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Is fish oil good for heart health?

For most people taking ordinary fish oil capsules, the effect on the heart is small at best. A 2020 Cochrane review of 86 randomized trials in 162,796 adults found long-chain omega-3 made little or no difference to cardiovascular events (risk ratio 0.96, 95% CI 0.92 to 1.01) or to death from any cause (0.97, 95% CI 0.93 to 1.01), on high-certainty evidence. Most of those trials used capsules, and the search ran to February 2019. The largest benefit in a single trial came from a prescription drug, 4 g a day of purified EPA, in statin users at high risk, and the placebo used in that trial leaves the size of the benefit in question.

Established. Omega-3 supplements make little or no difference to overall cardiovascular events or to death from any cause. The Cochrane review rated both findings high certainty.

Unsettled. Whether they trim heart attacks a little is where the reviews part ways. The same Cochrane review found coronary heart disease events fell (risk ratio 0.91, 95% CI 0.85 to 0.97), so 167 people would need to take omega-3 for one to avoid an event, and it rated this low certainty. A 2021 meta-analysis of 40 trials put heart attacks at 0.87 (95% CI 0.80 to 0.96), with 272 people treated for one heart attack avoided. Cochrane saw no effect of dose, and that later analysis found the effect grew with dose.

Omega-3 against placebo, ratio of risk
0.70.80.91.01.21.4no effectCardiovascular eventsCochrane 2020, 43 trials, 140,482 peopleCardiovascular events: 0.96 (95% CI 0.92 to 1.01)0.96Coronary heart disease eventsCochrane 2020, 32 trials, low certaintyCoronary heart disease events: 0.91 (95% CI 0.85 to 0.97)0.91Heart attack2021 meta-analysis, 40 trialsHeart attack: 0.87 (95% CI 0.80 to 0.96)0.87Major vascular events2018 meta-analysis, 10 large trialsMajor vascular events: 0.97 (95% CI 0.93 to 1.01)0.97VITAL, 1 g a day25,871 older US adults, 5.3 yearsVITAL, 1 g a day: 0.92 (95% CI 0.80 to 1.06)0.92ASCEND, 1 g a day15,480 people with diabetes, 7.4 yearsASCEND, 1 g a day: 0.97 (95% CI 0.87 to 1.08)0.97STRENGTH, 4 g EPA plus DHA13,078 high-risk statin usersSTRENGTH, 4 g EPA plus DHA: 0.99 (95% CI 0.90 to 1.09)0.99REDUCE-IT, 4 g purified EPA8,179 statin users, prescription drugREDUCE-IT, 4 g purified EPA: 0.75 (95% CI 0.68 to 0.83)0.75Atrial fibrillation2021 meta-analysis, 7 trials, 81,210 peopleAtrial fibrillation: 1.25 (95% CI 1.07 to 1.46)1.25
Meta-analysesSingle large trialsHarm

Left of the line means fewer events on omega-3. The meta-analysis rows report risk ratios, the trial rows hazard or rate ratios, and the last row is a harm. Sources: cards ev-fohd-01, ev-fohd-02, ev-fohd-05, ev-fohd-06, ev-fohd-09, ev-fohd-10, ev-fohd-11, ev-fohd-13 and ev-fohd-14 below.

What the trials found

The big reviews: close to the line

The Cochrane review also put cardiovascular death at 0.92 (95% CI 0.86 to 0.99) on moderate-certainty evidence, and coronary death at 0.90 (95% CI 0.81 to 1.00) on low certainty, which works out at 334 people treated for one death avoided. It found effects did not differ by trial length or omega-3 dose. A 2019 meta-analysis of 13 large trials in 127,477 people reached a similar size of effect. With REDUCE-IT left out, heart attack fell to 0.92 (95% CI 0.86 to 0.99) and total cardiovascular disease to 0.97 (95% CI 0.94 to 0.99). That analysis used a fixed-effect model, and the relative effects are small.

A 2018 meta-analysis of 10 large trials in 77,917 high-risk people, mean age 64, found no significant effect on major vascular events (0.97, 95% CI 0.93 to 1.01). No subgroup benefited, including people with prior coronary disease, diabetes, high blood fats or statin use. That review came before the newer large trials. A 2024 meta-analysis of 18 trials in 134,144 people, which included them, put heart attack at 0.89 (95% CI 0.81 to 0.98) and cardiovascular death at 0.92 (95% CI 0.85 to 0.99).

