0091; 0069-0550; 54893-0081; 63539-017; 16714-678; 0378-6679; 0093-8229; 63304-094; 53183-4012; 76302-007; 68724-1234; 0069-0830; 0378-6678; 63304-092; 0069-0770; 63304-091; 68554-0078; 0069-0980; 0378-6681; 0378-6680; 63304-093; 16714-676; 0093-8231; 53296-0091
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 C26H33FN4O7
CAS Registry Number 341031-54-7
SMILES CCN(CC)CCNC(=O)C1=C(NC(=C1C)C=C2C3=C(C=CC(=C3)F)NC2=O)C.C(C(C(=O)O)O)C(=O)O
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 ABCG2Q9UNQ0T56556Not Available
HypertensionBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T56556Not Available
Palmar-plantar erythrodysaesthesia syndromeBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T56556Not Available
VomitingBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T56556Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry mouth07.06.01.002--
Dry skin23.03.03.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dyspnoea22.02.01.004; 02.01.03.002--
Epistaxis24.07.01.005; 22.04.03.001--
Erythema23.03.06.001--Not Available
Fatigue08.01.01.002--
Fistula15.03.02.001--Not Available
Flatulence07.01.04.002--
Glossodynia07.14.02.001--Not Available
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemorrhoids24.10.02.002; 07.15.03.001--
Hair colour changes23.02.06.001--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypothyroidism14.11.01.012; 05.02.03.001--
Infection11.01.08.002--Not Available
Influenza like illness08.01.03.010--
Insomnia19.02.01.002; 17.15.03.002--
Lipase increased13.05.01.003--
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