Abstract: Objective To construct a knowledge graph for pharmacovigilance research in traditional Chinese medicine (TCM) by analyzing publicly published journal literature from both domestic and international sources, which is to identify research hotspots and future development directions in the field. Methods Relevant literatures published by academic and research institutions on “pharmacovigilance of TCM” published during the previous decade was searched using the National Knowledge Infrastructure of China and Web of Science databases. The knowledge graph was analyzed using CiteSpace software to explore author distribution, keyword co-occurrence, keywords clustering, and keywords burst. Results Three primary research teams and institutions were highlighted in a total of 2 785 Chinese and 229 English articles. The three main areas of research concentration were risk avoidance, rational medication, identification of adverse reactions to TCM, and understanding the processes of TCM toxicity. The study material had consistently been expanded and improved. Hotspots for publications, both domestically and internationally, have distinct focuses. There had been a continuous emphasis on safety concerns related to injections used in TCM. A mental map of TCM pharmacovigilance research and development was created by integrating the current knowledge of the field with future development prospects. Conclusion To establish pharmacovigilance, it is essential to honor the principles of TCM, while effectively utilizing modern technology, which will also contribute to the advancement of international pharmacovigilance of botanical medicines.

Key words: traditional Chinese medicine, pharmacovigilance, knowledge graphs analysis, mental map, TCM injections