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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

XARELTO: 3,504 Adverse Event Reports & Safety Profile

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3,504
Total FAERS Reports
395 (11.3%)
Deaths Reported
1,703
Hospitalizations
3,504
As Primary/Secondary Suspect
290
Life-Threatening
134
Disabilities

First Report: 20090503 · Latest Report: 20240724

What Are the Most Common XARELTO Side Effects?

#1 Most Reported
Pulmonary embolism
276 reports (7.9%)
#2 Most Reported
Deep vein thrombosis
234 reports (6.7%)
#3 Most Reported
Drug ineffective
199 reports (5.7%)

All XARELTO Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pulmonary embolism 276 7.9% 27 134
Deep vein thrombosis 234 6.7% 7 98
Drug ineffective 199 5.7% 10 98
Gastrointestinal haemorrhage 198 5.7% 38 148
Cerebrovascular accident 180 5.1% 18 92
Haemoglobin decreased 166 4.7% 21 112
Fall 124 3.5% 39 81
Anaemia 123 3.5% 9 88
Haemorrhage 121 3.5% 28 67
Cerebral haemorrhage 110 3.1% 50 80
Thrombosis 106 3.0% 4 36
Dyspnoea 97 2.8% 11 55
Incorrect dose administered 93 2.7% 8 45
Dizziness 91 2.6% 4 37
Epistaxis 90 2.6% 11 52
Ischaemic stroke 88 2.5% 10 58
Death 78 2.2% 78 30
Haemorrhage intracranial 77 2.2% 25 46
International normalised ratio increased 76 2.2% 11 56
Asthenia 74 2.1% 4 42

Who Reports XARELTO Side Effects? Age & Gender Data

Gender: 100.0% female, 0.0% male. Average age: 71.3 years. Most reports from: US. View detailed demographics →

Is XARELTO Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 0
2010 5 0 1
2011 8 0 5
2012 49 4 31
2013 903 104 557
2014 1,273 151 734
2024 1 0 0

View full timeline →

What Is XARELTO Used For?

IndicationReports
Atrial fibrillation 1,492
Cerebrovascular accident prophylaxis 1,433
Product used for unknown indication 683
Deep vein thrombosis 506
Embolism venous 366
Thrombosis prophylaxis 364
Pulmonary embolism 284
Knee arthroplasty 77
Thrombosis 74
Anticoagulant therapy 39

XARELTO vs Alternatives: Which Is Safer?

XARELTO vs XELJANZ XARELTO vs XELODA XARELTO vs XENAZINE XARELTO vs XEPLION XARELTO vs XEROQUEL XARELTO vs XGEVA XARELTO vs XIPAMIDE XARELTO vs XOLAIR XARELTO vs XTANDI XARELTO vs XYLAZINE

Official FDA Label for XARELTO

Official prescribing information from the FDA-approved drug label.