This page shows what was measured, who it was measured in, and what that does not settle.
What Rivaroxaban does in the body
Rivaroxaban blocks that enzyme directly in the bloodstream, so far less thrombin is produced and clots form much more slowly.
The clotting cascade converges on one enzyme just before the step that multiplies the signal a thousandfold. It works within hours, requires no blood test, and unlike warfarin does not depend on the liver having to build clotting factors differently.
Why people take it. Used to prevent stroke and to treat or prevent blood clots.
What happened in people
In irregular heartbeat, rivaroxaban prevented strokes about as well as carefully managed warfarin.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
A recalled testing device may have made the warfarin comparison less reliable.
Where it acts
Circulating plasma and the prothrombinase complex on activated platelet membranes
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
A reviewer approved this sentence against this exact record and its sources.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 84 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Healthy ageing
…Waiting for a reviewer1 registered study measure of this kind. No reviewed result yet.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Healthy ageing
all cause mortality
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
… Waiting for a reviewer
1 registered study measure of this kind. No reviewed result yet.
∅ Nothing in the sources checked
No registered study lists a performance measure for this goal.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Results from the one trial this record names
In NCT00403767, The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) was Rivaroxaban: 188 patients with an event against Warfarin: 241 patients with an event in the comparison group at Up to 4 years. The recorded difference is Hazard ratio 0.79 (95% CI 0.66 to 0.96; p<0.001 (Cox proportional hazards model)).
ClinicalTrials.gov record · NCT00403767 · read 2026-08-27
Stroke or systemic embolism, rivaroxaban versus dose-adjusted warfarin
✓ The study showed what it set out to show
Who was studied
ROCKET AF (NCT00403767)
How many people
14264
Study design
Randomised double-blind active-controlled trial
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Per-protocol HR 0.79 (95% CI 0.66-0.96), P < 0.001 for non-inferiority; intention-to-treat HR 0.88 (0.74-1.03), P = 0.12 for superiority
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Overall major and clinically relevant bleeding did not differ (HR 1.03, p=0.44). A BMJ investigation documented a recall of the INR device used to manage the warfarin comparator arm.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet in four strengths, and an oral suspension
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Composite of cardiovascular death, stroke or myocardial infarction
✓ The study showed what it set out to show
Who was studied
COMPASS (NCT01776424)
How many people
27395
Study design
Randomised double-blind three-arm trial, stopped early for superiority, mean 23 months
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
HR 0.76 (95% CI 0.66-0.86), P < 0.001 for rivaroxaban plus aspirin
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Major bleeding rose from 1.9% to 3.1% (HR 1.70, p<0.001). The mortality result (p=0.01) did not meet the trial's prespecified threshold of 0.0025. Rivaroxaban 5 mg alone did not beat aspirin and bled more.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet in four strengths, and an oral suspension
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Composite of stroke, systemic embolism, myocardial infarction or death from vascular or unknown causes
✗ The study did not show it
Who was studied
INVICTUS (NCT02832544)
How many people
4565
Study design
Randomised open trial in rheumatic heart disease-associated atrial fibrillation
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Restricted mean survival time 1,599 days against 1,675 days; difference -76 days (95% CI -121 to -31), P < 0.001 favouring the vitamin K antagonist
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Death alone was also higher on rivaroxaban, and permanent discontinuation of trial medication was more common on rivaroxaban at every visit. Major bleeding did not differ.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet in four strengths, and an oral suspension
Interval reported. 95% CI -121 to -31), P < 0
Written into the record, not signed off as a reviewed claim.
Composite of asymptomatic proximal or symptomatic venous thromboembolism at day 10 (non-inferiority) and day 35 (superiority)
✓ The study showed what it set out to show
Who was studied
MAGELLAN (NCT00571649)
How many people
8101
Study design
Randomised double-blind double-dummy active-controlled trial, 35 days
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Day 10 RR 0.97 (95% CI 0.71-1.31), P = 0.003 for non-inferiority; day 35 RR 0.77 (0.62-0.96), P = 0.02
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Major or clinically relevant non-major bleeding was 2.8% against 1.2% at day 10 and 4.1% against 1.7% at day 35, both p<0.001 — an absolute bleeding excess comparable to the absolute efficacy gain.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet in four strengths, and an oral suspension
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.2 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.4 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Where a source records it acting
Blood and vessels: Selective inhibitor of factor Xa; by inhibiting FXa, rivaroxaban decreases thrombin generation in the clotting cascade
US prescribing information · 10db92f9-2300-4a80-836b-673e1ae91610 · read 2026-08-27
Start
Rivaroxaban
What a person takes: Oral tablet in four strengths, and an oral suspension.
