Safety and tolerability of fluconazole in children

The safety profile of fluconazole was assessed for 562 children (ages, 0 to 17 years) comprising 323 males and 239 females. The data are derived from 12 clinical studies of fluconazole as prophylaxis or treatment for a variet y of fungal infections in predominantly immunocompromised patients. Most ch ildren received multiple doses of fluconazole in the range of 1 to 12 mg/kg of body weight; a few received single doses. Administration was mainly by oral suspension or intravenous injection. Overall, 58 (10.3%) children repo rted 80 treatment-related side effects. The most common side effects were a ssociated with the gastrointestinal tract (7.7%) or skin (1.2%), Self-limit ing, treatment-related side effects affecting the liver and biliary system were reported in three patients (0.5%), Overall, 18 patients (3.2%) discont inued treatment due to side effects, mainly gastrointestinal symptoms. Dose and age did not appear to influence the incidence and pattern of side effe cts. Treatment-related laboratory abnormalities were uncommon, the most fre quent being transient elevated alanine aminotransferase (4.9%), aspartate a minotransferase (2.7%), and alkaline phosphatase (2.3%) levels. Although 98 .6% of patients were taking concomitant medications, no clinical or laborat ory interactions were observed. The safety profile of fluconazole was compa red with those of other antifungal agents, mostly oral polyenes, by using a subset of data from five controlled studies. Side effects were reported by more patients treated with fluconazole (45 of 382; 11.8%) than by those pa tients treated with comparable agents (25 of 381; 6.6%); vomiting and diarr hea were the most common events in both groups. The incidence and type of t reatment-related laboratory abnormalities were similar for the two groups. In conclusion, fluconazole was well tolerated by the pediatric population, many of whom were suffering from severe underlying disease and were taking a variety of concurrent medications. The safety profile of fluconazole in c hildren mirrors the excellent safety profile seen in adults.