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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.

ENBUCRILATE: 88 Adverse Event Reports & Safety Profile

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88
Total FAERS Reports
8 (9.1%)
Deaths Reported
11
Hospitalizations
88
As Primary/Secondary Suspect
3
Life-Threatening
2
Disabilities

First Report: 2011 · Latest Report: 20240901

What Are the Most Common ENBUCRILATE Side Effects?

#1 Most Reported
Product use in unapproved indication
36 reports (40.9%)
#2 Most Reported
Device dislocation
11 reports (12.5%)
#3 Most Reported
Splenic infarction
6 reports (6.8%)

All ENBUCRILATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product use in unapproved indication 36 40.9% 5 4
Device dislocation 11 12.5% 0 1
Off label use 6 6.8% 0 1
Splenic infarction 6 6.8% 0 1

Who Reports ENBUCRILATE Side Effects? Age & Gender Data

Gender: 47.7% female, 52.3% male. Average age: 53.6 years. Most reports from: JP. View detailed demographics →

Is ENBUCRILATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 1 0
2016 1 0 0
2017 1 1 0
2019 2 1 0
2020 2 0 0
2022 1 0 0
2024 6 0 0

View full timeline →

What Is ENBUCRILATE Used For?

IndicationReports
Therapeutic embolisation 61
Sclerotherapy 9

Official FDA Label for ENBUCRILATE

Official prescribing information from the FDA-approved drug label.