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)
Musculoskeletal pain15.03.04.0070.001198%
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.0070.002295%
Myocardial ischaemia24.04.04.010; 02.02.02.0080.000280%Not Available
Myopathy15.05.05.0010.000168%Not Available
Nail discolouration23.02.05.0010.000168%
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.0010.018614%
Neck pain15.03.04.0090.000772%
Neoplasm16.16.02.0010.000336%Not Available
Neoplasm malignant16.16.01.001--Not Available
Nephrotic syndrome20.05.01.0020.000392%
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.0030.000392%Not Available
Neuralgia17.02.07.0050.000414%
Neuropathy peripheral17.09.03.003--Not Available
Neutropenia01.02.03.004--Not Available
Night sweats23.02.03.006; 08.01.03.0310.000526%Not Available
Nipple pain21.05.05.0090.000224%Not Available
Odynophagia07.01.06.0360.000168%Not Available
Oedema14.05.06.010; 08.01.07.0060.001063%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.003671%
Oesophageal haemorrhage24.07.02.021; 07.12.01.0020.000112%
Oesophageal pain07.01.05.012--
Oesophageal ulcer07.04.05.0020.000112%
Oesophageal varices haemorrhage09.01.06.004; 07.12.01.003; 24.07.02.0220.000504%
Optic ischaemic neuropathy24.04.10.001; 17.04.05.006; 06.07.03.0010.000112%Not Available
Oral discomfort07.05.05.0010.000504%Not Available
Oral mucosal blistering07.05.05.0170.001343%Not Available
Oral pain07.05.05.0340.001589%
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ADReCS-Target
Drug Name ADR Term Target
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