Black cohosh (Cimicifuga racemosa)

Herbal product for menopausal symptoms (food supplement under Spanish RD 1487/2009)

ATC code: G02CX-CIMICIFUGA (Black cohosh (Cimicifuga racemosa))

Brand names – supplements

Estroven Black Cohosh, Remifemin

Supplements are not tested in clinical trials and are not registered as medications.

Mechanism of action

Active constituents are triterpene glycosides (actein, cimicifugoside) and phenylpropanoids. There is no estrogenic activity: ER binding and ER-dependent gene expression studies are negative. Current data point to serotonergic and dopaminergic modulation in the hypothalamus and dampening of the vasomotor centre. HMPC recognises well-established use of standardised isopropanolic (Remifemin) and ethanolic (Klimadynon) extracts.

Indications

Hot flashes and night sweats

Individual decision

Black cohosh is a herbal product used in Europe for menopausal vasomotor symptoms. HMPC recognises well-established use of standardised extracts (Remifemin, Klimadynon). Cochrane Leach 2012 reviewed 16 RCTs and concluded the effect on hot flashes is inconsistent and on average small. NG23 (2015, updated 2024) mentions black cohosh as an option when a patient declines or has contraindications to menopausal hormone therapy. SEGO 2024 is cautious because of hepatotoxicity. If hot flashes are moderate and the patient prefers a herbal option, discuss with the gynaecologist treatment duration and liver enzyme checks at 2-3 months.

Sources

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.

Menopausal syndrome

Not recommended

Marketing promotes black cohosh as a complete replacement for menopausal hormone therapy (MHT). There is no such replacement: MHT addresses estrogen deficiency, while black cohosh has no estrogenic activity and does not correct osteoporosis, urogenital atrophy or cardiovascular risk. HMPC 2007 described rare but clinically meaningful cases of idiosyncratic hepatitis, including fulminant, on black cohosh. In patients with estrogen-receptor-positive breast or endometrial cancer the product is not recommended. If a doctor framed black cohosh as a natural replacement for MHT or suggested a long course without ALT/AST monitoring, consider seeking a second opinion from another gynaecologist. If jaundice, dark urine, right-upper-quadrant pain or unexplained fatigue appears, stop the supplement and contact a doctor.

Sources

NICE: NG23 Menopause: diagnosis and management (2024)

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Safety

Contraindications

Hypersensitivity to Cimicifuga racemosa
Active liver disease
Estrogen-dependent tumours (breast, endometrial, ovarian cancer)
Pregnancy and lactation
Under 18 years of age

Serious adverse effects

Idiosyncratic hepatitis with raised ALT/AST (rare, EMA HMPC 2007)
Fulminant liver failure (isolated cases requiring transplant)
Severe allergic reactions

Common adverse effects

Gastrointestinal discomfort (nausea, heaviness)
Skin rash
Weight gain
Headache

PregnancyFDA N

Not recommended. Safety data in pregnancy are absent, and historically black cohosh was used as a labour-inducing agent. AEMPS classifies it as do not use in pregnancy.

Breastfeeding

Not recommended. Data in lactating women are absent; active triterpenes may transfer into milk. eLactancia rates this as moderate risk.

Calculate RID

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

Frequently asked

What is Black cohosh (Cimicifuga racemosa) used for?

Black cohosh (Cimicifuga racemosa) is evaluated for the following indications with varying evidence strength: Hot flashes and night sweats (evidence tier C), Menopausal syndrome (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Black cohosh (Cimicifuga racemosa)?

Common side effects of Black cohosh (Cimicifuga racemosa) (≥ 1 in 100): Gastrointestinal discomfort (nausea, heaviness), Skin rash, Weight gain, Headache. See the Safety section for uncommon and serious reactions.

Is Black cohosh (Cimicifuga racemosa) safe during pregnancy?

FDA category N. Not recommended. Safety data in pregnancy are absent, and historically black cohosh was used as a labour-inducing agent. AEMPS classifies it as do not use in pregnancy.

Is Black cohosh (Cimicifuga racemosa) compatible with breastfeeding?

Not recommended. Data in lactating women are absent; active triterpenes may transfer into milk. eLactancia rates this as moderate risk.

Who should not take Black cohosh (Cimicifuga racemosa)?

Black cohosh (Cimicifuga racemosa) is contraindicated in: Hypersensitivity to Cimicifuga racemosa; Active liver disease; Estrogen-dependent tumours (breast, endometrial, ovarian cancer); Pregnancy and lactation; Under 18 years of age. Full list in the Safety section.

Mechanism of action

Indications

Hot flashes and night sweats

Individual decision

Sources

Safety

Contraindications

Hypersensitivity to Cimicifuga racemosa
Active liver disease
Estrogen-dependent tumours (breast, endometrial, ovarian cancer)
Pregnancy and lactation
Under 18 years of age

Serious adverse effects

Idiosyncratic hepatitis with raised ALT/AST (rare, EMA HMPC 2007)
Fulminant liver failure (isolated cases requiring transplant)
Severe allergic reactions

Common adverse effects

Gastrointestinal discomfort (nausea, heaviness)
Skin rash
Weight gain
Headache

PregnancyFDA N

Not recommended. Safety data in pregnancy are absent, and historically black cohosh was used as a labour-inducing agent. AEMPS classifies it as do not use in pregnancy.

Breastfeeding

Not recommended. Data in lactating women are absent; active triterpenes may transfer into milk. eLactancia rates this as moderate risk.

Calculate RID

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

Frequently asked

What is Black cohosh (Cimicifuga racemosa) used for?

What are the side effects of Black cohosh (Cimicifuga racemosa)?

Is Black cohosh (Cimicifuga racemosa) safe during pregnancy?

FDA category N. Not recommended. Safety data in pregnancy are absent, and historically black cohosh was used as a labour-inducing agent. AEMPS classifies it as do not use in pregnancy.

Is Black cohosh (Cimicifuga racemosa) compatible with breastfeeding?

Not recommended. Data in lactating women are absent; active triterpenes may transfer into milk. eLactancia rates this as moderate risk.

Who should not take Black cohosh (Cimicifuga racemosa)?