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 approved; investigational
ATC Code L01EX01
DrugBank ID DB01268
KEGG ID D06402
MeSH ID D000077210
PubChem ID 6456015
TTD Drug ID D0R0MW
NDC Product Code 53296-0091; 43598-048; 0378-6679; 0378-6681; 68554-0078; 0093-8199; 0093-8224; 63304-091; 0378-6678; 16714-678; 0093-8229; 0069-0830; 53183-4012; 16714-677; 63304-092; 43598-047; 63304-094; 63539-017; 0378-6680; 0069-0770; 0069-0980; 54893-0081; 68724-1234; 63304-093; 63539-019; 16436-0091; 16714-676; 16714-679; 43598-045; 43598-046; 0069-0550; 0093-8231
UNII LVX8N1UT73
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
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)
Lymphocyte count13.01.06.037---
Lymphocyte count decreased13.01.06.006--
Myopathy15.05.05.001---
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Necrotising fasciitis11.01.17.002; 15.03.03.004---
Nephrotic syndrome20.05.01.002--
Neutrophil count decreased13.01.06.010--
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Oral pain07.05.05.034--
Pain in extremity15.03.04.010--
Palmar-plantar erythrodysaesthesia syndrome17.02.07.009; 23.03.05.009--
Platelet count decreased13.01.04.001--
Platelet disorder01.08.03.001---
Proteinuria20.02.01.011--
Pruritus23.03.12.001--
Pulmonary embolism22.06.02.001; 24.01.06.001---
Pulmonary haemorrhage22.12.01.009; 24.07.01.016--
Pyoderma gangrenosum10.04.02.009; 16.32.03.005; 23.07.03.001---
Pyrexia08.05.02.003--
Rash23.03.13.001---
Renal failure20.01.03.005---
Rhabdomyolysis15.05.05.002--
Skin discolouration23.03.03.005---
Stomatitis07.05.06.005--
Thrombocytopenia01.08.01.002---
Thrombotic microangiopathy01.01.02.006; 20.01.07.004; 24.01.01.013---
Transient ischaemic attack17.08.04.001; 24.04.06.005--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Venous thrombosis24.01.01.008---
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