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
TTD Drug ID D0W5HK
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
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
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)
Renal cancer metastatic20.01.04.012; 16.08.02.0060.000278%Not Available
Skin ulcer haemorrhage24.07.01.078; 23.07.03.0210.000533%Not Available
Liver carcinoma ruptured16.07.02.007; 09.04.02.0120.003996%Not Available
Portal hypertensive gastropathy24.08.06.006; 09.01.06.022; 07.12.01.0070.000533%Not Available
Corneal bleeding24.07.05.012; 06.07.01.0050.000533%Not Available
Gastric antral vascular ectasia24.03.03.028; 07.15.04.0030.001598%Not Available
Metastases to abdominal wall16.22.02.011; 07.16.05.0070.000139%Not Available
Metastases to spleen16.22.02.025; 01.09.02.0100.000347%Not Available
Pulmonary sepsis22.07.01.014; 11.01.11.0140.000139%Not Available
Impaired self-care08.01.03.071; 19.01.02.0140.001066%Not Available
Thyroid cancer metastatic05.02.05.009; 16.24.03.0060.000764%Not Available
Protein induced by vitamin K absence or antagonist II increased13.09.01.0270.001332%Not Available
Hepatic infection11.01.18.008; 09.01.08.0140.000533%
Gastric infection11.01.07.008; 07.19.03.0030.000533%Not Available
Hepatic mass09.01.08.0150.000533%Not Available
Portal vein occlusion24.04.07.009; 09.01.06.0240.000533%Not Available
Acute myeloid leukaemia recurrent16.01.05.004; 01.10.05.0040.000139%Not Available
Sputum retention22.02.03.0120.000533%Not Available
Traumatic intracranial haemorrhage24.07.04.034; 17.08.05.005; 12.01.10.0170.000139%Not Available
Paracentesis13.18.01.0090.000533%Not Available
Perforated ulcer08.03.06.0020.000533%Not Available
Grip strength decreased13.15.01.0410.000799%Not Available
Portal venous gas07.01.06.0330.000533%Not Available
Gastrointestinal telangiectasia24.03.03.030; 07.15.04.0060.000533%Not Available
Quality of life decreased13.18.01.013--Not Available
Oncologic complication16.32.03.0250.000139%Not Available
Tumour thrombosis24.01.01.035; 16.32.03.0340.002131%Not Available
Escherichia test positive13.08.01.0090.000533%Not Available
Tumour rupture16.32.03.0330.001042%Not Available
Infected dermal cyst23.10.02.002; 16.26.02.002; 11.01.12.0240.000533%Not Available
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