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)
Haemorrhagic transformation stroke24.07.04.018; 17.08.01.0360.001710%Not Available
Haemorrhage24.07.01.0020.065722%Not Available
Haemorrhage urinary tract24.07.01.007; 20.02.03.0050.002894%Not Available
Postmenopausal haemorrhage24.07.03.002; 21.02.01.0020.001172%Not Available
Varices oesophageal24.10.02.004; 09.01.06.009; 07.15.05.0010.000285%Not Available
Fluid intake reduced14.05.10.0010.000158%Not Available
Intra-abdominal haematoma24.07.02.034; 07.12.02.0050.000887%Not Available
Gastrointestinal ulcer haemorrhage24.07.02.023; 07.04.04.0060.001045%Not Available
Rectal tenesmus15.05.03.011; 07.03.03.0010.000139%Not Available
Peripheral artery aneurysm24.02.05.0010.000095%Not Available
Ocular retrobulbar haemorrhage24.07.05.007; 06.07.02.003; 12.01.04.0350.000063%Not Available
Chronic hepatic failure09.01.03.0090.000063%Not Available
Chronic inflammatory demyelinating polyradiculoneuropathy17.09.04.004; 10.04.10.004--Not Available
Vascular dementia24.04.06.017; 19.20.04.001; 17.03.01.0030.000063%Not Available
Bloody discharge24.07.01.041; 08.01.03.0390.000095%Not Available
Ocular icterus09.01.01.007; 06.08.03.009; 01.06.04.0070.000222%Not Available
Pulseless electrical activity02.03.04.020--Not Available
Retroperitoneal haematoma24.07.01.060; 07.07.02.0050.001520%Not Available
Hypoperfusion24.06.02.0190.000095%Not Available
Aortic disorder24.03.04.0040.000095%Not Available
Skin oedema23.06.04.0010.000127%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.012--Not Available
Haemobilia24.07.01.049; 09.01.08.0090.000190%Not Available
Venous occlusion24.04.02.0090.000285%Not Available
Intestinal mass07.11.01.0100.000127%Not Available
Cerebral vasoconstriction24.04.06.025; 17.08.02.0120.000095%Not Available
Blue toe syndrome12.02.01.005; 24.01.02.0040.000127%Not Available
Infrequent bowel movements07.02.02.0110.000063%Not Available
Intestinal haemorrhage24.07.02.031; 07.12.03.0050.001203%Not Available
Perinephric collection12.01.05.003; 20.02.03.0140.000063%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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