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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.

OMEGA-3 FATTY ACIDS: 541 Adverse Event Reports & Safety Profile

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541
Total FAERS Reports
17 (3.1%)
Deaths Reported
285
Hospitalizations
541
As Primary/Secondary Suspect
15
Life-Threatening
17
Disabilities

First Report: 1999 · Latest Report: 20241219

What Are the Most Common OMEGA-3 FATTY ACIDS Side Effects?

#1 Most Reported
Somnolence
101 reports (18.7%)
#2 Most Reported
Gastrooesophageal reflux disease
101 reports (18.7%)
#3 Most Reported
Pneumonia aspiration
98 reports (18.1%)

All OMEGA-3 FATTY ACIDS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Gastrooesophageal reflux disease 101 18.7% 0 97
Somnolence 101 18.7% 0 98
Coma 98 18.1% 0 97
Pneumonia aspiration 98 18.1% 0 97
Drug ineffective 62 11.5% 6 34
Dyspnoea 42 7.8% 0 34
Off label use 36 6.7% 0 24
Fatigue 34 6.3% 0 24
Underdose 34 6.3% 0 30
Diarrhoea 30 5.6% 0 14
Nausea 28 5.2% 0 12
Constipation 23 4.3% 8 5
Depression 21 3.9% 0 1
Drug interaction 19 3.5% 0 17
Product odour abnormal 19 3.5% 0 0
Drug dependence 18 3.3% 0 17
Chest pain 17 3.1% 0 7
Exposure during pregnancy 17 3.1% 0 7
Headache 17 3.1% 0 6
Infection 17 3.1% 0 14

Who Reports OMEGA-3 FATTY ACIDS Side Effects? Age & Gender Data

Gender: 58.1% female, 41.9% male. Average age: 53.4 years. Most reports from: CA. View detailed demographics →

Is OMEGA-3 FATTY ACIDS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2003 1 0 1
2005 1 0 0
2006 2 0 2
2008 2 0 2
2009 4 0 3
2010 1 0 1
2011 3 0 0
2012 9 0 8
2013 2 0 2
2014 17 0 7
2015 20 0 3
2016 11 0 6
2017 7 0 5
2018 7 0 1
2019 12 0 5
2020 13 0 9
2021 11 8 1
2022 6 0 1
2023 8 0 0
2024 1 0 1

View full timeline →

What Is OMEGA-3 FATTY ACIDS Used For?

IndicationReports
Product used for unknown indication 308
Hypertriglyceridaemia 43
Blood triglycerides increased 10
Supplementation therapy 9
Ischaemic heart disease prophylaxis 7
Hyperlipidaemia 6
Myocardial infarction 5

OMEGA-3 FATTY ACIDS vs Alternatives: Which Is Safer?

OMEGA-3 FATTY ACIDS vs OMEPRAZOLE OMEGA-3 FATTY ACIDS vs OMEPRAZOLE\SODIUM BICARBONATE OMEGA-3 FATTY ACIDS vs OMNIPAQUE OMEGA-3 FATTY ACIDS vs OMNISCAN OMEGA-3 FATTY ACIDS vs ONABOTULINUMTOXINA OMEGA-3 FATTY ACIDS vs ONASEMNOGENE ABEPARVOVEC OMEGA-3 FATTY ACIDS vs ONASEMNOGENE ABEPARVOVEC-XIOI OMEGA-3 FATTY ACIDS vs ONBREZ OMEGA-3 FATTY ACIDS vs ONDANSETRON OMEGA-3 FATTY ACIDS vs ONFI

Official FDA Label for OMEGA-3 FATTY ACIDS

Official prescribing information from the FDA-approved drug label.