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)
Leukopenia01.02.02.001--Not Available
Lip dry07.06.01.0030.000224%Not Available
Lipase increased13.05.01.003--
Listless19.04.04.003; 08.01.01.0120.000168%Not Available
Liver disorder09.01.08.0010.003067%Not Available
Liver function test abnormal13.03.04.030--Not Available
Loss of consciousness17.02.04.004--Not Available
Lung disorder22.02.07.0010.000839%Not Available
Lung infiltration22.01.02.0040.000168%Not Available
Lymphadenopathy01.09.01.0020.000560%Not Available
Lymphopenia01.02.02.002--Not Available
Malaise08.01.01.0030.008104%
Mass08.03.05.0030.000716%Not Available
Melaena24.07.02.013; 07.12.02.0040.001343%Not Available
Melanocytic naevus23.10.01.007; 16.26.01.0070.000246%Not Available
Metastases to liver16.22.02.001; 09.04.02.0040.001063%Not Available
Metastases to lung16.22.02.002; 22.08.01.0050.005820%Not Available
Metastases to spine16.22.02.007; 15.09.03.0070.000616%Not Available
Micturition urgency20.02.02.0060.000112%
Middle insomnia19.02.01.003; 17.15.03.0030.000246%Not Available
Monoplegia17.01.04.0030.000112%Not Available
Mood altered19.04.02.007--Not Available
Mood swings19.04.03.001--Not Available
Mouth haemorrhage24.07.02.014; 07.05.02.0010.000448%
Mouth ulceration07.05.06.0040.001220%Not Available
Mucosal inflammation08.01.06.0020.000728%Not Available
Mucous stools07.01.03.0060.000112%Not Available
Muscle atrophy17.05.03.004; 15.05.03.0030.000280%Not Available
Muscle spasms15.05.03.0040.004343%
Muscular weakness17.05.03.005; 15.05.06.0010.001903%
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ADReCS-Target
Drug Name ADR Term Target
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