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 tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
Marketing Status Prescription
ATC Code L01EX05
DrugBank ID DB08896
KEGG ID D10138
MeSH ID C559147
PubChem ID 11167602
TTD Drug ID D09GDD
NDC Product Code 12527-0171; 50419-171; 54893-0033; 63415-0522
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Liver carcinoma ruptured09.04.02.012; 16.07.02.0070.000208%Not Available
Carbohydrate antigen 19-9 increased13.22.01.0070.000278%Not Available
Metastases to abdominal wall16.22.02.011; 07.16.05.0070.000347%Not Available
Pulmonary cavitation22.01.02.0220.001598%Not Available
Tumour associated fever16.32.03.0290.000799%Not Available
Impaired self-care19.01.02.014; 08.01.03.0710.000799%Not Available
Lymphangiosis carcinomatosa24.09.02.007; 16.22.02.009; 01.09.01.0270.000278%Not Available
Brain natriuretic peptide increased13.02.04.0110.000799%Not Available
Clostridium difficile infection11.02.02.0090.000799%Not Available
Rectal cancer metastatic16.13.01.007; 07.21.05.0030.000417%Not Available
Colon cancer metastatic16.13.01.012; 07.21.01.0100.001390%Not Available
Cell death14.11.02.005; 08.03.03.0030.000799%Not Available
Hyperphosphatasaemia14.11.01.002; 15.02.04.011; 09.01.08.0020.000533%Not Available
Trousseau's syndrome24.01.01.033; 16.32.03.0280.000533%Not Available
Female genital tract fistula21.10.05.009; 20.08.01.007; 07.11.05.004; 23.07.04.0150.000799%Not Available
International normalised ratio fluctuation13.01.02.0530.000533%Not Available
Genital erosion21.10.05.0150.000533%Not Available
Nail growth abnormal23.02.05.0240.000533%Not Available
Tumour perforation16.32.03.0310.000799%Not Available
Stomach mass07.11.01.0300.000533%Not Available
Retroperitoneal lymphadenopathy07.07.01.012; 01.09.01.0290.000799%Not Available
Hypercreatinaemia15.05.03.021; 14.11.01.0240.000533%Not Available
Oral mucosal erythema07.05.05.0230.000533%Not Available
Quality of life decreased13.18.01.0130.000533%Not Available
Tumour rupture16.32.03.0330.000139%Not Available
Metastases to pelvis21.07.04.008; 16.22.02.0210.000533%Not Available
Gastrointestinal stromal cancer16.13.04.003; 07.21.03.0040.000556%Not Available
Skin wound23.03.11.022; 12.01.06.0150.000799%Not Available
Prerenal failure20.01.03.022; 24.06.02.0250.000799%Not Available
Abdominal lymphadenopathy01.09.01.020; 07.11.01.0180.000799%Not Available
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