PRADAXA for Atrial flutter: Side Effects & Safety Data
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There are 31 adverse event reports in the FDA FAERS database where PRADAXA was used for Atrial flutter.
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)
Thrombosis prophylaxis (155)
Deep vein thrombosis (25)
Pulmonary embolism (19)
Arrhythmia (17)
Cerebrovascular accident (17)
Thrombosis (16)
Other Drugs Used for Atrial flutter
RIVAROXABAN (896)
AMIODARONE (441)
APIXABAN (235)
DABIGATRAN ETEXILATE (209)
DOFETILIDE (119)
METOPROLOL (108)
WARFARIN (100)
DIGOXIN (93)
DILTIAZEM (82)
DRONEDARONE (68)