ოთხშაბათი, აპრილი 15, 2026
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Global Ingredient Risk Index Hormonal

Saw Palmetto

Serenoa repens

Also known as: Serenoa repens, Sabal serrulata, American dwarf palm, Cabbage palm, Saw palmetto berry

LOW RISK 3.0/10 How?

Evidence Strength: MODERATE

This ingredient is classified as unclassified risk (GIRI score: 3.0/10). The score reflects 1 active safety or regulatory signal recorded in the monitoring database.

02

Safety Profile

Common Adverse Effects

  • Nausea
  • headache
  • dizziness
  • constipation
  • diarrhea

Serious Adverse Effects

  • Liver damage
  • pancreatitis
  • bleeding disorders

Contraindications

  • Liver disease
  • bleeding disorders
  • hormone-sensitive cancers
  • People taking Warfarin
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03

Interactions

Drug / Nutrient Interaction Mechanism Warning
Warfarin increased bleeding risk — monitor INR closely. Finasteride: additive effects — use with caution. Oral contraceptives: potential hormonal interference — consult healthcare provider. Monitor
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04

Evidence and Scientific Findings

Overview

Ingredient Overview

Saw Palmetto, derived from the berries of the Serenoa repens plant, is commonly used in dietary supplements for its potential benefits in supporting prostate health. It is native to the southeastern United States and has been traditionally used by Native Americans for urinary and reproductive issues. In modern supplements, Saw Palmetto is primarily marketed for benign prostatic hyperplasia (BPH) and hair loss prevention.
Classification

Biological and Chemical Classification

Chemical Class
Fatty acids and sterols
Biological Class
Phytosterol
Natural Source
Serenoa repens berries
Scientific Name
Serenoa repens
Chemical Formula
C30H50O
CAS Number
84604-15-9
Mechanism

Mechanism of Action

Saw Palmetto is believed to inhibit the enzyme 5-alpha-reductase, which converts testosterone to dihydrotestosterone (DHT), a hormone linked to prostate enlargement. It may also block DHT from binding to androgen receptors. Additionally, Saw Palmetto exhibits anti-inflammatory properties by inhibiting cyclooxygenase and lipoxygenase pathways, reducing prostatic inflammation.
Clinical Evidence

Clinical Evidence of Effectiveness

Indication Evidence Level Summary
General Moderate Clinical studies on Saw Palmetto have shown mixed results. Some trials suggest modest improvements in urinary symptoms associated with BPH, while others show no significant benefit compared to placebo. The variability in outcomes may be due to differences in study design, dosage, and extract standardization. Overall, the evidence is considered moderate, with some support for its use in mild to moderate BPH.
Evidence levels: Strong Moderate Limited Experimental
Pharmacokinetics

Pharmacokinetics

Absorption
Saw Palmetto is absorbed in the gastrointestinal tract, with peak plasma concentrations typically reached within 1-2 hours after oral administration. The bioavailability can vary based on the formulation, with lipid-soluble extracts generally showing better absorption.
Distribution
The distribution of Saw Palmetto's active components is not well-characterized, but it is thought to have a moderate volume of distribution. It is likely to bind to plasma proteins, although specific binding data is limited.
Metabolism
Saw Palmetto is metabolized primarily in the liver, involving cytochrome P450 enzymes. Its metabolites are not well-defined, but the process likely involves oxidation and conjugation pathways.
Excretion
Excretion of Saw Palmetto occurs mainly through the feces, with a smaller portion eliminated via the urine. The exact elimination half-life is not well-documented but is believed to be relatively short.
Dosage

Recommended Dosage

Condition / Use Typical Dose
BPH 160 mg twice daily. Hair loss: 200-320 mg daily. General prostate health: 160-320 mg daily.

Dosage ranges are based on clinical studies and commonly used supplement formulations. Individual requirements may vary.

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05

SETI — Scientific Evidence Transparency Index

SETI Score 49/100
Risk Level High risk
Scientific Confidence Low
Evidence Strength Limited
Key Benefit Saw Palmetto, derived from the berries of the Serenoa repens plant, is commonly used in dietary supplements for…
Key Safety Concern Saw Palmetto is generally considered safe for most adults when used at recommended doses. However, it may pose risks for individuals with liver disease or bleeding disorders due to its potential to affect liver enzymes and platelet function. Pregnant or breastfeeding women should avoid use due to insufficient safety data. Regulatory agencies have not issued significant warnings, but caution is advised in patients with hormone-sensitive conditions.
Evidence Reviewed 10 PubMed studies
Scientific Confidence Low
Based on study quality, consistency, and recency

