In an open, noncomparative, multicentre study the efficacy and safety of oral fluconazole was evaluated in the treatment of oropharyngeal candidiasis in children with HIV infection. Fifty-one children with a mean age of five years were enrolled. Oropharyngeal candidiasis was caused by Candida albicans in 28 cases (55%). Fluconazole was given in a mean dosage of 3.4 mg/kg/d (range 2 to 5.6 mg/kg/d) for a mean duration of 12 days (range 6 to 28 days). By the end of treatment, 90% of the children were clinically cured, 6% had improved and 4% failed to respond. Candida was eradicated in 82% of the patients. Clinical failure occurred only in children given 3 mg/kg/d or less. Two and four weeks after therapy, clinical cure was confirmed in 88% and 82% of the children respectively as well as eradication in 76% respectively. Six children experienced mild side effects (1 skin rash, 5 mild elevation of liver enzyme levels). The data show that fluconazole is safe and effective in treating oropharyngeal candidiasis in HIV-infected children.