Ordinary doses in ordinary people

VITAL gave 1 g a day of marine omega-3 or placebo to 25,871 US men aged 50 and over and women aged 55 and over. Over a median 5.3 years, a major cardiovascular event happened to 386 people on omega-3 and 419 on placebo, a hazard ratio of 0.92 (95% CI 0.80 to 1.06) that did not reach significance.

ASCEND gave the same 1 g a day to 15,480 people in the UK with diabetes and no heart disease, for a mean 7.4 years. A serious vascular event happened to 8.9% on omega-3 and 9.2% on olive oil placebo, rate ratio 0.97 (95% CI 0.87 to 1.08). About three in four people kept taking their capsules.

Myth. A daily 1 g fish oil capsule has not been shown to prevent major cardiovascular events in older adults from the general population or in people with diabetes. The two largest trials of exactly that, in over 41,000 people, did not reach significance on their main end point.

High doses: one success, one failure

People who had the trial's main cardiovascular end point, percent
0510152025REDUCE-IT, placebomineral oil, 4.9 years22REDUCE-IT, placebo: 22 percent (95% CI 22 to 22)REDUCE-IT, purified EPA4 g a day, prescription17.2REDUCE-IT, purified EPA: 17.2 percent (95% CI 17.2 to 17.2)STRENGTH, corn oilstopped early12.2STRENGTH, corn oil: 12.2 percent (95% CI 12.2 to 12.2)STRENGTH, EPA plus DHA4 g a day12STRENGTH, EPA plus DHA: 12 percent (95% CI 12 to 12)ASCEND, olive oildiabetes, 7.4 years9.2ASCEND, olive oil: 9.2 percent (95% CI 9.2 to 9.2)ASCEND, omega-31 g a day8.9ASCEND, omega-3: 8.9 percent (95% CI 8.9 to 8.9)

Each pair is one trial, with its own end point and population, so compare within a pair only. The three trials used three different placebo oils. Sources: cards ev-fohd-10, ev-fohd-11 and ev-fohd-13 below.

REDUCE-IT gave 8,179 statin users with established cardiovascular disease, or diabetes plus risk factors, and raised triglycerides 4 g a day of icosapent ethyl, a purified EPA sold as a prescription drug. Over a median 4.9 years the main end point happened to 17.2% against 22.0% on placebo, hazard ratio 0.75 (95% CI 0.68 to 0.83). The trial was industry funded, and its placebo was mineral oil, which may have raised risk in the control group.

STRENGTH gave 13,078 similar high-risk statin users 4 g a day of an EPA plus DHA mix against corn oil. The main end point happened to 12.0% against 12.2%, hazard ratio 0.99 (95% CI 0.90 to 1.09), and the trial was stopped at 1,384 of 1,600 planned events. A 2026 meta-analysis of 6 trials in 42,738 people concluded that, among blinded placebo-controlled trials, 4 g a day of icosapent ethyl is the only formulation independently linked with fewer cardiovascular events. It had few trials to work with, and the mineral oil question is still open.

For what fish oil does to blood fats, see the fish oil and triglycerides review.

Who should be careful

People prone to atrial fibrillation, at higher doses. A 2021 meta-analysis of 7 trials in 81,210 people, mean age 65, found marine omega-3 raised the risk of this irregular heart rhythm, hazard ratio 1.25 (95% CI 1.07 to 1.46). It was 1.49 (95% CI 1.04 to 2.15) in trials above 1 g a day and 1.12 (95% CI 1.03 to 1.22) at 1 g or less. In several trials the rhythm problem was taken from adverse event reports. A 2026 meta-analysis of 35 trials in 114,592 people aged 50 or older found a significant rise only in people at high cardiovascular risk taking more than 1.5 g a day, odds ratio 1.43 (95% CI 1.14 to 1.79), an absolute difference of 0.8%. In REDUCE-IT, 3.1% on purified EPA were hospitalized for atrial fibrillation or flutter against 2.1% on placebo.