The measurement behind this step
Once daily for atrial fibrillation and for venous thromboembolism after the initial period, twice daily at the 2.5 mg vascular dose and during the first weeks of venous thromboembolism treatment. The 15 mg and 20 mg strengths must be taken with food because absorption is dissolution-limited; the 2.5 mg and 10 mg strengths need not be.
Getting in
Absorbed quickly, but only properly with food at higher strengths
The small doses are absorbed regardless. The larger ones are only fully absorbed when taken with a meal, because the drug dissolves poorly and needs food to help.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Bioavailability is essentially complete at 10 mg fasted, but only about 66% for a 20 mg dose taken fasted, rising to near-complete with food — absorption at higher strengths is dissolution-limited. Peak concentration occurs at 2 to 4 hours and the terminal half-life is 5 to 9 hours in younger adults and 11 to 13 hours in the elderly. Roughly a third is excreted unchanged renally and the remainder metabolised by CYP3A4 and CYP2J2.
It acts in the plasma, on free and clot-bound enzyme alike
Its target circulates in the blood and assembles on the surface of activated platelets. It also reaches enzyme already inside a formed clot, which the injected heparins cannot.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Factor Xa circulates free and assembles with factor Va, calcium and anionic phospholipid into the prothrombinase complex on activated platelet membranes. Rivaroxaban inhibits free, complex-bound and clot-associated factor Xa. Heparins act indirectly through antithrombin and cannot reach the clot-bound enzyme, which is the pharmacological distinction between the classes.
A chlorine atom replaces the positive charge earlier inhibitors needed
Earlier factor Xa blockers used a permanently charged group to grip the enzyme, and that charge stopped them being absorbed by mouth. This one uses a chlorine atom instead and can be swallowed.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The chlorothiophene occupies the S1 pocket, where its chlorine makes a halogen interaction with the aromatic ring of Tyr228 in place of the salt bridge to Asp189 that benzamidine-based inhibitors required. Removing the permanent cation is what conferred oral bioavailability. The morpholinone fills the S4 aryl-binding box, and the oxazolidinone core acts as the rigid spacer holding the two at the required separation.
Thrombin generation is throttled before the amplification step
Because each blocked enzyme molecule would have produced roughly a thousand molecules of the next, cutting the cascade here has an outsized effect on how much clotting protein is made.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Inhibiting the prothrombinase step reduces thrombin generation, and with it fibrin formation, thrombin-mediated platelet activation and factor XIII-driven clot stabilisation. Platelet function itself is untouched, which is why bleeding risk is additive with aspirin — the trade COMPASS quantified as a 1.70 hazard ratio for major bleeding alongside a 0.76 hazard ratio for the primary composite.
Equivalent to warfarin in atrial fibrillation, worse in rheumatic valve disease
Against warfarin in ordinary atrial fibrillation the two came out the same. In rheumatic valve disease, more people died on rivaroxaban. Added to aspirin in stable artery disease it prevented events and caused bleeding.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
ROCKET AF: 2.1% against 2.4% per year in the intention-to-treat analysis, p=0.12 for superiority. INVICTUS: restricted mean survival 1,608 against 1,680 days, a 72-day deficit for rivaroxaban. COMPASS: primary composite 4.1% against 5.4% with major bleeding 3.1% against 1.9%.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
level of fibrin degradation product
level of fibrinopeptide a
level of prothrombin split products
level of thrombin antithrombin complex
Meaningful
Things that change how a life goes, not only a number.
all cause mortality
new stroke
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (34)
clinically relevant bleeding
incidence of bleeding
pharmacokinetics parameters
vitro reversal of anticoagulation
prothrombin time
international
modifications in hemostasis parameters
emax on prothrombin time
emax ba on prothrombin time
newly onset of symptomatic venous thromboembolism
clinically relevant bleedings
major bleedings
clinically significant hematoma
days on anticoagulation
thrombosis
adverse events
recurrence rate
pts assessment completion
days until a dry wound
amount and character of wound drainage
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 5 to 9 hours hours
Read from the label, which states: “The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Non-valvular atrial fibrillation, venous thromboembolism, post-arthroplasty prophylaxis, and — at the 2.5 mg twice-daily dose alongside aspirin — stable coronary or peripheral artery disease. It is contraindicated in mechanical heart valves and, on the INVICTUS result, is inappropriate in rheumatic mitral disease.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
Who a named study recorded including and excluding
It included: Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening; History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus.
ClinicalTrials.gov record · NCT00403767 · read 2026-08-27
It excluded: Significant mitral stenosis; Transient atrial fibrillation caused by a reversible disorder; Active internal bleeding; Severe disabling stroke; History of intracranial bleeding; Hemorrhagic disorders.
ClinicalTrials.gov record · NCT00403767 · read 2026-08-27
What the label states about particular groups
On pediatric, the label states: “For the rivaroxaban 2.5 mg tablets, there are no safety, efficacy, pharmacokinetic and pharmacodynamic data to support the use in pediatric patients.”
