ADReCS

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)
Pleuritic pain	22.12.01.007	0.000190%
Polyarthritis	15.01.01.005	0.000222%		Not Available
Polycythaemia vera	16.21.03.003; 01.13.03.002	0.000095%		Not Available
Polymyalgia rheumatica	15.06.01.001; 10.04.05.003	0.000190%		Not Available
Poor peripheral circulation	24.04.03.013	0.000190%		Not Available
Portal vein thrombosis	24.01.03.003; 09.01.06.007	0.000475%
Presyncope	24.06.02.010; 02.11.04.013; 17.02.05.009	-	-
Prurigo	23.03.04.017	0.000095%		Not Available
Pruritus	23.03.12.001	-	-
Pulmonary alveolar haemorrhage	22.01.02.005; 24.07.01.015	0.001615%		Not Available
Pulmonary embolism	24.01.06.001; 22.06.02.001	0.080384%		Not Available
Pulmonary haemorrhage	22.12.01.009; 24.07.01.016	0.003464%
Pulmonary infarction	24.04.09.001; 22.06.02.002	0.000538%		Not Available
Pulmonary microemboli	24.01.06.006; 22.06.02.006	0.000095%		Not Available
Pulmonary thrombosis	24.01.06.002; 22.06.02.003	0.000760%		Not Available
Purpura	24.07.06.005; 23.06.01.004; 01.01.04.003	0.002571%
Purpura senile	24.07.06.015; 23.06.01.012; 01.01.04.009	0.000063%		Not Available
Quadriplegia	17.01.04.013	0.000285%		Not Available
Rash	23.03.13.001	-	-	Not Available
Rash macular	23.03.13.003	-	-	Not Available
Rash vesicular	23.03.13.009	0.000557%		Not Available
Rectal cancer	16.13.01.003; 07.21.05.002	0.000285%		Not Available
Rectal haemorrhage	07.12.03.001; 24.07.02.018	0.021819%
Rectal ulcer	07.04.01.002	0.000190%
Renal artery thrombosis	24.01.11.001; 20.01.07.010	0.000127%		Not Available
Renal colic	20.02.03.010	0.000317%
Renal failure	20.01.03.005	-	-	Not Available
Renal haemorrhage	24.07.07.002; 20.01.02.013; 12.01.05.004	0.001647%
Renal infarct	24.01.11.004; 20.01.07.008	0.000887%		Not Available
Renal vein thrombosis	20.01.07.011; 24.01.11.002	0.000222%		Not Available

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