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
Fumitory (Fumaria officinalis) is a traditional European herb with choleretic and hepatobiliary actions used for bile duct spasms, liver congestion, and eczema. It contains isoquinoline alkaloids (protopine, fumaricine). Generally used at low doses for short periods. At high doses, alkaloid content may cause bradycardia and hypotension. Not recommended in biliary obstruction. Contraindicated in pregnancy (uterotonic alkaloids). Long-term high-dose use not established as safe.
Biological and Chemical Classification
- Scientific Name
- Fumaria officinalis
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 Fumitory 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 | 9/10 |
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 აპრ 2026, 12:10
Evidence Distribution
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Observational / other LOW evidence YELLOWDown-regulation of biofilm formation genes expression on some gram-negative bacteria by Fumaria officinalis extract. ↗Abdulsattar BO et al.. Down-regulation of biofilm formation genes expression on some gram-negative bacteria by Fumaria officinalis extract.. J Microbiol Methods. 2026. PMID:41871690.PMID 41871690 ↗Journal J Microbiol MethodsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41871690/
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Observational / other LOW evidence YELLOWHierarchical Porous Nickel Oxide Nanoparticles with High Specific Surface Area by Green Synthesis. ↗Khalugarova K et al.. Hierarchical Porous Nickel Oxide Nanoparticles with High Specific Surface Area by Green Synthesis.. Micromachines (Basel). 2026. PMID:41753814.PMID 41753814 ↗Journal Micromachines (Basel)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41753814/
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Observational / other LOW evidence YELLOWPlant-Derived Treatments for IBS: Clinical Outcomes, Mechanistic Insights, and Their Position in International Guidelines. ↗Pastras P et al.. Plant-Derived Treatments for IBS: Clinical Outcomes, Mechanistic Insights, and Their Position in International Guidelines.. Nutrients. 2026. PMID:41599795.PMID 41599795 ↗Journal NutrientsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41599795/
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Observational / other LOW evidence YELLOWFumaria officinalis: Phytochemical complexity and its medicinal significance. ↗Prokopenko Y et al.. Fumaria officinalis: Phytochemical complexity and its medicinal significance.. Fitoterapia. 2025. PMID:40763876.PMID 40763876 ↗Journal FitoterapiaYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40763876/
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Observational / other LOW evidence YELLOWResponse Surface Methodology-Based Extraction of Fumaric Acid From Fumaria officinalis L. and Quantification by RP-HPLC. ↗Mammadova G et al.. Response Surface Methodology-Based Extraction of Fumaric Acid From Fumaria officinalis L. and Quantification by RP-HPLC.. Biomed Chromatogr. 2025. PMID:40693429.PMID 40693429 ↗Journal Biomed ChromatogrYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40693429/
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Observational / other LOW evidence YELLOWAnti-inflammatory potential of isoquinoline alkaloids from Fumaria officinalis: in vitro, in vivo, and in silico evaluation. ↗Yahiaoui S et al.. Anti-inflammatory potential of isoquinoline alkaloids from Fumaria officinalis: in vitro, in vivo, and in silico evaluation.. J Comput Aided Mol Des. 2025. PMID:40650686.PMID 40650686 ↗Journal J Comput Aided Mol DesYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40650686/
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Observational / other LOW evidence YELLOWNano-Liposomal Carrier as Promising Dermal Delivery Platform for Fumaria officinalis L. Bioactives. ↗Ahmoda RA et al.. Nano-Liposomal Carrier as Promising Dermal Delivery Platform for Fumaria officinalis L. Bioactives.. Pharmaceutics. 2025. PMID:40574093.PMID 40574093 ↗Journal PharmaceuticsYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40574093/
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Observational / other LOW evidence YELLOWRETRACTION: The Pyrethroid Insecticide Permethrin Confers Hepatotoxicity Through DNA Damage and Mitochondria-Associated Apoptosis Induction in Rat: Palliative Benefits of Fumaria Officinalis. ↗RETRACTION: The Pyrethroid Insecticide Permethrin Confers Hepatotoxicity Through DNA Damage and Mitochondria-Associated Apoptosis Induction in Rat: Palliative Benefits of Fumaria Officinalis.. J Biochem Mol Toxicol. 2025. PMID:40275771.PMID 40275771 ↗Journal J Biochem Mol ToxicolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40275771/
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Observational / other LOW evidence YELLOWWhether pistil show diversity in bisymmetric and zygomorphic flowers in Fumarioideae (Papaveraceae): especially focus on stigma development, structure and secondary pollen presentation. ↗Zhang MY et al.. Whether pistil show diversity in bisymmetric and zygomorphic flowers in Fumarioideae (Papaveraceae): especially focus on stigma development, structure and secondary pollen presentation.. Protoplasma. 2025. PMID:40227452.PMID 40227452 ↗Journal ProtoplasmaYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40227452/
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Observational / other LOW evidence YELLOWFumaria officinalis Dust as a Source of Bioactives for Potential Dermal Application: Optimization of Extraction Procedures, Phytochemical Profiling, and Effects Related to… ↗Ahmoda RA et al.. Fumaria officinalis Dust as a Source of Bioactives for Potential Dermal Application: Optimization of Extraction Procedures, Phytochemical Profiling, and Effects Related to Skin Health Benefits.. Plants (Basel). 2025. PMID:39942914.PMID 39942914 ↗Journal Plants (Basel)Year 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/39942914/
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 Fumitory. 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 Fumitory
A score of 3.5 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.