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)
Peripheral swelling	08.01.03.053; 02.05.04.015	0.005059%		Not Available
Localised oedema	14.05.06.009; 08.01.07.011; 02.05.04.006	0.000112%
Lip blister	07.05.01.007; 23.03.01.016	0.000112%		Not Available
General physical health deterioration	08.01.03.018	0.004555%		Not Available
Muscle fatigue	15.05.03.006	0.000168%		Not Available
Left ventricular dysfunction	02.04.02.011	0.000358%
Tongue dry	07.14.02.009	0.000246%		Not Available
Tumour haemorrhage	24.07.01.028; 16.32.03.008	0.000839%
Shock haemorrhagic	14.05.05.003; 24.06.02.014	0.000224%		Not Available
Balance disorder	17.02.02.007; 08.01.03.081	0.001030%		Not Available
Dysstasia	08.01.03.089; 17.02.02.012; 15.03.05.011	0.000716%		Not Available
Metastatic renal cell carcinoma	20.01.04.005; 16.08.02.003	0.000616%		Not Available
Skin tightness	23.03.03.018	0.000112%		Not Available
Musculoskeletal chest pain	22.09.01.001; 15.03.04.012	0.000414%
Gastrointestinal stromal tumour	16.13.04.008; 07.21.04.003	0.000392%		Not Available
Plantar erythema	23.03.06.012	0.000392%		Not Available
Chylothorax	22.05.02.006	0.000112%
Madarosis	06.06.04.010; 23.02.02.004	0.000358%		Not Available
Exercise tolerance decreased	08.01.03.036	0.000750%		Not Available
Bile duct stenosis	09.02.02.001	0.000224%
Prostatomegaly	21.04.01.002	0.000112%		Not Available
Acute coronary syndrome	02.02.02.015; 24.04.04.011	0.000504%		Not Available
Metastases to peritoneum	16.22.02.008; 07.21.03.003	0.000560%		Not Available
Skin induration	23.03.03.020	0.000224%
Haemodynamic instability	24.03.02.006	0.000112%		Not Available
Ear discomfort	04.03.01.005	0.000112%		Not Available
Oesophageal rupture	12.01.17.015; 07.04.05.005	0.000168%		Not Available
Respiratory tract congestion	22.02.07.003	0.000336%		Not Available
Lymphatic disorder	01.09.01.003	-	-	Not Available
Large intestinal haemorrhage	24.07.02.026; 07.12.03.003	0.000168%

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