Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Rivaroxaban
Drug ID BADD_D01954
Description Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food. FDA approved on July 1, 2011.
Indications and Usage Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); to reduce risk of recurrent DVT and/or PE. Rivaroxaban is also indicated, in combination with aspirin, for reducing the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease. Its use is also not recommended in those with severe renal impairment (<30mL/min).[L12819] Rivaroxaban is also indicated for the treatment and prevention of VTE in pediatric patients (from birth to 18 years of age) and for thromboprophylaxis in pediatric patients ≥2 years old with congenital heart disease following the Fontan procedure.[L12819]
Marketing Status approved
ATC Code B01AF01
DrugBank ID DB06228
KEGG ID D07086
MeSH ID D000069552
PubChem ID 9875401
TTD Drug ID D0KG3R
NDC Product Code 66174-0087; 69218-0500; 50458-577; 53296-0109; 63415-0523; 64552-4049; 65862-971; 66039-913; 71610-690; 75945-050; 76072-1008; 86051-002; 14501-0079; 16436-0109; 86051-004; 50458-578; 50458-579; 50458-580; 50458-584; 55154-1422; 55111-966; 50458-575; 14799-2023; 58032-2029; 65015-898; 65977-0139; 86051-001; 55154-1423; 12658-0516; 53747-068; 83137-0007; 53104-7730; 59285-009; 65727-050; 47848-039; 52286-0025; 64220-176; 65372-1193; 66022-0203; 86051-003; 55154-1424; 62512-0079; 82513-0001
UNII 9NDF7JZ4M3
Synonyms Rivaroxaban | 5-chloro-N-(((5S)-2-oxo-3-(4-(3-oxomorpholin-4-yl)phenyl)-1,3-oxazolidin-5-yl)methyl)thiophene-2-carboxamide | Xarelto | BAY 59-7939 | BAY 59 7939 | BAY 597939
Chemical Information
Molecular Formula C19H18ClN3O5S
CAS Registry Number 366789-02-8
SMILES C1COCC(=O)N1C2=CC=C(C=C2)N3CC(OC3=O)CNC(=O)C4=CC=C(S4)Cl
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)
Tongue haematoma24.07.02.057; 07.14.01.0140.000279%Not Available
Urinary bladder haemorrhage24.07.01.086; 20.03.01.0230.001469%Not Available
Ventricle rupture02.04.02.037; 12.01.11.0120.000158%Not Available
Aneurysm ruptured24.02.01.0020.000412%Not Available
Subdural hygroma17.11.01.0180.000158%Not Available
Atrial thrombosis02.11.01.002; 24.01.05.0050.009912%Not Available
Basilar artery occlusion17.08.01.042; 24.04.06.0300.000063%Not Available
Vertebral artery occlusion24.04.06.043; 17.08.01.0640.000063%Not Available
Axillary mass15.03.02.0140.000063%Not Available
Subclavian vein thrombosis24.01.02.0130.000507%Not Available
Metastases to heart16.22.02.016; 02.10.01.0020.000063%Not Available
Tongue haemorrhage24.07.02.058; 07.14.01.0150.000684%Not Available
Mediastinal haematoma24.07.01.074; 22.09.03.0070.000158%Not Available
Spinal subdural haematoma24.07.04.032; 17.08.01.060; 12.01.13.0080.000095%Not Available
Skin ulcer haemorrhage23.07.03.021; 24.07.01.0780.000329%Not Available
Carotid artery dissection24.02.04.004; 17.08.06.0030.000063%Not Available
Tongue biting12.01.17.023; 17.02.05.064; 07.14.01.0130.000063%Not Available
Aortic valve calcification02.07.03.0060.000063%Not Available
Oral dysaesthesia17.02.06.033; 07.05.05.0220.000063%
Soft tissue haemorrhage24.07.01.043; 15.03.02.0110.000222%Not Available
Gastric antral vascular ectasia07.15.04.003; 24.03.03.0280.000063%Not Available
Pulmonary cavitation22.01.02.0220.000063%Not Available
Retinal infarction24.04.10.008; 06.10.01.0120.000063%Not Available
Small intestinal haemorrhage24.07.02.019; 07.12.03.0020.001267%
Meningorrhagia12.01.10.016; 24.07.04.030; 17.08.01.0560.000127%Not Available
Cardiac ventricular thrombosis02.11.01.008; 24.01.05.0060.001045%Not Available
Laryngeal discomfort22.12.03.0090.000063%Not Available
Small intestine carcinoma16.13.13.002; 07.21.01.0160.000095%Not Available
Mediastinal haemorrhage24.07.01.075; 22.09.03.0080.000063%
Subacute hepatic failure09.01.03.0110.000063%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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