PROTAMINE for Haemorrhage: Side Effects & Safety Data
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There are 13 adverse event reports in the FDA FAERS database where PROTAMINE was used for Haemorrhage.
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)
General anaesthesia (12)
Vascular operation (11)
Angiocardiogram (9)
Aortic valve replacement (9)
Other Drugs Used for Haemorrhage
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (751)
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN (318)
COAGULATION FACTOR IX RECOMBINANT HUMAN\ISOPROPYL ALCOHOL (273)
TRANEXAMIC ACID (247)
EFMOROCTOCOG ALFA (219)
ANTI-INHIBITOR COAGULANT COMPLEX (116)
EFTRENONACOG ALFA (109)
COAGULATION FACTOR VIIA RECOMBINANT HUMAN (92)
ANDEXANET ALFA (85)
IDARUCIZUMAB (83)