Rivaroxaban

Common brands: Xarelto, Bayer Low Dose, Lasix, Ecotrin, Aspirin 325

Top reporter: Janssen Pharmaceuticals, Inc.

Factor Xa Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Loop Diuretic [EPC]Platelet Aggregation Inhibitor [EPC]Corticosteroid [EPC]
205,037
Total Reports
61,389
Serious Reports
26,972
Death Reports
30
Reported Reactions
Death Report Ratio: High (13.15%)

Patient Demographics

Male
92,162
Female
91,931

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Rivaroxaban.

# Reaction Reports % of Total
1 GASTROINTESTINAL HAEMORRHAGE 21,611
12.4%
2 OFF LABEL USE 7,869
4.5%
3 HAEMORRHAGE 7,752
4.5%
4 DYSPNOEA 7,247
4.2%
5 EPISTAXIS 6,737
3.9%
6 FATIGUE 6,637
3.8%
7 DEATH 6,097
3.5%
8 FALL 6,062
3.5%
9 PULMONARY EMBOLISM 5,988
3.4%
10 DRUG INEFFECTIVE 5,858
3.4%
11 ANAEMIA 5,642
3.2%
12 DIARRHOEA 5,581
3.2%
13 CEREBROVASCULAR ACCIDENT 5,567
3.2%
14 DIZZINESS 5,448
3.1%
15 NAUSEA 5,327
3.1%
16 DEEP VEIN THROMBOSIS 5,175
3.0%
17 RECTAL HAEMORRHAGE 5,151
3.0%
18 ACUTE KIDNEY INJURY 5,119
2.9%
19 THROMBOSIS 4,942
2.8%
20 HAEMATURIA 4,921
2.8%
21 HEADACHE 4,745
2.7%
22 UPPER GASTROINTESTINAL HAEMORRHAGE 4,490
2.6%
23 ASTHENIA 4,467
2.6%
24 ATRIAL FIBRILLATION 4,385
2.5%
25 INTERNAL HAEMORRHAGE 3,651
2.1%
26 PNEUMONIA 3,640
2.1%
27 MALAISE 3,499
2.0%
28 CEREBRAL HAEMORRHAGE 3,463
2.0%
29 DRUG INTERACTION 3,396
2.0%
30 PAIN 3,265
1.9%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.