Drug side effects
rivaroxaban Side Effects
The reactions most often reported to the FDA for rivaroxaban (also sold as Xarelto), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 203,269
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2007 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of rivaroxaban come from 203,269 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 203,269 reports to the FDA Adverse Event Reporting System (FAERS) for rivaroxaban (Xarelto): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
203,269
Reports Mentioning Death
26,830
13.2% of reports — not proof the medicine caused the death
Hospitalizations
102,060
50.2% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 26,830 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 6,020 |
| GASTROINTESTINAL HAEMORRHAGE | 4,743 |
| CEREBRAL HAEMORRHAGE | 1,638 |
| ACUTE KIDNEY INJURY | 1,448 |
| FALL | 1,173 |
| HAEMORRHAGE | 1,142 |
| UPPER GASTROINTESTINAL HAEMORRHAGE | 988 |
| HAEMORRHAGE INTRACRANIAL | 986 |
| EPISTAXIS | 973 |
| INTERNAL HAEMORRHAGE | 964 |
| RECTAL HAEMORRHAGE | 916 |
| CEREBROVASCULAR ACCIDENT | 853 |
| HAEMORRHAGIC STROKE | 851 |
| HAEMATURIA | 797 |
| PNEUMONIA | 770 |
| ANAEMIA | 650 |
| DYSPNOEA | 647 |
| RESPIRATORY FAILURE | 628 |
| PULMONARY EMBOLISM | 616 |
Reactions in Hospitalization Reports
Top reactions in 102,060 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| GASTROINTESTINAL HAEMORRHAGE | 18,375 |
| ACUTE KIDNEY INJURY | 4,523 |
| FALL | 4,303 |
| UPPER GASTROINTESTINAL HAEMORRHAGE | 4,289 |
| ANAEMIA | 4,247 |
| DYSPNOEA | 4,166 |
| RECTAL HAEMORRHAGE | 4,053 |
| EPISTAXIS | 3,970 |
| HAEMATURIA | 3,456 |
| HAEMORRHAGE | 3,227 |
| PULMONARY EMBOLISM | 3,212 |
| PNEUMONIA | 2,917 |
| CEREBROVASCULAR ACCIDENT | 2,873 |
| INTERNAL HAEMORRHAGE | 2,780 |
| CEREBRAL HAEMORRHAGE | 2,519 |
| ATRIAL FIBRILLATION | 2,461 |
| FATIGUE | 2,459 |
| ASTHENIA | 2,405 |
| NAUSEA | 2,403 |
Nearby, Related Medications
What the FAERS Data Reveals About rivaroxaban Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 203,269 voluntary reports linked to rivaroxaban and its brand equivalents (Xarelto), spanning 2007 through 2025. Of those, 26,830 (13.2%) listed death as an outcome and 102,060 (50.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 50% were female and 50% male; age distribution skews toward 75+, with 56,115 reports in that bracket. The single most reported reaction is gastrointestinal haemorrhage with 21,559 submissions, followed by haemorrhage and dyspnoea.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to rivaroxaban's 203,269.
Read our methodology - how this data is sourced, computed, and verified.