Rivaroxaban vs Enoxaparin: side effects in FDA adverse event reports
At a glance
| Rivaroxaban | Enoxaparin | |
|---|---|---|
| Drug class | Factor Xa Inhibitor | – |
| Brand names | Xarelto | Enoxaparin Sodium |
| FAERS reports | 206,900 | 57,199 |
| Serious | 84% | 87% |
| Death outcome | 27,139 | 8,879 |
| Boxed warning | Yes (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. Premature discontinuation of XARELTO increases | Yes SPINAL/EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and |
Signals both drugs share
| Reaction | Rivaroxaban | Enoxaparin | Label screen (A / B) |
|---|---|---|---|
| Haemorrhagic stroke | 1,801 · PRR 29.9 | 405 · PRR 19.9 | Labeled adverse reaction / Labeled adverse reaction |
| Abdominal wall haematoma | 324 · PRR 20.1 | 258 · PRR 56.0 | Labeled (related wording) / Labeled (related wording) |
| Truncus arteriosus persistent | 82 · PRR 69.4 | 41 · PRR 93.6 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Rivaroxaban
- Gastrointestinal haemorrhage — n=21,636, PRR 34.9 Labeled (related wording)
- Upper gastrointestinal haemorrhage — n=4,502, PRR 36.7 Labeled (related wording)
- Lower gastrointestinal haemorrhage — n=2,378, PRR 47.6 Labeled (related wording)
- Diverticulum intestinal haemorrhagic — n=1,033, PRR 85.0 Labeled (related wording)
- Pericardial haemorrhage — n=519, PRR 31.3 Labeled (related wording)
- Duodenal ulcer haemorrhage — n=444, PRR 18.4 Labeled (related wording)
- Renal haemorrhage — n=438, PRR 27.5 Labeled (related wording)
- Intraventricular haemorrhage — n=400, PRR 19.2 Labeled (related wording)
Labeled signals distinctive to Enoxaparin
- Haematoma — n=1,109, PRR 16.3 Labeled — boxed warning
- Hepatocellular injury — n=656, PRR 17.7 Labeled (related wording)
- Heparin-induced thrombocytopenia — n=637, PRR 54.1 Labeled — boxed warning
- Eosinophilia — n=621, PRR 13.5 Labeled adverse reaction
- Shock haemorrhagic — n=549, PRR 26.5 Labeled (related wording)
- Retroperitoneal haemorrhage — n=341, PRR 58.6 Labeled (related wording)
- Retroperitoneal haematoma — n=286, PRR 54.8 Labeled (related wording)
- Vascular purpura — n=73, PRR 20.3 Labeled (related wording)
Common questions
Which has more reported side effects, Rivaroxaban or Enoxaparin?
Rivaroxaban has 206,900 FAERS reports and Enoxaparin 57,199. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (84% vs 87%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Rivaroxaban and Enoxaparin share?
Both drugs carry disproportionality signals for haemorrhagic stroke, abdominal wall haematoma, truncus arteriosus persistent. Shared signals often reflect a shared drug class or the condition both are used for.
Is Rivaroxaban or Enoxaparin safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.