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)
Polycythaemia01.07.01.0010.000168%Not Available
Polyneuropathy17.09.03.0120.000280%Not Available
Polyuria20.02.03.0020.000112%Not Available
Poor peripheral circulation24.04.03.0130.000112%Not Available
Portal hypertension24.08.06.001; 09.01.06.0060.000112%
Portal vein thrombosis24.01.03.003; 09.01.06.0070.001119%
Pre-existing condition improved08.01.03.0430.000560%Not Available
Proctalgia07.03.02.0010.000280%
Proctitis07.08.04.0010.000112%
Proteinuria20.02.01.0110.000728%
Prothrombin level abnormal13.01.02.028--Not Available
Pruritus23.03.12.0010.010040%
Pulmonary haemorrhage22.12.01.009; 24.07.01.0160.000112%
Purpura24.07.06.005; 23.06.01.004; 01.01.04.0030.000280%
Pustular psoriasis10.02.01.102; 23.03.14.0060.000112%Not Available
Pyrexia08.05.02.0030.010197%
Radiation pneumonitis12.05.02.002; 22.01.04.001--Not Available
Rash23.03.13.0010.025240%Not Available
Rash erythematous23.03.13.0290.001489%Not Available
Rash macular23.03.13.0030.001209%Not Available
Rash maculo-papular23.03.13.0040.000560%
Rash papular23.03.13.0170.001489%Not Available
Rash pruritic23.03.13.0300.002339%Not Available
Rash vesicular23.03.13.0090.000604%Not Available
Raynaud's phenomenon24.04.03.0030.000246%Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.0010.001030%
Renal cancer20.01.04.002; 16.08.02.0010.001164%Not Available
Renal cyst20.01.04.001; 16.27.01.0010.000112%Not Available
Renal disorder20.01.02.0020.001354%Not Available
Renal failure20.01.03.005--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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