DABIGATRAN for Anticoagulant therapy: Side Effects & Safety Data
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There are 127 adverse event reports in the FDA FAERS database where DABIGATRAN was used for Anticoagulant therapy.
Most Reported Side Effects for DABIGATRAN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Gastrointestinal haemorrhage | 210 | 10.1% | 44 | 157 |
| Hypotension | 167 | 8.0% | 11 | 139 |
| Atrial fibrillation | 150 | 7.2% | 3 | 110 |
| Drug interaction | 143 | 6.9% | 7 | 95 |
| Haemorrhage | 141 | 6.8% | 21 | 84 |
| Anaemia | 131 | 6.3% | 12 | 113 |
| Dizziness | 123 | 5.9% | 6 | 97 |
| Acute kidney injury | 120 | 5.8% | 14 | 99 |
| Drug ineffective | 118 | 5.7% | 10 | 88 |
| Fall | 117 | 5.6% | 3 | 97 |
| Gastric haemorrhage | 111 | 5.3% | 0 | 94 |
| Melaena | 100 | 4.8% | 5 | 90 |
| Haematuria | 85 | 4.1% | 2 | 62 |
| Cardiac failure | 79 | 3.8% | 7 | 65 |
| Dyspnoea | 76 | 3.7% | 7 | 61 |
Other Indications for DABIGATRAN
Atrial fibrillation (997)
Product used for unknown indication (478)
Deep vein thrombosis (58)
Cerebrovascular accident prophylaxis (48)
Pulmonary embolism (43)
Cerebrovascular accident (35)
Thrombosis prophylaxis (32)
Prophylaxis (23)
Atrial flutter (17)
Embolism venous (13)
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)
PRADAXA (418)