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apixaban

Sold as Eliquis. Class: Direct factor Xa inhibitors. First FDA approval 12/28/2012: 14 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

C

Score breakdown (73/100)

Safety ×35%
C
Evidence ×25%
C
Regulatory ×15%
A
Money & lawsuits ×15%
C
Options ×10%
A

Safety: 65

Evidence: 63

Regulatory history: 91

Money & lawsuits: 70

Options: 100

FDA 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: • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a ...

Independent reviews and post-approval warnings

WHO Essential Medicine

Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.

What the FDA label says

Approved uses

is a factor Xa inhibitor indicated: • to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. (1.1) • 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) • 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) • 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: • Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] • Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions) [see Adverse Reactions (6.1) ] • Active pathological bleeding (4) • Severe hypersensitivity to ELIQUIS (4)

Warnings and precautions

• 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) • Prosthetic heart valves: ELIQUIS use not recommended. (5.4) • 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...

Adverse reactions (label)

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%) in adult patients are related to bleeding. (6.1) • The most common adverse reactions (≥10%) 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...

Recent major label 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

Source: FDA SPL label for ELIQUIS (Cardinal Health 107, LLC), effective 20260424. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

272,899reports that mention this drug
271,460of those blame this drug, not another one the person was taking
75%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
14.7%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Death · 24,752Dyspnoea · 12,661Fatigue · 12,123Off Label Use · 12,006Atrial Fibrillation · 10,698Diarrhoea · 9,914Fall · 9,539Cerebrovascular Accident · 8,915Dizziness · 8,636Nausea · 8,505Headache · 7,675Thrombosis · 7,420Asthenia · 6,337Pneumonia · 6,267Cardiac Disorder · 6,193

Reports per year

20192020202120222023202420252026
27,24131,12234,94129,76326,47626,70423,83011,442

2,545 reports blaming this drug for every million Medicare prescriptions filled, which is 0.9× the typical drug on this site. (61,231 reports in 2024–2026, against 24,061,332 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

0recall actions on file
4 / 13brand / generic applications
4label changes since 2021
NoREMS program

Evidence base

188randomized trials (PubMed)
64systematic reviews
484registered trials
36%of completed trials posted results
10%terminated or withdrawn
41%industry-funded

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $2,538,449 in payments to US physicians and hospitals tied to this drug across 130,705 transactions (Eliquis $2,538,449).

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

4,424,796Medicare Part D patients (2024)
24,061,332prescriptions filled
$863average cost per fill
$20,775Mtotal Medicare spend

Same-class alternatives

betrixabanedoxaban

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
  2. The most-reported problems in FDA's adverse event data are death, dyspnoea, fatigue. How would we recognize and handle those?
  3. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
  4. Why this one over betrixaban, edoxaban, rivaroxaban? What would make you pick one of those instead?
  5. The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
  6. What result are we expecting, by when, and what is the plan if it does not happen?
  7. 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.)