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)
Hypophosphataemia14.04.03.0010.000392%
Hypoproteinaemia14.10.01.003; 09.01.02.0040.000112%Not Available
Hypothyroidism14.11.01.012; 05.02.03.0010.000448%
Hypovolaemic shock24.06.02.0170.000112%Not Available
Immune system disorder10.02.01.001--Not Available
Impaired healing08.03.02.0010.000918%Not Available
Incoherent19.10.03.006; 17.02.08.0020.000246%Not Available
Incontinence20.02.02.004; 17.05.01.006; 07.01.06.0110.000168%Not Available
Increased appetite08.01.09.027; 14.03.01.0030.000168%Not Available
Increased tendency to bruise24.07.06.012; 23.06.01.009; 01.01.03.0050.000112%Not Available
Infection11.01.08.002--Not Available
Influenza like illness08.01.03.010--
Initial insomnia19.02.01.005; 17.15.03.0050.000246%Not Available
International normalised ratio abnormal13.01.02.029--Not Available
International normalised ratio increased13.01.02.008--
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Intestinal ischaemia24.04.08.001; 07.15.02.0010.000112%Not Available
Intestinal perforation07.04.06.0020.000168%Not Available
Iridocyclitis06.04.03.0010.000168%Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.003537%Not Available
Jaundice cholestatic09.01.01.0050.000672%Not Available
Jaundice hepatocellular09.01.01.0060.000112%Not Available
Joint swelling15.01.02.0040.001444%Not Available
Keratoacanthoma23.08.02.007; 16.03.02.0070.000246%Not Available
Large intestine perforation12.02.03.005; 07.04.06.0050.000336%
Laryngeal oedema22.04.02.001; 10.01.05.003; 23.04.01.0050.000112%
Left ventricular failure02.05.02.0010.000112%Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.001589%
Leukocytosis01.02.01.002--
Leukoencephalopathy17.13.02.0030.000168%
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ADReCS-Target
Drug Name ADR Term Target
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