A 10-item questionnaire (the Tobacco Dependence Screener; TDS) for screening of tobacco/nicotine dependence according to ICD-10, DSM-III-R, and DSM-IV was newly developed. The reliability and validity were assessed in three samples of smokers in Japan. A total of 58 male smokers completed the TDS and the Fagerstrom Tolerance Questionnaire (FTQ), and they were interviewed using the World Health Organization's Composite International Diagnostic Interview (Sample 1). A total of 118 male and 36 female smoking outpatients completed the TDS and the FTQ and provided a breath sample for carbon monoxide measurement (Sample 2). A total of 194 male smokers joined a health education program using a health risk appraisal (HRA) and reported their smoking status and completed the TDS 6 months after receiving the HRA results (Sample 3). The Cronbach's alpha coefficients for the TDS ranged from .74 to .81 among the samples, whereas those for the FTQ ranged from .41 to .64. Receiver operator characteristic analyses indicated that the TDS had a better screening performance for ICD-10, DSM-III-R, and DSM-IV diagnoses than did the FTQ. The TDS score significantly and positively correlated with the severity of the diagnoses, the carbon monoxide levels, number of cigarettes smoked per day, and years of smoking. The TDS score was significantly lower in those who quit smoking than in those who did not quit smoking after the HRA. It is suggested that the TDS is a reliable and useful screening questionnaire for tobacco/nicotine dependence according to ICD-10, DSM-III- R, and DSM-IV.