Rivaroxaban vs Apixaban: side effects in FDA adverse event reports
At a glance
| Rivaroxaban | Apixaban | |
|---|---|---|
| Drug class | Factor Xa Inhibitor | Factor Xa Inhibitor |
| Brand names | Xarelto | – |
| FAERS reports | 206,900 | 66,516 |
| Serious | 84% | 96% |
| Death outcome | 27,139 | 7,220 |
| 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 WARNING: (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF APIXABA |
Signals both drugs share
| Reaction | Rivaroxaban | Apixaban | Label screen (A / B) |
|---|---|---|---|
| Pericardial haemorrhage | 519 · PRR 31.3 | 220 · PRR 35.1 | Labeled (related wording) / Labeled (related wording) |
| Adrenal haemorrhage | 122 · PRR 27.8 | 63 · PRR 39.5 | 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)
- 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 Apixaban
- Therapeutic drug monitoring analysis not performed — n=48, PRR 60.5 Labeled (related wording)
- Red blood cell transfusion — n=42, PRR 36.9 Labeled (related wording)
Common questions
Which has more reported side effects, Rivaroxaban or Apixaban?
Rivaroxaban has 206,900 FAERS reports and Apixaban 66,516. 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 96%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Rivaroxaban and Apixaban share?
Both drugs carry disproportionality signals for pericardial haemorrhage, adrenal haemorrhage. Shared signals often reflect a shared drug class or the condition both are used for.
Is Rivaroxaban or Apixaban 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.