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)
Cancer pain	16.32.03.004	0.000728%		Not Available
Ocular icterus	09.01.01.007; 06.08.03.009; 01.06.04.007	0.000336%		Not Available
Dermatitis psoriasiform	23.03.14.004	0.000302%		Not Available
Haemobilia	24.07.01.049; 09.01.08.009	0.000168%		Not Available
Intestinal mass	07.11.01.010	0.000112%		Not Available
Gastrointestinal toxicity	12.03.01.019; 07.08.03.006	0.000336%		Not Available
Intestinal haemorrhage	07.12.03.005; 24.07.02.031	0.000168%		Not Available
Early satiety	14.03.01.010; 08.01.09.004; 07.01.06.027	0.000112%		Not Available
Angiopathy	24.03.02.007	0.000168%		Not Available
Metastases to central nervous system	17.02.10.013; 16.22.02.004	0.000951%		Not Available
Skin toxicity	23.03.03.032; 12.03.01.020	0.001142%		Not Available
Blood alkaline phosphatase increased	13.04.02.004	-	-
Jugular vein distension	02.11.04.011; 24.03.04.005	0.000112%		Not Available
Hot flush	24.03.01.005; 21.02.02.001; 08.01.03.027	-	-
Recall phenomenon	23.03.07.005; 12.02.06.001	-	-
Adverse event	08.06.01.010	-	-	Not Available
Appetite disorder	19.09.01.002; 14.03.01.004	0.000112%		Not Available
Brain neoplasm	16.30.01.003; 17.20.01.003	0.000392%		Not Available
Breast disorder	21.05.04.004	-	-	Not Available
Cardiac disorder	02.11.01.003	0.001231%		Not Available
Connective tissue disorder	10.04.04.026; 15.06.01.006	-	-	Not Available
Eye movement disorder	17.02.05.025; 06.05.02.008	0.000112%		Not Available
Feeding disorder	19.09.01.003; 14.03.02.003	0.001589%		Not Available
Embolism	24.01.01.009	-	-
Gastrointestinal motility disorder	07.02.03.001	0.000280%		Not Available
Haematotoxicity	12.03.01.025; 01.05.01.007	0.000280%		Not Available
Infarction	24.04.02.017	-	-	Not Available
Infestation	23.11.01.002; 11.09.01.001	-	-	Not Available
Inflammation	10.02.01.089; 08.01.05.007	0.000582%		Not Available
Limb discomfort	15.03.04.014	0.000918%		Not Available

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