Xareltorivaroxaban
According to the FDA label: XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) to…
205,037 adverse event reports submitted to the FDA (2007–2026)
Top Reported Adverse Events
The most frequently reported events in association with Xarelto in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Gastrointestinal Haemorrhage 21,611 reports
Bleeding somewhere in the digestive tract, such as the stomach or intestines. Also spelled hemorrhage in American English.
Full definition in the glossary →Off Label Use 7,869 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Haemorrhage 7,752 reports
Bleeding, particularly heavy or uncontrolled bleeding. Also spelled hemorrhage in American English.
Full definition in the glossary →Dyspnoea 7,247 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Epistaxis 6,737 reports
The medical term for a nosebleed.
Full definition in the glossary → See all drugs reporting this event →Fatigue 6,637 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Death 6,097 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Fall 6,062 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Pulmonary Embolism 5,988 reports
A blockage in one of the arteries of the lungs, usually caused by a blood clot. This is a serious condition that needs urgent medical care.
Full definition in the glossary →Drug Ineffective 5,858 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Anaemia 5,642 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 5,581 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Cerebrovascular Accident 5,567 reports
The medical term for a stroke, which happens when blood flow to part of the brain is interrupted.
Full definition in the glossary →Dizziness 5,448 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Nausea 5,327 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 92,162 |
| Female | 91,930 |
| Unknown | 1,139 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,902 |
| 18-34 | 3,307 |
| 35-49 | 9,631 |
| 50-64 | 28,520 |
| 65-74 | 40,102 |
| 75+ | 56,613 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Xarelto. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Hospitalization | 102,734 |
| Other Serious | 84,696 |
| Non-Serious | 32,925 |
| Death | 26,972 |
| Life-Threatening | 9,302 |
| Disability | 3,987 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Xarelto. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2007 | 4 |
| 2008 | 3 |
| 2009 | 52 |
| 2010 | 54 |
| 2011 | 503 |
| 2012 | 3,862 |
| 2013 | 7,368 |
| 2014 | 9,409 |
| 2015 | 27,674 |
| 2016 | 29,714 |
| 2017 | 22,442 |
| 2018 | 21,009 |
| 2019 | 21,502 |
| 2020 | 14,670 |
| 2021 | 10,007 |
| 2022 | 10,492 |
| 2023 | 9,332 |
| 2024 | 8,314 |
| 2025 | 7,006 |
| 2026 (partial) | 1,620 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Xarelto
In FDA adverse event reports that mention Xarelto, these medications appeared most often in the same report.
- Aspirin (20,599 reports)
- Furosemide (18,760 reports)
- Metoprolol (13,757 reports)
- Omeprazole (10,439 reports)
- Pantoprazole (9,621 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026