THROMBIN for Haemostasis: Side Effects & Safety Data
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There are 52 adverse event reports in the FDA FAERS database where THROMBIN was used for Haemostasis.
Most Reported Side Effects for THROMBIN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Haemorrhage | 19 | 10.0% | 6 | 4 |
| Treatment failure | 15 | 7.9% | 0 | 0 |
| Anaphylactic reaction | 13 | 6.8% | 1 | 1 |
| Factor v inhibition | 12 | 6.3% | 0 | 1 |
| Activated partial thromboplastin time prolonged | 11 | 5.8% | 3 | 2 |
| Product use issue | 11 | 5.8% | 0 | 9 |
| Prothrombin time prolonged | 10 | 5.3% | 3 | 2 |
| Shock | 10 | 5.3% | 2 | 0 |
| Drug ineffective | 9 | 4.7% | 3 | 4 |
| Haemothorax | 9 | 4.7% | 1 | 2 |
| Hypotension | 9 | 4.7% | 1 | 2 |
| Incorrect route of product administration | 9 | 4.7% | 5 | 2 |
| Tonsil cancer | 9 | 4.7% | 0 | 8 |
| Appetite disorder | 8 | 4.2% | 0 | 8 |
| Diarrhoea | 8 | 4.2% | 0 | 8 |
Other Indications for THROMBIN
Product used for unknown indication (20)
Post procedural haemorrhage (16)
Surgery (12)
Tissue sealing (10)
Vascular pseudoaneurysm (6)
Haemorrhage (5)
Other Drugs Used for Haemostasis
FIBRINOGEN HUMAN\THROMBIN HUMAN (171)
THROMBIN HUMAN (87)
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (86)
TRANEXAMIC ACID (64)
EPINEPHRINE (61)
ANTI-INHIBITOR COAGULANT COMPLEX (32)
FIBRINOGEN HUMAN\HUMAN THROMBIN (32)
COAGULATION FACTOR VIIA RECOMBINANT HUMAN (30)
GELATIN\THROMBIN HUMAN (27)
CARBOPROST TROMETHAMINE (26)