Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sorafenib
Drug ID BADD_D02058
Description Sorafenib (rINN), marketed as Nexavar by Bayer, is a drug approved for the treatment of advanced renal cell carcinoma (primary kidney cancer). It has also received "Fast Track" designation by the FDA for the treatment of advanced hepatocellular carcinoma (primary liver cancer), and has since performed well in Phase III trials. Sorafenib is a small molecular inhibitor of Raf kinase, PDGF (platelet-derived growth factor), VEGF receptor 2 & 3 kinases and c Kit the receptor for Stem cell factor. A growing number of drugs target most of these pathways. The originality of Sorafenib lays in its simultaneous targeting of the Raf/Mek/Erk pathway.
Indications and Usage Sorafenib is indicated for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
Marketing Status approved; investigational
ATC Code L01EX02
DrugBank ID DB00398
KEGG ID D08524
MeSH ID D000077157
PubChem ID 216239
TTD Drug ID D0W5HK
NDC Product Code 24979-715; 51407-760; 13668-682; 12527-8488; 63850-8051; 68554-0073; 51990-201; 0378-1201; 0480-5425; 47049-848; 43598-458; 50419-488
UNII 9ZOQ3TZI87
Synonyms Sorafenib | Nexavar | BAY 43-9006 | BAY 43 9006 | BAY 439006 | Sorafenib N-Oxide | Sorafenib N Oxide | BAY-673472 | BAY 673472 | BAY 545-9085 | BAY 545 9085 | BAY 5459085 | BAY-545-9085 | BAY5459085 | Sorafenib Tosylate | 4-(4-(3-(4-Chloro-3-trifluoromethylphenyl)ureido)phenoxy)pyridine-2-carboxylic acid methyamide-4-methylbenzenesulfonate
Chemical Information
Molecular Formula C21H16ClF3N4O3
CAS Registry Number 284461-73-0
SMILES CNC(=O)C1=NC=CC(=C1)OC2=CC=C(C=C2)NC(=O)NC3=CC(=C(C=C3)Cl)C(F)(F)F
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)
Drug tolerance decreased08.06.01.0240.000168%Not Available
Protein urine present13.13.02.006--Not Available
Musculoskeletal discomfort15.03.04.0010.000168%Not Available
Organ failure08.01.03.0410.000168%Not Available
Epidermolysis10.04.02.017; 23.03.01.0140.000112%Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.000168%Not Available
Skin swelling23.03.03.0390.000414%Not Available
Oesophageal discomfort07.01.06.030--Not Available
Tumour necrosis24.04.02.013; 16.32.03.0090.000504%Not Available
Nodule08.03.05.0020.000112%Not Available
Cardiac discomfort02.11.04.0010.000112%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.000638%Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.0020.000168%
Transaminases increased13.03.04.036--Not Available
Scrotal erythema23.03.06.013; 21.12.02.0080.000112%Not Available
Brain cancer metastatic16.30.04.001; 17.20.04.001--Not Available
Bone cancer metastatic16.29.02.001; 15.09.03.0040.000112%Not Available
Hepatic cancer metastatic16.07.02.002; 09.04.02.0060.000504%Not Available
Haemorrhagic transformation stroke24.07.04.018; 17.08.01.0360.000112%Not Available
Haemorrhage24.07.01.0020.002194%Not Available
Varices oesophageal07.15.05.001; 24.10.02.004; 09.01.06.0090.000448%Not Available
Fluid intake reduced14.05.10.0010.000839%Not Available
Faecaloma07.01.03.0040.000168%Not Available
Pulmonary mass22.02.07.0040.000448%Not Available
Palpable purpura24.12.04.018; 23.06.02.006; 10.02.02.0190.000112%Not Available
Pneumatosis intestinalis07.11.01.0430.000224%Not Available
Temperature intolerance08.01.09.0220.000168%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000168%Not Available
Cognitive disorder17.03.03.003; 19.21.02.001--
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000280%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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