Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Regorafenib
Drug ID BADD_D01922
Description Regorafenib is an orally-administered inhibitor of multiple kinases. It is used for the treatment of metastatic colorectal cancer, advanced gastrointestinal stromal tumours, and hepatocellular carcinoma. FDA approved on September 27, 2012. Approved use of Regorafenib was expanded to treat Hepatocellular Carcinoma in April 2017.
Indications and Usage Regorafenib is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Regorafenib is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumour (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Regorafenib is also indicated for the treatment of patients with hepatocellular carcinoma (HCC) previously treated with sorafenib.[L16835]
Marketing Status approved
ATC Code L01EX05
DrugBank ID DB08896
KEGG ID D10138
MeSH ID C559147
PubChem ID 11167602
TTD Drug ID D09GDD
NDC Product Code 50419-171; 54893-0033; 12527-0171; 63415-0522
UNII MGN125FS9D
Synonyms regorafenib | 4-(4-(((4-chloro-3-(trifluoromethyl)phenyl)carbamoyl)amino)-3-fluorophenoxy)-n-methylpyridine-2-carboxamide | Stivarga | BAY 73-4506 | BAY73-4506 | BAY-73-4506
Chemical Information
Molecular Formula C21H15ClF4N4O3
CAS Registry Number 755037-03-7
SMILES CNC(=O)C1=NC=CC(=C1)OC2=CC(=C(C=C2)NC(=O)NC3=CC(=C(C=C3)Cl)C(F)(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)
Solar lentigo23.05.01.0130.000112%-
Skin haemorrhage23.06.07.001; 24.07.01.1030.000302%-
Exfoliative rash23.03.07.0060.000224%-
Bone marrow failure01.03.03.0050.000616%
Pharyngeal inflammation22.04.05.0080.000224%
Liver injury09.01.07.022; 12.01.17.0120.000504%-
Hyperammonaemic encephalopathy14.10.01.006; 17.13.01.0050.000168%-
Adverse reaction08.06.01.0180.000168%-
Oral disorder07.05.01.0050.000302%-
Traumatic liver injury09.01.08.010; 12.01.17.027---
Hypertransaminasaemia09.01.02.0050.000168%-
Tumour compression16.32.03.0210.000112%-
Anorectal discomfort07.03.03.0030.000224%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.003168%
Acute kidney injury20.01.03.016--
Upper-airway cough syndrome22.12.03.0360.000112%
Posterior reversible encephalopathy syndrome17.13.02.0070.000560%
Slow speech17.02.08.016; 19.19.02.0040.000112%-
Drug-induced liver injury09.01.07.023; 12.03.01.0440.000862%-
Hepatic cancer09.04.02.008; 16.07.02.0040.000638%-
Hepatocellular carcinoma09.04.02.010; 16.07.02.0050.007779%-
Faeces soft07.01.03.0080.000392%-
Perforation08.01.03.0580.000168%-
Anal incontinence07.01.06.029; 17.05.01.0210.000470%
Abdominal mass07.01.01.0030.000112%-
Abnormal loss of weight14.03.02.0190.000839%-
Adenocarcinoma of colon07.21.01.008; 16.13.01.0100.000728%-
Cholangitis acute09.02.01.0060.000112%-
Colon cancer recurrent07.21.01.011; 16.13.01.0130.000728%-
Colon cancer stage IV07.21.01.012; 16.13.01.0140.000280%-
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