{
 "query": "rivaroxaban",
 "ingredient": "rivaroxaban",
 "slug": "rivaroxaban",
 "rxcui": "1114195",
 "brands": [
  "Xarelto"
 ],
 "names": [
  "rivaroxaban"
 ],
 "classes": [
  {
   "id": "B01AF",
   "name": "Direct factor Xa inhibitors"
  }
 ],
 "alternatives": [
  "apixaban",
  "betrixaban",
  "edoxaban"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 26
  },
  "boxed_warning": "WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. If anticoagulation with XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3 , 2.4) , Warnings and Precautions (5.1) , and Clinical Studies (14.1) ] . B. Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulant...",
  "indications_and_usage": "is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 ) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9 ) for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation XARELTO is indicated to reduce the risk of stroke and system...",
  "contraindications": "is contraindicated in patients with: active pathological bleeding [see Warnings and Precautions (5.2) ] severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions) [see Adverse Reactions (6.2) ] Active pathological bleeding ( 4 ) Severe hypersensitivity reaction to XARELTO ( 4 )",
  "warnings_and_cautions": "Risk of bleeding: XARELTO can cause serious and fatal bleeding ( 5.2 ) Pregnancy-related hemorrhage: Use XARELTO with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery ( 5.7 , 8.1 ) Prosthetic heart valves: XARELTO use not recommended ( 5.8 ) Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: XARELTO use not recommended ( 5.10 ) 5.1 Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including XARELTO, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from XARELTO to warfarin in clinical trials in atrial fibrillation patients. If XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3 , 2.4) and Clinical Studies (14.1) ] . 5.2 Risk of Bleeding XARELTO increases the risk of bleeding, including in any organ, and can cause serious or fatal bleeding. In deciding whether to prescribe XARELTO to pat...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are also discussed in other sections of the labeling: Increased Risk of Stroke After Discontinuation in Nonvalvular Atrial Fibrillation [see Boxed Warning and Warnings and Precautions (5.1) ] Bleeding Risk [see Warnings and Precautions (5.2 , 5.4 , 5.5 , 5.6 , 5.7) ] Spinal/Epidural Hematoma [see Boxed Warning and Warnings and Precautions (5.3) ] The most common adverse reaction (>5%) in adult patients was bleeding ( 6.1 ) The most common adverse reactions (>10%) in pediatric patients were bleeding, cough, vomiting, and gastroenteritis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During clinical development for the approved indications, 34,947 adult patients were exposed to XARELTO. Hemorrhage The most common adverse reacti...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions ( 5.2 ) 03/2026",
  "information_for_patients": "For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). For the suspension, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instructions for Patient Use Advise patients to take XARELTO only as directed. Remind patients to not discontinue XARELTO without first talking to their healthcare professional. Adults Advise patients with atrial fibrillation to take XARELTO once daily with the evening meal. Advise patients for initial treatment of DVT and/or PE to take XARELTO 15 mg or 20 mg tablets with food at approximately the same time every day [see Dosage and Administration (2.1) ] . Advise patients who are at a continued risk of recurrent DVT and/or PE after at least 6 months of initial treatment, to take XARELTO 10 mg once daily with or without food [see Dosage and Administration (2.1) ]. Advise patients who cannot swallow the tablet whole to crush XARELTO and combine with a small amount of applesauce followed by food [see Dosage and Administration (2.6) ] . For patients requiring an NG tube or gastric feeding tube, instruct the patient or caregiver to ...",
  "spl_medguide": "MEDICATION GUIDE XARELTO \u00ae (zah-REL-toe) (rivaroxaban) tablets XARELTO \u00ae (zah-REL-toe) (rivaroxaban) oral suspension This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 06/2025 What is the most important information I should know about XARELTO? XARELTO may cause serious side effects, including: Increased risk of blood clots if you stop taking XARELTO. People with atrial fibrillation (a type of irregular heart beat) that is not caused by a heart valve problem (non-valvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO, you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. If you have to stop taking XARELTO, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. Increased risk of bleeding. XARELTO can cause bleeding which can be serious and may lead to ...",
