Xarelto

N/A

Manufactured by Janssen Pharmaceuticals, Inc.

302,183 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Xarelto

Xarelto is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Pharmaceuticals, Inc.. The most commonly reported adverse reactions for Xarelto include GASTROINTESTINAL HAEMORRHAGE, OFF LABEL USE, HAEMORRHAGE, DYSPNOEA, EPISTAXIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Xarelto.

Top Adverse Reactions

GASTROINTESTINAL HAEMORRHAGE21,611 reports
OFF LABEL USE7,869 reports
HAEMORRHAGE7,752 reports
DYSPNOEA7,247 reports
EPISTAXIS6,737 reports
FATIGUE6,637 reports
DEATH6,098 reports
FALL6,062 reports
PULMONARY EMBOLISM5,988 reports
DRUG INEFFECTIVE5,858 reports
ANAEMIA5,642 reports
DIARRHOEA5,581 reports
CEREBROVASCULAR ACCIDENT5,567 reports
DIZZINESS5,448 reports
NAUSEA5,327 reports
DEEP VEIN THROMBOSIS5,174 reports
RECTAL HAEMORRHAGE5,151 reports
ACUTE KIDNEY INJURY5,119 reports
THROMBOSIS4,943 reports
HAEMATURIA4,921 reports
HEADACHE4,745 reports
UPPER GASTROINTESTINAL HAEMORRHAGE4,490 reports
ASTHENIA4,467 reports
ATRIAL FIBRILLATION4,385 reports
INTERNAL HAEMORRHAGE3,651 reports
PNEUMONIA3,640 reports
MALAISE3,499 reports
CEREBRAL HAEMORRHAGE3,463 reports
DRUG INTERACTION3,396 reports
PAIN3,265 reports
HAEMOGLOBIN DECREASED3,175 reports
VOMITING3,117 reports
PAIN IN EXTREMITY3,020 reports
RASH2,977 reports
HYPOTENSION2,944 reports
ARTHRALGIA2,756 reports
CONTUSION2,651 reports
COUGH2,602 reports
WEIGHT DECREASED2,552 reports
PERIPHERAL SWELLING2,472 reports
INCORRECT DOSE ADMINISTERED2,471 reports
HAEMATOMA2,439 reports
PRURITUS2,427 reports
LOWER GASTROINTESTINAL HAEMORRHAGE2,373 reports
HAEMOPTYSIS2,357 reports
DECREASED APPETITE2,294 reports
HAEMATOCHEZIA2,222 reports
PYREXIA2,167 reports
ISCHAEMIC STROKE2,111 reports
BACK PAIN2,108 reports
CHEST PAIN2,096 reports
OEDEMA PERIPHERAL2,056 reports
HAEMORRHAGE INTRACRANIAL2,050 reports
HOSPITALISATION2,027 reports
PRODUCT USE IN UNAPPROVED INDICATION1,928 reports
CONSTIPATION1,858 reports
PRODUCT DOSE OMISSION ISSUE1,844 reports
URINARY TRACT INFECTION1,837 reports
HAEMORRHAGIC STROKE1,797 reports
MELAENA1,793 reports
ABDOMINAL PAIN1,770 reports
HYPERTENSION1,745 reports
DRUG DOSE OMISSION1,734 reports
CARDIAC FAILURE1,713 reports
ADVERSE EVENT1,712 reports
CONDITION AGGRAVATED1,695 reports
SUBDURAL HAEMATOMA1,679 reports
CEREBRAL INFARCTION1,653 reports
SYNCOPE1,644 reports
ALOPECIA1,573 reports
ABDOMINAL PAIN UPPER1,572 reports
VAGINAL HAEMORRHAGE1,562 reports
GAIT DISTURBANCE1,532 reports
MYOCARDIAL INFARCTION1,532 reports
CONFUSIONAL STATE1,518 reports
FEELING ABNORMAL1,512 reports
INSOMNIA1,482 reports
WEIGHT INCREASED1,464 reports
RENAL FAILURE1,454 reports
THROMBOCYTOPENIA1,450 reports
RENAL IMPAIRMENT1,443 reports
ABDOMINAL DISCOMFORT1,434 reports
BLOOD URINE PRESENT1,430 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1,417 reports
MUSCLE SPASMS1,393 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION1,341 reports
BLOOD PRESSURE INCREASED1,300 reports
HAEMATEMESIS1,298 reports
NASOPHARYNGITIS1,292 reports
DEHYDRATION1,280 reports
COVID 191,263 reports
INTERNATIONAL NORMALISED RATIO INCREASED1,258 reports
PRODUCT USE ISSUE1,252 reports
ANXIETY1,229 reports
MYALGIA1,228 reports
PALPITATIONS1,227 reports
DYSPNOEA EXERTIONAL1,215 reports
TRANSIENT ISCHAEMIC ATTACK1,215 reports
SOMNOLENCE1,214 reports
GENERAL PHYSICAL HEALTH DETERIORATION1,204 reports

Report Outcomes

Out of 204,995 classified reports for Xarelto:

  • Serious: 172,070 reports (83.9%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 32,925 reports (16.1%)
Serious 83.9%Non-Serious 16.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male92,163 (49.8%)
Female91,930 (49.6%)
Unknown1,139 (0.6%)

Reports by Age

Age 754,678 reports
Age 784,571 reports
Age 704,557 reports
Age 774,502 reports
Age 764,441 reports
Age 804,432 reports
Age 744,338 reports
Age 724,320 reports
Age 734,315 reports
Age 714,296 reports
Age 794,281 reports
Age 693,920 reports
Age 823,828 reports
Age 683,817 reports
Age 813,738 reports
Age 673,722 reports
Age 663,476 reports
Age 833,447 reports
Age 653,344 reports
Age 843,164 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Xarelto?

This profile reflects 302,183 FDA FAERS reports that mention Xarelto. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Xarelto?

Frequently reported terms in FAERS include GASTROINTESTINAL HAEMORRHAGE, OFF LABEL USE, HAEMORRHAGE, DYSPNOEA, EPISTAXIS, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Xarelto?

Labeling and FAERS entries often list Janssen Pharmaceuticals, Inc. in connection with Xarelto. Always verify the specific product and NDC with your pharmacist.

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Drugs Also Linked to GASTROINTESTINAL HAEMORRHAGE

The following drugs share commonly reported adverse reactions with Xarelto:

ACETAMINOPHEN AND CODEINE PHOSPHATE (85/100)APIXABAN (85/100)ARGATROBAN (85/100)ASPIRIN (85/100)ASPIRIN 81MG (85/100)BAYER GENUINE ASPIRIN (78/100)BIVALIRUDIN (82/100)CLOPIDOGREL (85/100)CLOPIDOGREL BISULFATE (82/100)DABIGATRAN ETEXILATE (82/100)DABIGATRAN ETEXILATE MESYLATE (82/100)DRONEDARONE (82/100)

View all drugs reporting GASTROINTESTINAL HAEMORRHAGE →

Explore More

Safety RankingsSearch All DrugsCompare DrugsJanssen Pharmaceuticals, Inc. PortfolioGASTROINTESTINAL HAEMORRHAGE in Other DrugsOFF LABEL USE in Other DrugsHAEMORRHAGE in Other Drugs
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.