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
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
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
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)
Abdominal discomfort07.01.06.0010.003078%Not Available
Abdominal distension07.01.04.0010.004018%
Abdominal pain07.01.05.0020.012167%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.009615%
Abdominal rigidity07.01.05.0110.000224%Not Available
Abdominal tenderness07.01.05.004--Not Available
Acne23.02.01.0010.002216%Not Available
Acute hepatic failure09.01.03.0010.000616%Not Available
Acute myeloid leukaemia16.01.05.001; Available
Acute myocardial infarction24.04.04.001; Available
Acute pulmonary oedema02.05.02.004; Available
Acute respiratory distress syndrome24.03.02.034;;
Ageusia17.02.07.001; Available
Alanine aminotransferase increased13.03.04.005--
Altered state of consciousness19.07.01.003; Available
Amylase increased13.05.01.009--
Anal fissure07.03.01.0020.000224%
Anaphylactic reaction24.06.03.006;
Anaphylactic shock24.06.02.004; Available
Anaplastic thyroid cancer16.24.03.003; Available
Angina pectoris24.04.04.002;
Angioedema22.04.02.008;; Available
Anuria20.01.03.0020.000336%Not Available
Aortic dissection24.02.03.0020.000112%Not Available
Apathy19.04.04.0020.000280%Not Available
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Drug Name ADR Term Target
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