Update of safety of cefotaxime.

Adverse reactions to various antibacterial drugs were compared in a review of the following: multiple-dose studies of cefotaxime (n = 3,463), cefazolin (n = 554), the combination gentamicin-clindamycin (n = 163), and cefoxitin (n = 18); prophylactic studies of cefotaxime (n = 300) and cefazolin (n = 149); and single-dose studies of cefotaxime (n = 314) and penicillin G procaine (n - 265). The demographic and background characteristics of the groups were similar. Results of extensive pretreatment and posttreatment laboratory tests, measures of vital signs, and physical examinations revealed no clinically important intergroup differences. In the multiple-dose studies, side effects were reported in 9.8% of the cefotaxime, 3.8% of the cefazolin, 17.2% of the gentamicin-clindamycin, and 16.7% of the cefoxitin patients. The most frequent side effects were reactions at the injection site, of the skin and appendages, and of the digestive and urogenital systems, the only significant difference being fewer injection-site reactions in the cefazolin group than in the other three groups. In the prophylactic studies one cefotaxime patient reported rash and pruritus. In the single-dose studies, side effects were reported in 1.6% of the cefotaxime and 4.2% of the penicillin patients. Side effects sufficiently severe to warrant drug discontinuation were reported in 2.1% of the cefotaxime, 0.7% of the cefazolin, 1.8% of the gentamicin-clindamycin, and in none of the cefoxitin patients. Posttreatment prolongation of prothrombin time was found in one cefotaxime patient, whose pretreatment value was also abnormal, and in two gentamicin-clindamycin patients. No patient deaths were attributed to any of the drugs.