Safety of ofloxacin--adverse drug reactions reported during phase-II studies in Europe and in Japan.

During phase-II studies monitored by Hoechst AG (Germany) and Daiichi (Japan) and phase-III/IV studies of Hoechst AG 577 adverse drug reactions were recorded among 13,717 patients treated with ofloxacin. Treatment was stopped in about 40% of the patients with adverse drug reactions. Most of the adverse reactions concerned the gastrointestinal tract. 124 adverse reactions concerned the central nervous system, mostly headache and sleep disturbances (n = 84). For the rare occurrences of other symptoms of the central nervous system, such as hallucinations (n = 1), nightmares (n = 1), confusion (n = 1), and depression (n = 2) the data are inadequate to appraise the relative importance of possible contributing factors.