PRADAXA for Anticoagulant therapy: Side Effects & Safety Data
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There are 418 adverse event reports in the FDA FAERS database where PRADAXA was used for Anticoagulant therapy.
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)
Cerebrovascular accident prophylaxis (286)
Thrombosis prophylaxis (155)
Atrial flutter (31)
Deep vein thrombosis (25)
Pulmonary embolism (19)
Arrhythmia (17)
Cerebrovascular accident (17)
Thrombosis (16)
Other Drugs Used for Anticoagulant therapy
SODIUM (6,795)
HEPARIN (3,476)
WARFARIN (3,055)
RIVAROXABAN (2,573)
ASPIRIN (2,154)
ENOXAPARIN (1,439)
CLOPIDOGREL BISULFATE (1,340)
APIXABAN (1,275)
DABIGATRAN ETEXILATE (780)
TICAGRELOR (305)