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)
Slow response to stimuli17.02.05.0630.000112%Not Available
Tumour embolism24.01.01.034; 16.32.03.0300.000224%Not Available
Varicose vein ruptured24.10.04.0050.000168%Not Available
Terminal state08.01.03.0790.000246%Not Available
Metastases to heart16.22.02.016; 02.10.01.0020.000112%Not Available
Metastases to stomach16.22.02.026; 07.21.03.0070.000112%Not Available
Renal cancer metastatic20.01.04.012; 16.08.02.0060.000224%Not Available
Skin ulcer haemorrhage24.07.01.078; 23.07.03.0210.000112%Not Available
Liver carcinoma ruptured09.04.02.012; 16.07.02.0070.000895%Not Available
Portal hypertensive gastropathy24.08.06.006; 09.01.06.022; 07.12.01.0070.000112%Not Available
Corneal bleeding24.07.05.012; 06.07.01.0050.000112%Not Available
Gastric antral vascular ectasia24.03.03.028; 07.15.04.0030.000448%Not Available
Metastases to abdominal wall16.22.02.011; 07.16.05.0070.000112%Not Available
Metastases to spleen01.09.02.010; 16.22.02.0250.000280%Not Available
Thyroid cancer metastatic16.24.03.006; 05.02.05.0090.000672%Not Available
Hepatic mass09.01.08.0150.000224%Not Available
Gastrointestinal oedema07.11.01.0120.000112%Not Available
Portal vein occlusion09.01.06.024; 24.04.07.0090.000112%Not Available
Desmoid tumour15.09.01.005; 16.18.01.0060.000224%Not Available
Sputum retention22.02.03.0120.000112%Not Available
Gallbladder enlargement09.03.02.0050.000112%Not Available
Portal venous gas07.01.06.0330.000112%Not Available
Retroperitoneal lymphadenopathy07.07.01.012; 01.09.01.0290.000112%Not Available
Oncologic complication16.32.03.0250.000112%Not Available
Tumour thrombosis16.32.03.034; 24.01.01.0350.000504%Not Available
Tumour rupture16.32.03.0330.000839%Not Available
Exposed bone in jaw15.02.04.0340.000246%Not Available
Clear cell renal cell carcinoma20.01.04.008; 16.08.02.0040.000168%Not Available
Blister rupture23.03.01.027; 12.01.06.0120.000112%Not Available
Anorectal swelling07.03.03.0080.000168%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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