Executive Summary — Ingredient Assessment

SETI Score 49/100
Risk Level High risk
Evidence Strength Limited
Main Benefit Saw Palmetto, derived from the berries of the Serenoa repens plant, is commonly used in dietary supplements for…
Main Safety Concern Saw Palmetto is generally considered safe for most adults when used at recommended doses. However, it may pose risks for individuals with liver disease or bleeding disorders due to its potential to affect liver enzymes and platelet function. Pregnant or breastfeeding women should avoid use due to insufficient safety data. Regulatory agencies have not issued significant warnings, but caution is advised in patients with hormone-sensitive conditions.
Ingredient Saw Palmetto
Scientific name Serenoa repens
Scientific Evidence Overview
  • 10 studies reviewed
  • 0 high-quality studies (meta-analysis or RCT)
  • Main clinical benefit observed: Saw Palmetto, derived from the berries of the Serenoa repens plant, is commonly used in dietary supplements for…
  • Evidence consistency: High consistency across studies (100%)
Safety Signals
  • Saw Palmetto is generally considered safe for most adults when used at recommended doses. However, it may pose risks for individuals with liver disease or bleeding disorders due to its potential to affect liver enzymes and platelet function. Pregnant or breastfeeding women should avoid use due to insufficient safety data. Regulatory agencies have not issued significant warnings, but caution is advised in patients with hormone-sensitive conditions.
Evidence Strength Limited
Regulatory Status
  • USA/FDA — Approved
Final Scientific Assessment

The available scientific evidence for Saw Palmetto indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.

Ingredient Saw Palmetto
Evidence reviewed 10 peer-reviewed studies (last 10 years)
Scientific name Serenoa repens
49 /100

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: 15 აპრ 2026, 19:05

Evidence Distribution

10 Other / unclassified
  1. Observational / other LOW evidence YELLOW
    A Multi-Target Phytotherapeutic Approach to Benign Prostatic Hyperplasia: Preclinical Characterization of a PhytoBPH-Mix. ↗
    PMID 41754167 ↗
    Journal Nutrients
    Year 2026
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/41754167/
    Amante C et al.. A Multi-Target Phytotherapeutic Approach to Benign Prostatic Hyperplasia: Preclinical Characterization of a PhytoBPH-Mix.. Nutrients. 2026. PMID:41754167.
  2. Observational / other LOW evidence YELLOW
    Investigating the Neuroprotective Effects of Saw Palmetto Fruit Extract Against D-Galactose and Aluminum Chloride Induced Alzheimer's Disease: In Vivo Study. ↗
    PMID 41701395 ↗
    Journal Neurochem Res
    Year 2026
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/41701395/
    Nisar A et al.. Investigating the Neuroprotective Effects of Saw Palmetto Fruit Extract Against D-Galactose and Aluminum Chloride Induced Alzheimer's Disease: In Vivo Study.. Neurochem Res. 2026. PMID:41701395.
  3. Observational / other LOW evidence YELLOW
    Correction to "[Efficacy of Serenoa repens Extract Combined With Alfuzosin Versus Alfuzosin Alone in Men With Lower Urinary Tract Symptoms Due to… ↗
    PMID 41664556 ↗
    Journal Prostate
    Year 2026
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/41664556/
    Correction to "[Efficacy of Serenoa repens Extract Combined With Alfuzosin Versus Alfuzosin Alone in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Multicenter Randomized Study (The Prostate, 2025). https://doi.org/10.1002/pros.70071]".. Prostate. 2026. PMID:41664556.
  4. Observational / other LOW evidence YELLOW
    The Safety and Efficacy of a Novel Saw Palmetto (Serenoa repens) Extract for Promoting Hair Growth in Adults With Self-Perceived Thinning Hair:… ↗
    PMID 41652806 ↗
    Journal J Cosmet Dermatol
    Year 2026
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/41652806/
    Ablon G. The Safety and Efficacy of a Novel Saw Palmetto (Serenoa repens) Extract for Promoting Hair Growth in Adults With Self-Perceived Thinning Hair: 180-Day Results.. J Cosmet Dermatol. 2026. PMID:41652806.
  5. Observational / other LOW evidence YELLOW
    Novel therapeutic potential of Serenoa repens in rat PCOS: Insights from network pharmacology and in vivo studies. ↗
    PMID 41628869 ↗
    Journal J Ethnopharmacol
    Year 2026
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/41628869/
    Taha AM et al.. Novel therapeutic potential of Serenoa repens in rat PCOS: Insights from network pharmacology and in vivo studies.. J Ethnopharmacol. 2026. PMID:41628869.
  6. Observational / other LOW evidence YELLOW
    Can we identify a post-Serenoa syndrome (PSS)? A case series on sexual and psychiatric side effects of Serenoa repens. ↗
    PMID 41507085 ↗
    Journal Br J Clin Pharmacol
    Year 2026
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/41507085/
    Firenzuoli F et al.. Can we identify a post-Serenoa syndrome (PSS)? A case series on sexual and psychiatric side effects of Serenoa repens.. Br J Clin Pharmacol. 2026. PMID:41507085.
  7. Observational / other LOW evidence YELLOW
    A proprietary lipidosterolic extract of Serenoa repens promotes hair growth through mechanisms that extend beyond 5-alpha reductase inhibition: Insights from human hair… ↗
    PMID 41126502 ↗
    Journal Int J Cosmet Sci
    Year 2026
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/41126502/
    Broadley D et al.. A proprietary lipidosterolic extract of Serenoa repens promotes hair growth through mechanisms that extend beyond 5-alpha reductase inhibition: Insights from human hair follicle organ culture.. Int J Cosmet Sci. 2026. PMID:41126502.
  8. Observational / other LOW evidence YELLOW
    Botanical drug preparations for alleviating hair loss in menopausal women: a global ethnopharmacological mini-review. ↗
    PMID 41383467 ↗
    Journal Front Pharmacol
    Year 2025
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/41383467/
    Huang Z et al.. Botanical drug preparations for alleviating hair loss in menopausal women: a global ethnopharmacological mini-review.. Front Pharmacol. 2025. PMID:41383467.
  9. Observational / other LOW evidence YELLOW
    The Safety and Efficacy of a Proprietary Bioactive Fatty Acids Extract From Saw Palmetto (Serenoa repens) for Promoting Hair Growth and Reducing… ↗
    PMID 41319217 ↗
    Journal J Cosmet Dermatol
    Year 2025
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/41319217/
    Ablon G. The Safety and Efficacy of a Proprietary Bioactive Fatty Acids Extract From Saw Palmetto (Serenoa repens) for Promoting Hair Growth and Reducing Hair Loss in Adults With Self-Perceived Thinning Hair: 90-Day Results.. J Cosmet Dermatol. 2025. PMID:41319217.
  10. Observational / other LOW evidence YELLOW
    Non-interventional and medical management of lower urinary tract symptoms related to benign prostatic hyperplasia in men: Guidelines of the French LUTS Committee… ↗
    PMID 41271371 ↗
    Journal Fr J Urol
    Year 2025
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/41271371/
    Anract J et al.. Non-interventional and medical management of lower urinary tract symptoms related to benign prostatic hyperplasia in men: Guidelines of the French LUTS Committee (CTMH).. Fr J Urol. 2025. PMID:41271371.
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06

