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.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000009:adverse effects*; D003875:Drug Eruptions / Q000209:etiology; D004341:Drug Evaluation; D005060:Europe; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin; D010078:Oxazines / Q000009:adverse effects*; D012893:Sleep Wake Disorders / Q000139:chemically induced
D000890:Anti-Infective Agents; D010078:Oxazines; D015242:Ofloxacin