The safety profile of ofloxacin.
The safety profile of ofloxacin was evaluated on the basis of adverse reactions and abnormal laboratory values seen in United States clinical trials and phase I studies addressing specific issues. The most frequently reported adverse reactions occurring in 2,197 patients who received three to 10 days of ofloxacin in United States clinical trials were nausea (3.5 percent), insomnia (1.8 percent), headache (1.4 percent), and dizziness (1.2 percent). Adverse reactions were not serious and usually rapidly reversible. The incidence of adverse reactions did not increase with increasing age. There is no clinically significant interaction with methylxanthines (caffeine or theophylline). Crystalluria was not observed. Ofloxacin is a well-tolerated fluoroquinolone antimicrobial agent.