Rivaroxaban vs Warfarin: side effects in FDA adverse event reports
At a glance
| Rivaroxaban | Warfarin | |
|---|---|---|
| Drug class | Factor Xa Inhibitor | – |
| Brand names | Xarelto | Warfarin Sodium |
| FAERS reports | 206,900 | 126,271 |
| Serious | 84% | 80% |
| Death outcome | 27,139 | 16,103 |
| 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 BLEEDING RISK Warfarin sodium can cause major or fatal bleeding [see Warnings and Precautions (5.1) ] . Perform regular monitoring of INR in all treated patient |
Signals both drugs share
| Reaction | Rivaroxaban | Warfarin | Label screen (A / B) |
|---|---|---|---|
| Abdominal wall haematoma | 324 · PRR 20.1 | 285 · PRR 28.4 | Labeled (related wording) / 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)
- Haemorrhagic stroke — n=1,801, PRR 29.9 Labeled adverse reaction
- 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)
Labeled signals distinctive to Warfarin
- Calciphylaxis — n=729, PRR 110.2 Labeled — boxed warning
- Vascular calcification — n=134, PRR 23.6 Labeled (related wording)
- Catheter site pruritus — n=84, PRR 17.5 Labeled (related wording)
Common questions
Which has more reported side effects, Rivaroxaban or Warfarin?
Rivaroxaban has 206,900 FAERS reports and Warfarin 126,271. 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 80%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Rivaroxaban and Warfarin share?
Both drugs carry disproportionality signals for abdominal wall haematoma. Shared signals often reflect a shared drug class or the condition both are used for.
Is Rivaroxaban or Warfarin 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.