Brand name · Rivaroxaban
Xarelto: adverse event reports filed with FDA
133,243 reports list it as a suspect or interacting product, 2009–2026. Class: Factor Xa inhibitor. Also reported as Xarelto 10, Xarelto Tablet, Xarelto Tab.
- 133,243
- reports as suspect product
- 0.7% of all reports · about 7,726 a year
- 1,512
- reports, 12 months to June 2026
- 2,024 in the 12 months before
- 86%
- marked serious by the reporter
- 81.6% across the class
- 14.5%
- record death among outcomes, as reported
- 19,367 reports · not verified by FDA
133,243 adverse event reports received by FDA list the brand name Xarelto (rivaroxaban) as a suspect or interacting product, from April 2009 to June 2026. A further 46,830 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 1,512 reports listed it, down 25% from 2,024 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 7,726 reports a year and 0.7% of the 20,646,523 reports in the database, and 40.4% of the reports for the factor Xa inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are gastrointestinal haemorrhage (15.4%), haemorrhage (5%) and epistaxis (4.3%). A report can list several reactions, so shares add to more than 100%; 3,148 different terms appear across these reports. Gastrointestinal haemorrhage is recorded in 15.4% of these reports, a larger share than in the median factor Xa inhibitor drug (4.2%).
86% of the reports are marked serious by the reporter (81.6% across the class); 14.5% record death among the outcomes and 53.1% record hospitalisation, as reported. 51.3% of the reports came from consumers, and the largest patient age group is 75 and over (28.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Xarelto reports recording the termmedian drug in factor xa inhibitor
- Gastrointestinal haemorrhagebleeding in the stomach or bowel15.4%20,481
- Haemorrhagebleeding5%6,699
- Epistaxisnosebleed4.3%5,745
- Rectal haemorrhage3.4%4,551
- Cerebrovascular accidentstroke3.3%4,408
- Haematuriablood in the urine3.3%4,371
- Upper gastrointestinal haemorrhage3.2%4,260
- Pulmonary embolisma blood clot in the lung3.1%4,170
- Off label useused for a purpose or in a way not on the label3.1%4,156
- Deep vein thrombosisa blood clot in a deep vein2.9%3,851
- Acute kidney injurysudden loss of kidney function2.7%3,572
- Anaemialow red blood cells2.7%3,552
- Internal haemorrhage2.6%3,520
- Falla fall2.6%3,398
- Thrombosis2.4%3,255
- Deaththe patient died; cause not stated by this term2.3%3,113
- Cerebral haemorrhage2.2%2,991
- Drug ineffectivethe medicine did not work as expected2.1%2,781
- Dyspnoeashortness of breath1.8%2,427
- Dizzinesslight-headedness or unsteadiness1.8%2,334
- Lower gastrointestinal haemorrhage1.7%2,270
- Haematomaa collection of blood under the skin or in tissue1.5%2,043
- Haemoglobin decreasedlow haemoglobin1.5%1,976
- Contusiona bruise1.5%1,971
- Headachehead pain1.4%1,925
- Haemoptysiscoughing up blood1.4%1,919
- Fatiguetiredness1.4%1,910
- Incorrect dose administeredthe wrong dose was given1.4%1,878
- Haemorrhage intracranial1.4%1,835
- Atrial fibrillationan irregular heart rhythm1.4%1,810
Top 30 of 3,148 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the factor xa inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 329,539 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 73.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Atrial fibrillation | 25,343 | 19% |
| Cerebrovascular accident prophylaxis | 21,506 | 16.1% |
| Thrombosis prophylaxis | 13,309 | 10% |
| Deep vein thrombosis | 12,778 | 9.6% |
| Pulmonary embolism | 7,803 | 5.9% |
| Thrombosis | 4,197 | 3.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 133,243 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Xarelto reports |
|---|---|---|
| Aspirin | 14,380 | 10.8% |
| Acetylsalicylic Acid | 7,417 | 5.6% |
| Metoprolol | 4,901 | 3.7% |
| Plavix | 4,748 | 3.6% |
| Furosemide | 4,686 | 3.5% |
| Lisinopril | 4,336 | 3.3% |
| Atorvastatin | 3,945 | 3% |
| Amlodipine | 3,136 | 2.4% |
| Omeprazole | 3,119 | 2.3% |
| Simvastatin | 3,107 | 2.3% |
Other products listed in reports where Xarelto is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Xarelto | Factor Xa inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 133,243 | 329,539 | 20,646,523 |
| Share of that pool | — | 40.4% | 0.7% |
| Reports, latest 12 months | 1,512 | — | 1,332,454 |
| Marked serious | 86% | 81.6% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 145 | 157 | 91 |
| Hospitalisation recorded, per 1,000 reports | 531 | 394 | 213 |
| Consumer-filed share | 51.3% | 53.2% | 45.8% |
| Top term, share of reports | Gastrointestinal haemorrhage 15.4% | median 4.2% | 0.4% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the factor xa inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Eliquis | brand | 125,107 | 5,574 | 69.4% |
| Apixaban | generic | 46,029 | 3,513 | 95.9% |
| Rivaroxaban | generic | 16,490 | 1,610 | 96.7% |
| Arixtra | brand | 5,361 | 46 | 86.2% |
| Edoxaban tosylate | generic | 2,543 | 387 | 98.7% |
| Savaysa | brand | 766 | 7 | 33.3% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Xarelto reports
How many adverse event reports has FDA received for Xarelto?
133,243 reports list Xarelto as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,512 of them arrived in the latest 12 months. Another 46,830 list it only as a concomitant medication.
What reactions are recorded in Xarelto reports?
gastrointestinal haemorrhage (15.4%), haemorrhage (5%), epistaxis (4.3%), rectal haemorrhage (3.4%) and cerebrovascular accident (3.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Xarelto was responsible.
How serious are the reports?
86% are marked serious by the reporter. Among the outcomes recorded, 14.5% of reports include death and 53.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (51.3%), physician (27.4%) and other health professional (14.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Xarelto rising?
1,512 reports in the 12 months to June 2026, down 25% from 2,024 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Xarelto was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Xarelto?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Xarelto as a suspect or interacting product; reports listing it only as a concomitant medication (46,830) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.