US prescribing information · e8e4275c-6cbe-4976-8cae-f62baf954d27 · read 2026-08-30
On older people, the label states: “Of the total number of adult patients in clinical trials for the approved indications of rivaroxaban (N=64,943 patients), 64 percent were 65 years and over, with 27 percent 75 years and over.”
US prescribing information · e8e4275c-6cbe-4976-8cae-f62baf954d27 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary The limited available data on rivaroxaban in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.”
US prescribing information · e8e4275c-6cbe-4976-8cae-f62baf954d27 · read 2026-08-30
On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician.”
US prescribing information · e8e4275c-6cbe-4976-8cae-f62baf954d27 · read 2026-08-30
On people with reduced liver function, the label states: “In a pharmacokinetic study, compared to healthy adult subjects with normal liver function, AUC increases of 127% were observed in adult subjects with moderate hepatic impairment (ChildPugh B).”
US prescribing information · e8e4275c-6cbe-4976-8cae-f62baf954d27 · read 2026-08-30
On people with reduced kidney function, the label states: “In pharmacokinetic studies, compared to healthy adult subjects with normal creatinine clearance, rivaroxaban exposure increased by approximately 44 to 64% in adult subjects with renal impairment.”
US prescribing information · e8e4275c-6cbe-4976-8cae-f62baf954d27 · read 2026-08-30
Where the result stopped carrying
INVICTUS: more primary-outcome events and more deaths on rivaroxaban than on a vitamin K antagonist, without a bleeding advantage
The rivaroxaban 5 mg twice-daily monotherapy arm of COMPASS did not beat aspirin and caused more major bleeding
MAGELLAN prevented more clots at day 35 and roughly tripled bleeding, and did not yield an extended prophylaxis indication
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral tablet in four strengths, and an oral suspension
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
5 mg vascular dose and during the first weeks of venous thromboembolism treatment. 5 mg and 10 mg strengths need not be.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
The US label carries two boxed warnings: increased risk of thrombotic events including stroke on premature discontinuation, and spinal or epidural haematoma with neuraxial anaesthesia or spinal puncture. Bleeding is the principal risk and is additive with antiplatelet drugs. Gastrointestinal bleeding was more frequent than with warfarin in ROCKET AF even though intracranial and fatal bleeding were less frequent. Combined strong CYP3A4 and P-glycoprotein inhibitors or inducers change exposure. It is contraindicated in mechanical prosthetic heart valves and was inferior to a vitamin K antagonist in rheumatic mitral disease.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Rivaroxaban appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 24915 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet in four strengths, and an oral suspension
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
5 mg vascular dose and during the first weeks of venous thromboembolism treatment. 5 mg and 10 mg strengths need not be.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
86 products list this as an active ingredient in the United States drug directory. 86 of them contain it and nothing else.
FDA National Drug Code directory · 14501-0079 · read 2026-08-29
They are sold as for suspension, granule, for suspension, powder, tablet, tablet, coated and tablet, film coated, taken oral.
FDA National Drug Code directory · 14501-0079 · read 2026-08-29
The regulator's established pharmacologic class for it is factor xa inhibitor [epc] and factor xa inhibitors [moa].
FDA National Drug Code directory · 14501-0079 · read 2026-08-29
27 published labels name it as an active ingredient. 27 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · e8e4275c-6cbe-4976-8cae-f62baf954d27 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · e8e4275c-6cbe-4976-8cae-f62baf954d27 · read 2026-08-29
Xarelto is film-coated tablets; granules for oral suspension at Tablets: 2.5 mg, 10 mg, 15 mg, and 20 mg; for oral suspension: 1 mg/mL once reconstituted, recorded as prescription product; fda label in effect 2026-01-16 in the United States.
US prescribing information · 10db92f9-2300-4a80-836b-673e1ae91610 · read 2026-08-27
Recorded price in US: 0.656 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 20 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Recorded price in US: 1.74823 USD per one millilitre, across 2 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Rivaroxaban studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That rivaroxaban is superior to warfarin in atrial fibrillation — the intention-to-treat superiority p-value was 0.12
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That COMPASS demonstrated a mortality reduction — the observed p=0.01 did not meet the trial's own prespecified 0.0025 threshold
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the ROCKET AF safety comparison is unaffected by the recalled INR device — no reanalysis can reconstruct the readings a working device would have given
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the factor Xa inhibitors are interchangeable — no head-to-head trial exists, and INVICTUS shows at least one setting where the class does not behave as one
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Rivaroxaban are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
ROCKET AF: non-inferior to warfarin, and not superior
In plain words
In more than fourteen thousand patients with atrial fibrillation, rivaroxaban matched warfarin for preventing stroke. In the analysis that counts everyone as randomised, the difference did not reach statistical significance.
