Rivaroxaban vs Clopidogrel: side effects in FDA adverse event reports
At a glance
| Rivaroxaban | Clopidogrel | |
|---|---|---|
| Drug class | Factor Xa Inhibitor | – |
| Brand names | Xarelto | – |
| FAERS reports | 206,900 | 197,000 |
| Serious | 84% | 81% |
| Death outcome | 27,139 | 21,779 |
| 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 DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS The effectiveness of clopidogrel is dependent on its activation to an active metabolite by the cytochrome P450 (CY |
Signals both drugs share
| Reaction | Rivaroxaban | Clopidogrel | Label screen (A / B) |
|---|---|---|---|
| Gastrointestinal haemorrhage | 21,636 · PRR 34.9 | 8,285 · PRR 11.5 | Labeled (related wording) / Labeled adverse reaction |
| Upper gastrointestinal haemorrhage | 4,502 · PRR 36.7 | 1,605 · PRR 11.1 | Labeled (related wording) / Labeled (related wording) |
| Diverticulum intestinal haemorrhagic | 1,033 · PRR 85.0 | 249 · PRR 13.0 | Labeled (related wording) / Labeled (related wording) |
| Blood loss anaemia | 449 · PRR 25.4 | 216 · PRR 11.3 | Not in label — unassessed / Labeled (related wording) |
| Haemorrhagic arteriovenous malformation | 816 · PRR 690.4 | 127 · PRR 16.4 | Not in label — unassessed / Likely indication confounding |
Labeled signals distinctive to Rivaroxaban
- Lower gastrointestinal haemorrhage — n=2,378, PRR 47.6 Labeled (related wording)
- Haemorrhagic stroke — n=1,801, PRR 29.9 Labeled adverse reaction
- 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)
- Abdominal wall haematoma — n=324, PRR 20.1 Labeled (related wording)
- Small intestinal haemorrhage — n=314, PRR 18.7 Labeled (related wording)
Labeled signals distinctive to Clopidogrel
- Ulcer haemorrhage — n=998, PRR 18.3 Labeled (related wording)
- Acute coronary syndrome — n=774, PRR 10.8 Labeled — boxed warning
- Thrombotic thrombocytopenic purpura — n=456, PRR 15.7 Labeled — boxed warning
- Retroperitoneal haemorrhage — n=253, PRR 12.0 Labeled adverse reaction
- Retroperitoneal haematoma — n=229, PRR 12.3 Labeled (related wording)
Common questions
Which has more reported side effects, Rivaroxaban or Clopidogrel?
Rivaroxaban has 206,900 FAERS reports and Clopidogrel 197,000. 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 81%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Rivaroxaban and Clopidogrel share?
Both drugs carry disproportionality signals for gastrointestinal haemorrhage, upper gastrointestinal haemorrhage, diverticulum intestinal haemorrhagic, blood loss anaemia, haemorrhagic arteriovenous malformation. Shared signals often reflect a shared drug class or the condition both are used for.
Is Rivaroxaban or Clopidogrel 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.