In a prospective randomized study, the efficacy and safety of 1 and 2 g of cefodizime administered as single intramuscular injections were compared in a total of 50 women having either complicated or uncomplicated lower urinary tract infections (LUTI). Bacteriological culture of urine and safety laboratory tests were performed before and after treatment. 18/25 patients in the 1 g cefodizime group and 22/25 in the 2 g cefodizime group showed satisfactory clinical and bacteriological response to treatment. The inadequately treated patients all had complicating factors on entry to the study (residual urine in six cases, a bladder malignancy in two, neurogenic bladder and diabetes mellitus with glucosuria in one case each). Cefodizime proved efficacious in female patients with uncomplicated LU-TI, as well as in those aged over 65 years, patients having mild renal insufficiency, mild glucosuria, unsuccessful oral antibiotic pretreatment or recurrent and post-operative infections. In no case were there any systemic adverse reactions to cefodizime or clinically significant changes in laboratory tests.