ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT: 10,586 Adverse Event Reports & Safety Profile
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10,586
Total FAERS Reports
367 (3.5%)
Deaths Reported
2,090
Hospitalizations
10,586
As Primary/Secondary Suspect
129
Life-Threatening
101
Disabilities
First Report: 2000 · Latest Report: 20250926
What Are the Most Common ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT Side Effects?
#1 Most Reported
Haemarthrosis
3,360 reports (31.7%)
#2 Most Reported
Haemorrhage
2,925 reports (27.6%)
#3 Most Reported
Fall
709 reports (6.7%)
All ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Haemarthrosis | 3,360 | 31.7% | 12 | 398 |
| Haemorrhage | 2,925 | 27.6% | 19 | 399 |
| Fall | 709 | 6.7% | 13 | 228 |
| Arthralgia | 561 | 5.3% | 3 | 102 |
| Muscle haemorrhage | 554 | 5.2% | 1 | 127 |
| Limb injury | 525 | 5.0% | 1 | 82 |
| Drug ineffective | 513 | 4.9% | 8 | 47 |
| Joint injury | 511 | 4.8% | 3 | 82 |
| Contusion | 496 | 4.7% | 5 | 100 |
| Pain | 484 | 4.6% | 4 | 88 |
| Joint swelling | 354 | 3.3% | 2 | 84 |
| Epistaxis | 350 | 3.3% | 3 | 58 |
| Factor viii inhibition | 286 | 2.7% | 5 | 102 |
| Anti factor viii antibody positive | 280 | 2.7% | 6 | 52 |
| Head injury | 275 | 2.6% | 3 | 74 |
| Haematoma | 251 | 2.4% | 3 | 95 |
| Product dose omission issue | 237 | 2.2% | 1 | 56 |
| Spontaneous haemorrhage | 227 | 2.1% | 1 | 42 |
| Peripheral swelling | 223 | 2.1% | 1 | 60 |
| Extra dose administered | 216 | 2.0% | 2 | 43 |
Who Reports ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT Side Effects? Age & Gender Data
Gender: 3.0% female, 97.0% male. Average age: 27.3 years. Most reports from: US. View detailed demographics →
Is ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 3 | 0 | 1 |
| 2001 | 5 | 0 | 1 |
| 2003 | 2 | 0 | 0 |
| 2004 | 3 | 0 | 0 |
| 2005 | 4 | 0 | 1 |
| 2006 | 3 | 0 | 2 |
| 2007 | 7 | 1 | 0 |
| 2008 | 11 | 1 | 3 |
| 2009 | 10 | 1 | 3 |
| 2010 | 12 | 1 | 5 |
| 2011 | 14 | 0 | 6 |
| 2012 | 27 | 1 | 18 |
| 2013 | 87 | 0 | 43 |
| 2014 | 214 | 6 | 72 |
| 2015 | 399 | 18 | 100 |
| 2016 | 330 | 15 | 94 |
| 2017 | 313 | 18 | 92 |
| 2018 | 301 | 20 | 94 |
| 2019 | 631 | 17 | 94 |
| 2020 | 1,208 | 24 | 209 |
| 2021 | 876 | 28 | 177 |
| 2022 | 781 | 18 | 161 |
| 2023 | 725 | 17 | 165 |
| 2024 | 609 | 10 | 125 |
| 2025 | 372 | 6 | 87 |
What Is ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT Used For?
| Indication | Reports |
|---|---|
| Factor viii deficiency | 4,268 |
| Product used for unknown indication | 2,568 |
| Prophylaxis | 1,107 |
| Haemophilia | 796 |
| Haemorrhage | 751 |
| Haemorrhage prophylaxis | 343 |
| Haemostasis | 86 |
| Haemarthrosis | 67 |
| Immune tolerance induction | 53 |
| Acquired haemophilia | 50 |
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT vs Alternatives: Which Is Safer?
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ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT vs ANTIHEMOPHILIC FACTOR, PEGYLATED HUMAN SEQUENCE RECOMBINANT
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT vs ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT vs APALUTAMIDE
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT vs APATINIB
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT vs APIDRA
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT vs APIDRA SOLOSTAR
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT vs APIXABAN
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT vs APLISOL DIAGNOSTIC ANTIGEN
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT vs APOMORPHINE
Official FDA Label for ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT
Official prescribing information from the FDA-approved drug label.