Saw palmetto (Serenoa repens)

Dietary supplements and phytotherapeutics, sabal palm fruit extracts (local classification)

ATC code: A11JA-SAW-PALMETTO

Brand names – drugs: Permixon, Prostagutt

Brand names – supplements: Saw Palmetto Now FoodsSupplements are not tested in clinical trials and are not registered as medications.

Updated 24 Sep 2026 · Methodology

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Androgenetic alopecia

Not recommended

Over the past 10 years saw palmetto has been marketed as a «natural finasteride» for androgenetic alopecia. Five to seven small RCTs (Prager 2002, Rossi 2012) totaling about 350 participants show modest hair density gains of 20–40 hairs/cm² at 6–12 months. Head-to-head comparisons with finasteride (Rossi 2012, n=100) show finasteride is substantially more effective. and BAD guidelines for androgenetic alopecia do not include saw palmetto.

Sources

ICD-10: L64 · ICD-11: ED70.0

Benign prostatic hyperplasia

Not recommended

Saw palmetto has been marketed for decades as a herbal remedy for benign prostatic hyperplasia. The largest Cochrane update 2012 (Tacklind, 32 RCTs, n=5666) showed no significant benefit over placebo on urinary symptoms (IPSS score), post-void residual urine volume, or maximum flow rate. STEP (n=225) and CAMUS (n=369) trials also showed no effect. AUA 2021 guidelines classify saw palmetto as «failed to demonstrate efficacy» – not recommended. EAU 2023 guidelines permit Permixon extract as an option for mild symptoms.

Sources

ICD-10: N40 · ICD-11: GA90

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

Saw palmetto is the extract of dwarf palm Serenoa repens fruit. Active components include free fatty acids, phytosterols, and flavonoids. Cellular models describe weak inhibition of 5α-reductase types 1 and 2, antiandrogenic effects, and anti-inflammatory activity. In humans, the effect on serum dihydrotestosterone is less pronounced than with pharmacological 5α-reductase inhibitors (finasteride, dutasteride).

Safety

Contraindications

Pregnancy
Breastfeeding
Age under 18
Hypersensitivity
Liver disease

Serious adverse effects

Drug-induced liver injury (DILI) – rare
Bleeding when combined with anticoagulants (theoretical risk)

Common adverse effects

GI discomfort, nausea
Headache
Decreased libido (rare)

Pregnancy: can you take Saw palmetto (Serenoa repens)?

Contraindicated in pregnancy: antiandrogenic effect is potentially harmful to the male fetus.

Breastfeeding: can you take Saw palmetto (Serenoa repens)?

Not recommended during breastfeeding.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

In Russia, some extracts (Prostamol Uno, Prostaplant, Permixon) are registered as medicinal products, others sold as supplements. Marketing dose is 320 mg once daily, retail 800–2500 ₽/month. Extract quality matters: lipophilic extracts (CO2 or hexane extraction) differ from aqueous extracts in fatty acid composition. Most RCTs studied the lipophilic Permixon specifically.

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Frequently asked

What is Saw palmetto (Serenoa repens) used for?

Saw palmetto (Serenoa repens) is evaluated for the following indications with varying evidence strength: Benign prostatic hyperplasia (evidence tier D), Androgenetic alopecia (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Saw palmetto (Serenoa repens)?

Common side effects of Saw palmetto (Serenoa repens) (≥ 1 in 100): GI discomfort, nausea, Headache, Decreased libido (rare). See the Safety section for uncommon and serious reactions.

Is Saw palmetto (Serenoa repens) safe during pregnancy?

Contraindicated in pregnancy: antiandrogenic effect is potentially harmful to the male fetus.

Is Saw palmetto (Serenoa repens) compatible with breastfeeding?

Not recommended during breastfeeding.

Who should not take Saw palmetto (Serenoa repens)?

Saw palmetto (Serenoa repens) is contraindicated in: Pregnancy; Breastfeeding; Age under 18; Hypersensitivity; Liver disease. Full list in the Safety section.

Other drugs in this group

Schisandra chinensis (magnolia berry), Sea buckthorn, Silicon (organic silicon, silica from horsetail or bamboo), Spermidine, Vitex agnus-castus (chasteberry, monk's pepper), Chlorella, Indole-3-carbinol (I3C), Omega-9 monounsaturated fatty acid (oleic acid)