OBJECTIVES: To compare parent-reported outcomes for children receiving either cefdinir (Omnicef®) or amoxicillin/clavulanate (Augmentin ES-600®) oral suspensions for the treatment of acute otitis media. Outcomes of satisfaction, tolerability, compliance and work/daycare missed were assessed using the Otitis Parent Questionnaire (OPQ). METHODS: In a phase 4, single-blind, parallel-group, randomized, multi-center study designed to compare safety and efficacy of cefdinir oral suspension (7mg/kg/day every 12 hours for 10 days) to amoxicillin/clavulanate oral suspension (90/6.4 mg/kg/day amoxicillin base every 12 hours for 10 days), parents or legally authorized representatives of patients were asked to complete the OPQ, 12-15 days after the first dose of treatment. RESULTS: The intent-to-treat population included 311 patients, with a mean age of 37 months. Parents reported significantly better ease of use and taste in the cefdinir vs. the amoxicillin/clavulanate treatment groups (both p<0.0001); parents were satisfied or very satisfied with the ease of use (89%) and with the taste of cefdinir (85%) as compared with amoxicillin/clavulanate (57% and 39%, respectively). Children were more likely to take their medication in the cefdinir group compared to the amoxicillin/clavulanate group: parents reported 82% of children took at least 95% of their doses of cefdinir, while 61% took at least 95% of the prescribed dose of amoxicillin/clavulanate (p<0.0001). Parent reported data suggested that their children were significantly more likely to experience diarrhea/loose stools in the amoxicillin/clavulanate group than in the cefdinir group (28% vs. 18%; p=0.0341). There were no statistically significant differences in work/daycare missed. CONCLUSIONS: Based on parents' assessments using the OPQ, cefdinir was easier to administer and better tasting. Children who received cefdinir experienced less vomiting and diarrhea/loose stools. In addition, these children were reported to be more compliant than those who received amoxicillin/clavulanate.