Itraconazole and fluconazole and certain rare, serious adverse events.
OBJECTIVE
To determine rates of drug-induced, rare, serious adverse events affecting the liver, kidneys, skin, or blood, occurring within 45 days of completing a prescription or refill for itraconazole or fluconazole.


METHODS
Population-based follow-up study


METHODS
United Kingdom-based General Practice Research Database.


METHODS
Total of 54,803 users of either fluconazole or itraconazole.


RESULTS
Four patients were identified with illnesses for which a drug-induced etiology could not be ruled out; one with an elevated liver function test while taking itraconazole, one with thrombocytopenia, one with neutropenia, and one with an abnormal liver function test just after receiving fluconazole. For itraconazole the rate was 3.2/100,000 prescriptions (95% confidence interval [CI] 0.6-17.9) for serious, adverse liver events; for fluconazole 2.8/100,000 prescriptions (95% CI 0.8-10.3) for serious, adverse blood events and 1.4/100,000 prescriptions (95% CI 0.25-8.2) for serious, adverse liver events.


CONCLUSIONS
Itraconazole and fluconazole do not commonly cause rare, serious adverse events affecting the liver, kidneys, skin, or blood.
Bradbury
Brian D
BD
Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, Lexington, Massachusetts 02421, USA.
Jick
Susan S
SS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D056486:Chemical and Drug Induced Liver Injury / Q000473:pathology; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D004338:Drug Combinations; D005260:Female; D015725:Fluconazole / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D017964:Itraconazole / Q000009:adverse effects* / Q000627:therapeutic use; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D013921:Thrombocytopenia / Q000139:chemically induced; D006113:United Kingdom
D000935:Antifungal Agents; D004338:Drug Combinations; D017964:Itraconazole; D015725:Fluconazole