Safety evaluation of chronic fluconazole therapy. Fluconazole Pan-American Study Group.
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.
Stevens
D A
DA
Santa Clara Valley Medical Center, Stanford University Medical School, San Jose, Calif 95128-2699, USA. vierrman@wpgate.hhs.co.santa-clara.ca.us
Diaz
M
M
Negroni
R
R
Montero-Gei
F
F
Castro
L G
LG
Sampaio
S A
SA
Borelli
D
D
Restrepo
A
A
Franco
L
L
Bran
J L
JL
Arathoon
E G
EG
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*
D000935:Antifungal Agents; D015725:Fluconazole; D001219:Aspartate Aminotransferases