Safety Profile
Known Safety Concerns
- GI upset at high doses
- Interaction with BPH medications
- Tree bark sustainability concerns -- over-harvested species
Contraindications
- GI upset at high doses
- Interaction with BPH medications
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Pygeum africanum bark extract is used for benign prostatic hyperplasia (BPH) and prostate health. Contains phytosterols, pentacyclic triterpenoids, and ferulic acid esters. Generally well-tolerated. Mild GI effects at high doses. Interacts with finasteride and other 5-alpha reductase inhibitors.
Biological and Chemical Classification
- Scientific Name
- Pygeum africanum (Prunus africana)
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%)
- GI upset at high doses
- Interaction with BPH medications
- Tree bark sustainability concerns -- over-harvested species
The available scientific evidence for Pygeum 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: 25 მარ 2026, 22:28
Evidence Distribution
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Observational / other LOW evidence YELLOWA Multi-Target Phytotherapeutic Approach to Benign Prostatic Hyperplasia: Preclinical Characterization of a PhytoBPH-Mix. ↗Amante C et al.. A Multi-Target Phytotherapeutic Approach to Benign Prostatic Hyperplasia: Preclinical Characterization of a PhytoBPH-Mix.. Nutrients. 2026. PMID:41754167.PMID 41754167 ↗Journal NutrientsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41754167/
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Observational / other LOW evidence YELLOWOral Supplementation with l-Cystine, Serenoa repens, Cucurbita pepo, and Pygeum africanum in Chronic Telogen Effluvium and Androgenetic Alopecia: A Double-Blind, Placebo-Controlled, Randomized… ↗Piquero-Casals J et al.. Oral Supplementation with l-Cystine, Serenoa repens, Cucurbita pepo, and Pygeum africanum in Chronic Telogen Effluvium and Androgenetic Alopecia: A Double-Blind, Placebo-Controlled, Randomized Clinical Study.. Skin Appendage Disord. 2025. PMID:39911983.PMID 39911983 ↗Journal Skin Appendage DisordYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/39911983/
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Observational / other LOW evidence YELLOWAnti-Inflammatory Potential of Pygeum africanum Bark Extract: An In Vitro Study of Cytokine Release by Lipopolysaccharide-Stimulated Human Peripheral Blood Mononuclear Cells. ↗Villar A et al.. Anti-Inflammatory Potential of Pygeum africanum Bark Extract: An In Vitro Study of Cytokine Release by Lipopolysaccharide-Stimulated Human Peripheral Blood Mononuclear Cells.. Int J Mol Sci. 2024. PMID:39125867.PMID 39125867 ↗Journal Int J Mol SciYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/39125867/
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Observational / other LOW evidence YELLOWBenign Prostatic Hyperplasia: Rapid Evidence Review. ↗Arnold MJ et al.. Benign Prostatic Hyperplasia: Rapid Evidence Review.. Am Fam Physician. 2023. PMID:37327163.PMID 37327163 ↗Journal Am Fam PhysicianYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/37327163/
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Observational / other LOW evidence YELLOWNatural Compounds Used for Treating Hair Loss. ↗Gasmi A et al.. Natural Compounds Used for Treating Hair Loss.. Curr Pharm Des. 2023. PMID:37151166.PMID 37151166 ↗Journal Curr Pharm DesYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/37151166/
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Observational / other LOW evidence YELLOWRole of Phytotherapy in the Management of BPH: A Summary of the Literature. ↗Antoniou V et al.. Role of Phytotherapy in the Management of BPH: A Summary of the Literature.. J Clin Med. 2023. PMID:36902686.PMID 36902686 ↗Journal J Clin MedYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/36902686/
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Observational / other LOW evidence YELLOWThe African cherry: A review of the botany, traditional uses, phytochemistry, and biological activities of Prunus africana (Hook.f.) Kalkman. ↗Rubegeta E et al.. The African cherry: A review of the botany, traditional uses, phytochemistry, and biological activities of Prunus africana (Hook.f.) Kalkman.. J Ethnopharmacol. 2023. PMID:36535336.PMID 36535336 ↗Journal J EthnopharmacolYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/36535336/
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Observational / other LOW evidence YELLOWA UPLC- MS/MS Method to Quantify u03b2-Sitosterol and Ferulic Acid of Pygeum Africanum Extract in Bulk and Pharmaceutical Preparation. ↗Samir H et al.. A UPLC- MS/MS Method to Quantify u03b2-Sitosterol and Ferulic Acid of Pygeum Africanum Extract in Bulk and Pharmaceutical Preparation.. J Chromatogr Sci. 2023. PMID:36097799.PMID 36097799 ↗Journal J Chromatogr SciYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/36097799/
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Observational / other LOW evidence YELLOWChanges in the Mechanical Properties of Alginate-Gelatin Hydrogels with the Addition of Pygeum africanum with Potential Application in Urology. ↗Kurowiak J et al.. Changes in the Mechanical Properties of Alginate-Gelatin Hydrogels with the Addition of Pygeum africanum with Potential Application in Urology.. Int J Mol Sci. 2022. PMID:36142228.PMID 36142228 ↗Journal Int J Mol SciYear 2022Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/36142228/
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Observational / other LOW evidence YELLOW[Effectiveness of treatment with Pygeum africanum in patients with lower urinary tract symptoms and benign prostatic hyperplasia: a cross-sectional study in the… ↗Cambronero J et al.. [Effectiveness of treatment with Pygeum africanum in patients with lower urinary tract symptoms and benign prostatic hyperplasia: a cross-sectional study in the real-world clinical practice in Spain (The PROFIT Study)].. Arch Esp Urol. 2022. PMID:35435166.PMID 35435166 ↗Journal Arch Esp UrolYear 2022Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/35435166/
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 Pygeum. 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 Pygeum
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.