Abnormal laboratory test values during ceftriaxone therapy.

Laboratory tests were conducted to determine the safety of ceftriaxone during clinical use. Laboratory test values were evaluated in 153 individual clinical studies. A total of 2,640 patients received ceftriaxone at various doses, ranging from a single dose to six weeks of administration. The most frequently encountered laboratory test abnormalities in the overall population were hematologic (14.4 percent), hepatic (5 percent), and renal (1.4 percent). When analyzed separately, the incidences of hematologic, hepatic, and renal laboratory test abnormalities in the pediatric population were 30.8, 7.7, and 0.7 percent, respectively. The incidence of abnormal laboratory test results for once- and twice-daily drug administration was comparable. There were no significant differences except for the frequency of thrombocytosis for which the incidence for once-daily administration was 1.8 percent and for twice-daily administration 5.3 percent. The incidence of abnormal laboratory test values during ceftriaxone therapy (19.0 percent) was comparable to that observed with the cephalosporins (18.3 percent) and other comparative drugs used in these studies. Ceftriaxone is at least as safe and as well tolerated as other currently available antimicrobial agents used in the therapy of serious bacterial infections.