Safety profile of ofloxacin: the Italian data base

In clinical trials performed in Italy, 2,003 patients, suffering from various infectious diseases, have so far been treated with ofloxacin. In most cases dosages of 200 mg, 300 mg or 400 mg b. i. d. have been used. In all, 130 adverse reactions have been recorded in 116 patients (5.8%): gastrointestinal events (mostly nausea, vomiting and gastric pain) in 4.8% of the patients, neurological events (mostly headache and insomnia) in 0.7%, cutaneous reactions in 0.4% and others in 0.5% cases. The drug-event causal relationship was assessed by the investigators as unlikely in 5.0% of the events, as possible in 47.1%, as probable in 31.4% and as almost certain in 16.5%. The severity of adverse reactions was judged as mild in 55% of the cases, as moderate in 38% and as severe in 7%. In 30 patients (1.5%), treatment was discontinued because of occurrence of side effects. Abnormal laboratory values probably related to treatment were reported in 25 patients (2.1%). Ofloxacin is well tolerated and shows a safety profile comparable with that of the best tolerated oral antibacterials.