Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Edoxaban
Drug ID BADD_D02469
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 D09710
MeSH ID C552171
PubChem ID 10280735
TTD Drug ID D0C3BS
NDC Product Code Not Available
UNII NDU3J18APO
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 C24H30ClN7O4S
CAS Registry Number 480449-70-5
SMILES 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)
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.0060.000263%-
Haemorrhage subcutaneous23.06.07.002; 24.07.06.0100.000082%-
Haemothorax12.01.18.005; 22.05.02.001; 24.07.01.0080.000082%
Hypertensive crisis24.08.01.0010.000082%-
Hypochromic anaemia01.03.02.0040.000082%-
Insomnia17.15.03.002; 19.02.01.0020.000461%
Interstitial lung disease10.02.01.033; 22.01.02.0030.000123%-
Marasmus14.03.02.0130.000082%-
Melaena07.12.02.004; 24.07.02.0130.000428%-
Metastases to liver09.04.02.004; 16.22.02.0010.000082%-
Neoplasm malignant16.16.01.0010.000082%-
Nervous system disorder17.02.10.0010.000082%-
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.0110.000082%
Pallor08.01.03.032; 23.03.03.031; 24.03.04.0010.000181%-
Palpitations02.11.04.0120.000280%
Paralysis17.01.04.0040.000082%-
Pericarditis constrictive02.06.02.0020.000082%-
Pleural effusion22.05.02.0020.000082%
Pulmonary alveolar haemorrhage22.01.02.005; 24.07.01.0150.000123%-
Pulmonary embolism22.06.02.001; 24.01.06.0010.000329%-
Rectal haemorrhage07.12.03.001; 24.07.02.0180.000123%
Renal failure20.01.03.0050.000123%-
Speech disorder17.02.08.003; 19.19.02.002; 22.12.03.0270.000181%-
Subarachnoid haemorrhage12.01.10.011; 17.08.01.010; 24.07.04.0040.000082%-
Sudden death02.03.04.013; 08.04.01.0030.000082%
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.000082%
Thrombosis24.01.01.0060.000444%-
Thrombotic stroke17.08.01.021; 24.01.04.0060.000082%-
Vaginal haemorrhage21.08.01.001; 24.07.03.0050.000321%
Carotid artery occlusion17.08.01.012; 24.04.06.0080.000082%-
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