People on blood thinners. In REDUCE-IT serious bleeding was 2.7% against 2.1% on placebo, a difference that did not reach significance (P=0.06). A 2024 meta-analysis of 15 trials found prescription EPA ethyl ester carried a high risk of bleeding, and prescription omega-3 acid ethyl ester a good safety profile. That statement is qualitative in the abstract. We could not get the NIH fact sheet on omega-3, so we have no card on warfarin interaction.

Stomach. In STRENGTH, gut side effects affected 24.7% on 4 g a day of the EPA plus DHA mix against 14.7% on corn oil.

Pregnancy is covered on the fish oil and pregnancy review. This search produced no card on children.

Not for everyone. If you have atrial fibrillation, a high cardiovascular risk, or take an anticoagulant or antiplatelet drug, a dose above 1 g a day is something to discuss with whoever treats you.

What expert bodies say

The bodies disagree in tone. The American Heart Association, in a 2017 advisory, judged omega-3 supplements reasonable for preventing coronary death in people who already have coronary heart disease (Class IIa). The same advisory said they are not indicated to prevent cardiovascular disease in people with or at risk of diabetes (Class III, no benefit), which ASCEND later confirmed. The advisory came before VITAL, ASCEND, REDUCE-IT and STRENGTH.

The US Food and Drug Administration allows a qualified claim that EPA and DHA may reduce coronary heart disease risk, and requires it to say the evidence is inconsistent and inconclusive. The EU authorizes the claim that EPA and DHA contribute to the normal function of the heart, a function claim rather than a disease risk claim. The European Food Safety Authority concluded that supplemental EPA plus DHA up to 5 g a day raises no safety concerns for adults. That opinion dates from 2012 and does not cover the atrial fibrillation risk seen in later trials.

How we searched

Searched: a local copy of the PubMed baseline across all study types. The broad query combining fish oil, omega-3, EPA and icosapent with cardiovascular and coronary terms returned 1,709 records, and we read the top 40 by title. A query on icosapent ethyl and REDUCE-IT returned 59, and a query for meta-analyses of trials returned 45 syntheses from 2009 to 2026. We also searched the EU health claims register, our layer of agency reviews and ClinicalTrials.gov, and ran web searches for newer meta-analyses, the FDA qualified claim and the EFSA opinion. Search run on 7 October 2026.

Included: 21 cards from six meta-analyses on benefit, three on harm, four large randomized trials, the 2017 AHA advisory, the FDA qualified claim, the EU register entry and the EFSA opinion. None of the 13 studies used is in the Retraction Watch database.

Excluded: a 2026 review of 25 secondary prevention trials that reported effects only on a log scale, a dialysis review that mixed trials with observational data, overlapping dose-category analyses, reviews on heart failure, leg artery disease and blood vessel markers, and studies of triglycerides and blood pressure, which have their own reviews.

What we read: abstracts from the PubMed baseline for most studies. The 2019 meta-analysis and the AHA advisory were read in full text. REDUCE-IT is not in our corpus and was taken from Europe PMC with two independent requests. The FDA and EFSA pages were each checked twice.

What we could not get: the full text of the Cochrane review, the NIH omega-3 fact sheet and a 2021 meta-analysis outside our corpus. We did not check AHA statements after 2017. A ClinicalTrials.gov query failed on the hyphen in omega-3 and was not retried.

