Skip to content
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.

COAGULATION FACTOR IX RECOMBINANT HUMAN: 1,066 Adverse Event Reports & Safety Profile

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now
1,066
Total FAERS Reports
20 (1.9%)
Deaths Reported
167
Hospitalizations
1,066
As Primary/Secondary Suspect
6
Life-Threatening
2
Disabilities

First Report: 20110814 · Latest Report: 20250901

What Are the Most Common COAGULATION FACTOR IX RECOMBINANT HUMAN Side Effects?

#1 Most Reported
Haemarthrosis
318 reports (29.8%)
#2 Most Reported
Haemorrhage
261 reports (24.5%)
#3 Most Reported
No adverse event
97 reports (9.1%)

All COAGULATION FACTOR IX RECOMBINANT HUMAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Haemarthrosis 318 29.8% 2 48
Haemorrhage 261 24.5% 1 34
No adverse event 97 9.1% 0 4
Traumatic haemorrhage 62 5.8% 1 11
Fall 61 5.7% 0 14
Drug ineffective 60 5.6% 1 6
Muscle haemorrhage 54 5.1% 0 12
Arthralgia 52 4.9% 0 6
Contusion 52 4.9% 0 5
Device issue 43 4.0% 0 0
Product preparation issue 39 3.7% 0 0
Head injury 33 3.1% 0 5
Joint swelling 32 3.0% 0 6
Pain 31 2.9% 1 10
Epistaxis 29 2.7% 0 3
Off label use 29 2.7% 0 6
Limb injury 24 2.3% 0 2
Joint injury 20 1.9% 0 1
Treatment noncompliance 20 1.9% 0 2
Mouth haemorrhage 19 1.8% 0 2

Who Reports COAGULATION FACTOR IX RECOMBINANT HUMAN Side Effects? Age & Gender Data

Gender: 1.3% female, 98.7% male. Average age: 27.7 years. Most reports from: US. View detailed demographics →

Is COAGULATION FACTOR IX RECOMBINANT HUMAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 0 0
2013 2 0 2
2014 7 0 2
2015 5 0 2
2016 14 0 3
2017 30 0 6
2018 50 4 10
2019 70 1 9
2020 36 2 7
2021 56 0 11
2022 74 1 17
2023 136 3 26
2024 119 1 34
2025 65 0 13

View full timeline →

What Is COAGULATION FACTOR IX RECOMBINANT HUMAN Used For?

IndicationReports
Factor ix deficiency 758
Prophylaxis 239
Product used for unknown indication 88
Haemorrhage 65
Haemorrhage prophylaxis 52
Haemarthrosis 26
Haemophilia 25
Factor viii deficiency 24
Haemostasis 22
Haemorrhagic diathesis 8

COAGULATION FACTOR IX RECOMBINANT HUMAN vs Alternatives: Which Is Safer?

COAGULATION FACTOR IX RECOMBINANT HUMAN vs COAGULATION FACTOR IX RECOMBINANT HUMAN\ISOPROPYL ALCOHOL COAGULATION FACTOR IX RECOMBINANT HUMAN vs COAGULATION FACTOR VIIA RECOMBINANT HUMAN COAGULATION FACTOR IX RECOMBINANT HUMAN vs COBAMAMIDE COAGULATION FACTOR IX RECOMBINANT HUMAN vs COBICISTAT COAGULATION FACTOR IX RECOMBINANT HUMAN vs COBICISTAT\DARUNAVIR ETHANOLATE COAGULATION FACTOR IX RECOMBINANT HUMAN vs COBICISTAT\DARUNAVIR\EMTRICITABINE\TENOFOVIR ALAFENAMIDE COAGULATION FACTOR IX RECOMBINANT HUMAN vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR COAGULATION FACTOR IX RECOMBINANT HUMAN vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR ALAFENAMIDE COAGULATION FACTOR IX RECOMBINANT HUMAN vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR DISOPROXIL COAGULATION FACTOR IX RECOMBINANT HUMAN vs COBIMETINIB

Official FDA Label for COAGULATION FACTOR IX RECOMBINANT HUMAN

Official prescribing information from the FDA-approved drug label.