The photosensitivity effect of lomefloxacin hydrochloride (LFLX) was investigated in terms of patient background factors (sex, age, underlying disease, complications, history, occupation, and residential condition, etc.), treatment factors (daily dosage of LFLX, duration of treatment, total dose, concomitant drugs, and previous medication, etc.), and correlations among them. In 100 institutions throughout Japan, 4,284 patients were enrolled over a period of 2 years, beginning in October 1991, avoiding the accumulation of patients in any specific season. Since 8 patients did not visit again after enrollment, the clinical records of 4,276 patients were analyzed. Photosensitivity in 44 patients was found (1.03%), but the symptoms in most patients were not severe and improved after discontinuation of LFLX treatment. The photosensitivity reaction was more prevalent in patients who were 60 years of age and older with concomitant diseases and complications, in patients treated with a total amount of 20 g and more of LFLX for 30 days or longer, and in patients with a history of previous treatment with quinolone drugs. Although the incidence and degree of the photosensitivity reaction vary significantly among new quinolone drugs, every quinolone drug is potentially phototoxic. In particular, long-term use of LFLX should be avoided, and patients taking LFLX should be advised to abstain from prolonged exposure to sunlight.