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Sources

  1. ev-fohd-01 · Meta-analysis or systematic review · Cochrane systematic review and meta-analysis of randomized controlled trials · n = 86 RCTs, 162796 participants
    Meta-analysis and sensitivity analyses suggested little or no effect of increasing LCn3 on all-cause mortality (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.93 to 1.01; 143,693 participants; 11,297 deaths in 45 RCTs; high-certainty evidence), cardiovascular mortality (RR 0.92, 95% CI 0.86 to 0.99; 117,837 participants; 5658 deaths in 29 RCTs; moderate-certainty evidence), cardiovascular events (RR 0.96, 95% CI 0.92 to 1.01; 140,482 participants; 17,619 people experienced events in 43 RCTs; high-certainty evidence)
    Who: adults at varying cardiovascular risk in RCTs lasting at least 12 months, mainly high-income countries
    Effect: cardiovascular events RR 0.96 (95% CI 0.92 to 1.01, high certainty); all-cause mortality RR 0.97 (0.93 to 1.01, high certainty); cardiovascular mortality RR 0.92 (0.86 to 0.99, moderate certainty)
    Certainty: Best synthesis for the question; search to February 2019, so REDUCE-IT (2018) is in but STRENGTH (2020) is not; most trials used capsules.
    Cochrane Database Syst Rev, 2020 · checked 2026-10-07 · we read the abstract
  2. ev-fohd-02 · Meta-analysis or systematic review · Cochrane systematic review and meta-analysis of randomized controlled trials · n = 32 RCTs, 134116 participants (CHD events)
    Increasing LCn3 may slightly reduce coronary heart disease mortality (number needed to treat for an additional beneficial outcome (NNTB) 334, RR 0.90, 95% CI 0.81 to 1.00; 127,378 participants; 3598 coronary heart disease deaths in 24 RCTs, low-certainty evidence) and coronary heart disease events (NNTB 167, RR 0.91, 95% CI 0.85 to 0.97; 134,116 participants; 8791 people experienced coronary heart disease events in 32 RCTs, low-certainty evidence).
    Who: adults in RCTs of long-chain omega-3 lasting at least 12 months
    Effect: CHD events RR 0.91 (95% CI 0.85 to 0.97), NNTB 167; CHD mortality RR 0.90 (0.81 to 1.00), NNTB 334; both low certainty
    Certainty: Low-certainty evidence; absolute benefit small.
    Cochrane Database Syst Rev, 2020 · checked 2026-10-07 · we read the abstract
  3. ev-fohd-03 · Meta-analysis or systematic review · Cochrane systematic review and meta-analysis of randomized controlled trials · n = 86 RCTs
    Overall, effects did not differ by trial duration or LCn3 dose in pre-planned subgrouping or meta-regression. There is little evidence of effects of eating fish.
    Who: adults in RCTs of long-chain omega-3 lasting 12 to 88 months
    Effect: no effect modification by duration or dose (subgroups and meta-regression); little trial evidence for fish intake
    Certainty: Contrasts with later dose-response meta-analyses (ev-fohd-05); fish as food is untested in trials.
    Cochrane Database Syst Rev, 2020 · checked 2026-10-07 · we read the abstract
  4. ev-fohd-04 · Meta-analysis or systematic review · meta-analysis of randomized controlled trials (fixed effect, meta-regression) · n = 13 RCTs, 127477 participants
    In the analysis excluding REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial), marine omega-3 supplementation was associated with significantly lower risk of myocardial infarction (rate ratio [RR] [95% CI]: 0.92 [0.86, 0.99]; P=0.020), CHD death (RR [95% CI]: 0.92 [0.86, 0.98]; P=0.014), total CHD (RR [95% CI]: 0.95 [0.91, 0.99]; P=0.008), CVD death (RR [95% CI]: 0.93 [0.88, 0.99]; P=0.013), and total CVD (RR [95% CI]: 0.97 [0.94, 0.99]; P=0.015).
    Who: participants of 13 large RCTs of marine omega-3 supplementation, mean treatment 5.0 years
    Effect: excluding REDUCE-IT: MI RR 0.92 (0.86 to 0.99); CHD death RR 0.92 (0.86 to 0.98); total CVD RR 0.97 (0.94 to 0.99); linear dose-response for total CVD
    Certainty: Large trials only; fixed-effect model; relative effects small.
    J Am Heart Assoc, 2019 · checked 2026-10-07 · we read the abstract
  5. ev-fohd-05 · Meta-analysis or systematic review · random-effects meta-analysis and meta-regression of randomized controlled trials, GRADE · n = 40 studies, 135267 participants
