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)
Left atrial enlargement02.04.02.0420.000063%Not Available
Limb mass15.03.05.0190.000127%Not Available
Lung diffusion disorder22.02.07.0220.000095%Not Available
Medical device site haemorrhage12.02.21.013; 08.07.01.029; 24.07.01.1010.000127%Not Available
Medical device site thrombosis24.01.01.042; 12.02.21.025; 08.07.01.0410.000095%Not Available
Mesenteric haemorrhage24.07.02.066; 07.12.03.0120.000190%Not Available
Mitral valve calcification02.07.01.0110.000063%Not Available
Myelodysplastic syndrome with single lineage dysplasia16.01.04.013; 01.10.04.0130.000127%Not Available
Normocytic anaemia01.03.02.0220.000063%Not Available
Organic brain syndrome19.07.03.0110.000063%Not Available
Peritoneal neoplasm16.13.11.004; 07.21.04.0080.000063%Not Available
Posthaemorrhagic hydrocephalus18.04.04.020; 17.07.01.0050.000063%Not Available
Potentiating drug interaction08.06.03.0150.000823%Not Available
Precancerous condition08.03.04.0100.000095%Not Available
Proctitis haemorrhagic24.07.02.068; 07.08.04.0040.000063%Not Available
Prostatic varices24.10.03.003; 21.04.01.0130.000095%Not Available
Prosthetic cardiac valve thrombosis27.01.01.004; 24.01.05.015; 08.07.07.003; 02.07.02.0140.000095%Not Available
Renal artery occlusion24.04.11.006; 20.01.07.0190.000063%Not Available
Renal hypertrophy20.01.06.0170.000063%Not Available
Renal vascular thrombosis24.01.11.005; 20.01.07.0210.000095%Not Available
Right hemisphere deficit syndrome19.21.01.016; 17.02.03.0240.000063%Not Available
Right ventricular dilatation02.04.02.0500.000095%Not Available
Sarcoma metastatic16.33.01.005; 15.09.03.0350.000063%Not Available
Scrotal haemorrhage24.07.03.036; 21.12.02.0120.000063%Not Available
Subcapsular renal haematoma24.07.07.006; 20.01.02.021; 12.01.05.0080.000317%Not Available
Subgaleal haematoma24.07.01.106; 18.04.19.001; 12.01.09.0240.000190%Not Available
Superficial vein thrombosis24.01.02.0160.002008%Not Available
Therapeutic product ineffective08.06.01.0570.000602%Not Available
Thrombophlebitis migrans24.01.01.043; 16.32.01.0160.000190%Not Available
Tonsillar haemorrhage24.07.01.107; 22.04.05.0310.000063%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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