PRADAXA for Product used for unknown indication: Side Effects & Safety Data
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There are 692 adverse event reports in the FDA FAERS database where PRADAXA was used for Product used for unknown indication.
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)
Anticoagulant therapy (418)
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 Product used for unknown indication
OXYCODONE (129,391)
ADAPALENE (91,681)
APIXABAN (88,417)
ETANERCEPT (71,866)
SACUBITRIL\VALSARTAN (69,693)
ACETAMINOPHEN (68,427)
AVOBENZONE\OCTISALATE\OCTOCRYLENE (65,206)
ADALIMUMAB (63,549)
EVOLOCUMAB (60,696)
MORPHINE (59,440)