Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Edoxaban tosylate
Drug ID BADD_D00746
Description Edoxaban is a member of the Novel Oral Anti-Coagulants (NOACs) class of drugs, and is a rapidly acting, oral, selective factor Xa inhibitor. By inhibiting factor Xa, a key protein in the coagulation cascade, edoxaban prevents the stepwise amplification of protein factors needed to form blood clots. It is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant. Traditionally, warfarin, a vitamin K antagonist, was used for stroke prevention in these individuals but effective use of this drug is limited by it's delayed onset, narrow therapeutic window, need for regular monitoring and INR testing, and numerous drug-drug and drug-food interactions. This has prompted enthusiasm for newer agents such as dabigatran, apixaban, and rivaroxaban for effective clot prevention. In addition to once daily dosing, the benefits over warfarin also include significant reductions in hemorrhagic stroke and GI bleeding, and improved compliance, which is beneficial as many patients will be on lifelong therapy.
Indications and Usage Edoxaban is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). However, it should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg). It is also indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant.
Marketing Status Prescription
ATC Code B01AF03
DrugBank ID DB09075
KEGG ID D11568
MeSH ID C552171
PubChem ID 44610678
TTD Drug ID D0SL8X
NDC Product Code 66003-201; 65597-202; 66003-202; 66003-203; 65597-201; 65597-203
Synonyms edoxaban | N-(5-chloropyridin-2-yl)-N'-((1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7- tetrahydro(1,3)thiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)oxamide | N-(5-chloropyridin-2-yl)-N'-((1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)ethanediamide p-toluenesulfonate monohydrate | Savaysa | DU-176 | DU-176b | edoxaban tosylate
Chemical Information
Molecular Formula C31H38ClN7O7S2
CAS Registry Number 480449-71-6
SMILES CC1=CC=C(C=C1)S(=O)(=O)O.CN1CCC2=C(C1)SC(=N2)C(=O)NC3CC(CCC3NC(=O)C(=O)NC4=NC=C( C=C4)Cl)C(=O)N(C)C
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)
Anaemia01.03.02.001--
Compartment syndrome24.04.05.006; 15.05.05.005--Not Available
Death08.04.01.001--
Epistaxis24.07.01.005; 22.04.03.001--
Eye haemorrhage06.07.02.001; 24.07.05.002--Not Available
Gastric haemorrhage24.07.02.007; 07.12.01.001--
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Haemarthrosis24.07.01.046; 15.01.01.004; 12.04.03.001--Not Available
Haematuria24.07.01.047; 20.02.01.006--
Haemoglobin decreased13.01.05.003--Not Available
Haemorrhage intracranial24.07.04.003; 17.08.01.008--
Haemorrhagic stroke24.07.04.014; 17.08.01.011--Not Available
Interstitial lung disease10.02.01.033; 22.01.02.003--Not Available
Liver function test abnormal13.03.01.013--Not Available
Neoplasm16.16.02.001--Not Available
Oral discomfort07.05.05.001--Not Available
Packed red blood cell transfusion25.06.01.002--Not Available
Pericardial haemorrhage24.07.01.013; 02.06.01.003--Not Available
Rash23.03.13.001--Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Retroperitoneal haemorrhage24.07.01.017; 07.07.02.002--
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.011--Not Available
Subdural haemorrhage24.07.04.012; 17.08.05.003; 12.01.10.006--Not Available
X-ray with contrast upper gastrointestinal tract13.05.05.003--Not Available
Spinal cord haemorrhage24.07.04.010; 17.08.01.030; 12.01.13.003--Not Available
Brain death17.02.03.003; 08.04.01.004--Not Available
Lower gastrointestinal haemorrhage24.07.02.030; 07.12.02.007--
Puncture site reaction12.07.04.013; 08.02.04.013--Not Available
Haemorrhagic transformation stroke24.07.04.018; 17.08.01.036--Not Available
Haemorrhage24.07.01.002--Not Available
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