  "clinical_studies": "14.1 Stroke Prevention in Nonvalvular Atrial Fibrillation The evidence for the efficacy and safety of XARELTO was derived from R ivaroxaban O nce-daily oral direct factor Xa inhibition C ompared with vitamin K antagonist for the prevention of stroke and E mbolism T rial in A trial F ibrillation (ROCKET AF) [NCT00403767], a multi-national, double-blind study comparing XARELTO (at a dose of 20 mg once daily with the evening meal in patients with CrCl >50 mL/min and 15 mg once daily with the evening meal in patients with CrCl 30 to 50 mL/min) to warfarin (titrated to INR 2.0 to 3.0) to reduce the risk of stroke and non-central nervous system (CNS) systemic embolism in patients with nonvalvular atrial fibrillation (AF). Patients had to have one or more of the following additional risk factors for stroke: a prior stroke (ischemic or unknown type), transient ischemic attack (TIA) or non-CNS systemic embolism, or 2 or more of the following risk factors: age \u226575 years, hypertension, heart failure or left ventricular ejection fraction \u226435%, or diabetes mellitus ROCKET AF was a non-inferiority study designed to demonstrate that XARELTO preserved more than 50% of warfarin's effect on stroke a...",
  "brand_name": "Xarelto",
  "manufacturer": "Janssen Pharmaceuticals, Inc.",
  "application_number": "NDA215859",
  "pharm_class_epc": [
   "Factor Xa Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260910",
  "set_id": "10db92f9-2300-4a80-836b-673e1ae91610",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 192118,
  "serious": 159084,
  "death": 25512,
  "hospitalization": 96934,
  "primary_suspect": 191292,
  "top_reactions": [
   [
    "Gastrointestinal Haemorrhage",
    20830
   ],
   [
    "Off Label Use",
    7804
   ],
   [
    "Haemorrhage",
    7220
   ],
   [
    "Dyspnoea",
    6875
   ],
   [
    "Fatigue",
    6459
   ],
   [
    "Epistaxis",
    6426
   ],
   [
    "Death",
    5738
   ],
   [
    "Fall",
    5667
   ],
   [
    "Diarrhoea",
    5498
   ],
   [
    "Anaemia",
    5298
   ],
   [
    "Acute Kidney Injury",
    5188
   ],
   [
    "Dizziness",
    5166
   ],
   [
    "Drug Ineffective",
    5141
   ],
   [
    "Nausea",
    5115
   ],
   [
    "Rectal Haemorrhage",
    4990
   ]
  ],
  "by_year": {
   "2019": 21537,
   "2020": 14811,
   "2021": 10087,
   "2022": 10475,
   "2023": 9308,
   "2024": 8294,
   "2025": 7028,
   "2026": 3495
  },
  "by_year_primary": {
   "2019": 21523,
   "2020": 14799,
   "2021": 10044,
   "2022": 10258,
   "2023": 9142,
   "2024": 8133,
   "2025": 6899,
   "2026": 3426
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 30,
  "nda": 4,
  "anda": 24,
  "first_approval": "20110701",
  "rems": false,
  "rems_last": "20140212",
  "labeling_supplements": 41,
  "labeling_recent": 11,
  "sponsors": [
   "AIPING PHARM INC",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "APOTEX",
   "ASCENT PHARMS INC",
   "AUROBINDO PHARMA LTD",
   "BIOCON PHARMA",
   "BRECKENRIDGE"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/01/2011"
 },
 "trials": {
  "total": 692,
  "completed": 377,
  "terminated": 52,
  "with_results": 85,
  "industry": 274,
  "phase3": 130,
  "results_share": 0.22546419098143236,
  "terminated_share": 0.07514450867052024
 },
 "pubmed": {
  "rct": 358,
  "meta": 98,
  "recent_rct": 117,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 5207809.79,
  "records": 77619,
  "by_name": [
   [
    "Xarelto",
    5207809.79
   ]
  ],
  "names_checked": [
   "rivaroxaban",
   "Xarelto"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 6660246,
  "beneficiaries": 1321019,
  "spend": 6232231839.7,
  "by_brand": [
   {
    "brand": "Xarelto",
    "claims": 6660246,
    "per_claim": 935.73598327,
    "is_generic": false
   }
  ],
  "per_claim": 935.7359832804974
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "rivaroxaban",
  "matched": "rivaroxaban",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 18458,
  "fills": 6660246,
  "per_million": 2771.3691055855893,
  "ratio": 1.000873743480479,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,771 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.5x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "358 randomized trials and 98 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 23% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "11 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $5,207,810 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (24 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are gastrointestinal haemorrhage, haemorrhage, dyspnoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over apixaban, betrixaban, edoxaban? What would make you pick one of those instead?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}