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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX: 1,077 Adverse Event Reports & Safety Profile

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1,077
Total FAERS Reports
27 (2.5%)
Deaths Reported
268
Hospitalizations
1,077
As Primary/Secondary Suspect
28
Life-Threatening
3
Disabilities

First Report: 1986 · Latest Report: 20250909

What Are the Most Common HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX Side Effects?

#1 Most Reported
Haemorrhage
158 reports (14.7%)
#2 Most Reported
Epistaxis
131 reports (12.2%)
#3 Most Reported
No adverse event
88 reports (8.2%)

All HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Haemorrhage 158 14.7% 3 50
Epistaxis 131 12.2% 1 30
No adverse event 88 8.2% 0 6
Haemarthrosis 86 8.0% 0 15
Fall 55 5.1% 0 9
Device issue 54 5.0% 0 2
Contusion 48 4.5% 0 2
Drug ineffective 45 4.2% 6 7
Gastrointestinal haemorrhage 41 3.8% 0 24
Dyspnoea 40 3.7% 1 12
Urticaria 39 3.6% 0 3
Product preparation issue 38 3.5% 0 2
Hypersensitivity 34 3.2% 0 7
Anaphylactic reaction 32 3.0% 0 6
Mouth haemorrhage 23 2.1% 0 8
Flushing 22 2.0% 0 4
Head injury 22 2.0% 0 6
Traumatic haemorrhage 22 2.0% 0 5
Dizziness 21 2.0% 0 4
Headache 21 2.0% 0 6

Who Reports HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX Side Effects? Age & Gender Data

Gender: 54.6% female, 45.4% male. Average age: 34.9 years. Most reports from: US. View detailed demographics →

Is HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 2 0 2
2005 1 0 0
2010 1 0 0
2011 2 0 0
2012 1 0 0
2013 3 0 2
2014 22 0 6
2015 35 2 9
2016 33 2 8
2017 20 0 2
2018 38 4 9
2019 58 2 18
2020 30 0 4
2021 51 1 12
2022 49 0 18
2023 84 4 27
2024 116 2 45
2025 80 2 30

View full timeline →

What Is HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX Used For?

IndicationReports
Von willebrand's disease 662
Product used for unknown indication 116
Factor viii deficiency 113
Prophylaxis 81
Haemorrhage 56
Epistaxis 19
Haemophilia 19
Haemorrhage prophylaxis 15
Coagulopathy 13
Immune tolerance induction 12

HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs Alternatives: Which Is Safer?

HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs HUMAN IMMUNOGLOBULIN G HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs HUMAN IMMUNOGLOBULIN G\HYALURONIDASE HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs HUMAN IMMUNOGLOBULIN G\HYALURONIDASE RECOMBINANT HUMAN HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs HUMAN PAPILLOMAVIRUS QUADRIVALENT VACCINE, RECOMBINANT HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs HUMAN RABIES VIRUS IMMUNE GLOBULIN HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs HUMAN RHO IMMUNE GLOBULIN HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs HUMIRA HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX vs HUMIRA PEN

Official FDA Label for HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX

Official prescribing information from the FDA-approved drug label.