Score Transparency

Q × L × D × S × 10 = 3.0 / 10

The GIRI Score is the product of four independently computed evidence components, each normalised to 0–1, then scaled to 0–10. Every component is derived exclusively from peer-reviewed references and regulatory data — no editorial judgement is applied.

Q
Evidence Quantity 0 / 10
0%

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)

L
Evidence Quality 5 / 10
50%

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.

D
Evidence Direction 5 / 10
Benefit
Risk
50%

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.

S
Safety Signals 5 / 10
50%

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.

0Q × 5L × 5D × 5S = 3.0 / 10

Final GIRI Score for Saw Palmetto. 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.
07

Risk Level Classification

LOW RISK 3.0/10

Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.

LOW
0–3.0
MODERATE
3.0–5.5
HIGH
5.5–7.5
CRITICAL
7.5–10
3.0

The score pin shows exactly where this ingredient falls on the fixed risk scale.

What drove the Low classification for Saw Palmetto

GIRI Score 3.0 / 10

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.

Evidence Quantity (Q) 0 / 10 refs

0 approved references.

Evidence Quality (L) 50%

Limited — mostly case reports or animal studies (Level 4–5).

Evidence Direction (D) 50% toward risk

Neutral or mixed — benefit and risk signals roughly balanced.

Safety Signals (S) 1 active signal

1 active signal (highest severity: Moderate). Each active signal raises S above the neutral baseline of 0.5.

Regulatory Status 1 jurisdiction with restrictions

1 jurisdiction has active restrictions or advisories. Regulatory signals are recorded as Safety Signals and raise the S component.

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:

LevelScoreMeaning
LOW0.0 – 2.9Sparse or predominantly beneficial evidence. No active safety alerts.
MODERATE3.0 – 5.4Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups.
HIGH5.5 – 7.4Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended.
CRITICAL7.5 – 10Regulatory 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.

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