    Supplementation was associated with reduced risk of MI (relative risk [RR], 0.87; 95% CI, 0.80 to 0.96), high certainty number needed to treat (NNT) of 272; CHD events (RR, 0.90; 95% CI, 0.84 to 0.97), high certainty NNT of 192; fatal MI (RR, 0.65; 95% CI, 0.46 to 0.91]), moderate certainty NNT = 128; and CHD mortality (RR, 0.91; 95% CI, 0.85 to 0.98), low certainty NNT = 431, but not CVD events (RR, 0.95; 95% CI, 0.90 to 1.00). The effect is dose dependent for CVD events and MI.
    Who: participants of RCTs of EPA/DHA supplementation published before August 2019
    Effect: MI RR 0.87 (0.80 to 0.96), NNT 272, high certainty; CHD events RR 0.90 (0.84 to 0.97), NNT 192; CVD events RR 0.95 (0.90 to 1.00); dose dependent for CVD events and MI
    Certainty: Dose-response conclusion differs from Cochrane (ev-fohd-03).
    Mayo Clin Proc, 2021 · checked 2026-10-07 · we read the abstract
  6. ev-fohd-06 · Meta-analysis or systematic review · meta-analysis of large randomized trials (study-level data) · n = 10 RCTs, 77917 participants
    Neither did randomization to omega-3 fatty acid supplementation have any significant associations with major vascular events (RR, 0.97; 95% CI, 0.93-1.01; P = .10), overall or in any subgroups, including subgroups composed of persons with prior coronary heart disease, diabetes, lipid levels greater than a given cutoff level, or statin use.
    Who: 77,917 high-risk individuals in trials of at least 500 people and 1 year, mean age 64.0, EPA 226-1800 mg/d
    Effect: any CHD event RR 0.96 (95% CI 0.90 to 1.01); major vascular events RR 0.97 (0.93 to 1.01); no subgroup (prior CHD, diabetes, statin use) benefited
    Certainty: Predates VITAL, ASCEND and REDUCE-IT.
    JAMA Cardiol, 2018 · checked 2026-10-07 · we read the abstract
  7. ev-fohd-07 · Meta-analysis or systematic review · random-effects meta-analysis of randomized controlled trials · n = 18 RCTs, 134144 participants
    Overall, compared with controls, omega-3 supplementation reduced the risk of revascularization [0.90, 95% confidence interval (CI) 0.84-0.98; P = 0.001; P-heterogeneity = 0.0002; I2 = 68%], MI (0.89, 95% CI 0.81-0.98; P = 0.02; P-heterogeneity = 0.06; I2 = 41%), and cardiovascular death (0.92, 95% CI 0.85-0.99; P = 0.02; P-heterogeneity = 0.13; I2 = 33%).
    Who: participants in primary and secondary prevention RCTs receiving DHA + EPA, EPA alone, or control
    Effect: MI 0.89 (0.81 to 0.98); cardiovascular death 0.92 (0.85 to 0.99); revascularisation 0.90 (0.84 to 0.98)
    Certainty: EPA-alone signal driven mainly by REDUCE-IT and JELIS (open-label); revascularisation heterogeneity I2 68%.
    Eur J Prev Cardiol, 2024 · checked 2026-10-07 · we read the abstract
  8. ev-fohd-08 · Meta-analysis or systematic review · systematic review and meta-analysis of randomized controlled trials · n = 6 RCTs, 42738 participants
    Among blinded, placebo-controlled, cardiovascular outcomes trials, 4 g/day icosapent ethyl is the only formulation independently associated with reduced cardiovascular events.
    Who: adults with established CVD or other high-risk settings in RCTs of high-dose EPA-dominant omega-3 (>= 1.8 g/day)
    Effect: unstable angina hospitalization RR 0.75 (0.66 to 0.87); no significant effect on cardiovascular death or ischemic stroke; formulation modified benefit
    Certainty: Few trials; mixes placebo-controlled and open-label designs; mineral-oil placebo question in REDUCE-IT unresolved.
    Am J Cardiovasc Drugs, 2026 · checked 2026-10-07 · we read the abstract
  9. ev-fohd-09 · Randomized controlled trial(s) · randomized, placebo-controlled 2x2 factorial trial, median 5.3 years · n = 25871
    During a median follow-up of 5.3 years, a major cardiovascular event occurred in 386 participants in the n-3 group and in 419 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P=0.24).
    Who: men aged 50 or older and women aged 55 or older in the US, general population (primary prevention)
    Effect: major cardiovascular events HR 0.92 (95% CI 0.80 to 1.06), P=0.24
    Certainty: MI was a secondary end point; primary end point null.
