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)
Dementia19.20.02.001; 17.03.01.001--Not Available
Depressed level of consciousness17.02.04.0020.002398%
Depressed mood19.15.02.001--Not Available
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Dermatitis acneiform23.02.01.0040.001066%
Dermatitis bullous23.03.01.0020.000533%
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Diarrhoea07.02.01.0010.108429%
Diplopia17.17.01.005; 06.02.06.002--Not Available
Discomfort08.01.08.0030.001598%Not Available
Disorientation19.13.01.002; 17.02.05.0150.004529%Not Available
Disseminated intravascular coagulation24.01.01.010; 01.01.02.0020.001459%
Disturbance in attention19.21.02.002; 17.03.03.001--
Diverticulitis11.01.07.003; 07.10.02.0010.000799%Not Available
Dizziness02.01.02.004; 24.06.02.007; 17.02.05.003--
Dizziness postural24.06.02.008; 17.02.05.004; 02.01.02.0050.000533%Not Available
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.015--Not Available
Drug hypersensitivity10.01.01.001--Not Available
Dry mouth07.06.01.0020.013587%
Dry skin23.03.03.0010.021579%
Dry throat07.06.01.005; 22.02.05.0040.000533%Not Available
Dysgeusia17.02.07.003; 07.14.03.0010.006394%
Dyspepsia07.01.02.0010.004263%
Dysphagia07.01.06.0030.013853%
Dysphonia19.19.03.002; 17.02.08.004; 22.02.05.0050.074595%
Dyspnoea22.02.01.004; 02.01.03.0020.033301%
Dyspnoea at rest22.02.01.025; 02.01.03.0070.000533%Not Available
Dyspnoea exertional02.01.03.003; 22.02.01.0050.005861%Not Available
Dysuria20.02.02.0020.002398%
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