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
Butterbur extract is evidence-supported for migraine prophylaxis. Crude butterbur plant contains hepatotoxic and carcinogenic pyrrolizidine alkaloids (PAs). Only PA-free certified extracts (e.g., Petadolex) should be used. Even with PA-free extracts, cases of hepatotoxicity have been reported, likely from product contamination. Liver function should be monitored with prolonged use. Avoid in liver disease and pregnancy.
Biological and Chemical Classification
- Scientific Name
- Petasites hybridus
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%)
- No significant safety signals identified in the reviewed literature.
The available scientific evidence for Butterbur 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: 06 ივნ 2026, 12:05
Evidence Distribution
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Observational / other LOW evidence YELLOWEfficacy of Petasites hybridus in migraine prophylaxis: the first real-world study. ↗Silva-Nu00e9to RP. Efficacy of Petasites hybridus in migraine prophylaxis: the first real-world study.. Front Neurol. 2026. PMID:41908273.PMID 41908273 ↗Journal Front NeurolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41908273/
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Observational / other LOW evidence YELLOWEvaluation of the antimigraine and anti-neuroinflammatory activity of purified constituents of Petasites hybridus L. in a migraine-like pain model in mice. ↗Kulinowski u0141 et al.. Evaluation of the antimigraine and anti-neuroinflammatory activity of purified constituents of Petasites hybridus L. in a migraine-like pain model in mice.. Inflammopharmacology. 2026. PMID:41555115.PMID 41555115 ↗Journal InflammopharmacologyYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41555115/
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Observational / other LOW evidence YELLOWEfficacy and Safety of P. hybridus Leaf Extract Ze 339 for the Treatment of Allergic Rhinitis. ↗Merk VM et al.. Efficacy and Safety of P. hybridus Leaf Extract Ze 339 for the Treatment of Allergic Rhinitis.. Adv Respir Med. 2025. PMID:40558112.PMID 40558112 ↗Journal Adv Respir MedYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40558112/
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Observational / other LOW evidence YELLOWEvidence for a Functional Link Between the Nrf2 Signalling Pathway and Cytoprotective Effect of S-Petasin in Human Retinal Pigment Epithelium Cells Exposed… ↗Pizzoferrato M et al.. Evidence for a Functional Link Between the Nrf2 Signalling Pathway and Cytoprotective Effect of S-Petasin in Human Retinal Pigment Epithelium Cells Exposed to Oxidative Stress.. Antioxidants (Basel). 2025. PMID:40002367.PMID 40002367 ↗Journal Antioxidants (Basel)Year 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40002367/
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Observational / other LOW evidence YELLOWGreen Synthesis of New Derivatives of Iminothiazole Using Cefixime and Removing Organic Pollutants from Aqueous Environment by Employing Cu@KF/Clinoptilolite NPs. ↗Zamani-Hargalani F et al.. Green Synthesis of New Derivatives of Iminothiazole Using Cefixime and Removing Organic Pollutants from Aqueous Environment by Employing Cu@KF/Clinoptilolite NPs.. Comb Chem High Throughput Screen. 2025. PMID:39377406.PMID 39377406 ↗Journal Comb Chem High Throughput ScreenYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/39377406/
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Observational / other LOW evidence YELLOWEfficacy and Safety of Phytotherapy and Anthroposophic Medicine in Seasonal Allergic Rhinitis: A Systematic Review. ↗Braunwalder C et al.. Efficacy and Safety of Phytotherapy and Anthroposophic Medicine in Seasonal Allergic Rhinitis: A Systematic Review.. Int Arch Allergy Immunol. 2025. PMID:39084196.PMID 39084196 ↗Journal Int Arch Allergy ImmunolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/39084196/
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Observational / other LOW evidence YELLOWTotal phenolic content, flavonoid content and antioxidant potential of Petasites hybridus and related species from Croatia and considerations regarding their pharmaceutical significance. ↗Friu0161u010diu0107 M et al.. Total phenolic content, flavonoid content and antioxidant potential of Petasites hybridus and related species from Croatia and considerations regarding their pharmaceutical significance.. Acta Pharm. 2024. PMID:39560317.PMID 39560317 ↗Journal Acta PharmYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/39560317/
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Observational / other LOW evidence YELLOWMedicinal plants for allergic rhinitis: A systematic review and meta-analysis. ↗Lim XY et al.. Medicinal plants for allergic rhinitis: A systematic review and meta-analysis.. PLoS One. 2024. PMID:38603736.PMID 38603736 ↗Journal PLoS OneYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/38603736/
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Observational / other LOW evidence YELLOWInhibition of SARS-CoV-2 infection and replication by Petasites hybridus CO2-extract (Ze 339). ↗Jakwerth CA et al.. Inhibition of SARS-CoV-2 infection and replication by Petasites hybridus CO2-extract (Ze 339).. Biomed Pharmacother. 2024. PMID:38061134.PMID 38061134 ↗Journal Biomed PharmacotherYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/38061134/
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Observational / other LOW evidence YELLOWA Standardized Extract of Petasites hybridus L., Containing the Active Ingredients Petasins, Acts as a Pro-Oxidant and Triggers Apoptosis through Elevating of… ↗Apostolova S et al.. A Standardized Extract of Petasites hybridus L., Containing the Active Ingredients Petasins, Acts as a Pro-Oxidant and Triggers Apoptosis through Elevating of NF-u03baB in a Highly Invasive Human Breast Cancer Cell Line.. Front Biosci (Landmark Ed). 2023. PMID:37395030.PMID 37395030 ↗Journal Front Biosci (Landmark Ed)Year 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/37395030/
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 Butterbur 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 moderate safety concern. Caution is advised, particularly at high doses or in sensitive populations.
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 Moderate classification for Butterbur Extract
A score of 4.0 places this ingredient in the Moderate 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.