What is it used for?
All subpopulations (associated with the active ingredient Saw palmetto only and not with Saw palmetto liposterolic extract, which is based on non-traditional data)
Traditionally used in Herbal Medicine as a mild diuretic to help relieve symptoms associated with minor urinary tract infections, such as burning sensation and/or frequent urination (Bradley 2006; Blumenthal et al. 2000; Grieve 1971; Felter and Lloyd 1898).
Adult males only (associated with both active ingredients, Saw palmetto or Saw palmetto liposterolic extract)
Used in Herbal Medicine to help relieve the urologic symptoms associated with mild to moderate benign prostatic hyperplasia (BPH) (e.g., weak urine flow/incomplete voiding/frequent daytime/nighttime urination) [Source note 2].
Who does this guide cover?
Adults 18 years and older
How is it taken?
Oral
Which forms are covered?
this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.
Acceptable dosage forms oral use are indicated in the dosage form drop-down list of the source’s list of accepted product forms.
Quantities
All uses
Methods of preparation: Dry, Powdered, Non-Standardized or Standardized* Extracts (Dry extract¹,², Glycerite, Tincture, Fluid extract, Supercritical Fluid Extraction)
1 - 4 grams of dried fruit, per day [Source note 3].
*Note: Optional potency: 70 - 95% total fatty acids.
Urologic symptoms associated with benign prostatic hyperplasia
Methods of preparation: Standardized Extracts (Dry extract¹,², Supercritical Fluid Extraction)
100 - 400 milligrams of liposterolic extract of dried fruit standardized to 70 - 95% total fatty acids, per day [Source note 4].
Notes:
¹Dry extract means that any solvent was evaporated; however, it includes lipidic/liposterolic fractions that are liquid at room temperature.
²Does not include water extracts as water would not be an appropriate solvent to extract the active constituents.
How is it used?
Take with food to minimize gastric disturbance (USP NF-2024; derMarderosian and Beutler 2009).
How long is it used?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Warnings and precautions
All subpopulations
Ask a healthcare professional if symptoms persist or worsen.
Adult males only
Ask a healthcare professional before use to exclude a diagnosis of prostate cancer [Source note 5].
Adult females only
Ask a healthcare professional before use if you are taking oral contraceptives or hormone replacement therapy [Source note 6].
When should it be avoided?
Adult females only
Do not use if you are pregnant, breastfeeding, or attempting to conceive [Source note 7].
Possible side effects
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Storage
Must be established in accordance with the requirements described in the applicable product regulations.
All products (information for industry; not for labelling)
Preserve in tight containers, protected from light [Source note 8].
Conditions for combined preparations
The two active ingredients listed in Table 1 cannot be combined in Class I. However, they may be combined in Class II if the total combined amount of saw palmetto fruit (e.g., Quantity for powdered/dry and/or Quantity crude equivalent (QCE) for extracts) does not exceed 4 grams per day. In order to verify this, the QCE must be provided on the product documentation form or cover letter for standardized Saw palmetto liposterolic extracts.
Preparation details
Ingredient identity, preparation requirements, and other details that define the scope of this guide.
Ingredients and preparations
| Proper name(s) | Common name(s) | Source information / Source material(s) | Source information / Part(s) | Source information / Preparation(s) |
|---|---|---|---|---|
| Serenoa repens |
| Serenoa repens | Fruit | Dry |
| Serenoa repens | Saw palmetto liposterolic extract | Serenoa repens | Fruit | Dry |
References: Proper name: USDA 2024; Common names: USDA 2024, Gardner and McGuffin 2013; Source information: USP-NF 2024, Blumenthal et al. 2000, Mills and Bone 2000.
Other ingredients
Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.
Preparation and quality requirements
The finished product specifications must be established in accordance with the requirements described in the source authority source’s product quality guidance.
The active ingredient must comply with the requirements outlined in the source ingredient database.
Guide change history
Updates to this SupplementSafety.org guide.
Minor updates
Updated guide wording, organization, and source presentation. Added our editorial change history.
Initial release
Initial SupplementSafety.org guide prepared from source reference material.
Validation: Not yet completed. Editorial updates do not constitute clinical validation.
Sources
Source information
This guide organizes source material about uses, preparations, amounts, and precautions. Read the conditions alongside each statement; the information may apply only to particular preparations or populations.
The source document includes supporting references. We have not independently summarized or assessed every cited study for this guide.
- Source document version
- December 19, 2025
- Source captured
- Aug 15, 2026
- Editorial work
- Editorial preparation. Independent clinical review has not been recorded for this guide.
Full citations are available through the link above. Verification is required to open them; reading this guide does not require verification.
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Explore our supplement–medication interaction checker. Its coverage and review status are shown with the results; a missing finding does not establish that a combination is safe.