Aspirin vs Rivaroxaban: side effects in FDA adverse event reports
At a glance
| Aspirin | Rivaroxaban | |
|---|---|---|
| Drug class | Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor | Factor Xa Inhibitor |
| Brand names | Cardiaspirin Protect | Xarelto |
| FAERS reports | 533,828 | 206,900 |
| Serious | 71% | 84% |
| Death outcome | 48,985 | 27,139 |
| Boxed warning | No | Yes (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. Premature discontinuation of XARELTO increases |
Signals both drugs share
| Reaction | Aspirin | Rivaroxaban | Label screen (A / B) |
|---|---|---|---|
| Gastrointestinal haemorrhage | 13,582 · PRR 7.4 | 21,636 · PRR 34.9 | Not in label — unassessed / Labeled (related wording) |
| Upper gastrointestinal haemorrhage | 3,153 · PRR 8.8 | 4,502 · PRR 36.7 | Not in label — unassessed / Labeled (related wording) |
| Lower gastrointestinal haemorrhage | 1,457 · PRR 9.4 | 2,378 · PRR 47.6 | Not in label — unassessed / Labeled (related wording) |
| Haemorrhagic stroke | 1,089 · PRR 6.2 | 1,801 · PRR 29.9 | Not in label — unassessed / Labeled adverse reaction |
| Diverticulum intestinal haemorrhagic | 489 · PRR 10.6 | 1,033 · PRR 85.0 | Not in label — unassessed / Labeled (related wording) |
| Duodenal ulcer haemorrhage | 443 · PRR 7.0 | 444 · PRR 18.4 | Not in label — unassessed / Labeled (related wording) |
| Haemorrhagic anaemia | 912 · PRR 9.9 | 829 · PRR 23.0 | Not in label — unassessed / Not in label — unassessed |
| Gastric ulcer haemorrhage | 819 · PRR 6.6 | 867 · PRR 18.5 | Not in label — unassessed / Not in label — unassessed |
| Blood loss anaemia | 341 · PRR 6.9 | 449 · PRR 25.4 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Aspirin
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Rivaroxaban
- Pericardial haemorrhage — n=519, PRR 31.3 Labeled (related wording)
- Renal haemorrhage — n=438, PRR 27.5 Labeled (related wording)
- Intraventricular haemorrhage — n=400, PRR 19.2 Labeled (related wording)
- Abdominal wall haematoma — n=324, PRR 20.1 Labeled (related wording)
- Small intestinal haemorrhage — n=314, PRR 18.7 Labeled (related wording)
- Gastrointestinal vascular malformation haemorrhagic — n=249, PRR 200.4 Labeled (related wording)
- Gastrointestinal polyp haemorrhage — n=178, PRR 42.4 Labeled (related wording)
- Embolic cerebral infarction — n=163, PRR 32.6 Labeled (related wording)
Common questions
Which has more reported side effects, Aspirin or Rivaroxaban?
Aspirin has 533,828 FAERS reports and Rivaroxaban 206,900. 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 (71% vs 84%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Aspirin and Rivaroxaban share?
Both drugs carry disproportionality signals for gastrointestinal haemorrhage, upper gastrointestinal haemorrhage, lower gastrointestinal haemorrhage, haemorrhagic stroke, diverticulum intestinal haemorrhagic. Shared signals often reflect a shared drug class or the condition both are used for.
Is Aspirin or Rivaroxaban 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.