PRADAXA for Thrombosis prophylaxis: Side Effects & Safety Data
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There are 155 adverse event reports in the FDA FAERS database where PRADAXA was used for Thrombosis prophylaxis.
Most Reported Side Effects for PRADAXA
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Gastrointestinal haemorrhage | 907 | 24.5% | 224 | 813 |
| Anaemia | 332 | 9.0% | 69 | 312 |
| Haemorrhage | 311 | 8.4% | 122 | 191 |
| Haemorrhagic anaemia | 286 | 7.7% | 47 | 281 |
| Cerebrovascular accident | 218 | 5.9% | 37 | 131 |
| Coagulopathy | 215 | 5.8% | 56 | 211 |
| Renal failure acute | 193 | 5.2% | 59 | 184 |
| Lower gastrointestinal haemorrhage | 135 | 3.7% | 22 | 130 |
| Fall | 127 | 3.4% | 44 | 100 |
| Cerebral haemorrhage | 125 | 3.4% | 79 | 98 |
| Epistaxis | 125 | 3.4% | 28 | 103 |
| Ischaemic stroke | 124 | 3.4% | 19 | 89 |
| Rectal haemorrhage | 124 | 3.4% | 33 | 100 |
| Off label use | 122 | 3.3% | 8 | 35 |
| Upper gastrointestinal haemorrhage | 119 | 3.2% | 28 | 111 |
Other Indications for PRADAXA
Atrial fibrillation (2,325)
Product used for unknown indication (692)
Anticoagulant therapy (418)
Cerebrovascular accident prophylaxis (286)
Atrial flutter (31)
Deep vein thrombosis (25)
Pulmonary embolism (19)
Arrhythmia (17)
Cerebrovascular accident (17)
Thrombosis (16)
Other Drugs Used for Thrombosis prophylaxis
RIVAROXABAN (27,466)
APIXABAN (4,304)
ENOXAPARIN (4,166)
ASPIRIN (2,442)
HEPARIN (1,633)
CLOPIDOGREL BISULFATE (1,529)
DABIGATRAN ETEXILATE (1,113)
WARFARIN (959)
TICAGRELOR (524)
DALTEPARIN (519)