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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.

DOCONEXENT\ICOSAPENT: 165 Adverse Event Reports & Safety Profile

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165
Total FAERS Reports
16 (9.7%)
Deaths Reported
149
Hospitalizations
165
As Primary/Secondary Suspect
13
Life-Threatening
24
Disabilities

First Report: 20060810 · Latest Report: 20220625

What Are the Most Common DOCONEXENT\ICOSAPENT Side Effects?

#1 Most Reported
Somnolence
76 reports (46.1%)
#2 Most Reported
Pneumonia aspiration
66 reports (40.0%)
#3 Most Reported
Gastrooesophageal reflux disease
66 reports (40.0%)

All DOCONEXENT\ICOSAPENT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Somnolence 76 46.1% 10 73
Coma 66 40.0% 0 64
Gastrooesophageal reflux disease 66 40.0% 0 64
Pneumonia aspiration 66 40.0% 0 64
Drug ineffective 36 21.8% 12 33
Infection 35 21.2% 1 35
Off label use 35 21.2% 14 33
Asthma 33 20.0% 11 32
Gastrointestinal disorder 32 19.4% 12 31
Drug intolerance 31 18.8% 14 29
Underdose 27 16.4% 0 27
Dyspnoea 26 15.8% 3 26
Fatigue 26 15.8% 13 24
Drug hypersensitivity 24 14.6% 12 23
Incorrect route of product administration 23 13.9% 11 22
Therapeutic product effect incomplete 23 13.9% 1 23
Blood creatinine increased 22 13.3% 10 21
Productive cough 22 13.3% 0 22
Sleep disorder due to a general medical condition 22 13.3% 0 22
Wheezing 22 13.3% 0 22

Who Reports DOCONEXENT\ICOSAPENT Side Effects? Age & Gender Data

Gender: 60.5% female, 39.5% male. Average age: 52.5 years. Most reports from: CA. View detailed demographics →

Is DOCONEXENT\ICOSAPENT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 1
2009 2 0 2
2010 1 0 0
2012 5 0 5
2014 1 0 1
2016 1 0 1
2019 1 0 1
2020 1 0 1
2022 1 0 1

View full timeline →

What Is DOCONEXENT\ICOSAPENT Used For?

IndicationReports
Product used for unknown indication 118
Hypertriglyceridaemia 16
Hyperlipidaemia 6
Rheumatoid arthritis 6

DOCONEXENT\ICOSAPENT vs Alternatives: Which Is Safer?

DOCONEXENT\ICOSAPENT vs DOCONEXENT\ICOSAPENT\PHOSPHATIDYL SERINE DOCONEXENT\ICOSAPENT vs DOCOSANOL DOCONEXENT\ICOSAPENT vs DOCUSATE DOCONEXENT\ICOSAPENT vs DOCUSATE\SENNOSIDES DOCONEXENT\ICOSAPENT vs DOCUSATE\SENNOSIDES A AND B DOCONEXENT\ICOSAPENT vs DOFETILIDE DOCONEXENT\ICOSAPENT vs DOLUTEGRAVIR DOCONEXENT\ICOSAPENT vs DOLUTEGRAVIR\LAMIVUDINE DOCONEXENT\ICOSAPENT vs DOLUTEGRAVIR\LAMIVUDINE\TENOFOVIR DISOPROXIL DOCONEXENT\ICOSAPENT vs DOLUTEGRAVIR\RILPIVIRINE

Official FDA Label for DOCONEXENT\ICOSAPENT

Official prescribing information from the FDA-approved drug label.