ADReCS

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 injury	20.01.03.016	-	-
Posterior reversible encephalopathy syndrome	17.13.02.007	-	-
Drug-induced liver injury	12.03.01.044; 09.01.07.023	-	-	Not Available
Hepatic cancer	09.04.02.008; 16.07.02.004	0.005843%		Not Available
Hepatocellular carcinoma	16.07.02.005; 09.04.02.010	0.056636%		Not Available
Faeces soft	07.01.03.008	0.000112%		Not Available
Mouth swelling	23.04.01.020; 10.01.05.020; 07.05.04.007	0.000168%		Not Available
Multiple organ dysfunction syndrome	08.01.03.057	0.000918%
Anal incontinence	17.05.01.021; 07.01.06.029	0.000280%
Abnormal loss of weight	14.03.02.019	0.000280%		Not Available
Anal ulcer	07.04.01.001	0.000168%
Blood blister	23.03.01.028; 12.01.06.013	0.000437%		Not Available
Cerebellar haemorrhage	24.07.04.023; 17.08.01.046	0.000168%		Not Available
Faeces pale	07.01.03.005	0.000112%		Not Available
Follicular thyroid cancer	16.24.03.005; 05.02.05.008	0.000112%		Not Available
Hepatic haematoma	24.07.01.071; 09.01.06.016; 12.01.17.008	0.000168%		Not Available
Hepatic infarction	09.01.06.017; 24.04.07.007	0.000112%		Not Available
Hilar lymphadenopathy	22.09.03.005; 01.09.01.023	0.000280%		Not Available
Lymphadenopathy mediastinal	22.09.03.006; 01.09.01.025	0.000504%		Not Available
Malignant ascites	16.32.03.013; 07.07.01.004	0.000168%		Not Available
Malignant pleural effusion	16.32.03.014; 22.05.04.001	0.000280%		Not Available
Mesenteric vein thrombosis	24.01.08.004; 07.15.02.013	0.000112%		Not Available
Metastases to abdominal cavity	07.21.03.006; 16.22.02.010	0.000168%		Not Available
Metastases to adrenals	16.22.02.012; 05.01.04.007	0.000616%		Not Available
Metastases to bone	16.22.02.005; 15.09.03.006	0.002071%		Not Available
Metastases to lymph nodes	16.22.02.006; 01.09.01.015	0.001343%		Not Available
Metastases to pleura	22.05.04.002; 16.22.02.022	0.000168%		Not Available
Metastases to skin	16.22.02.023; 23.07.04.026	0.000112%		Not Available
Palmoplantar keratoderma	23.01.01.007	0.000694%		Not Available
Senile dementia	17.03.01.008; 19.20.02.009	0.000112%		Not Available

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