COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN: 187 Adverse Event Reports & Safety Profile
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187
Total FAERS Reports
51 (27.3%)
Deaths Reported
22
Hospitalizations
187
As Primary/Secondary Suspect
13
Life-Threatening
3
Disabilities
First Report: 1985 · Latest Report: 20220509
What Are the Most Common COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Side Effects?
#1 Most Reported
No adverse event
33 reports (17.6%)
#2 Most Reported
Off label use
31 reports (16.6%)
#3 Most Reported
Deep vein thrombosis
25 reports (13.4%)
All COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| No adverse event | 33 | 17.7% | 5 | 0 |
| Off label use | 31 | 16.6% | 10 | 8 |
| Deep vein thrombosis | 25 | 13.4% | 1 | 0 |
| Embolism | 23 | 12.3% | 1 | 0 |
| Product use in unapproved indication | 23 | 12.3% | 4 | 0 |
| Ischaemic stroke | 21 | 11.2% | 6 | 2 |
| Pulmonary embolism | 16 | 8.6% | 3 | 1 |
| Drug ineffective for unapproved indication | 12 | 6.4% | 9 | 0 |
| Drug ineffective | 10 | 5.4% | 3 | 4 |
| Haemorrhage | 9 | 4.8% | 1 | 1 |
| Acute kidney injury | 8 | 4.3% | 1 | 2 |
| Thrombosis | 8 | 4.3% | 3 | 0 |
| Gastrointestinal haemorrhage | 7 | 3.7% | 1 | 2 |
| Device related thrombosis | 6 | 3.2% | 0 | 0 |
| Dyspnoea | 6 | 3.2% | 2 | 2 |
| Pleural effusion | 6 | 3.2% | 2 | 2 |
| Cerebrovascular accident | 5 | 2.7% | 1 | 2 |
| Complication associated with device | 5 | 2.7% | 0 | 0 |
| Drug effect incomplete | 5 | 2.7% | 5 | 0 |
| Embolism venous | 5 | 2.7% | 0 | 1 |
Who Reports COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Side Effects? Age & Gender Data
Gender: 33.3% female, 66.7% male. Average age: 59.8 years. Most reports from: US. View detailed demographics →
Is COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2012 | 1 | 1 | 1 |
| 2015 | 2 | 0 | 1 |
| 2017 | 1 | 1 | 1 |
| 2018 | 3 | 0 | 1 |
| 2019 | 3 | 1 | 2 |
| 2022 | 2 | 1 | 0 |
What Is COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Used For?
| Indication | Reports |
|---|---|
| Procoagulant therapy | 97 |
| Haemorrhage intracranial | 30 |
| Haemorrhage | 18 |
| Gastrointestinal haemorrhage | 16 |
| Coagulopathy | 8 |
| Cerebral haemorrhage | 7 |
| Haemorrhage prophylaxis | 6 |
| Subarachnoid haemorrhage | 6 |
| Subdural haematoma | 6 |
| Respiratory distress | 5 |
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs Alternatives: Which Is Safer?
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COAGULATION FACTOR IX RECOMBINANT HUMAN
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COAGULATION FACTOR IX RECOMBINANT HUMAN\ISOPROPYL ALCOHOL
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COAGULATION FACTOR VIIA RECOMBINANT HUMAN
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COBAMAMIDE
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COBICISTAT
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COBICISTAT\DARUNAVIR ETHANOLATE
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COBICISTAT\DARUNAVIR\EMTRICITABINE\TENOFOVIR ALAFENAMIDE
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR ALAFENAMIDE
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR DISOPROXIL
Official FDA Label for COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN
Official prescribing information from the FDA-approved drug label.