What was measured
Stroke or systemic embolism per year, per-protocol and intention-to-treat, rivaroxaban versus warfarin
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ROCKET AF randomised 14,264 patients with non-valvular atrial fibrillation at increased stroke risk to rivaroxaban 20 mg daily or dose-adjusted warfarin. In the prespecified per-protocol as-treated primary analysis, stroke or systemic embolism occurred in 188 patients on rivaroxaban (1.7% per year) against 241 on warfarin (2.2% per year): hazard ratio 0.79 (95% CI 0.66 to 0.96), p<0.001 for non-inferiority. In the intention-to-treat analysis the endpoint occurred in 269 (2.1% per year) against 306 (2.4% per year): hazard ratio 0.88 (0.74 to 1.03), p<0.001 for non-inferiority and p=0.12 for superiority. Major and non-major clinically relevant bleeding occurred in 14.9% per year against 14.5%: hazard ratio 1.03 (0.96 to 1.11), p=0.44. Intracranial haemorrhage (0.5% against 0.7%, p=0.02) and fatal bleeding (0.2% against 0.5%, p=0.003) were less frequent on rivaroxaban.
Written into the record, not signed off as a reviewed claim
A published question about the INR device used in ROCKET AF has never been resolved
In plain words
The point-of-care device used to manage warfarin dosing in the comparator arm was later recalled for producing falsely low readings. Whether that made warfarin look worse than it was is a question the trial data cannot settle.
What was measured
That the ROCKET AF safety comparison is unaffected by the recalled INR device — an assessment based on reanalysis of data the fault itself may have shaped
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The BMJ published an investigation in 2016 under the title "Rivaroxaban: can we trust the evidence?" documenting that the INRatio point-of-care device used to manage the warfarin arm of ROCKET AF was subject to a recall for producing INR values lower than laboratory measurement in certain patients. A falsely low reading prompts a dose increase, which could over-anticoagulate warfarin patients and inflate their bleeding rate, making the comparator look worse on safety. The trial investigators and the FDA conducted analyses and concluded the effect on the primary result was limited; the FDA maintained the approval. What the episode establishes for certain is narrower than either side has claimed: a measurement device with a documented fault was used to manage the control arm of a pivotal trial, and no reanalysis can reconstruct the INR values that would have been obtained with a working device. This entry records the dispute, not a verdict on it.
Written into the record, not signed off as a reviewed claim
INVICTUS: rivaroxaban lost outright to a vitamin K antagonist
In plain words
In more than four and a half thousand patients with rheumatic heart valve disease and an irregular heartbeat, more people died on rivaroxaban than on warfarin, and the bleeding rate was no lower.
What was measured
Restricted mean survival time for a composite of vascular events or death, and for death alone, over the trial period
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
INVICTUS enrolled 4,565 patients with atrial fibrillation and echocardiographically documented rheumatic heart disease meeting at least one of a CHA2DS2-VASc score of 2 or more, mitral valve area of 2 cm2 or less, left atrial spontaneous echo contrast or left atrial thrombus, randomising to standard-dose rivaroxaban or dose-adjusted vitamin K antagonist; 4,531 were analysed. Mean age was 50.5 years and 72.3% were women. Permanent discontinuation was more common on rivaroxaban at every visit. In the intention-to-treat analysis, 560 patients on rivaroxaban and 446 on the vitamin K antagonist had a primary-outcome event of stroke, systemic embolism, myocardial infarction or death from vascular or unknown causes. Survival curves were non-proportional, so restricted mean survival time was used: 1,599 days on rivaroxaban against 1,675 days, a difference of -76 days (95% CI -121 to -31), p<0.001. Death was higher on rivaroxaban: restricted mean survival 1,608 against 1,680 days, difference -72 days (-117 to -28). Major bleeding did not differ significantly.
Written into the record, not signed off as a reviewed claim
COMPASS: a low vascular dose reduced events and deaths, and increased bleeding by 70%
In plain words
Adding a small twice-daily dose of rivaroxaban to aspirin in stable artery disease cut cardiovascular events and deaths. It also caused about twelve extra major bleeds per thousand patients.
What was measured
Composite of cardiovascular death, stroke or myocardial infarction, and major bleeding, over a mean 23 months
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
COMPASS randomised 27,395 participants with stable atherosclerotic vascular disease to rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg daily alone. The trial was stopped for superiority of the combination after a mean 23 months. The primary composite of cardiovascular death, stroke or myocardial infarction occurred in 379 (4.1%) on the combination against 496 (5.4%) on aspirin alone: hazard ratio 0.76 (95% CI 0.66 to 0.86), p<0.001. Major bleeding occurred in 288 (3.1%) against 170 (1.9%): hazard ratio 1.70 (1.40 to 2.05), p<0.001, with no significant difference in intracranial or fatal bleeding. Deaths were 313 (3.4%) against 378 (4.1%): hazard ratio 0.82 (0.71 to 0.96), p=0.01 against a prespecified significance threshold of 0.0025 — so by the trial's own rule the mortality result was nominal rather than significant. Rivaroxaban 5 mg twice daily alone did not improve cardiovascular outcomes over aspirin and caused more major bleeding.
