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OBJECTIVE: The greater acceptance of acupuncture by healthcare professionals and the public has increased the importance of addressing public concern about its safety. Of particular concern has been the potential for transmission of infectious disease and organ and tissue injury, as well as the training and professional standards of acupuncture practitioners. This paper, therefore, addresses the following question: What is the frequency and severity of adverse complications and events in acupuncture treatment? DATA SOURCES: All first-hand case reports of complications and adverse effects of acupuncture that could be identified in the English language literature were reviewed and classified according to type of complication or adverse effect, circumstances of the event, credentials of the acupuncturist, country of occurrence, and long-term patient outcome. STUDY SELECTION: The case reports were selected by a search of 9 databases and covered the years between 1965-1999. DATA EXTRACTION: Relevant papers were collected and analyzed by 2 reviewers. Over the 35 years, 202 incidents were identified in 98 relevant papers reported from 22 countries. RESULTS: Types of complications included infections (primarily hepatitis from a few practitioners), and organ, tissue, and nerve injury. Adverse effects included cutaneous disorders, hypotension, fainting, and vomiting. There is a trend toward fewer reported serious complications after 1988. CONCLUSIONS: Declines in adverse reports may suggest that recent practices, such as clean needle techniques and more rigorous acupuncturist training requirements, have reduced the risks associated with the procedure. Therefore, acupuncture performed by trained practitioners using clean needle techniques is a generally safe procedure.