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%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.000302%Not Available
Exfoliative rash23.03.07.0060.000224%Not Available
Bone marrow failure01.03.03.0050.000616%
Pharyngeal inflammation22.04.05.0080.000224%
Liver injury12.01.17.012; 09.01.07.0220.000504%Not Available
Hyperammonaemic encephalopathy17.13.01.005; 14.10.01.0060.000168%Not Available
Adverse reaction08.06.01.0180.000168%Not Available
Oral disorder07.05.01.0050.000302%Not Available
Traumatic liver injury12.01.17.027; 09.01.08.010--Not Available
Hypertransaminasaemia09.01.02.0050.000168%Not Available
Tumour compression16.32.03.0210.000112%Not Available
Anorectal discomfort07.03.03.0030.000224%Not Available
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 speech19.19.02.004; 17.02.08.0160.000112%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000862%Not Available
Hepatic cancer09.04.02.008; 16.07.02.0040.000638%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.007779%Not Available
Faeces soft07.01.03.0080.000392%Not Available
Perforation08.01.03.0580.000168%Not Available
Anal incontinence07.01.06.029; 17.05.01.0210.000470%
Abdominal mass07.01.01.0030.000112%Not Available
Abnormal loss of weight14.03.02.0190.000839%Not Available
Adenocarcinoma of colon16.13.01.010; 07.21.01.0080.000728%Not Available
Cholangitis acute09.02.01.0060.000112%Not Available
Colon cancer recurrent16.13.01.013; 07.21.01.0110.000728%Not Available
Colon cancer stage IV16.13.01.014; 07.21.01.0120.000280%Not Available
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