title: 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.affiliation: Santa Clara Valley Medical Center, Stanford University Medical School, San Jose, Calif 95128-2699, USA. vierrman@wpgate.hhs.co.santa-clara.ca.us
authors.forename: D A
authors.initials: DA
authors.lastname: Stevens
authors.forename: M
authors.initials: M
authors.lastname: Diaz
authors.forename: R
authors.initials: R
authors.lastname: Negroni
authors.forename: F
authors.initials: F
authors.lastname: Montero-Gei
authors.forename: L G
authors.initials: LG
authors.lastname: Castro
authors.forename: S A
authors.initials: SA
authors.lastname: Sampaio
authors.forename: D
authors.initials: D
authors.lastname: Borelli
authors.forename: A
authors.initials: A
authors.lastname: Restrepo
authors.forename: L
authors.initials: L
authors.lastname: Franco
authors.forename: J L
authors.initials: JL
authors.lastname: Bran
authors.forename: E G
authors.initials: EG
authors.lastname: Arathoon
mesh_terms: D000328:Adult; D000505:Alopecia / Q000139:chemically induced; D000855:Anorexia / Q000139:chemically induced; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001219:Aspartate Aminotransferases / Q000097:blood / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004802:Eosinophilia / Q000139:chemically induced; D015725:Fluconazole / Q000008:administration & dosage / Q000009:adverse effects*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D009181:Mycoses / Q000188:drug therapy*
chemical_list: D000935:Antifungal Agents; D015725:Fluconazole; D001219:Aspartate Aminotransferases