Written into the record, not signed off as a reviewed claim
The COMPASS mortality result did not meet the trial's own significance threshold
In plain words
The trial is often described as showing rivaroxaban plus aspirin reduces deaths. Its own prespecified rule required a p-value below 0.0025 for that claim, and the result was 0.01.
What was measured
That COMPASS demonstrated a mortality reduction — the observed p-value of 0.01 did not meet the trial's own prespecified threshold of 0.0025
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
COMPASS prespecified a significance threshold of 0.0025 for the mortality comparison to account for multiplicity across the trial's hypotheses. All-cause death occurred in 313 of the combination group (3.4%) against 378 on aspirin alone (4.1%), hazard ratio 0.82 (95% CI 0.71 to 0.96), p=0.01 — a nominally impressive number that does not cross the bar the trial set for itself. The primary composite endpoint did cross its threshold decisively (p<0.001, z=-4.126) and is not in question. This is a distinction between a result the trial was designed to establish and one it was designed only to observe, and it is exactly the distinction multiplicity thresholds exist to preserve. The trial also stopped early for superiority of the combination, which independently inflates measured effect sizes.
Written into the record, not signed off as a reviewed claim
MAGELLAN: extended prophylaxis prevented clots and caused more bleeding
In plain words
Five weeks of rivaroxaban after a medical admission prevented more clots than a ten-day course of an injected drug, and roughly doubled to tripled the bleeding rate at both time points.
What was measured
Venous thromboembolism composite and major or clinically relevant non-major bleeding at days 10 and 35
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
MAGELLAN randomised 8,101 patients aged 40 or older hospitalised for acute medical illness to enoxaparin 40 mg subcutaneously for 10 plus or minus 4 days followed by oral placebo for 35 plus or minus 4 days, or to subcutaneous placebo followed by oral rivaroxaban 10 mg daily for 35 plus or minus 4 days. At day 10 the composite of asymptomatic proximal or symptomatic venous thromboembolism occurred in 78 of 2,938 (2.7%) on rivaroxaban against 82 of 2,993 (2.7%) on enoxaparin: relative risk 0.97 (95% CI 0.71 to 1.31), p=0.003 for non-inferiority. At day 35 it occurred in 131 of 2,967 (4.4%) against 175 of 3,057 (5.7%): relative risk 0.77 (0.62 to 0.96), p=0.02 — superiority for the extended course. But the principal safety outcome of major or clinically relevant non-major bleeding occurred in 111 of 3,997 (2.8%) against 49 of 4,001 (1.2%) at day 10 (p<0.001), and in 164 (4.1%) against 67 (1.7%) at day 35 (p<0.001). The efficacy gain and the bleeding cost are of comparable absolute size, which is why the extended indication was not granted on this trial.
This order is fixed in code and does not count clicks or time on the page.
What is not here
3 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A once-daily factor Xa inhibitor that was non-inferior but not superior to warfarin in 14,264 patients with atrial fibrillation, that reduced cardiovascular events and deaths at a low dose alongside aspirin in 27,395 patients with stable vascular disease at the cost of a 70% relative increase in major bleeding, and that lost outright to a vitamin K antagonist in 4,565 patients with rheumatic heart disease.
Recorded evidence blocks (15)
Q1
What did Rivaroxaban's largest trial (2140403 people) and its longest (12 years) measure?
2140403 people in Rivaroxaban's largest registered study, 12 years in its longest registered window, measuring Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events; Uncommon adverse events (incidence rate… ClinicalTrials.gov · 2026-09-01
124 na or unstated, 107 phase3, 92 phase4, 49 phase2, 42 phase1, 29 na, 2 early phase1; NCT03642509; 2030-10-01. Last human test completed 2026, NCT04618913.
Interpretation These counts include studies where Rivaroxaban was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
na or unstated
124
phase3
107
phase4
92
phase2
49
phase1
42
na
29
2 more recorded rows
early phase1
2
Last recorded human testNCT04618913
2026-06-22
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Rivaroxaban shown lifespan?
Interpretation Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events;… — the recorded outcome words.
