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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.

THROMBIN: 190 Adverse Event Reports & Safety Profile

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190
Total FAERS Reports
25 (13.2%)
Deaths Reported
39
Hospitalizations
190
As Primary/Secondary Suspect
19
Life-Threatening
1
Disabilities

First Report: 199210 · Latest Report: 20250708

What Are the Most Common THROMBIN Side Effects?

#1 Most Reported
Haemorrhage
19 reports (10.0%)
#2 Most Reported
Treatment failure
15 reports (7.9%)
#3 Most Reported
Anaphylactic reaction
13 reports (6.8%)

All THROMBIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Haemorrhage 19 10.0% 6 4
Treatment failure 15 7.9% 0 0
Anaphylactic reaction 13 6.8% 1 1
Factor v inhibition 12 6.3% 0 1
Activated partial thromboplastin time prolonged 11 5.8% 3 2
Product use issue 11 5.8% 0 9
Prothrombin time prolonged 10 5.3% 3 2
Shock 10 5.3% 2 0
Drug ineffective 9 4.7% 3 4
Haemothorax 9 4.7% 1 2
Hypotension 9 4.7% 1 2
Incorrect route of product administration 9 4.7% 5 2
Tonsil cancer 9 4.7% 0 8
Appetite disorder 8 4.2% 0 8
Diarrhoea 8 4.2% 0 8
Epistaxis 8 4.2% 1 2
Product reconstitution quality issue 8 4.2% 0 0
Coagulation factor decreased 7 3.7% 2 0
Coagulopathy 7 3.7% 1 5
Death 7 3.7% 7 3

Who Reports THROMBIN Side Effects? Age & Gender Data

Gender: 34.1% female, 65.9% male. Average age: 50.4 years. Most reports from: US. View detailed demographics →

Is THROMBIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 0
2011 1 0 0
2012 1 0 1
2013 1 1 0
2014 3 2 1
2015 1 0 0
2016 3 0 1
2017 3 1 0
2018 4 0 2
2019 2 1 1
2020 2 0 2
2021 8 0 1
2022 2 0 1
2023 3 0 2
2024 4 1 1
2025 1 0 0

View full timeline →

What Is THROMBIN Used For?

IndicationReports
Haemostasis 52
Product used for unknown indication 20
Post procedural haemorrhage 16
Surgery 12
Tissue sealing 10
Vascular pseudoaneurysm 6
Haemorrhage 5

THROMBIN vs Alternatives: Which Is Safer?

THROMBIN vs THROMBIN HUMAN THROMBIN vs THYMOCYTE IMMUNE GLOBULIN NOS THROMBIN vs THYMOGLOBULINE THROMBIN vs THYMOL THROMBIN vs THYROID, PORCINE THROMBIN vs THYROID, PORCINE\THYROID, UNSPECIFIED THROMBIN vs THYROTROPIN ALFA THROMBIN vs TIAGABINE THROMBIN vs TIANEPTINE THROMBIN vs TIAPRIDE

Official FDA Label for THROMBIN

Official prescribing information from the FDA-approved drug label.