Lion’s Mane Mushroom Extract
Hericium erinaceus
Also known as: Yamabushitake, Monkey head mushroom, Hericium erinaceus extract
This ingredient is classified as unclassified risk (GIRI score: 2.0/10).
Safety Profile
Information not yet available for this ingredient profile.
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Lion’s Mane mushroom is used for cognitive support and nerve growth factor stimulation. Human clinical data is limited but it appears well tolerated in most people. Rare cases of allergic reactions including respiratory distress have been reported. It may interact with blood thinners and diabetes medications. Avoid in those with mushroom allergies.
Biological and Chemical Classification
- Scientific Name
- Hericium erinaceus
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: Nootropics
- Evidence consistency: High consistency across studies (100%)
- No significant safety signals identified in the reviewed literature.
The available scientific evidence for Lion’s Mane Mushroom Extract 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: 26 მარ 2026, 14:01
Evidence Distribution
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Observational / other LOW evidence YELLOWPeripheral nerve regeneration and synergistic pharmacology using Hericium erinaceus, lithium, and vitamin B12: The triple neuromodulatory axis hypothesis. ↗Radanoviu0107 D et al.. Peripheral nerve regeneration and synergistic pharmacology using Hericium erinaceus, lithium, and vitamin B12: The triple neuromodulatory axis hypothesis.. Int J Clin Pharmacol Ther. 2026. PMID:41878942.PMID 41878942 ↗Journal Int J Clin Pharmacol TherYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41878942/
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Observational / other LOW evidence YELLOWComparative proteomic analysis reveals the effects of different light spectra on protein expression in Hericium erinaceus mycelium. ↗Sukdee S et al.. Comparative proteomic analysis reveals the effects of different light spectra on protein expression in Hericium erinaceus mycelium.. Front Fungal Biol. 2026. PMID:41878355.PMID 41878355 ↗Journal Front Fungal BiolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41878355/
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Observational / other LOW evidence YELLOWImpact of Ginger Straw on Cultivation and Quality of Pleurotus geesteranus and Hericium erinaceus. ↗Zhang Y et al.. Impact of Ginger Straw on Cultivation and Quality of Pleurotus geesteranus and Hericium erinaceus.. Foods. 2026. PMID:41829170.PMID 41829170 ↗Journal FoodsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41829170/
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Observational / other LOW evidence YELLOWu03b2-Glucan-rich Hericium erinaceus hot-water extract ameliorates acute colitis by suppressing inflammation, preserving the epithelial barrier, and modulating gut microbiota ecosystem. ↗Yu H et al.. u03b2-Glucan-rich Hericium erinaceus hot-water extract ameliorates acute colitis by suppressing inflammation, preserving the epithelial barrier, and modulating gut microbiota ecosystem.. Int J Biol Macromol. 2026. PMID:41819322.PMID 41819322 ↗Journal Int J Biol MacromolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41819322/
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Observational / other LOW evidence YELLOWChemistry and bioactivities of erinacines from Hericium fungi. ↗Amen Y et al.. Chemistry and bioactivities of erinacines from Hericium fungi.. J Nat Med. 2026. PMID:41801298.PMID 41801298 ↗Journal J Nat MedYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41801298/
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Observational / other LOW evidence YELLOWEfficacy of Combined Hericium erinaceus Mycelium and Undenatured Type II Collagen in Reducing Osteoarthritis Progression in a Preclinical Animal Model. ↗Lee KT et al.. Efficacy of Combined Hericium erinaceus Mycelium and Undenatured Type II Collagen in Reducing Osteoarthritis Progression in a Preclinical Animal Model.. Int J Med Sci. 2026. PMID:41799751.PMID 41799751 ↗Journal Int J Med SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41799751/
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Observational / other LOW evidence YELLOWStrategic ultrasonic degradation enhances immunomodulatory and hypolipidemic activities of Hericium Erinaceus u03b2-glucan. ↗Wu D et al.. Strategic ultrasonic degradation enhances immunomodulatory and hypolipidemic activities of Hericium Erinaceus u03b2-glucan.. Int J Biol Macromol. 2026. PMID:41780782.PMID 41780782 ↗Journal Int J Biol MacromolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41780782/
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Observational / other LOW evidence YELLOWMultiscale interaction of Hericium coralloides polysaccharide with maize starch: Impact on structural properties and digestibility. ↗Wang W et al.. Multiscale interaction of Hericium coralloides polysaccharide with maize starch: Impact on structural properties and digestibility.. Int J Biol Macromol. 2026. PMID:41724293.PMID 41724293 ↗Journal Int J Biol MacromolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41724293/
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Observational / other LOW evidence YELLOWFungal extracts influence lifespan and immune responses in the Carniolan honey bee (Apis mellifera carnica, Pollmann 1879). ↗Ansaloni LS et al.. Fungal extracts influence lifespan and immune responses in the Carniolan honey bee (Apis mellifera carnica, Pollmann 1879).. Sci Rep. 2026. PMID:41714705.PMID 41714705 ↗Journal Sci RepYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41714705/
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Observational / other LOW evidence YELLOWTherapeutic potential of combination medicinal mushrooms (NevG) in ischemic stroke: correlating motor function, cognitive recovery, and hippocampal integrity in MCAO rats. ↗Athirah Azlan N et al.. Therapeutic potential of combination medicinal mushrooms (NevG) in ischemic stroke: correlating motor function, cognitive recovery, and hippocampal integrity in MCAO rats.. Front Pharmacol. 2025. PMID:41725907.PMID 41725907 ↗Journal Front PharmacolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41725907/
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 Lion’s Mane Mushroom Extract. 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 Lion’s Mane Mushroom Extract
A score of 2.0 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.