Systematic literature searches were conducted in seven electronic databases, and the reference lists of all papers located were checked for further relevant publications. Information was also sought from the spontaneous reporting programmes of the WHO and national drug safety bodies. A total of 16 manufacturers of Cimicifuga racemosa (black cohosh) preparations were contacted and asked for data held on file. Finally, the researchers’ own departmental files were searched. No language restrictions were imposed. Combination products and homoeopathic preparations were excluded. Data from clinical studies and spontaneous reporting programmes suggest that adverse events (AEs) with C. racemosa are rare, mild and reversible. Gastrointestinal upsets and rashes are the most common AEs. The spontaneous reporting programmes do contain a few serious AEs, including hepatic and circulatory conditions, but causality cannot be determined. Although there is a large amount of data investigating the efficacy of C. racemosa, in particular the product Remifemin, safety issues and the monitoring of AEs have not been the focus.