⚠ Regulatory caution
Updated: 2026-05-29 · v2.0 · Prof. G. Pkhakadze, MD, MPH, PhDCiteEditorial
3
Limited
Black Cohosh
Actaea racemosa
Limited EvidenceModerateBotanicals
RDA
Typical 20–40 mg
Target
Normal
Upper limit
No UL
Products
144
Dosage by population group — reference
🔗 Best with: Saffron Extract, Red Clover, Dong Quai✅ USP Verified, ConsumerLab Approved, Clean Label Project Certified
⚠ NOT estrogenic — common misconception [1]
⚠ Hepatotoxicity cases including liver failure — limit 6 months [1]
⚠ New fatigue/dark urine/jaundice → stop and check LFTs [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
ALT, AST
Reference range / target
Normal
When to test
Baseline and 3 months [1].
Hepatotoxicity monitoring [1].
Full lab monitoring ↓
⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Black cohosh is NOT estrogenic (common misconception). Some positive RCTs for hot flashes (Remifemin). Cochrane: insufficient evidence overall. Rare hepatotoxicity — limit to 6 months, monitor liver symptoms. Safety in breast cancer is debated but 'probably safe' per NAMS [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
AVOID — possible uterotonic effects [1].
👦 Pediatric: See guidance
Not appropriate [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: BID [2].
💊 With food: With food [1].
🚫 Avoid: Hepatotoxic drugs. Prolonged use >6 months. Pregnancy [1].
2 Which form?
FormBioavailabilityVeganCost
['Remifemin (isopropanolic extract)', 'preferred', 'Most studied brand. 20 mg BID. German pharmaceutical standard [2].']StandardCheck label
['Standardized extract (2.5% triterpene glycosides)', 'common', 'Various brands [1].']StandardCheck label
3 Common questions
Is black cohosh safe for breast cancer survivors? ▼
Debated. Black cohosh is NOT estrogenic, which is reassuring. Some oncologists allow it; others advise caution. NAMS considers it 'probably safe' but data are limited [1].
What about liver damage? ▼
Rare hepatotoxicity cases have been reported, including liver failure requiring transplant. Regulatory agencies (Australia, EU) require liver warnings. Limit use to 6 months. Monitor for symptoms (fatigue, dark urine, jaundice) [1].
4 Clinical evidence

Strong

NOT estrogenic — does not bind estrogen receptors. This is established receptor binding data [1]. HIGH

Moderate

Hot flashes: some positive RCTs (Remifemin). German Commission E approved for menopausal complaints [2]. NAMS acknowledges black cohosh as a non-hormonal option [2]. MODERATE

Insufficient

Cochrane: overall evidence insufficient to recommend [2]. Bone density [1]. Breast cancer risk (safety in hormone-sensitive cancers is debated) [1]. Mood/anxiety [1]. LOW
5 Safety, toxicity & adverse events

Absolute contraindications

✕ Active liver disease — rare but documented hepatotoxicity

Relative

⚠ Hormone-sensitive conditions — estrogenicity uncertain
⚠ Concurrent hepatotoxic drugs
⚠ Pregnancy (except brief, supervised use at term)
⚠ Discontinue and seek care if jaundice or liver symptoms develop

🚩 Red flags

● Jaundice or dark urine in black cohosh user — liver injury [1]
● Prolonged use >6 months [1]
● Pregnancy — uterotonic [1]
6 Interactions

Drug interactions

Hepatotoxic drugs Major
Mechanism: Additive liver injury risk. [1]
Effect: Increased hepatotoxicity. [1]
Action: Avoid concurrent hepatotoxic medications [1].
CYP2D6 substrates Moderate
Mechanism: Black cohosh may inhibit CYP2D6. [1]
Effect: Elevated CYP2D6 drug levels. [1]
Action: Monitor [1].

Supplement synergies

Saffron Extract · 30 mg saffron
Both used for menopausal mood/vasomotor symptoms [1].
7 Regulatory
Germany (Commission E): Approved for menopausal complaints [2].
Australia/EU: Liver warning labels required [1].
United States: Dietary supplement [1].
8 Regulatory alerts by country
3 regulatory actions on record — 2 with a verified source link, 1 with the official reference being verified.
Warning · 3
🇪🇺
EMA — HMPC assessment: hepatotoxicity risk. Labeling requirements.
EMA Committee on Herbal Medicinal Products (HMPC) monograph / assessment for this herbal substance.
Source ↗ · 2024-01-01
🇨🇦
Health Canada — Liver injury warnings required on labels.
Health Canada Natural Health Products Ingredients Database (NHPID) — permitted use, restrictions and label-warning requirements for NHP ingredients.
2024-01-01 · official reference being verified
🇦🇺
TGA — Mandatory liver warning on all products since 2007.
TGA complementary-medicines requirements / mandatory label warnings and permitted-ingredient determinations.
Source ↗ · 2024-01-01
Browse all regulatory alerts by country →
9 US supplement products
144
on-market products containing Black Cohosh (NIH DSLD)

Brands carrying Black Cohosh (91)

Click a brand to see its Black Cohosh products.
Or browse all 144 products in one list →
10 Frequently paired with
Silicon 64 sharedMagnesium 54 sharedCalcium 50 sharedDong Quai 44 shared
Black Cohosh vs Saffron ExtractBlack Cohosh vs Red Clover
11 References (2)
[1]National Institutes of Health, NCCIH. Black Cohosh. Updated 2024. www.nccih.nih.gov REVIEW Accessed: 2026-05-29
[2]Leach MJ, Moore V. Black cohosh (Cimicifuga spp.) for menopausal symptoms. Cochrane Database Syst Rev. 2012;(9):CD007244. doi:10.1002/14651858.CD007244.pub2 REVIEW Accessed: 2026-05-29
12 Related articles
📰 Article — news.gmj.ge📰 Article — news.gmj.ge📰 Article — news.gmj.ge📰 Article — news.gmj.ge
Auto-populated from GMJ Newsroom. Articles tagged "Black Cohosh".
13 Cite this page
Vancouver: Pkhakadze G. Black Cohosh — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Jun 02]. Available from: https://www.tga.gov.au/products/complementary-medicines/complementary-medicines-information
APA 7th: Pkhakadze, G. (2026). Black Cohosh — Safety profile. Public Health Institute of Georgia. https://www.tga.gov.au/products/complementary-medicines/complementary-medicines-information
📋 Editorial information
Author: Prof. G. Pkhakadze, MD, MPH, PhD
Institution: Public Health Institute of Georgia (PHIG)
Affiliation: David Tvildiani Medical University (DTMU)
First published: January 2026
Last reviewed: 2026-05-29
Next review: December 2026
References: 2 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. "Black Cohosh — Safety Profile." SupplementIndex, PHIG, 2026. https://www.tga.gov.au/products/complementary-medicines/complementary-medicines-information 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