Prescription medication · Direct Oral Anticoagulant (Factor Xa Inhibitor)
rivaroxaban
Also sold as Xarelto. This medicine can help prevent strokes in people with an irregular heartbeat called atrial fibrillation.
Data updated 2026-05-15
- 203,269
- FDA reportsHeavily reported
- 14
- InteractionsSeveral interactions
- $18.21
- Brand price (NADAC)
What the data shows
rivaroxaban (Xarelto) is a prescription Direct Oral Anticoagulant (Factor Xa Inhibitor), in the top 5% of tracked drugs by FAERS report volume (203,269 FDA reports), with 14 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
rivaroxaban (Xarelto) is a prescription Direct Oral Anticoagulant (Factor Xa Inhibitor). This medicine can help prevent strokes in people with an irregular heartbeat called atrial fibrillation.
Rivaroxaban (Xarelto) is a drug that helps to prevent blood clots from forming. It is used to lower the risk of stroke and treat or prevent dangerous clots in your veins and lungs.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$18.21/unit
Generic Available
Yes (13 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine can help prevent strokes in people with an irregular heartbeat called atrial fibrillation.
Common side effects
Bleeding, Cough, Vomiting
Key warnings
This medicine has two important warnings.
The sections below are summarized in plain English from rivaroxaban's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Rivaroxaban is a factor Xa inhibitor. It blocks a substance in your blood called factor Xa. By blocking factor Xa, the medicine helps to prevent blood clots from forming.
Side Effects (from patient reports)
Based on 203,269 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for rivaroxaban, by number of reports
- Gastrointestinal Haemorrhage
Gastrointestinal Haemorrhage
21,559 reports
- Haemorrhage 7,714
Haemorrhage
7,714 reports
- Dyspnoea 7,149
Dyspnoea
7,149 reports
- Epistaxis 6,698
Epistaxis
6,698 reports
- Fatigue 6,546
Fatigue
6,546 reports
- Death 6,030
Death
6,030 reports
- Fall 6,003
Fall
6,003 reports
- Pulmonary Embolism 5,962
Pulmonary Embolism
5,962 reports
- Anaemia 5,590
Anaemia
5,590 reports
- Cerebrovascular Accident 5,543
Cerebrovascular Accident
5,543 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for rivaroxaban each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where rivaroxaban sits
rivaroxaban has more FDA adverse-event reports than 95% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is rivaroxaban; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 203,269 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2007–2025.
Total Reports
203,269
Reports Mentioning Death
26,830
13.2% of reports — not proof of cause
Hospitalization Reports
102,060
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | GASTROINTESTINAL HAEMORRHAGE | 21,559 |
| 3 | HAEMORRHAGE | 7,714 |
| 4 | DYSPNOEA | 7,149 |
| 5 | EPISTAXIS | 6,698 |
| 6 | FATIGUE | 6,546 |
| 7 | DEATH | 6,030 |
| 8 | FALL | 6,003 |
| 9 | PULMONARY EMBOLISM | 5,962 |
| 11 | ANAEMIA | 5,590 |
| 12 | CEREBROVASCULAR ACCIDENT | 5,543 |
| 13 | DIARRHOEA | 5,496 |
| 14 | DIZZINESS | 5,364 |
| 15 | NAUSEA | 5,235 |
| 16 | DEEP VEIN THROMBOSIS | 5,152 |
| 17 | RECTAL HAEMORRHAGE | 5,129 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine has two important warnings. First, stopping this medicine too early can increase your risk of blood clots. Do not stop taking it without talking to your doctor first. Second, if you receive spinal anesthesia or have a spinal puncture while taking this medicine, you have a risk of a blood clot forming around your spine, which can cause long-term paralysis.
Known Drug Interactions
7.4 Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ].
Mechanism: Both drugs work to prevent blood clots, so taking them together makes it much easier for you to bleed.
7.4 Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ]. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs [see Warnings and Precautions (5.2) ] .
Mechanism: Using these two medicines at the same time increases the risk of bleeding because they both interfere with how blood clots.
7.4 Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ].
Mechanism: These are both powerful blood thinners, and using them together significantly raises the chance of dangerous bleeding.
7.2 Drugs that Inhibit Cytochrome P450 3A Enzymes and Drug Transport Systems Interaction with Combined P-gp and Strong CYP3A Inhibitors Avoid concomitant administration of XARELTO with known combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3) ] .
Mechanism: Ketoconazole stops your body from breaking down rivaroxaban, which can cause the medicine to build up to unsafe levels.
7.3 Drugs that Induce Cytochrome P450 3A Enzymes and Drug Transport Systems Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St.
Mechanism: Carbamazepine causes your body to process rivaroxaban too quickly, which may prevent the drug from protecting you against blood clots.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What should I do if I experience heavy bleeding?
Can I take aspirin or ibuprofen with rivaroxaban?
Will I need regular blood tests while taking rivaroxaban?
Can I drink alcohol while taking rivaroxaban?
What if I need surgery or a dental procedure?
How long will I need to take rivaroxaban?
Can I crush or chew the tablets?
What are the symptoms of a blood clot?
Is there an antidote for rivaroxaban?
What are the common side effects of rivaroxaban?
Does rivaroxaban interact with other medications?
What drug class is rivaroxaban?
What pregnancy or breastfeeding source fields are listed for rivaroxaban?
Related Medications in Direct Oral Anticoagulant (Factor Xa Inhibitor)
Other drugs grouped near rivaroxaban - same-class peers and common alternatives.
apixaban
Eliquis
Apixaban (Eliquis) is a medicine that helps prevent blood clots.
Compare with rivaroxaban →
aspirin
Bayer, Ecotrin
Aspirin is a common medicine used to relieve minor pain.
Compare with rivaroxaban →
cilostazol
Pletal
Cilostazol is a medicine that helps improve walking distance in people with leg pain due to poor circulation.
Compare with rivaroxaban →
clopidogrel
Plavix
Clopidogrel is a drug that helps to prevent blood clots.
Compare with rivaroxaban →
dabigatran
Pradaxa
Dabigatran (Pradaxa) is a drug that helps to prevent blood clots from forming.
Compare with rivaroxaban →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for rivaroxaban: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 203,269.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 13.20%.
- nitroglycerin Δ 0.02 pts · 51,859 reports · Nitrate Vasodilator 13.22%death share
- spironolactone Δ 0.04 pts · 133,996 reports · Potassium-Sparing Diuretic / Aldosterone Antagonist 13.16%death share
- calcitriol Δ 0.06 pts · 20,452 reports · Active Vitamin D (1,25-dihydroxy) 13.14%death share
- isosorbide dinitrate Δ 0.08 pts · 19,058 reports · Nitrate Vasodilator 13.28%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for rivaroxaban
The FDA label for rivaroxaban (sold under brand names such as Xarelto) classifies it as a prescription-only medication in the Direct Oral Anticoagulant (Factor Xa Inhibitor) class. This medicine can help prevent strokes in people with an irregular heartbeat called atrial fibrillation. Official labeling lists 4 commonly reported side effects, including Bleeding, Cough, Vomiting.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 203,269 voluntary reports. The database also lists 14 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: January 16, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages