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)
Hyperaesthesia17.02.06.0040.002131%Not Available
Hyperammonaemia14.10.01.001; 09.01.02.0020.000799%Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.0030.005861%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.0020.001066%
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkalaemia14.05.03.001--
Hyperkeratosis23.01.01.0010.014120%
Hypersensitivity10.01.03.003--
Hypersomnia19.02.05.001; 17.15.01.0010.003996%
Hypertension24.08.02.0010.058078%
Hypertensive crisis24.08.01.0010.001865%Not Available
Hyperthermia12.05.01.002; 08.05.01.0010.001332%Not Available
Hyperthyroidism14.11.01.011; 05.02.02.0010.002398%
Hyperuricaemia14.09.01.0030.000799%
Hypoaesthesia17.02.06.0230.011456%Not Available
Hypoalbuminaemia14.10.01.002; 09.01.02.0030.003996%
Hypocalcaemia14.04.01.0040.002398%
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypokalaemia14.05.03.0020.003463%
Hypomagnesaemia14.04.02.0010.001332%
Hyponatraemia14.05.04.002--
Hypophosphataemia14.04.03.0010.003463%
Hypoproteinaemia09.01.02.004; 14.10.01.0030.000799%Not Available
Hypotension24.06.03.002--
Hypothermia12.05.03.001; 08.05.01.0030.000799%
Hypothyroidism05.02.03.001; 14.11.01.0120.006127%
Hypovolaemic shock24.06.02.0170.000139%Not Available
Hypoxia22.02.02.003--
Ileus07.13.01.0010.005595%
Incoherent19.10.03.006; 17.02.08.0020.000533%Not Available
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