Safety Profile
Known Safety Concerns
- Raw berries/flowers/leaves contain cyanogenic compounds -- must be processed
- Theoretical concern in autoimmune conditions from immune stimulation
- GI distress if improperly prepared or in excess
- May interact with immunosuppressant medications
Contraindications
- Raw berries/flowers/leaves contain cyanogenic compounds -- must be processed
- Theoretical concern in autoimmune conditions from immune stimulation
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Elderberry extracts are used for immune support and cold/flu management. Clinical trials show modest reduction in duration of cold/flu symptoms. Raw elderberries contain cyanogenic glycosides that require heat processing to be safe. Elderberry may stimulate cytokine production, raising theoretical concerns in autoimmune conditions. Generally well tolerated at standard doses.
Biological and Chemical Classification
- Scientific Name
- Sambucus nigra
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%)
- Raw berries/flowers/leaves contain cyanogenic compounds -- must be processed
- Theoretical concern in autoimmune conditions from immune stimulation
- GI distress if improperly prepared or in excess
- May interact with immunosuppressant medications
The available scientific evidence for Elderberry (Sambucus) 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: 23 მარ 2026, 18:48
Evidence Distribution
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Observational / other LOW evidence YELLOWElderberry and Linden Flowers Ethanol-Water Extracts: Extraction Type Effect, Analysis and Biological Activity Determination. ↗Polak B et al.. Elderberry and Linden Flowers Ethanol-Water Extracts: Extraction Type Effect, Analysis and Biological Activity Determination.. Molecules. 2026. PMID:41828765.PMID 41828765 ↗Journal MoleculesYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41828765/
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Observational / other LOW evidence YELLOWChemical Class-Driven Polyphenolic Profiles Shape In Vitro Regenerative Activity of Four Medicinal Plants Relevant to Burn Wound Healing. ↗Rou0219ca OJ et al.. Chemical Class-Driven Polyphenolic Profiles Shape In Vitro Regenerative Activity of Four Medicinal Plants Relevant to Burn Wound Healing.. Pharmaceuticals (Basel). 2026. PMID:41754786.PMID 41754786 ↗Journal Pharmaceuticals (Basel)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41754786/
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Observational / other LOW evidence YELLOWFrom Elderflower to Bioactive Extracts: Phytochemical Characterization and Anti-Inflammatory Activity. ↗Koval M et al.. From Elderflower to Bioactive Extracts: Phytochemical Characterization and Anti-Inflammatory Activity.. Molecules. 2026. PMID:41683541.PMID 41683541 ↗Journal MoleculesYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41683541/
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Observational / other LOW evidence YELLOWElderberry (Sambucus nigra L.): an ethnopharmacological, phytochemical and biological review for a prospective nutraceutical plant. ↗Khalil AM et al.. Elderberry (Sambucus nigra L.): an ethnopharmacological, phytochemical and biological review for a prospective nutraceutical plant.. Inflammopharmacology. 2026. PMID:41665742.PMID 41665742 ↗Journal InflammopharmacologyYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41665742/
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Observational / other LOW evidence YELLOWObservation of climatic parameters and plant phenology in the international phenological garden of Klaipu0117da University Botanic Garden, Lithuania. ↗Klimienu0117 A et al.. Observation of climatic parameters and plant phenology in the international phenological garden of Klaipu0117da University Botanic Garden, Lithuania.. Int J Biometeorol. 2026. PMID:41627525.PMID 41627525 ↗Journal Int J BiometeorolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41627525/
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Observational / other LOW evidence YELLOWComparison of the phenolic and antioxidant potential of five European herbal remedies by effect-directed analysis using offline two-dimensional liquid chromatography-high resolution mass… ↗Hu00e4u00dfler M et al.. Comparison of the phenolic and antioxidant potential of five European herbal remedies by effect-directed analysis using offline two-dimensional liquid chromatography-high resolution mass spectrometry.. Anal Bioanal Chem. 2026. PMID:41603958.PMID 41603958 ↗Journal Anal Bioanal ChemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41603958/
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Observational / other LOW evidence YELLOWCurrent Knowledge and Utilization of Medicinal Plants and Fungi in Northeastern Croatia. ↗Krstin L et al.. Current Knowledge and Utilization of Medicinal Plants and Fungi in Northeastern Croatia.. Plants (Basel). 2026. PMID:41600130.PMID 41600130 ↗Journal Plants (Basel)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41600130/
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Observational / other LOW evidence YELLOWComparative Review of Cardioprotective Potential of Various Parts of Sambucus nigra L., Sambucus williamsii Hance, and Their Products. ↗Olas B. Comparative Review of Cardioprotective Potential of Various Parts of Sambucus nigra L., Sambucus williamsii Hance, and Their Products.. Int J Mol Sci. 2026. PMID:41516333.PMID 41516333 ↗Journal Int J Mol SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41516333/
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Observational / other LOW evidence YELLOWHistorical texts as a potential resource for plant-based antiviral agents against SARS-CoV-2: the example of the Receptarium of Burkhard III von Hallwyl… ↗Vahekeni N et al.. Historical texts as a potential resource for plant-based antiviral agents against SARS-CoV-2: the example of the Receptarium of Burkhard III von Hallwyl from 16th-century Switzerland.. Front Pharmacol. 2025. PMID:41799383.PMID 41799383 ↗Journal Front PharmacolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41799383/
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Observational / other LOW evidence YELLOWExpression of Concern for Interfering with Lipid Raft Association: A Mechanism to Control Influenza Virus Infection By Sambucus nigra [Iran J Pharm… ↗Ijpr EI. Expression of Concern for Interfering with Lipid Raft Association: A Mechanism to Control Influenza Virus Infection By Sambucus nigra [Iran J Pharm Res. 2017; 16 (3): e124953].. Iran J Pharm Res. 2025. PMID:41589548.PMID 41589548 ↗Journal Iran J Pharm ResYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41589548/
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 Elderberry (Sambucus). 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 Elderberry (Sambucus)
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.


