DABIGATRAN for Prophylaxis: Side Effects & Safety Data
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There are 23 adverse event reports in the FDA FAERS database where DABIGATRAN was used for Prophylaxis.
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)
Anticoagulant therapy (127)
Deep vein thrombosis (58)
Cerebrovascular accident prophylaxis (48)
Pulmonary embolism (43)
Cerebrovascular accident (35)
Thrombosis prophylaxis (32)
Atrial flutter (17)
Embolism venous (13)
Other Drugs Used for Prophylaxis
PEGFILGRASTIM (7,424)
HUMAN C1-ESTERASE INHIBITOR (5,950)
DENOSUMAB (4,541)
SULFAMETHOXAZOLE\TRIMETHOPRIM (3,197)
ASPIRIN (2,083)
VALACYCLOVIR (1,574)
PANTOPRAZOLE (1,502)
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (1,444)
CLOPIDOGREL BISULFATE (1,296)
ENOXAPARIN (1,278)