Show the evidence
mouse
mechanism-only
rat
mechanism-only
humanNCT00831714
lifespan; Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events; Uncommon adverse events (incidence rate between 0.1 % and 1 %); All cause…; 433
recorded 2026-09-01 · last checked 2026-09-04
Q3
30 of Rivaroxaban's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?
safety (1), futility/efficacy (3), accrual/recruitment (16), funding/business (1) and other (9): Rivaroxaban's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"slow recruitment"; 30 of 433 registered studies
Show the evidence
Trial
NCT01598168
terminated; "slow recruitment"
NCT02054936
withdrawn; "Change in standard of care, no possibility of recruitment"
NCT02058199
terminated; "PI left the Institution; No replacement PI identified;"
NCT02128841
terminated; "not enough patients"
NCT02157272
terminated; "Unbalance in the composite endpoint between arms."
NCT02313909
terminated; "Study halted early due to no efficacy improvement over aspirin at an interim analysis and very little chance of showing overall benefit if study were completed"
14 further recorded trials
NCT02387229
terminated; "Consensus BRAIN-AF Executive Steering Committee to terminate."
NCT02401594
terminated; "Remaining outdated treatments and additional costs too high for new manufacturing"
NCT02556203
terminated; "Imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator"
NCT02583191
terminated; "Recruitment was not as expected."
NCT02664155
terminated; "recruiting difficulties"
NCT02832531
withdrawn; "Focus on recruitment for non-inferiority trial"
NCT02970773
withdrawn; "insufficient recruitment; sponsor-investigator has left the institution"
NCT03196349
terminated; "Lack of enrollment"
NCT03465735
terminated; "Due to lack of recruitment of eligible participants"
NCT03566303
terminated; "Coronavirus Pandemic"
NCT03630055
terminated; "Assessment for futility"
NCT03673605
withdrawn; "No patients Enrollment"
NCT03715725
terminated; "After feasibility assessment and due to delays in data receipt study was terminated"
NCT03926156
terminated; "COVID-19 has impacted our study recruitment"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Rivaroxaban used Rivaroxaban 2.5 mg — over how long?
20 recorded entries; human; tablet; also "Rivaroxaban 5 mg", "rivaroxaban 2.5 mg", "rivaroxaban 15 mg"
Show the evidence
human
NCT00809965
Rivaroxaban 2.5 mg
NCT00809965
Rivaroxaban 5 mg
NCT01830543
rivaroxaban 2.5 mg
NCT01830543
rivaroxaban 15 mg
NCT01830543
rivaroxaban 10 mg
NCT02047006
Rivaroxaban 10 mg
14 more recorded rows
humanNCT02111564
Rivaroxaban, 10 mg
humanNCT02111564
Rivaroxaban, 7.5 mg
humanNCT02289703
Rivaroxaban 15 mg
humanNCT02453802
rivaroxaban (10mg)
humanNCT02832531
Rivaroxaban (15 mg)
humanNCT02832544
Rivaroxaban (20 mg)
humanNCT02894307
Xarelto 15 mg
humanNCT02974920
Rivaroxaban 10 MG
humanNCT03083704
Rivaroxaban 20 MG
humanNCT03506815
tablet; Xarelto 10mg tablet po daily
humanNCT03566303
Rivaroxabana 15 mg
humanNCT03630055
Rivaroxaban 15 MG Oral Tablet [Xarelto]
humanNCT03718429
Rivaroxaban 2.5 mg Tablet
humanNCT03775746
Rivaroxaban 2.5Mg Tablet
recorded 2026-09-01 · last checked 2026-09-04
Q5
Rivaroxaban's half-life is 5 to 9 hours — which schedules were studied?
5 to 9 hours, the half-life Rivaroxaban's label states. openfda-label · d0e105f6-28f3-45ee-83bd-7d458835242b · 2026-08-27
bioavailability 80% to 100% %.
Show the evidence
half life
5 to 9 hours hours; The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years.
bioavailability
80% to 100% %; The absolute bioavailability of rivaroxaban is dose-dependent. For the 2.5 mg and 10 mg dose, it is estimated to be 80% to 100% and is not affected by food. XARELTO 20 mg administered in the fasted state has an absolute bioavailability of approximately 66%.
metabolism
The steady-state volume of distribution in healthy subjects is approximately 50 L. Metabolism Approximately 51% of an orally administered [ 14 C]-rivaroxaban dose was recovered as inactive metabolites in urine (30%) and feces (21%).
recorded 2026-08-27 · last checked 2026-09-04
Q6
Could one person measure Rivaroxaban's effect on clinically relevant bleeding?
Clinically relevant bleeding: measured in Rivaroxaban's trials.
Interpretation clinically relevant bleeding is the recorded endpoint.
