No active regulatory warningsFDA MedWatch, EMA EudraVigilance, WHO VigiBase, WADA Prohibited List · 2026-05-29
Updated: 2026-05-29 · v2.0 · Prof. G. Pkhakadze, MD, MPH, PhDCiteEditorial
📰Read the full Vitex / Chaste Tree evidence review on GMJ News →Complete clinical article, references and updates on news.gmj.ge. This page is the structured safety summary.
2
Conditional
Vitex / Chaste Tree
Vitex agnus-castus
Conditionally SafeModerateBotanicals
RDA
Typical 20–40 mg
Target
N/A
Upper limit
No UL
Products
Dosage by population group — reference
🔗 Best with: Magnesium, Vitamin B6 (Pyridoxine), Evening Primrose Oil✅ USP Verified, ConsumerLab Approved, Clean Label Project Certified
⚠ Patient on oral contraceptives adding Vitex — HPG axis interference; contraindicated [1]
⚠ Patient on antipsychotics using Vitex — directly opposes D2 antagonist mechanism [1]
⚠ Patient expecting results in 2 weeks — needs 3 full menstrual cycles [1] [2]
⚠ Patient continuing Vitex after confirmed pregnancy — discontinue at conception [1]
ℹ️ Not obtained from food. Not applicable — this is not obtained from food in meaningful amounts; supplementation is the practical route.
🔬 Lab interpreter
Recommended test
No routine monitoring for PMS use
Reference range / target
N/A
When to test
N/A
Monitor mid-luteal progesterone if using for luteal phase defect [1].
Full lab monitoring ↓
⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Vitex is the strongest evidence-based botanical for PMS (meta-analysis of 12 RCTs, n=1,806). The mechanism is genuinely pharmacological — D2 dopamine receptor agonism reducing prolactin. Three critical rules: (1) morning dosing (prolactin rhythm); (2) 3 cycles minimum for effect; (3) contraindicated with OCs, dopamine agonists, and antipsychotics [1] [2].
1 How much do I need?
👤 Adults: Specific dosage data under clinical review
👴 Elderly: Specific dosage data under clinical review
🤰 Pregnancy: See guidance
Discontinue upon confirmed pregnancy. Dopaminergic effects could theoretically affect fetal development. EMA recommends stopping at conception [1].
👦 Pediatric: See guidance
Not indicated before menarche. May be considered in adolescents with established menstrual cycles and PMS, though no pediatric RCTs exist [1].
🏃 Athletes: Standard dose
⚖️ Obesity: Standard dose
Fat-soluble compounds may require dose adjustment in obesity.
🩺 Renal: Consult specialist
Dose adjustment may be needed in renal impairment.
🌱 Vegan: Standard dose

How to take

🍽 Timing: MORNING dosing (prolactin rhythm). Empty stomach preferred [1].
💊 With food: On empty stomach for optimal absorption [1].
🚫 Avoid: Evening dosing. Concurrent hormonal contraception. Use with dopamine agonists or antagonists [1].
2 Which form?
FormBioavailabilityVeganCost
['Ze 440 extract (20 mg/day)', 'preferred', 'Ethanol 60% extract standardized to casticin. Most-studied in European RCTs [1].']StandardCheck label
['BNO 1095 extract (40 mg/day)', 'alternative', 'Aqueous-ethanol extract. German RCT evidence [1].']StandardCheck label
['Dried berry capsules (400–500 mg)', 'common', 'Whole berry powder. Less standardized but widely available [1].']StandardCheck label
['Vitex tincture', 'traditional', '40 drops in water, morning. Traditional European naturopathic preparation [1].']StandardCheck label
3 Common questions
How long does Vitex take to work for PMS?
Most women need 3 full menstrual cycles (approximately 3 months) to see the full effect. Some notice improvement in cycle 2. The D2-mediated prolactin reduction needs time to normalize the hormonal milieu [1] [2].
Can I take Vitex with birth control pills?
No. Vitex modulates the hypothalamic-pituitary-gonadal (HPG) axis and could theoretically interfere with hormonal contraception. EMA and most guidelines recommend against concurrent use [1].
Why should I take Vitex in the morning?
Prolactin has a diurnal secretion pattern, peaking during sleep. Morning dosing aligns Vitex's D2 agonist effect with the post-sleep prolactin peak, optimizing the suppressive effect [1].
Is Vitex effective for PCOS?
The evidence is insufficient. While prolactin reduction is theoretically relevant to some PCOS patients (especially those with hyperprolactinemia), only 1 small pilot study exists. Do not use Vitex as primary PCOS treatment [1].
4 Clinical evidence