    N Engl J Med, 2019 · checked 2026-10-07 · we read the abstract
  10. ev-fohd-10 · Randomized controlled trial(s) · randomized placebo (olive oil)-controlled trial, mean 7.4 years · n = 15480
    During a mean follow-up of 7.4 years (adherence rate, 76%), a serious vascular event occurred in 689 patients (8.9%) in the fatty acid group and in 712 (9.2%) in the placebo group (rate ratio, 0.97; 95% confidence interval [CI], 0.87 to 1.08; P=0.55).
    Who: patients with diabetes but without evidence of atherosclerotic cardiovascular disease, UK
    Effect: serious vascular event 8.9% vs 9.2%, rate ratio 0.97 (95% CI 0.87 to 1.08)
    Certainty: Adherence 76%.
    N Engl J Med, 2018 · checked 2026-10-07 · we read the abstract
  11. ev-fohd-11 · Randomized controlled trial(s) · multicenter randomized double-blind placebo-controlled trial, median 4.9 years · n = 8179
    A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001)
    Who: statin-treated patients with established cardiovascular disease or diabetes plus risk factors, fasting triglycerides 135 to 499 mg/dL
    Effect: primary end point 17.2% vs 22.0%, HR 0.75 (95% CI 0.68 to 0.83); cardiovascular death HR 0.80 (0.66 to 0.98)
    Certainty: Prescription drug, not a supplement; mineral-oil placebo may have raised risk in the control arm; industry funded.
    New England Journal of Medicine, 2019, 380(1):11-22 (REDUCE-IT) · checked 2026-10-07 · we read the abstract
  12. ev-fohd-12 · Randomized controlled trial(s) · multicenter randomized double-blind placebo-controlled trial, median 4.9 years · n = 8179
    A larger percentage of patients in the icosapent ethyl group than in the placebo group were hospitalized for atrial fibrillation or flutter (3.1% vs. 2.1%, P=0.004). Serious bleeding events occurred in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P=0.06).
    Who: statin-treated patients with raised triglycerides and high cardiovascular risk
    Effect: AF or flutter hospitalization 3.1% vs 2.1% (P=0.004); serious bleeding 2.7% vs 2.1% (P=0.06)
    Certainty: Bleeding difference not significant; relevant for people on anticoagulants or antiplatelets.
    New England Journal of Medicine, 2019, 380(1):11-22 (REDUCE-IT) · checked 2026-10-07 · we read the abstract
  13. ev-fohd-13 · Randomized controlled trial(s) · double-blind randomized multicenter trial vs corn oil, stopped early for futility · n = 13078
    The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84). A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%).
    Who: statin-treated patients with high cardiovascular risk, hypertriglyceridemia and low HDL-C, 22 countries
    Effect: primary end point 12.0% vs 12.2%, HR 0.99 (95% CI 0.90 to 1.09); gastrointestinal adverse events 24.7% vs 14.7%
    Certainty: Stopped at 1384 of 1600 planned events.
    JAMA, 2020 · checked 2026-10-07 · we read the abstract
  14. ev-fohd-14 · Meta-analysis or systematic review · systematic review and meta-analysis of randomized controlled trials, meta-regression · n = 7 RCTs, 81210 participants
    In meta-analysis, the use of marine ɷ-3 fatty acid supplements was associated with an increased risk of AF (n=2905; HR, 1.25 [95% CI, 1.07-1.46]; P=0.013). In analyses stratified by dose, the HR was greater in the trials testing >1 g/d (HR, 1.49 [95% CI, 1.04-2.15]; P=0.042) compared with those testing ≤1 g/d (HR, 1.12 [95% CI, 1.03-1.22]; P=0.024; P for interaction <0.001).
    Who: patients in cardiovascular outcome RCTs of marine omega-3 (>= 500 people, >= 1 year), mean age 65
    Effect: AF HR 1.25 (95% CI 1.07 to 1.46); >1 g/d HR 1.49 (1.04 to 2.15); <=1 g/d HR 1.12 (1.03 to 1.22); HR 1.11 per extra 1 g/d
    Certainty: AF from adverse-event reports in several trials.
    Circulation, 2021 · checked 2026-10-07 · we read the abstract
  15. ev-fohd-15 · Meta-analysis or systematic review · meta-analysis of randomized controlled trials including unpublished data · n = 35 RCTs, 114592 participants
    Only studies including patients at high-risk for cardiovascular disease who were treated with high-doses of EPA/DHA (>1500 mg/d) showed a statistically significant increase in AF risk with a pooled odds ratio (OR) of 1.43 (95% CI, 1.14-1.79) and an absolute risk difference of 0.8% (0.40%-1.1%).
