ModerateHerbal product for menopausal symptoms (food supplement under Spanish RD 1487/2009)×Anilides. Analgesics and antipyretics
Updated · Methodology
Mechanism
The EMA 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 EMA 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.
Check the full regimen, not just this pair
Opens the checker with these two drugs prefilled. Add the rest of the regimen and recompute additive risks.
Summary of a multi-drug list →
Medicine list: everything you take in one place →
Sources
- EMA: Herbal medicinal products containing cimicifugae racemosae rhizoma – serious hepatic reactions (2006)– EMEA/HMPC public statement on Cimicifuga racemosa and hepatic reactions
- EMA: European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma (2018)– EMA/HMPC, final EU herbal monograph, revision 1