{
 "query": "apixaban",
 "ingredient": "apixaban",
 "slug": "apixaban",
 "rxcui": "1364430",
 "brands": [
  "Eliquis"
 ],
 "names": [
  "apixaban"
 ],
 "classes": [
  {
   "id": "B01AF",
   "name": "Direct factor Xa inhibitors"
  }
 ],
 "alternatives": [
  "betrixaban",
  "edoxaban",
  "rivaroxaban"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 8
  },
  "boxed_warning": "WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS 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 (2.5) , Warnings and Precautions (5.1) , and Clinical Studies (14.1) ] . (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with ELIQUIS 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: \u2022 use of indwelling epidural catheters \u2022 concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants \u2022 a ...",
  "indications_and_usage": "is a factor Xa inhibitor indicated: \u2022 to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. (1.1) \u2022 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. (1.2) \u2022 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy. (1.3 , 1.4 , 1.5) \u2022 Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment. (1.6) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 1.2 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. 1.3 Treatment of Deep Vein Thrombosis ELIQU...",
  "contraindications": "is contraindicated in patients with the following conditions: \u2022 Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] \u2022 Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions) [see Adverse Reactions (6.1) ] \u2022 Active pathological bleeding (4) \u2022 Severe hypersensitivity to ELIQUIS (4)",
  "warnings_and_cautions": "\u2022 ELIQUIS can cause serious, potentially fatal, bleeding. Promptly evaluate signs and symptoms of blood loss. An agent to reverse the anti-factor Xa activity of apixaban is available. (5.2) \u2022 Prosthetic heart valves: ELIQUIS use not recommended. (5.4) \u2022 Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: ELIQUIS use not recommended. (5.6) 5.1 Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including ELIQUIS, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS 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 (2.5) and Clinical Studies (14.1) ] . 5.2 Bleeding ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding [see Dosage and Administration (2.1) and Adverse Reactions (6.1) ] . Concomitant use of drugs affecting hemostasis...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information. \u2022 Increased Risk of Thrombotic Events After Premature Discontinuation [see Warnings and Precautions (5.1) ] \u2022 Bleeding [see Warnings and Precautions (5.2) ] \u2022 Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.3) ] \u2022 Most common adverse reactions (>1%) in adult patients are related to bleeding. (6.1) \u2022 The most common adverse reactions (\u226510%) in pediatric patients were headache, vomiting, and excessive menstrual bleeding. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adult Patients 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 practice. Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation The safety of ELIQUIS was evaluated in the ARISTOTLE and AVERROES...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.6 ) 04/2025 Dosage and Administration ( 2.2 , 2.6 , 2.7 ) 04/2025 Warnings and Precautions ( 5.2 , 5.3 ) 04/2025",
  "information_for_patients": "Advise patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Advise patients of the following: \u2022 Not to discontinue ELIQUIS without talking to their physician first. \u2022 That it might take longer than usual for bleeding to stop, and they may bruise or bleed more easily when treated with ELIQUIS. Advise patients about how to recognize bleeding or symptoms of hypovolemia and of the urgent need to report any unusual bleeding to their physician. \u2022 To tell their physicians and dentists they are taking ELIQUIS, and/or any other product known to affect bleeding (including nonprescription products, such as aspirin or NSAIDs), before any surgery or medical or dental procedure is scheduled and before any new drug is taken. \u2022 If the patient is having neuraxial anesthesia or spinal puncture, inform the patient to watch for signs and symptoms of spinal or epidural hematomas [see Warnings and Precautions (5.3) ] . If any of these symptoms occur, advise the patient to seek emergent medical attention. \u2022 To tell their physicians if they are pregnant or plan to become pregnant or are breastfeeding or intend to breastfeed during treatment with ELIQUIS [see Use ...",
  "spl_medguide": "MEDICATION GUIDE ELIQUIS \u00ae (ELL eh kwiss) (apixaban) tablets ELIQUIS \u00ae (ELL eh kwiss) SPRINKLE (SPRINK el) (apixaban) for oral suspension What is the most important information I should know about ELIQUIS? ELIQUIS may cause serious side effects, including: \u2022 Increased risk of blood clots if you stop taking ELIQUIS. ELIQUIS lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking ELIQUIS, you may have increased risk of forming a clot in your blood. Do not stop taking ELIQUIS without talking to the healthcare provider who prescribes it for you. Stopping ELIQUIS increases your risk of having a stroke. ELIQUIS may need to be stopped, if possible, prior to surgery or a medical or dental procedure. Ask the healthcare provider who prescribed ELIQUIS for you when you should stop taking it. Your healthcare provider will tell you when you may start taking ELIQUIS again after your surgery or procedure. If you have to stop taking ELIQUIS, your healthcare provider may prescribe another medicine to help prevent a blood clot from forming. \u2022 Increased risk of bleeding. ELIQUIS can cause bleeding which can be serious and may lead to death. This is because E...",
