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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.

SIVELESTAT: 20 Adverse Event Reports & Safety Profile

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20
Total FAERS Reports
8 (40.0%)
Deaths Reported
6
Hospitalizations
20
As Primary/Secondary Suspect
7
Life-Threatening

Active Ingredient: SIVELESTAT SODIUM ·

First Report: 20110302 · Latest Report: 20230124

What Are the Most Common SIVELESTAT Side Effects?

#1 Most Reported
Interstitial lung disease
6 reports (30.0%)
#2 Most Reported
Off label use
5 reports (25.0%)
#3 Most Reported
Hepatic function abnormal
4 reports (20.0%)

All SIVELESTAT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Interstitial lung disease 6 30.0% 4 1
Off label use 5 25.0% 0 2

Who Reports SIVELESTAT Side Effects? Age & Gender Data

Gender: 26.3% female, 73.7% male. Average age: 65.4 years. Most reports from: JP. View detailed demographics →

Is SIVELESTAT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 1 0
2013 3 2 0
2015 1 1 1
2017 2 2 0
2018 1 0 0
2019 1 0 1
2023 1 0 1

View full timeline →

What Is SIVELESTAT Used For?

IndicationReports
Covid-19 5

Official FDA Label for SIVELESTAT

Official prescribing information from the FDA-approved drug label.