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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.

EMICIZUMAB-KXWH: 9,283 Adverse Event Reports & Safety Profile

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9,283
Total FAERS Reports
261 (2.8%)
Deaths Reported
1,241
Hospitalizations
9,283
As Primary/Secondary Suspect
61
Life-Threatening
31
Disabilities

First Report: 20080901 · Latest Report: 20250923

What Are the Most Common EMICIZUMAB-KXWH Side Effects?

#1 Most Reported
Haemorrhage
3,612 reports (38.9%)
#2 Most Reported
No adverse event
654 reports (7.0%)
#3 Most Reported
Off label use
542 reports (5.8%)

All EMICIZUMAB-KXWH Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Haemorrhage 3,612 38.9% 15 403
No adverse event 654 7.1% 0 0
Off label use 542 5.8% 22 54
Haemarthrosis 487 5.3% 1 71
Fall 484 5.2% 9 100
Arthralgia 385 4.2% 1 31
Contusion 321 3.5% 1 22
Epistaxis 313 3.4% 0 26
Pain 260 2.8% 0 26
Head injury 248 2.7% 4 42
Muscle haemorrhage 222 2.4% 0 35
Mouth haemorrhage 177 1.9% 2 30
Weight increased 174 1.9% 1 18
Joint injury 163 1.8% 0 18
Injury 158 1.7% 3 32
Limb injury 154 1.7% 0 19
Headache 131 1.4% 0 11
Injection site pain 131 1.4% 0 2
Joint swelling 125 1.4% 0 16
Drug ineffective 122 1.3% 1 8

Who Reports EMICIZUMAB-KXWH Side Effects? Age & Gender Data

Gender: 3.6% female, 96.4% male. Average age: 30.0 years. Most reports from: US. View detailed demographics →

Is EMICIZUMAB-KXWH Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 1 0 0
2017 4 2 2
2018 75 1 21
2019 189 5 63
2020 199 20 58
2021 300 15 65
2022 389 19 87
2023 1,006 25 153
2024 1,061 26 165
2025 543 20 108

View full timeline →

What Is EMICIZUMAB-KXWH Used For?

IndicationReports
Factor viii deficiency 6,532
Product used for unknown indication 1,097
Haemophilia a without inhibitors 589
Haemophilia 402
Acquired haemophilia 267
Haemophilia a with anti factor viii 128
Factor vii deficiency 94
Von willebrand's disease 90
Prophylaxis 55
Haemorrhage prophylaxis 17

EMICIZUMAB-KXWH vs Alternatives: Which Is Safer?

EMICIZUMAB-KXWH vs EMPAGLIFLOZIN EMICIZUMAB-KXWH vs EMPAGLIFLOZIN\LINAGLIPTIN EMICIZUMAB-KXWH vs EMPAGLIFLOZIN\LINAGLIPTIN\METFORMIN EMICIZUMAB-KXWH vs EMPAGLIFLOZIN\METFORMIN EMICIZUMAB-KXWH vs EMSAM EMICIZUMAB-KXWH vs EMTRICITABINE EMICIZUMAB-KXWH vs EMTRICITABINE\RILPIVIRINE\TENOFOVIR ALAFENAMIDE EMICIZUMAB-KXWH vs EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL EMICIZUMAB-KXWH vs EMTRICITABINE\TENOFOVIR EMICIZUMAB-KXWH vs EMTRICITABINE\TENOFOVIR ALAFENAMIDE

Official FDA Label for EMICIZUMAB-KXWH

Official prescribing information from the FDA-approved drug label.