  "clinical_studies": "14.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation ARISTOTLE Evidence for the efficacy and safety of ELIQUIS was derived from ARISTOTLE, a multinational, double-blind study in patients with nonvalvular AF comparing the effects of ELIQUIS and warfarin on the risk of stroke and non-central nervous system (CNS) systemic embolism. In ARISTOTLE, patients were randomized to ELIQUIS 5 mg orally twice daily (or 2.5 mg twice daily in subjects with at least 2 of the following characteristics: age greater than or equal to 80 years, body weight less than or equal to 60 kg, or serum creatinine greater than or equal to 1.5 mg/dL) or to warfarin (targeted to an INR range of 2.0-3.0). Patients had to have one or more of the following additional risk factors for stroke: \u2022 prior stroke or transient ischemic attack (TIA) \u2022 prior systemic embolism \u2022 age greater than or equal to 75 years \u2022 arterial hypertension requiring treatment \u2022 diabetes mellitus \u2022 heart failure \u2265New York Heart Association Class 2 \u2022 left ventricular ejection fraction \u226440% The primary objective of ARISTOTLE was to determine whether ELIQUIS 5 mg twice daily (or 2.5 mg twice daily) was effective ...",
  "brand_name": "ELIQUIS",
  "manufacturer": "Cardinal Health 107, LLC",
  "application_number": "NDA202155",
  "pharm_class_epc": [
   "Factor Xa Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260424",
  "set_id": "a454cd24-0c6d-46e8-b1e4-197388606175",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 272899,
  "serious": 205786,
  "death": 40196,
  "hospitalization": 90621,
  "primary_suspect": 271460,
  "top_reactions": [
   [
    "Death",
    24752
   ],
   [
    "Dyspnoea",
    12661
   ],
   [
    "Fatigue",
    12123
   ],
   [
    "Off Label Use",
    12006
   ],
   [
    "Atrial Fibrillation",
    10698
   ],
   [
    "Diarrhoea",
    9914
   ],
   [
    "Fall",
    9539
   ],
   [
    "Cerebrovascular Accident",
    8915
   ],
   [
    "Dizziness",
    8636
   ],
   [
    "Nausea",
    8505
   ],
   [
    "Headache",
    7675
   ],
   [
    "Thrombosis",
    7420
   ],
   [
    "Asthenia",
    6337
   ],
   [
    "Pneumonia",
    6267
   ],
   [
    "Cardiac Disorder",
    6193
   ]
  ],
  "by_year": {
   "2019": 27241,
   "2020": 31122,
   "2021": 34941,
   "2022": 29763,
   "2023": 26476,
   "2024": 26704,
   "2025": 23830,
   "2026": 11442
  },
  "by_year_primary": {
   "2019": 27228,
   "2020": 31091,
   "2021": 34854,
   "2022": 29483,
   "2023": 26198,
   "2024": 26358,
   "2025": 23553,
   "2026": 11320
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 27,
  "nda": 4,
  "anda": 13,
  "first_approval": "20121228",
  "rems": false,
  "rems_last": "20160302",
  "labeling_supplements": 14,
  "labeling_recent": 4,
  "sponsors": [
   "ACCORD HLTHCARE",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "AZURITY",
   "BIONPHARMA",
   "BRECKENRIDGE",
   "BRISTOL",
   "BRISTOL MYERS SQUIBB"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/28/2012"
 },
 "trials": {
  "total": 484,
  "completed": 255,
  "terminated": 48,
  "with_results": 93,
  "industry": 199,
  "phase3": 84,
  "results_share": 0.36470588235294116,
  "terminated_share": 0.09917355371900827
 },
 "pubmed": {
  "rct": 188,
  "meta": 64,
  "recent_rct": 68,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 2538448.55,
  "records": 130705,
  "by_name": [
   [
    "Eliquis",
    2538448.55
   ]
  ],
  "names_checked": [
   "apixaban",
   "Eliquis"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 24061332,
  "beneficiaries": 4424796,
  "spend": 20774929225.0,
  "by_brand": [
   {
    "brand": "Eliquis",
    "claims": 24061332,
    "per_claim": 863.41559248,
    "is_generic": false
   }
  ],
  "per_claim": 863.4155924950455
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "apixaban",
  "matched": "apixaban",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 61231,
  "fills": 24061332,
  "per_million": 2544.788459757756,
  "ratio": 0.9190446508731953,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,545 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Death appears in 1.6x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 63,
   "letter": "C",
   "why": [
    "188 randomized trials and 64 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 36% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "4 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $2,538,449 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 (13 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "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 death, dyspnoea, fatigue. 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 betrixaban, edoxaban, rivaroxaban? 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.)"
 ]
}