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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.

FACTOR XIII CONCENTRATE: 155 Adverse Event Reports & Safety Profile

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155
Total FAERS Reports
9 (5.8%)
Deaths Reported
32
Hospitalizations
155
As Primary/Secondary Suspect
14
Life-Threatening
5
Disabilities

First Report: 19940912 · Latest Report: 20250710

What Are the Most Common FACTOR XIII CONCENTRATE Side Effects?

#1 Most Reported
Drug ineffective
25 reports (16.1%)
#2 Most Reported
No adverse event
20 reports (12.9%)
#3 Most Reported
Haemorrhage
12 reports (7.7%)

All FACTOR XIII CONCENTRATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 25 16.1% 4 6
No adverse event 20 12.9% 0 0
Haemorrhage 12 7.7% 1 1
Device issue 9 5.8% 0 0
Off label use 8 5.2% 0 2
Product preparation issue 8 5.2% 0 0
Product use in unapproved indication 8 5.2% 1 0
Abortion spontaneous 7 4.5% 0 0
Exposure during pregnancy 7 4.5% 0 3
Factor xiii inhibition 7 4.5% 0 2
Deep vein thrombosis 5 3.2% 0 1
Drug ineffective for unapproved indication 5 3.2% 0 0
Dyspnoea 5 3.2% 0 3
Epistaxis 5 3.2% 0 0
Hypersensitivity 5 3.2% 0 1

Who Reports FACTOR XIII CONCENTRATE Side Effects? Age & Gender Data

Gender: 65.2% female, 34.8% male. Average age: 38.2 years. Most reports from: US. View detailed demographics →

Is FACTOR XIII CONCENTRATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2009 3 0 0
2010 4 0 3
2012 1 0 1
2013 2 0 0
2014 2 0 0
2015 9 0 4
2016 3 0 1
2017 1 0 0
2018 5 1 2
2019 10 0 1
2020 3 0 1
2021 4 0 1
2022 4 0 1
2023 5 0 0
2024 6 0 4
2025 2 0 1

View full timeline →

What Is FACTOR XIII CONCENTRATE Used For?

IndicationReports
Factor xiii deficiency 57
Product used for unknown indication 19
Prophylaxis 18
Coagulation factor deficiency 9
Haemorrhage 6
Abnormal clotting factor 5
Haemorrhage prophylaxis 5

FACTOR XIII CONCENTRATE vs Alternatives: Which Is Safer?

FACTOR XIII CONCENTRATE vs FAM-TRASTUZUMAB DERUXTECAN-NXKI FACTOR XIII CONCENTRATE vs FAMCICLOVIR FACTOR XIII CONCENTRATE vs FAMOTIDINE FACTOR XIII CONCENTRATE vs FAMOTIDINE\IBUPROFEN FACTOR XIII CONCENTRATE vs FARICIMAB FACTOR XIII CONCENTRATE vs FARICIMAB-SVOA FACTOR XIII CONCENTRATE vs FARICIMAB\FARICIMAB-SVOA FACTOR XIII CONCENTRATE vs FASLODEX FACTOR XIII CONCENTRATE vs FAVIPIRAVIR FACTOR XIII CONCENTRATE vs FEBUXOSTAT

Official FDA Label for FACTOR XIII CONCENTRATE

Official prescribing information from the FDA-approved drug label.