Show the evidence
biomarkers
clinically relevant bleeding; 2026-09-01
incidence of bleeding; 2026-09-01
pharmacokinetics parameters; 2026-09-01
vitro reversal of anticoagulation; 2026-09-01
level of fibrin degradation product; 2026-09-01
level of fibrinopeptide a; 2026-09-01
14 more recorded rows
biomarkers
level of prothrombin split products; 2026-09-01
biomarkers
level of thrombin antithrombin complex; 2026-09-01
biomarkers
prothrombin time; 2026-09-01
biomarkers
international; 2026-09-01
biomarkers
modifications in hemostasis parameters; 2026-09-01
biomarkers
emax on prothrombin time; 2026-09-01
biomarkers
emax ba on prothrombin time; 2026-09-01
biomarkers
newly onset of symptomatic venous thromboembolism; 2026-09-01
biomarkers
clinically relevant bleedings; 2026-09-01
biomarkers
all cause mortality; 2026-09-01
biomarkers
major bleedings; 2026-09-01
biomarkers
clinically significant hematoma; 2026-09-01
biomarkers
days on anticoagulation; 2026-09-01
biomarkers
thrombosis; 2026-09-01
half life
2026-09-04; halfLife; hours; 5 to 9 hours; 2026-08-27
human trials at or under30
53
smallest human trial
0; NCT01523418; NA_OR_UNSTATED; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of adverse events, all cause mortality and amount and character of wound drainage did Rivaroxaban's trials measure?
adverse events, all cause mortality and amount and character of wound drainage lead 40 outcome terms across Rivaroxaban's trials. ClinicalTrials.gov · 2026-09-01
Interpretation vitro reversal of anticoagulation, level of fibrin degradation product, level of fibrinopeptide a, level of prothrombin split products, level of thrombin antithrombin complex and prothrombin time follow.
Show the evidence
clinically relevant bleeding
1
incidence of bleeding
1
pharmacokinetics parameters
1
vitro reversal of anticoagulation
1
level of fibrin degradation product
1
level of fibrinopeptide a
1
14 more recorded rows
level of prothrombin split products
1
level of thrombin antithrombin complex
1
prothrombin time
1
international
1
modifications in hemostasis parameters
1
emax on prothrombin time
1
emax ba on prothrombin time
1
newly onset of symptomatic venous thromboembolism
1
clinically relevant bleedings
1
all cause mortality
1
major bleedings
1
clinically significant hematoma
1
days on anticoagulation
1
thrombosis
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Rivaroxaban's 70 ongoing trials reports first?
Primary efficacy outcome: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death.; Primary efficacy outcome: a composite endpoint of new venous thromboembolism or all-cause death.; latest 2033-10-03
Show the evidence
Trial
NCT03129490
"The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Atrial Fibrillation"; n 11000; "Primary efficacy outcome: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death."; 2027-10-30
NCT03129555
"The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE)"; n 5000; "Primary efficacy outcome: a composite endpoint of new venous thromboembolism or all-cause death."; 2029-03-31
NCT03642509
"Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation"; n 750; "Composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, major bleeding and all-cause mortality."; 2030-10-01
NCT03968393
"Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress"; n 2270; "Incidence of Non-hemorrhagic stroke or systemic embolism"; 2028-12
NCT04258488
"Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement"; n 1300; "The event rate of the composite of cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding, and clinically-relevant non-major bleeding"; 2028-12-30
NCT04262492
"International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants"; n 500; "Rate of Recurrent Thrombosis"; 2031-04-21
14 further recorded trials
NCT04263038
"Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism"; n 276; "Recurrent venous thromboembolism"; 2028-05
NCT04284839
"The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial"; n 3500; "Major Bleeding"; 2027-06
NCT04642430
"COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation"; n 3018; "The rate of adjudicated clinically relevant bleeding (CRB) events"; 2027-12-31
NCT04694248
"Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting"; n 172; "Primary Effectiveness Endpoints"; 2027-06-30
NCT04700826
"Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation"; n 3000; "Composite primary endpoint - Time to first event"; 2031-01
NCT04755283
"Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation"; n 1287; "Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events"; 2028-12-29
NCT04847752
"Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis"; n 1000; "all-cause mortality"; 2028-12-31
NCT04874428
"Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis"; n 24; "Area under the plasma concentration-time curve (AUC) of rivaroxaban"; 2026-12
NCT05029063
"Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters"; n 1828; "Major VTE prevention"; 2027-12
NCT05047172
"Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis"; n 1683; "Number of participants with parenchymal ICH or non-ICH major hemorrhage"; 2027-01-31
NCT05180773
"Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy"; n 250; "Left ventricular ejection fraction (LVEF) at 6 months post entry as determined by echocardiography"; 2028-12-31
NCT05198960
"AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms"; n 1308; "Time to occurrence of arterial or venous thromboembolic events."; 2027-07-13
NCT05410275
"Chronic Anticoagulation With a Reduced Dose Regimen of Rivaroxaban in End-stage Renal Disease Patients"; n 10; "Pharmacodynamics of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day)"; 2027-01-30
NCT05498428
"A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer"; n 520; "All Cohorts Except Cohort 4: Objective Response Rate (ORR) Based on Investigator Assessment (INV)"; 2028-08-18
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Rivaroxaban could settle lifespan?
