In a multicentre general practice study, 660 children aged between 3 months and 12 years with otitis media were randomized to receive a 10-day course of cefuroxime axetil suspension or amoxycillin syrup. Children under 2 years of age were given 125 mg cefuroxime axetil twice daily after food or 125 mg amoxycillin three times daily; older children received 250 mg cefuroxime axetil twice daily or 250 mg amoxycillin three times daily. The overall cure or improvement rate was 94.3% for those treated with cefuroxime axetil and 94.5% for those receiving amoxycillin. Both treatments were well tolerated, with no differences in the number of patients who experienced at least one adverse event or who were withdrawn from treatment. Haemophilus influenzae was isolated in 29% of specimens obtained, Streptococcus pneumoniae in 22% and Moraxella catarrhalis in 6%. Some Strep. pneumonia and M. catarrhalis infections were resistant to amoxycillin. It is concluded that cefuroxime axetil suspension given twice daily has comparable efficacy to amoxycillin syrup given three times daily in the treatment of children with otitis media.