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)
Acute kidney injury20.01.03.016--
Posterior reversible encephalopathy syndrome17.13.02.007--
Drug-induced liver injury12.03.01.044; 09.01.07.023--Not Available
Hepatic cancer16.07.02.004; 09.04.02.0080.005843%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.056636%Not Available
Faeces soft07.01.03.0080.000112%Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.000168%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000918%
Anal incontinence17.05.01.021; 07.01.06.0290.000280%
Abnormal loss of weight14.03.02.0190.000280%Not Available
Anal ulcer07.04.01.0010.000168%
Blood blister23.03.01.028; 12.01.06.0130.000437%Not Available
Cerebellar haemorrhage17.08.01.046; 24.07.04.0230.000168%Not Available
Faeces pale07.01.03.0050.000112%Not Available
Follicular thyroid cancer16.24.03.005; 05.02.05.0080.000112%Not Available
Hepatic haematoma12.01.17.008; 24.07.01.071; 09.01.06.0160.000168%Not Available
Hepatic infarction09.01.06.017; 24.04.07.0070.000112%Not Available
Hilar lymphadenopathy22.09.03.005; 01.09.01.0230.000280%Not Available
Lymphadenopathy mediastinal01.09.01.025; 22.09.03.0060.000504%Not Available
Malignant ascites16.32.03.013; 07.07.01.0040.000168%Not Available
Malignant pleural effusion16.32.03.014; 22.05.04.0010.000280%Not Available
Mesenteric vein thrombosis24.01.08.004; 07.15.02.0130.000112%Not Available
Metastases to abdominal cavity16.22.02.010; 07.21.03.0060.000168%Not Available
Metastases to adrenals05.01.04.007; 16.22.02.0120.000616%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.002071%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.001343%Not Available
Metastases to pleura22.05.04.002; 16.22.02.0220.000168%Not Available
Metastases to skin23.07.04.026; 16.22.02.0230.000112%Not Available
Palmoplantar keratoderma23.01.01.0070.000694%Not Available
Senile dementia19.20.02.009; 17.03.01.0080.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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