Safety evaluation of chronic fluconazole therapy. Fluconazole Pan-American Study Group.

Abstract

The possible adverse effects of chronic, high-dose fluconazole therapy are detailed from analysis of a multicenter, dose-escalating study of the therapy of invasive mycoses. Ninety-three adult patients were studied, 48 of these received > or = 6 months therapy and 20 received > or = 1 year. Fifty-eight patients received > or = 300 mg/day, and 7 received > or = 600 mg/day. One patient received 1,997 g over 86 months. Twenty-seven percent experienced possible symptomatic side effects, which resulted in 2 patients discontinuing therapy, and 42% had asymptomatic laboratory abnormalities, none of which were progressive. Headache, hair loss and anorexia were the most common symptoms experienced (each by 3% of patients), and eosinophilia and aspartate aminotransferase increases were the most common laboratory findings (12 and 10%, respectively). Fluconazole appears well tolerated and safe in these doses and durations.

• Authors: D A Stevens, M Diaz, R Negroni, F Montero-Gei, L G Castro, S A Sampaio, D Borelli, A Restrepo, L Franco, J L Bran, E G Arathoon
• Journal: Chemotherapy (Chemotherapy) 1997 Sep-Oct Vol. 43 Issue 5 Pg. 371-7 ISSN: 0009-3157 [Print] Switzerland
• PMID: 9309372 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Antifungal Agents
• Fluconazole
• Aspartate Aminotransferases

Topics

• Adult
• Alopecia (chemically induced)
• Anorexia (chemically induced)
• Antifungal Agents (administration & dosage, adverse effects)
• Aspartate Aminotransferases (blood, drug effects)
• Dose-Response Relationship, Drug
• Eosinophilia (chemically induced)
• Fluconazole (administration & dosage, adverse effects)
• Headache (chemically induced)
• Humans
• Mycoses (drug therapy)