Safety Profile
Known Safety Concerns
- ALA conversion to EPA/DHA is inefficient -- poor substitute for marine omega-3
- Anticoagulant at high doses -- caution with warfarin
- Rapidly oxidises -- rancid oil is pro-inflammatory
- Phytoestrogen content -- caution in hormone-sensitive cancers
Contraindications
- ALA conversion to EPA/DHA is inefficient -- poor substitute for marine omega-3
- Anticoagulant at high doses -- caution with warfarin
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Flaxseed oil is a rich source of alpha-linolenic acid (ALA), a plant-based omega-3. ALA conversion to EPA and DHA is inefficient in humans (under 5%). Anticoagulant at high doses. May lower blood pressure. Phytoestrogen (lignan) content has theoretical implications for hormone-sensitive conditions. Highly susceptible to oxidation — quality and freshness are critical.
Biological and Chemical Classification
- Scientific Name
- Linum usitatissimum seed oil
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Metabolic
- Evidence consistency: High consistency across studies (100%)
- ALA conversion to EPA/DHA is inefficient -- poor substitute for marine omega-3
- Anticoagulant at high doses -- caution with warfarin
- Rapidly oxidises -- rancid oil is pro-inflammatory
- Phytoestrogen content -- caution in hormone-sensitive cancers
The available scientific evidence for Flaxseed Oil indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 14 აპრ 2026, 00:03
Evidence Distribution
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Observational / other LOW evidence YELLOWAntioxidant mechanism of indole-Maillard reaction products in hot-pressed flaxseed oil: a combined experimental and theoretical approach. ↗Zhao K et al.. Antioxidant mechanism of indole-Maillard reaction products in hot-pressed flaxseed oil: a combined experimental and theoretical approach.. Food Chem. 2026. PMID:41967410.PMID 41967410 ↗Journal Food ChemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41967410/
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Observational / other LOW evidence YELLOWMitigation of malondialdehyde and eight u03b1,u03b2-unsaturated aldehydes in flaxseed oil systems by gallates: Matrix-dependent formation patterns and inhibitory mechanisms. ↗Wei S et al.. Mitigation of malondialdehyde and eight u03b1,u03b2-unsaturated aldehydes in flaxseed oil systems by gallates: Matrix-dependent formation patterns and inhibitory mechanisms.. Food Chem. 2026. PMID:41962484.PMID 41962484 ↗Journal Food ChemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41962484/
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Observational / other LOW evidence YELLOWFlaxseed Supplementation Confers Resilience to Stress-Induced Depression-Like Behaviors via GDNF Epigenetic Modulation in the Ventral Tegmental Area of Rats. ↗Lu Q et al.. Flaxseed Supplementation Confers Resilience to Stress-Induced Depression-Like Behaviors via GDNF Epigenetic Modulation in the Ventral Tegmental Area of Rats.. Neuropsychiatr Dis Treat. 2026. PMID:41938831.PMID 41938831 ↗Journal Neuropsychiatr Dis TreatYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41938831/
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Observational / other LOW evidence YELLOWA study on the inhibitory effect of flaxseed oil emulsion coatings on Tyrophagus putrescentiae and quality of dry-cured ham. ↗Wu H et al.. A study on the inhibitory effect of flaxseed oil emulsion coatings on Tyrophagus putrescentiae and quality of dry-cured ham.. Meat Sci. 2026. PMID:41932042.PMID 41932042 ↗Journal Meat SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41932042/
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Observational / other LOW evidence YELLOWThe causal relationship between Omega-3 fatty acids and Achilles Tendinitis risk: A two-sample Mendelian randomization study in European populations. ↗Wang B et al.. The causal relationship between Omega-3 fatty acids and Achilles Tendinitis risk: A two-sample Mendelian randomization study in European populations.. Medicine (Baltimore). 2026. PMID:41931313.PMID 41931313 ↗Journal Medicine (Baltimore)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41931313/
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Observational / other LOW evidence YELLOWOil phase-driven nanoemulsions improve CoQ10 stability, in vitro bioaccessibility and ex vivo intestinal uptake. ↗Jin X et al.. Oil phase-driven nanoemulsions improve CoQ10 stability, in vitro bioaccessibility and ex vivo intestinal uptake.. Food Res Int. 2026. PMID:41895943.PMID 41895943 ↗Journal Food Res IntYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41895943/
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Observational / other LOW evidence YELLOWu03b1-linolenic acid-rich diet boosts docosahexaenoic acid levels and restores lipid balance in the brain parenchyma and vasculature of APOE4 mice. ↗Leikin-Frenkel A et al.. u03b1-linolenic acid-rich diet boosts docosahexaenoic acid levels and restores lipid balance in the brain parenchyma and vasculature of APOE4 mice.. J Nutr Biochem. 2026. PMID:41887535.PMID 41887535 ↗Journal J Nutr BiochemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41887535/
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Observational / other LOW evidence YELLOWValorization of flaxseed Cyclolinopeptides from byproduct: Optimization of extraction and evaluation of cellular protective effects. ↗Xu J et al.. Valorization of flaxseed Cyclolinopeptides from byproduct: Optimization of extraction and evaluation of cellular protective effects.. Food Chem (Oxf). 2026. PMID:41859363.PMID 41859363 ↗Journal Food Chem (Oxf)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41859363/
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Observational / other LOW evidence YELLOWProtein-phospholipid assembly governs the delivery and digestion of bioactives in natural and reconstituted flaxseed oil bodies. ↗Zhang S et al.. Protein-phospholipid assembly governs the delivery and digestion of bioactives in natural and reconstituted flaxseed oil bodies.. Int J Biol Macromol. 2026. PMID:41812948.PMID 41812948 ↗Journal Int J Biol MacromolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41812948/
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Observational / other LOW evidence YELLOWDietary supplementation with plant essential oils-loaded chitosan nanoparticles improves growth, body composition, digestive enzymes, and immune response in whiteleg shrimp (Litopenaeus vannamei):… ↗Eissa EH et al.. Dietary supplementation with plant essential oils-loaded chitosan nanoparticles improves growth, body composition, digestive enzymes, and immune response in whiteleg shrimp (Litopenaeus vannamei): Influence on histopathology and survivability against Vibrioparahaemolyticus.. Dev Comp Immunol. 2026. PMID:41812717.PMID 41812717 ↗Journal Dev Comp ImmunolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41812717/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Flaxseed Oil. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Low classification for Flaxseed Oil
A score of 3.0 places this ingredient in the Low band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.