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 for reducing 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 approved
ATC Code B01AF03
DrugBank ID DB09075
KEGG ID D11568
MeSH ID C552171
PubChem ID 44610678
TTD Drug ID D0SL8X
NDC Product Code 65597-201; 65597-202; 65597-203; 66003-202; 66003-203; 66003-201
UNII 32W99UE810
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
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)
Anaemia01.03.02.001--
Compartment syndrome15.05.05.005; 24.04.05.006---
Death08.04.01.001--
Epistaxis22.04.03.001; 24.07.01.005--
Eye haemorrhage06.07.02.001; 12.02.02.012; 24.07.05.002---
Gastric haemorrhage07.12.01.001; 24.07.02.007--
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Haemarthrosis12.04.03.001; 15.01.01.004; 24.07.01.046---
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.047--
Haemoglobin decreased13.01.05.003---
Haemorrhage intracranial17.08.01.008; 24.07.04.003--
Haemorrhagic stroke17.08.01.011; 24.07.04.014---
Interstitial lung disease10.02.01.033; 22.01.02.003---
Liver function test abnormal13.03.04.030---
Neoplasm16.16.02.001---
Oral discomfort07.05.05.001---
Pericardial haemorrhage02.06.01.003; 24.07.01.013---
Rash23.03.13.001---
Rectal haemorrhage07.12.03.001; 24.07.02.018--
Retroperitoneal haemorrhage07.07.02.002; 12.01.17.018; 24.07.01.017--
Subarachnoid haemorrhage12.01.10.011; 17.08.01.010; 24.07.04.004---
Subdural haemorrhage12.01.10.006; 17.08.05.003; 24.07.04.012---
X-ray with contrast upper gastrointestinal tract13.05.05.003---
Spinal cord haemorrhage12.01.13.003; 17.08.01.030; 24.07.04.010---
Brain death08.04.01.004; 17.02.03.003---
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.030--
Puncture site reaction08.02.04.013; 12.07.04.013---
Haemorrhagic transformation stroke17.08.01.036; 24.07.04.018---
Haemorrhage24.07.01.002---
X-ray with contrast lower gastrointestinal tract13.05.05.002---
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