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Phase IV study and post-marketing surveillance of ofloxacin in Japan.

Data derived from phase IV clinical trials of ofloxacin in 13,850 patients show that the incidence of adverse drug reactions was 2.6%. Gastrointestinal symptoms topped other symptoms in order of frequency, followed by neuropsychiatric and hypersensitivity symptoms. On the other hand, we received 155 spontaneous reports on ofloxacin adverse reactions, including severe convulsions and shock. Examination of various cases of adverse drug reactions suggested that both severe renal dysfunction and a predisposition to epilepsy were risk factors contributing to the onset of convulsions, and a predisposition to allergy was also a risk factor in hypersensitivity reactions including shock. Data from phase IV trials aimed at efficacy analysis show a high efficacy rate. The usefulness of ofloxacin was confirmed by the data obtained after its marketing.