    Who: people aged 50 or older in RCTs of >= 500 mg/d EPA/DHA for >= 12 months
    Effect: high CVD risk and >1500 mg/d: AF OR 1.43 (95% CI 1.14 to 1.79), absolute risk difference 0.8%; other groups OR 1.03 to 1.07, not significant
    Certainty: Odds ratio, not risk ratio; stratification hypothesis prespecified by authors.
    Circ Arrhythm Electrophysiol, 2026 · checked 2026-10-07 · we read the abstract
  16. ev-fohd-16 · Meta-analysis or systematic review · systematic review and meta-analysis of randomized controlled trials · n = 15 RCTs
    In addition, prescription omega-3 acid ethyl ester has a good safety profile, and prescription EPA ethyl ester has a high risk of bleeding.
    Who: participants in RCTs of omega-3 supplements for cardiovascular prevention
    Effect: prescription omega-3 acid ethyl ester: good safety profile; prescription EPA ethyl ester: high risk of bleeding (qualitative)
    Certainty: Bleeding statement is qualitative in the abstract.
    Cardiovasc Drugs Ther, 2024 · checked 2026-10-07 · we read the abstract
  17. ev-fohd-17 · Position of an expert body · science advisory · n = —
    the majority of coauthors concluded that treatment with omega-3 PUFA supplements is reasonable for the secondary prevention of CHD death (Class IIa Recommendation)
    Who: patients with prevalent coronary heart disease
    Effect: Class IIa recommendation for secondary prevention of CHD death; Class IIa also for heart failure with reduced ejection fraction
    Certainty: Predates VITAL, ASCEND, REDUCE-IT, STRENGTH.
    Circulation, 2017, 135(15):e867-e884 (Siscovick et al., AHA science advisory) · checked 2026-10-07 · we read the fulltext
  18. ev-fohd-18 · Position of an expert body · science advisory · n = —
    Overall, the current evidence from RCTs suggests no benefit of omega-3 PUFA supplementation among patients with or at risk for diabetes mellitus to prevent CVD (Treatment is not indicated: Class III: No Benefit Recommendation).
    Who: patients with diabetes mellitus or prediabetes
    Effect: Class III: No Benefit
    Certainty: Later confirmed by ASCEND (ev-fohd-10).
    Circulation, 2017, 135(15):e867-e884 (Siscovick et al., AHA science advisory) · checked 2026-10-07 · we read the fulltext
  19. ev-fohd-19 · Position of an expert body · regulatory qualified health claim · n = —
    Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive.
    Who: US food and supplement labeling
    Effect: qualified health claim (enforcement discretion), with mandatory disclaimer
    Certainty: Qualified claim, not an authorized health claim.
    US FDA, 2019, FDA Announces New Qualified Health Claims for EPA and DHA Omega-3 Consumption and the Risk of Hypertension and Coronary Heart Disease (constituent update, June 19, 2019) · checked 2026-10-07 · we read the section
  20. ev-fohd-20 · Position of an expert body · regulatory register entry · n = —
    POL-HC-6368 Eicosapentaenoic acid and docosahexaenoic acid (EPA/DHA) EPA and DHA contribute to the normal function of the heart Authorised
    Who: EU food labeling
    Effect: authorized health claim (conditions of use in Regulation (EU) No 432/2012, not quoted here)
    Certainty: Function claim, not a disease-risk reduction claim; EU and FDA differ in tone.
    EU Register on nutrition and health claims, claim POL-HC-6368, snapshot 2026-09-21 · checked 2026-10-07 · we read the section
  21. ev-fohd-21 · Position of an expert body · agency scientific opinion · n = —
    It concludes that supplemental intakes of EPA and DHA combined at doses up to 5g a day do not raise safety concerns for adults.
    Who: adults
    Effect: no safety concern up to 5 g/day EPA+DHA combined (bleeding, glucose regulation, immune function)
    Certainty: Covers general safety, not atrial fibrillation risk seen in later trials.
    EFSA, 2012, news: EFSA assesses safety of long-chain omega-3 fatty acids (Scientific Opinion EFSA Journal 2012;10(7):2815) · checked 2026-10-07 · we read the section

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