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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.

ICOSAPENT: 123 Adverse Event Reports & Safety Profile

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123
Total FAERS Reports
4 (3.3%)
Deaths Reported
87
Hospitalizations
123
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities

First Report: 20120822 · Latest Report: 20240826

What Are the Most Common ICOSAPENT Side Effects?

#1 Most Reported
Hepatotoxicity
36 reports (29.3%)
#2 Most Reported
Drug-induced liver injury
35 reports (28.5%)
#3 Most Reported
Hepatic necrosis
33 reports (26.8%)

All ICOSAPENT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hepatotoxicity 36 29.3% 0 33
Drug-induced liver injury 35 28.5% 0 34
Hepatic cirrhosis 33 26.8% 0 33
Hepatic encephalopathy 33 26.8% 0 33
Hepatic necrosis 33 26.8% 0 33
Drug interaction 29 23.6% 0 29
Drug ineffective 24 19.5% 0 21
Hypertriglyceridaemia 16 13.0% 1 16
Myocardial infarction 15 12.2% 0 15
Coronary artery disease 12 9.8% 0 12
Acute myocardial infarction 9 7.3% 0 9
Cerebrovascular accident 9 7.3% 0 9
Hypertransaminasaemia 9 7.3% 1 9
Gastrointestinal disorder 7 5.7% 1 7
Increased appetite 7 5.7% 0 6
Cerebral haemorrhage 5 4.1% 3 3

Who Reports ICOSAPENT Side Effects? Age & Gender Data

Gender: 50.4% female, 49.6% male. Average age: 50.0 years. Most reports from: CA. View detailed demographics →

Is ICOSAPENT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 12 0 12
2014 8 0 3
2015 3 1 2
2016 3 0 2
2018 4 0 2
2019 4 1 3
2020 1 0 0
2021 3 0 0
2024 1 0 1

View full timeline →

What Is ICOSAPENT Used For?

IndicationReports
Product used for unknown indication 65
Hypertriglyceridaemia 24
Low density lipoprotein 5

ICOSAPENT vs Alternatives: Which Is Safer?

ICOSAPENT vs ICOSAPENT ETHYL ICOSAPENT vs IDARUBICIN ICOSAPENT vs IDARUCIZUMAB ICOSAPENT vs IDECABTAGENE VICLEUCEL ICOSAPENT vs IDELALISIB ICOSAPENT vs IDURSULFASE ICOSAPENT vs IFOSFAMIDE ICOSAPENT vs IGURATIMOD ICOSAPENT vs ILOPERIDONE ICOSAPENT vs ILOPROST

Official FDA Label for ICOSAPENT

Official prescribing information from the FDA-approved drug label.