title: Itraconazole and fluconazole and certain rare, serious adverse events.
abstract: 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.
authors.affiliation: Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, Lexington, Massachusetts 02421, USA.
authors.forename: Brian D
authors.initials: BD
authors.lastname: Bradbury
authors.forename: Susan S
authors.initials: SS
authors.lastname: Jick
mesh_terms: 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
chemical_list: D000935:Antifungal Agents; D004338:Drug Combinations; D017964:Itraconazole; D015725:Fluconazole