COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN: 1,154 Adverse Event Reports & Safety Profile
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1,154
Total FAERS Reports
313 (27.1%)
Deaths Reported
158
Hospitalizations
1,154
As Primary/Secondary Suspect
110
Life-Threatening
53
Disabilities
First Report: 20051028 · Latest Report: 20250806
What Are the Most Common COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN Side Effects?
#1 Most Reported
No adverse event
352 reports (30.5%)
#2 Most Reported
Device issue
285 reports (24.7%)
#3 Most Reported
Product preparation issue
252 reports (21.8%)
All COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| No adverse event | 352 | 30.5% | 8 | 4 |
| Device issue | 285 | 24.7% | 1 | 0 |
| Product preparation issue | 252 | 21.8% | 2 | 0 |
| Cerebral haemorrhage | 61 | 5.3% | 48 | 11 |
| Cerebral infarction | 49 | 4.3% | 14 | 17 |
| Deep vein thrombosis | 44 | 3.8% | 3 | 9 |
| Drug ineffective | 39 | 3.4% | 16 | 8 |
| Pneumonia | 35 | 3.0% | 20 | 14 |
| Product use in unapproved indication | 34 | 3.0% | 7 | 2 |
| Hypotension | 30 | 2.6% | 13 | 9 |
| Off label use | 28 | 2.4% | 4 | 7 |
| Device leakage | 25 | 2.2% | 0 | 0 |
| Haemorrhage | 25 | 2.2% | 9 | 9 |
| Pyrexia | 24 | 2.1% | 8 | 9 |
| Subdural haematoma | 24 | 2.1% | 19 | 4 |
| Pneumonia aspiration | 23 | 2.0% | 11 | 7 |
| Pulmonary embolism | 23 | 2.0% | 7 | 6 |
| Blood pressure decreased | 21 | 1.8% | 10 | 3 |
| Brain herniation | 21 | 1.8% | 20 | 0 |
| Infusion site extravasation | 21 | 1.8% | 0 | 1 |
Who Reports COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN Side Effects? Age & Gender Data
Gender: 39.5% female, 60.5% male. Average age: 73.1 years. Most reports from: JP. View detailed demographics →
Is COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 1 | 0 | 1 |
| 2006 | 2 | 1 | 0 |
| 2008 | 1 | 1 | 1 |
| 2009 | 1 | 0 | 0 |
| 2013 | 2 | 0 | 0 |
| 2014 | 27 | 4 | 12 |
| 2015 | 27 | 5 | 7 |
| 2016 | 37 | 10 | 9 |
| 2017 | 64 | 28 | 14 |
| 2018 | 294 | 164 | 49 |
| 2019 | 34 | 12 | 12 |
| 2020 | 17 | 4 | 6 |
| 2021 | 11 | 4 | 2 |
| 2022 | 18 | 1 | 14 |
| 2023 | 12 | 2 | 2 |
| 2024 | 16 | 1 | 6 |
| 2025 | 14 | 3 | 1 |
What Is COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN Used For?
| Indication | Reports |
|---|---|
| Haemorrhage | 318 |
| Product used for unknown indication | 134 |
| Surgery | 132 |
| Procoagulant therapy | 128 |
| Cerebral haemorrhage | 47 |
| International normalised ratio increased | 24 |
| Therapeutic procedure | 24 |
| Haemorrhage intracranial | 23 |
| Emergency care | 22 |
| Coagulopathy | 20 |
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs Alternatives: Which Is Safer?
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs COAGULATION FACTOR IX RECOMBINANT HUMAN
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs COAGULATION FACTOR IX RECOMBINANT HUMAN\ISOPROPYL ALCOHOL
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs COAGULATION FACTOR VIIA RECOMBINANT HUMAN
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs COBAMAMIDE
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs COBICISTAT
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs COBICISTAT\DARUNAVIR ETHANOLATE
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs COBICISTAT\DARUNAVIR\EMTRICITABINE\TENOFOVIR ALAFENAMIDE
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR ALAFENAMIDE
Official FDA Label for COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN
Official prescribing information from the FDA-approved drug label.