PRADAXA for Cerebrovascular accident prophylaxis: Side Effects & Safety Data
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There are 286 adverse event reports in the FDA FAERS database where PRADAXA was used for Cerebrovascular accident 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)
Thrombosis prophylaxis (155)
Atrial flutter (31)
Deep vein thrombosis (25)
Pulmonary embolism (19)
Arrhythmia (17)
Cerebrovascular accident (17)
Thrombosis (16)
Other Drugs Used for Cerebrovascular accident prophylaxis
RIVAROXABAN (42,963)
APIXABAN (36,113)
DABIGATRAN ETEXILATE (2,567)
XARELTO (1,433)
ASPIRIN (878)
WARFARIN (519)
DIGOXIN (381)
BISOPROLOL (351)
CLOPIDOGREL BISULFATE (290)
ATORVASTATIN (155)