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The most common undesirable effects observed during clinical trials and associated with fluconazole are: Central and Peripheral Nervous System: Headache.
Skin/Appendages: Rash.
Gastrointestinal: Abdominal pain, diarrhea, flatulence and nausea. In some patients, particularly those with serious underlying diseases e.g., AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities (see Precautions) have been observed during treatment with fluconazole and comparative agents but the clinical significance and relationship to treatment is uncertain.
Liver/Biliary: Hepatic toxicity including rare cases of fatalities, elevated alkaline phosphatase, bilirubin, SGOT and SGPT.
In addition, the following undesirable effects have occurred during post-marketing: Cardiac Disorders: QT prolongation, torsade de pointes.
Central and Peripheral Nervous System: Dizziness and seizures.
Skin/Appendages: Alopecia, exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Gastrointestinal: Dyspepsia and vomiting.
Hematopoietic and Lymphatic: Leukopenia including neutropenia and agranulocytosis, and thrombocytopenia.
Body as a Whole: Anaphylaxis (including angioedema, face edema, pruritus and urticaria).
Liver/Biliary: Hepatic failure, hepatitis, hepatocellular necrosis and jaundice.
Metabolic/Nutritional: Hypercholesterolemia, hypertriglyceridemia and hypokalemia.
Other Senses: Taste perversion.
Patients with AIDS are more prone to the development of severe cutaneous reactions to many drugs. If a rash develops in a patient treated for a superficial fungal infection which is considered attributable to fluconazole, further therapy with this agent should be discontinued. If patients with invasive/systemic fungal infections develop rashes, they should be monitored closely and fluconazole discontinued if bullous lesions or erythema multiforme develop. In rare cases, as with other azoles, anaphylaxis has been reported.
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