NCT06370273 measures Composite of net clinical benefit comprising clinical VTE event, major bleeding, and cause-specific mortality, reading out 2028-08-31.
3 open trials; n 10044; "Thromboprophylaxis in Lower Limb Immobilisation"
Show the evidence
Trial
NCT06370273
"Thromboprophylaxis in Lower Limb Immobilisation"; n 10044; "Composite of net clinical benefit comprising clinical VTE event, major bleeding, and cause-specific mortality"; 2028-08-31
NCT04847752
"Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis"; n 1000; "all-cause mortality"; 2028-12-31
NCT03642509
"Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation"; n 750; "Composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, major bleeding and all-cause mortality."; 2030-10-01
Q10
Which 181 trials of Rivaroxaban posted no result?
Posted no result
181 of 181 completed trials
Registrations
NCT00839826, NCT00398905, NCT00402467, NCT00779064, NCT00396786 and NCT00839163, and 175 more
Completion dates
oldest 2003-11; newest 2024-06-15
Show the evidence
Trial
NCT00839826
2003-11
NCT00398905
2004-09
NCT00402467
2004-11
NCT00779064
2005-06
NCT00396786
2005-07
NCT00839163
2005-10
14 further recorded trials
NCT00395772
2005-12
NCT00973323
2006-03
NCT00361894
2007-01
NCT00973245
2007-01
NCT00329628
2007-03
NCT00332020
2007-06
NCT01206972
2011-06
NCT01210755
2011-06
NCT01205932
2011-08
NCT01379300
2011-12
NCT01464450
2011-12
NCT01309438
2012-03
NCT01344954
2012-05
NCT01400646
2012-05
Q11
At the median, Rivaroxaban's trials enrolled 257.5 people — anything larger?
Median enrolment
257.5
Largest enrolment
2140403
Registered trials counted
432
Q12
What do 24915 spontaneous reports say about Rivaroxaban — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Rivaroxaban appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 24915 reaction mentions were counted: gastrointestinal haemorrhage 5556; deep vein thrombosis 3221; pulmonary embolism 3140; cerebrovascular accident 2365. open-targets-adr · CHEMBL198362 · 2026-06-24
Show the evidence
gastrointestinal haemorrhage
5556
deep vein thrombosis
3221
pulmonary embolism
3140
cerebrovascular accident
2365
anaemia
2136
haemorrhage
2122
4 more recorded rows
epistaxis
1835
haemoglobin decreased
1674
haematuria
1538
thrombosis
1328
recorded 2026-06-24 · last checked 2026-09-04
Q13
Rivaroxaban and P-GP, BCRP and CYP1A2: shared by which compounds?
P-GP, BCRP and CYP1A2 appear in Rivaroxaban's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
Drug Interactions In vitro studies indicate that rivaroxaban neither inhibits the major cytochrome P450 enzymes CYP1A2, 2C8, 2C9, 2C19, 2D6, 2J2, and 3A nor induces CYP1A2, 2B6, 2C19, or 3A.
CYP2J2pharmacokinetics
Oxidative degradation catalyzed by CYP3A4/5 and CYP2J2 and hydrolysis are the major sites of biotransformation.
CYP3A4pharmacokinetics
Oxidative degradation catalyzed by CYP3A4/5 and CYP2J2 and hydrolysis are the major sites of biotransformation.
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Rivaroxaban studied with fasting?
fasting is named in Rivaroxaban's label sentences: "To evaluate the bioequivalence and safety of oral rivaroxaban tablets between a test formulation and a reference formulation in healthy Chinese subjects, a randomized, open, 2-formulation, 4-cycle, complete repeat crossover study was conducted under both fasting and fed states." openfda-label+europepmc · 2026-08-30
1 recorded statement; fasting
Show the evidence
fasting
To evaluate the bioequivalence and safety of oral rivaroxaban tablets between a test formulation and a reference formulation in healthy Chinese subjects, a randomized, open, 2-formulation, 4-cycle, complete repeat crossover study was conducted under both fasting and fed states.
recorded 2026-08-30 · last checked 2026-09-04
Q15
What is recorded about Rivaroxaban and mTOR?
"To this end, a combination of sirolimus, an mTOR inhibitor, and rivaroxaban, a factor Xa inhibitor, were used to reduce the size of the lesion and minimize the risk of thromboembolic events." — where Rivaroxaban and mTOR appear together. Europe PMC · pathway abstract search · 2021-05-25
mTOR; PMID 34030590
Show the evidence
mTORPMID 34030590
"To this end, a combination of sirolimus, an mTOR inhibitor, and rivaroxaban, a factor Xa inhibitor, were used to reduce the size of the lesion and minimize the risk of thromboembolic events."
recorded 2021-05-25 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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