pharmacopeia
GET
/api/v1/drug/apixaban

Boxed warning

WARNING: (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including apixaban, increases the risk of thrombotic events. If anticoagulation with apixaban 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 (2.4), Warnings and Precautions (5.1), and Clinical Studies ( 14.1)] . (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with apixaban 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.

2D structure
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[5,4-c]pyridine-3-carboxamide
SMILES COC1=CC=C(C=C1)N2C3=C(CCN(C3=O)C4=CC=C(C=C4)N5CCCCC5=O)C(=N2)C(=O)N
InChIKey QNZCBYKSOIHPEH-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Apixaban is a selective inhibitor of FXa. It does not require antithrombin III for antithrombotic activity.

Factor Xa

Indications

Sourced from openFDA
  • & USAGE Apixaban is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. ( 1.1 ) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.ICD-10: I26.99, I48.91, I63.9, I82.409

Contraindications

Sourced from openFDA
  • Apixaban tablets are contraindicated in patients with the following conditions: • Active pathological bleeding [see Warnings and Precautions ( 5.2 ) and Adverse Reactions( 6.1) ] • Severe hypersensitivity reaction to apixaban (e.g., anaphylactic reactions) [see Adverse Reactions ( 6.1 )] Active pathological bleeding ( 4 ) Severe hypersensitivity to apixaban ( 4 )contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation: The recommended dose is 5 mg orally twice daily. ( 2.1 ) In patients 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, the recommended dose is 2.5 mg orally twice daily. ( 2.1 ) Prophylaxis of DVT following hip or knee replacement surgery: The recommended dose is 2.5 mg orally twice daily. ( 2.1 ) Treatment of DVT and PE: The recommended dose is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily. ( 2.1 ) Reduction in the risk of recurrent DVT and PE following initial therapy: The recommended dose is 2.5 mg taken orally twice daily. ( 2.1 ) 2.1 Recommended Dose Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation The recommended dose of apixaban tablets for most patients is 5 mg taken orally twice daily. The recommended dose of apixaban tablets is 2.5 mg twice daily in patients with at least two of the following characteristics: • age greater than or equal to 80 years • body weight less than or equal to 60 kg • serum creatinine greater than or equal to 1.5 mg/dL Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery The recommended dose of apixaban tablets is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.

Warnings & precautions

Sourced from openFDA

Apixaban 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 ) Prosthetic heart valves: Apixaban use not recommended. ( 5.4 ) Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholid Syndrome: Apixaban Tablets are use not recommended. ( 5.6 ) 5.1 Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including apixaban tablets, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from apixaban tablets to warfarin in clinical trials in atrial fibrillation patients. If apixaban tablets are discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration ( 2.4) and Clinical Studies ( 14.1 )]. 5.2 Bleeding Apixaban tablets 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 increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions ( 7.3) ].

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information. • Increased risk of thrombotic events after premature discontinuation [see Warnings and Precautions ( 5.1 )] • Bleeding [see Warnings and Precautions ( 5.2 )] • Spinal/epidural anesthesia or puncture [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (>1%) are related to bleeding. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Indoco Remedies Limited at +1-855-642-2594 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 practice. Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation The safety of apixaban tablets was evaluated in the ARISTOTLE and AVERROES studies [see Clinical Studies ( 14 )] , including 11,284 patients exposed to apixaban tablets 5 mg twice daily and 602 patients exposed to apixaban tablets 2.5 mg twice daily. The duration of apixaban tablets exposure was ≥12 months for 9375 patients and ≥24 months for 3369 patients in the two studies. In ARISTOTLE, the mean duration of exposure was 89 weeks (>15,000 patient-years). In AVERROES, the mean duration of exposure was approximately 59 weeks (>3000 patient-years).

Use in specific populations

Sourced from openFDA

Pregnancy: Not recommended. ( 8.1 ) Lactation : Discontinue drug or discontinue nursing. ( 8.2 ) Severe Hepatic Impairment: Not recommended. ( 8.7 , 12.2 ) 8.1 Pregnancy Risk Summary The limited available data on apixaban tablets use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. Treatment may increase the risk of bleeding during pregnancy and delivery. In animal reproduction studies, no adverse developmental effects were seen when apixaban was administered to rats (orally), rabbits (intravenously) and mice (orally) during organogenesis at unbound apixaban exposure levels up to 4, 1 and 19 times, respectively, the human exposure based on area under plasma-concentration time curve (AUC) at the Maximum Recommended Human Dose (MRHD) of 5 mg twice daily. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Apixaban demonstrates linear pharmacokinetics with dose-proportional increases in exposure for oral doses up to 10 mg. Absorption The absolute bioavailability of apixaban is approximately 50% for doses up to 10 mg of apixaban.

Overdosage

Sourced from openFDA

Overdose of apixaban tablets increases the risk of bleeding [see Warnings and Precautions ( 5.2 )]. In controlled clinical trials, orally administered apixaban in healthy subjects at doses up to 50 mg daily for 3 to 7 days (25 mg twice daily for 7 days or 50 mg once daily for 3 days) had no clinically relevant adverse effects. In healthy subjects, administration of activated charcoal 2 and 6 hours after ingestion of a 20-mg dose of apixaban reduced mean apixaban AUC by 50% and 27%, respectively. Thus, administration of activated charcoal may be useful in the management of apixaban overdose or accidental ingestion. An agent to reverse the anti-factor Xa activity of apixaban is available.

Approval history

Sourced from openFDA
  • Sep 11, 2020ANDAANDA209898Regcon Holdings
  • Feb 14, 2025ANDAANDA209810Impax
  • Feb 27, 2025ANDAANDA210067Macleods Pharms Ltd

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
64,339 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Atrial Fibrillation4,0156.2%
  2. 2Dyspnoea3,6635.7%
  3. 3Cerebrovascular Accident3,5405.5%
  4. 4Thrombosis2,8314.4%
  5. 5Off Label Use2,7674.3%
  6. 6Cardiac Disorder2,5133.9%
  7. 7Death2,3713.7%
  8. 8Fall2,3553.7%
  9. 9Fatigue2,2623.5%
  10. 10Dizziness1,9873.1%
  11. 11Anaemia1,9793.1%
  12. 12Diarrhoea1,8252.8%
  13. 13Nausea1,7432.7%
  14. 14Acute Kidney Injury1,7262.7%
  15. 15Drug Ineffective1,7052.7%

Clinical trials

View JSON

The 10 most recently updated of 468 ClinicalTrials.gov registrations naming Apixaban as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Apixaban work?
Apixaban is a selective inhibitor of FXa. It does not require antithrombin III for antithrombotic activity.
What is Apixaban used for?
According to FDA labeling, Apixaban carries indications including: & USAGE Apixaban is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. ( 1.1 ) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Apixaban?
Apixaban is classified as Direct factor Xa inhibitors, Factor Xa Inhibitor, Antithrombins, Factor Xa Inhibitors, Decreased Coagulation Factor Activity.
What are the brand names for Apixaban?
Apixaban is marketed under brand names including Eliquis.
What are the contraindications for Apixaban?
Apixaban labeling lists contraindications including: Apixaban tablets are contraindicated in patients with the following conditions: • Active pathological bleeding [see Warnings and Precautions ( 5.2 ) and Adverse Reactions( 6.1) ] • Severe hypersensitivity reaction to apixaban (e.g., anaphylactic reactions) [see Adverse Reactions ( 6.1 )] Active pathological bleeding ( 4 ) Severe hypersensitivity to apixaban ( 4 ). Always consult the full prescribing information and a clinician.
Note. Data for apixaban is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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