HIGH-VOLUME · HOSP-HEAVY
rivaroxaban Side Effects
rivaroxaban (also sold as Xarelto) is HIGH-VOLUME in this FAERS book #26 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 50.2% mention hospitalization (102,060 reports).
Data updated 2026-05-15
- 203,269
- FAERS reports
FAERS voluntary reports, 2007 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
rivaroxaban: 50.2% mention hospitalization (102,060 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #26 of 524 by FAERS report count.
High-report extract for rivaroxaban (Xarelto): 203,269 FAERS rows (2007-2025). Top named reactions: GASTROINTESTINAL HAEMORRHAGE, HAEMORRHAGE, DYSPNOEA. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2007–2025). Stamps MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
GASTROINTESTINAL HAEMORRHAGE leads 21,559 of 203,269 reports
Who reports · age peak 75+ (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 75+ (56,115 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (26,830 reports, 13.2%). Top co-reported reactions in that subset - voluntary, not causal.
| 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
Hospitalization is HEAVY (102,060, 50.2% of the book). Top reactions in those rows:
| 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 |
How to read rivaroxaban FAERS figures (MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 203,269 voluntary reports linked to rivaroxaban (Xarelto), 2007-2025. Death is listed on 26,830 (13.2%). Hospitalization appears on 102,060 (50.2%). Top co-reported indication: Product Used For Unknown Indication.
MEGA-CASE books overweight common drugs and loud reporting cultures; HOSP-HEAVY is the page opener, not a per-patient risk.
Read with rivaroxaban
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 200,719 FAERS cases (Δ 2,550 lighter vs rivaroxaban); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 197,405 FAERS cases (Δ 5,864 lighter vs rivaroxaban); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 197,074 FAERS cases (Δ 6,195 lighter vs rivaroxaban); DEATH-RARE · HOSP-LIGHT · FEMALE-LED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 196,342 FAERS cases (Δ 6,927 lighter vs rivaroxaban); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 48.9 pp vs rivaroxaban's DEATH-HEAVY): CASELOAD · HOSP-MID.
rivaroxaban stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload MEGA-CASE and the label guide.