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)
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000336%
Tumour pain16.32.03.0030.000336%
Ulcer08.03.06.0010.000392%Not Available
Upper gastrointestinal haemorrhage07.12.02.006; 24.07.02.0240.000448%
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.000414%
Urinary retention20.02.02.0110.000504%
Urinary tract disorder20.08.01.001--Not Available
Urogenital disorder21.10.05.010; 20.08.01.002--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Uveitis10.02.01.023; 06.04.03.0030.000168%
Varicose vein24.10.04.0010.000280%Not Available
Vascular headache24.03.05.007; 17.14.01.005--Not Available
Vasculitis24.12.04.027; 10.02.02.0060.000224%
Vasoconstriction23.06.05.007; 24.04.03.0080.000112%Not Available
Vasodilatation24.03.02.003; 23.06.05.0060.000168%Not Available
Vena cava thrombosis24.01.10.0010.000112%Not Available
Visual field defect17.17.01.001; 06.02.07.0030.000168%Not Available
Vitreous haemorrhage24.07.05.005; 06.10.03.0010.000112%
Vomiting07.01.07.0030.012402%
Weight decreased13.15.01.005--
Yellow skin09.01.01.009; 08.01.03.046; 23.03.03.0420.000448%Not Available
Pneumoperitoneum07.07.01.0080.000112%Not Available
Tubulointerstitial nephritis20.05.02.002--Not Available
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.002059%Not Available
Musculoskeletal disorder15.03.05.0250.000526%Not Available
Hydrothorax22.05.02.0040.000112%Not Available
Deafness unilateral04.02.01.0110.000246%Not Available
Performance status decreased08.01.03.0420.000448%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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