Safety Profile
Known Safety Concerns
- Skin yellowing at very high doses
- RCTs have not confirmed prostate cancer prevention despite observational data
- High-dose supplements may interact with warfarin
- Generally one of the safer carotenoid supplements
Contraindications
- Skin yellowing at very high doses
- RCTs have not confirmed prostate cancer prevention despite observational data
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Lycopene is a carotenoid antioxidant from tomatoes associated with reduced prostate cancer risk in observational studies. However RCTs have not confirmed a protective effect. Generally very well tolerated. Skin yellowing at very high doses. May interact with warfarin in high-dose supplements.
Biological and Chemical Classification
- Scientific Name
- Lycopene from Lycopersicon esculentum (tomato)
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: Botanical
- Evidence consistency: High consistency across studies (100%)
- Skin yellowing at very high doses
- RCTs have not confirmed prostate cancer prevention despite observational data
- High-dose supplements may interact with warfarin
- Generally one of the safer carotenoid supplements
The available scientific evidence for Lycopene 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: 31 მარ 2026, 07:11
Evidence Distribution
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Observational / other LOW evidence YELLOWDynamic Lysine Acetylation Disrupts Isocitrate Lyase Function and Enables Metabolic Optimisation. ↗Martu00ednez-Vivancos A et al.. Dynamic Lysine Acetylation Disrupts Isocitrate Lyase Function and Enables Metabolic Optimisation.. Microb Biotechnol. 2026. PMID:41910453.PMID 41910453 ↗Journal Microb BiotechnolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41910453/
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Observational / other LOW evidence YELLOWLmCCS Impacts the Flower Colour of Lily by Manipulating the Carotenoid Metabolic Flux. ↗Li H et al.. LmCCS Impacts the Flower Colour of Lily by Manipulating the Carotenoid Metabolic Flux.. Physiol Plant. 2026. PMID:41906951.PMID 41906951 ↗Journal Physiol PlantYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41906951/
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Observational / other LOW evidence YELLOWLycopene ameliorates swainsonine-induced autophagy in rat renal tubular epithelial cells via the endoplasmic reticulum stress UPR pathway. ↗Wang P et al.. Lycopene ameliorates swainsonine-induced autophagy in rat renal tubular epithelial cells via the endoplasmic reticulum stress UPR pathway.. Res Vet Sci. 2026. PMID:41905027.PMID 41905027 ↗Journal Res Vet SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41905027/
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Observational / other LOW evidence YELLOWEffects of supplementary lighting with different spectral compositions on plant growth, fruit development, and quality formation of facility-grown tomatoes. ↗Sun D et al.. Effects of supplementary lighting with different spectral compositions on plant growth, fruit development, and quality formation of facility-grown tomatoes.. Sci Rep. 2026. PMID:41904292.PMID 41904292 ↗Journal Sci RepYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41904292/
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Observational / other LOW evidence YELLOWAcute Combination of Nitrogen Deprivation and High Irradiance Induces the Simultaneous Accumulation of Astaxanthin and Lutein in Continuous Cultures of the Microalga… ↗Morales-Pineda M et al.. Acute Combination of Nitrogen Deprivation and High Irradiance Induces the Simultaneous Accumulation of Astaxanthin and Lutein in Continuous Cultures of the Microalga Chromochloris zofingiensis.. Plants (Basel). 2026. PMID:41901421.PMID 41901421 ↗Journal Plants (Basel)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41901421/
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Observational / other LOW evidence YELLOWThe ATP Binding Cassette (ABC) Transporter Gene Family in Lotus (Nelumbo Adans.): Genome-Wide Survey, Characterization and Gene Expression Profile. ↗Zhao Y et al.. The ATP Binding Cassette (ABC) Transporter Gene Family in Lotus (Nelumbo Adans.): Genome-Wide Survey, Characterization and Gene Expression Profile.. Biology (Basel). 2026. PMID:41892229.PMID 41892229 ↗Journal Biology (Basel)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41892229/
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Observational / other LOW evidence YELLOWBioconversion of carotenoids into high-value crocins using a marine sponge carotenoid cleavage dioxygenase. ↗Moreno-Gimu00e9nez E et al.. Bioconversion of carotenoids into high-value crocins using a marine sponge carotenoid cleavage dioxygenase.. New Phytol. 2026. PMID:41889127.PMID 41889127 ↗Journal New PhytolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41889127/
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Observational / other LOW evidence YELLOWSoybean protein complexes as diglyceride nanostructured lipid carriers for lycopene delivery: preparation via metal-phenol network formation. ↗Guo X et al.. Soybean protein complexes as diglyceride nanostructured lipid carriers for lycopene delivery: preparation via metal-phenol network formation.. Food Chem. 2026. PMID:41886988.PMID 41886988 ↗Journal Food ChemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41886988/
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Observational / other LOW evidence YELLOWGenetic determinants of lycopene concentration in subcutaneous adipose tissue: insights into interindividual variability in adult males. ↗Zumaraga MP et al.. Genetic determinants of lycopene concentration in subcutaneous adipose tissue: insights into interindividual variability in adult males.. Food Funct. 2026. PMID:41848742.PMID 41848742 ↗Journal Food FunctYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41848742/
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Observational / other LOW evidence YELLOWSupplemental Lycopene Reduces Feed Intake, Increases Fluid Consumption, and Enhances Bone and Stomach Growth in Growing Wistar Rats Fed a High-Fructose Diet. ↗Shafe MO et al.. Supplemental Lycopene Reduces Feed Intake, Increases Fluid Consumption, and Enhances Bone and Stomach Growth in Growing Wistar Rats Fed a High-Fructose Diet.. J Med Food. 2025. PMID:41870163.PMID 41870163 ↗Journal J Med FoodYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41870163/
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 Lycopene. 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 Lycopene
A score of 2.5 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.