Strong

PMS: meta-analysis of 12 RCTs (n=1,806) demonstrated significant improvement in global PMS symptoms, with particular benefit for mastalgia (breast pain), irritability, mood changes, and bloating. NNT ~3–4 for clinically meaningful improvement [2]. HIGH

Moderate

Mastalgia (cyclical breast pain): 3 RCTs showed significant reduction in breast pain scores [1]. Luteal phase deficiency: Vitex normalized progesterone levels and improved luteal phase length in 2 small RCTs [1]. Hyperprolactinemia (mild, stress-related): Vitex reduced prolactin levels in women with latent hyperprolactinemia in 1 RCT [1]. Acne (hormonal): 1 RCT showed improvement in premenstrual acne [1]. MODERATE

Insufficient

PCOS: theoretical prolactin-lowering benefit; 1 pilot study only [1]. Infertility: improved fertility in women with luteal phase defect in observational studies; no definitive RCT [1]. Menopause: conflicting results in 2 small trials [1]. Male libido suppression: historical claim; no modern evidence [1]. LOW
5 Safety, toxicity & adverse events

Absolute contraindications

✕ Pregnancy — affects prolactin and hormonal balance

Relative

⚠ Dopamine agonists/antagonists (antipsychotics) — opposing/additive effects
⚠ Hormone-sensitive conditions and combined oral contraceptives
⚠ IVF/hormonal treatment — may interfere
⚠ (Same botanical as 'Chaste Tree Berry (Vitex)')

🚩 Red flags

Patient on antipsychotic therapy adding Vitex — D2 agonist vs antagonist conflict [1]
Patient on OCs using Vitex — potential contraception failure [1]
Patient with prolactinoma using Vitex instead of bromocriptine — needs medical management [1]
6 Interactions

Drug interactions

Oral contraceptives / HRT Major
Mechanism: Vitex modulates HPG axis via D2-mediated prolactin suppression [1].
Effect: Potential interference with hormonal contraception efficacy [1].
Action: Do NOT combine. Choose one or the other [1].
Antipsychotics (haloperidol, risperidone) Major
Mechanism: Vitex (D2 agonist) directly opposes D2 antagonist antipsychotics [1].
Effect: May reduce antipsychotic efficacy [1].
Action: Contraindicated [1].

Supplement synergies

Magnesium · 200–400 mg elemental Mg + Vitex
Mg deficiency worsens PMS. Combination addresses hormonal (Vitex) and mineral (Mg) components [1].
Vitamin B6 · 50–100 mg B6
B6 is a dopamine cofactor; may enhance Vitex's prolactin-lowering effect [1].
7 Regulatory
Germany (Commission E): Approved for menstrual cycle irregularities, premenstrual complaints, and mastodynia [1].
European Union (EMA): Well-established use for PMS. Traditional use for menstrual irregularities [1].
United States (FDA): Available as dietary supplement. No FDA-approved claims [1].
Vitex / Chaste Tree vs MagnesiumVitex / Chaste Tree vs Vitamin B6
8 Cite this page
Vancouver: Pkhakadze G. Vitex / Chaste Tree — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Aug 15]. Available from: https://supplement.ge/ingredients/vitex-chaste-tree/
APA 7th: Pkhakadze, G. (2026). Vitex / Chaste Tree — Safety profile. Public Health Institute of Georgia. https://supplement.ge/ingredients/vitex-chaste-tree/
📋 Editorial information
Author: Prof. G. Pkhakadze, MD, MPH, PhD
Affiliation: David Tvildiani Medical University (DTMU)
First published: January 2026
Last reviewed: 2026-05-29
Next review: February 2027
References: 4 cited sources
COI: SupplementIndex receives no funding from supplement manufacturers. All content independently authored by PHIG.
Process: Systematic literature review
📄 License & reuse
Published under Creative Commons Attribution 4.0 International (CC BY 4.0). You may share and adapt for any purpose with attribution.
Pkhakadze G. "Vitex / Chaste Tree — Safety Profile." SupplementIndex, PHIG, 2026. https://supplement.ge/ingredients/vitex-chaste-tree/ CC BY 4.0.
GP
Prof. G. Pkhakadze, MD, MPH, PhD
Professor of Public Health · Head of Department, DTMU
Editor-in-Chief, Georgian Medical Journal (ISSN 3088-4322)
Chair, Public Health Institute of Georgia · UEMS Public Health Section
Educational and public health purposes. CC BY 4.0. Consult your healthcare provider before starting any supplement. Corrections: info@accreditation.ge. Publisher: PHIG