Evigrade

Black cohosh (Cimicifuga racemosa)

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

ATC code: G02CX-CIMICIFUGA

Brand names – supplements: Estroven Black Cohosh, RemifeminSupplements are not tested in clinical trials and are not registered as medications.

Updated · Methodology

Indications

C

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.

ICD-10: N95.1 · ICD-11: GA30.4

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.

F

Menopausal symptoms

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.

ICD-10: N95.1 · ICD-11: GA30

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

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.

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

Pregnancy: can you take Black cohosh (Cimicifuga racemosa)?

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: can you take Black cohosh (Cimicifuga racemosa)?

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

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

Drug–drug interactions

2 pairs found. Sorted from critical to minor.

ModerateCurcumin (Curcuma longa extract)Herbal anti-inflammatory agents

Mechanism

Both herbs appear among the plant causes of liver injury reported in Europe. Black cohosh carries an public statement for serious hepatic reactions; curcumin, especially in high-bioavailability formulations with piperine, has accumulated reports of cholestatic hepatitis. Neither label warns about the other, and someone going through menopause with joint pain may end up taking both.

Symptoms

Jaundice, itching, dark urine, right upper quadrant pain, marked fatigue. In cholestatic hepatitis, itching can precede jaundice by several weeks.

Management

Avoid stacking two herbs with a hepatic signal in the same regimen, especially alongside alcohol, regular paracetamol or a statin. If both are taken, get baseline liver tests and repeat at two or three months. With any symptom, stop both at once and work out which one it was afterwards.

Pair details →Curcumin (Curcuma longa extract) →

ModerateParacetamolAnilides. Analgesics and antipyretics

Mechanism

The reviewed 42 reports of hepatic reactions with Cimicifuga racemosa; in four well-documented cases there was a temporal relationship, among them one fulminant hepatic failure and two autoimmune hepatitis. Paracetamol is hepatotoxic in a dose-dependent way and its margin narrows with fasting, alcohol use or low body weight. Overlap does not multiply the risk in any established way, but it does complicate attributing the injury when it appears.

Symptoms

Unusual tiredness, persistent nausea, right upper quadrant pain, dark urine, pale stools, jaundice. The states that with these signs black cohosh is stopped and advice sought immediately.

Management

Keep paracetamol within the maximum daily dose in the label and do not extend it without review. Black cohosh is taken for limited periods; if any hepatic sign appears, stop it and request transaminases. In anyone with existing liver disease or on other hepatotoxic drugs, avoid the herb.

Pair details →Paracetamol →

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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 symptoms (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?

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.

Other drugs in this group

Copper intrauterine device, Dong quai (Angelica sinensis), Etonogestrel + Ethinylestradiol (vaginal ring), Levonorgestrel (intrauterine system)