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 Prescription
ATC Code L01EX02
DrugBank ID DB00398
KEGG ID D08524
MeSH ID D000077157
PubChem ID 216239
NDC Product Code 0378-1201; 68554-0073; 12527-8488; 63850-8051; 47049-848; 50419-488; 43744-545
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.010390%Not Available
Abdominal distension07.01.04.0010.015718%
Abdominal pain07.01.05.0020.046089%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.029838%
Abdominal rigidity07.01.05.0110.001066%Not Available
Abdominal tenderness07.01.05.004--Not Available
Abnormal dreams19.02.03.001; Available
Abscess11.01.08.0010.000533%Not Available
Acne23.02.01.0010.004263%Not Available
Activated partial thromboplastin time prolonged13.01.02.0010.000533%
Acute hepatic failure09.01.03.0010.000834%Not Available
Acute myeloid leukaemia16.01.05.001; Available
Acute myocardial infarction24.04.04.001; Available
Acute prerenal failure24.06.02.003; Available
Acute respiratory distress syndrome22.01.03.001--
Acute respiratory failure22.02.06.001; Available
Ageusia07.14.03.003; Available
Aggression19.05.01.001--Not Available
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase abnormal13.03.01.0010.001598%Not Available
Alanine aminotransferase decreased13.03.01.0020.000533%Not Available
Alanine aminotransferase increased13.03.01.0030.019981%
Altered state of consciousness19.07.01.003; Available
Ammonia increased13.03.01.0230.011189%Not Available
Amylase increased13.05.01.0090.002664%
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