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.
How to Take It
Take this medicine exactly as your doctor tells you. The dose depends on what condition you have. Some doses should be taken with food, while others can be taken with or without food. If you have trouble swallowing pills, talk to your doctor about the oral suspension form.
This is a plain-language summary of rivaroxaban's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Talk to your doctor if you are pregnant or plan to become pregnant. This medicine may cause bleeding problems during pregnancy and delivery. It is not known if this medicine passes into breast milk, so talk to your doctor about the risks and benefits of breastfeeding.
This is a plain-language summary of rivaroxaban's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If you take it twice a day, take both doses at once to make up for the missed dose.
This is a plain-language summary of rivaroxaban's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature between 68°F to 77°F. Keep out of the reach of children.
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
- Bleeding in the stomach or intestines
Bleeding in the stomach or intestines
21,559 reports
- Bleeding 7,713
Bleeding
7,713 reports
- Shortness of breath 7,149
Shortness of breath
7,149 reports
- Nosebleed 6,698
Nosebleed
6,698 reports
- Tiredness 6,546
Tiredness
6,546 reports
- Death 6,030
Death
6,030 reports
- Fall 6,003
Fall
6,003 reports
- Blood clot in the lungs 5,962
Blood clot in the lungs
5,962 reports
- Low red blood cell count 5,590
Low red blood cell count
5,590 reports
- Stroke 5,543
Stroke
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) 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.
What to do: Your doctor should monitor you closely for any signs of bleeding while taking these medicines.
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.
What to do: Seek medical help immediately if you notice signs of blood loss, like coughing up blood or black stools.
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.
What to do: This combination should generally be avoided unless specifically directed and monitored by your healthcare provider.
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.
What to do: Do not take these two medications together as it can increase your risk of side effects.
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.
What to do: Avoid taking these drugs together to ensure your blood thinner stays at the right level in your body.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is rivaroxaban safe during pregnancy?
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.
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cilostazol
Pletal
Cilostazol is a medicine that helps improve walking distance in people with leg pain due to poor circulation.
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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 →
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
Why some drugs demand precise dosing and monitoring
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: January 16, 2026
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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