PROTAMINE for Haemostasis: Side Effects & Safety Data
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There are 7 adverse event reports in the FDA FAERS database where PROTAMINE was used for Haemostasis.
Most Reported Side Effects for PROTAMINE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Hypotension | 133 | 22.4% | 15 | 26 |
| Anaphylactic reaction | 64 | 10.8% | 8 | 19 |
| Drug ineffective | 59 | 9.9% | 13 | 14 |
| Post procedural haemorrhage | 49 | 8.2% | 5 | 15 |
| Cardiac arrest | 36 | 6.1% | 14 | 9 |
| Therapeutic product effect decreased | 31 | 5.2% | 0 | 0 |
| Haemorrhage | 29 | 4.9% | 12 | 12 |
| Blood pressure decreased | 27 | 4.5% | 4 | 3 |
| Bradycardia | 27 | 4.5% | 6 | 8 |
| Circulatory collapse | 26 | 4.4% | 11 | 6 |
| Vasoplegia syndrome | 18 | 3.0% | 4 | 12 |
| Dyspnoea | 17 | 2.9% | 1 | 3 |
| Pulmonary hypertension | 17 | 2.9% | 5 | 6 |
| Hypersensitivity | 16 | 2.7% | 6 | 3 |
| Drug interaction | 15 | 2.5% | 1 | 11 |
Other Indications for PROTAMINE
Procoagulant therapy (152)
Product used for unknown indication (125)
Heparin neutralisation therapy (61)
Surgery (19)
Coronary artery bypass (17)
Cardiac operation (15)
Haemorrhage (13)
General anaesthesia (12)
Vascular operation (11)
Angiocardiogram (9)
Other Drugs Used for Haemostasis
FIBRINOGEN HUMAN\THROMBIN HUMAN (171)
THROMBIN HUMAN (87)
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (86)
TRANEXAMIC ACID (64)
EPINEPHRINE (61)
THROMBIN (52)
ANTI-INHIBITOR COAGULANT COMPLEX (32)
FIBRINOGEN HUMAN\HUMAN THROMBIN (32)
COAGULATION FACTOR VIIA RECOMBINANT HUMAN (30)
GELATIN\THROMBIN HUMAN (27)