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 approved; investigational
ATC Code L01EX01
DrugBank ID DB01268
KEGG ID D08552
MeSH ID D000077210
PubChem ID 5329102
TTD Drug ID D0R0MW
NDC Product Code Not Available
UNII V99T50803M
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
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)
Anal inflammation07.03.03.0040.000112%
Dysstasia08.01.03.089; 17.02.02.012; 15.03.05.0110.000772%Not Available
Abscess limb15.03.05.001; 11.01.08.014--Not Available
Metastatic renal cell carcinoma20.01.04.005; 16.08.02.0030.013375%Not Available
Ejection fraction decreased13.14.02.003--
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.000582%
Deep vein thrombosis24.01.02.003--Not Available
Gastrointestinal stromal tumour16.13.04.008; 07.21.04.0030.006682%Not Available
Cardiopulmonary failure22.02.06.004; 02.05.01.0040.002015%Not Available
Blood pressure inadequately controlled24.06.01.0070.000112%Not Available
Plantar erythema23.03.06.0120.000302%Not Available
Dyschezia07.02.03.0050.000246%Not Available
Bile duct stenosis09.02.02.0010.000112%
Wound haemorrhage24.07.01.029; 12.01.08.017--Not Available
Malignant neoplasm progression16.16.01.005--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.000336%Not Available
Metastases to peritoneum16.22.02.008; 07.21.03.0030.000112%Not Available
Eye oedema06.08.03.0130.000302%Not Available
Lymphatic disorder01.09.01.003--Not Available
Gingival abscess11.01.04.011; 07.09.10.001--Not Available
Nasal discomfort22.12.03.0120.001254%Not Available
Paranasal sinus discomfort22.12.03.0180.000112%Not Available
Perineal abscess21.10.03.018; 18.07.02.004; 15.03.03.005; 11.01.17.003--Not Available
Large intestinal haemorrhage24.07.02.026; 07.12.03.0030.000112%
Perirectal abscess11.01.07.005; 07.19.04.001--Not Available
Protein urine present13.13.02.006--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Organ failure08.01.03.0410.000280%Not Available
Inappropriate antidiuretic hormone secretion05.03.03.001; 14.05.07.0010.000392%Not Available
Skin swelling23.03.03.0390.000246%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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