Safety profile of cefixime.

The clinical and laboratory safety of cefixime based on analysis of data from 1575 adults (1118 treated daily and 457 treated twice a day) and 615 children (299 treated daily and 316 treated twice a day) in studies of urinary tract and lower and upper respiratory tract infections (including otitis media) is reviewed. The incidence of adverse clinical experiences and occurrence of laboratory abnormalities were similar to those seen with other beta-lactam antimicrobial agents. Gastrointestinal side effects were the predominant adverse experiences seen in both daily and twice daily programs in adults and children. The incidence of gastrointestinal intolerance was not dependent upon the frequency of the dosage. Symptoms of drug hypersensitivity were infrequently reported. No serious chemical, hematologic or urologic abnormalities were noted. The data confirm the safety of cefiximine in both adults and children, whether it is administered once or twice a day.