The most common undesirable effects observed during clinical trials and associated with fluconazole are: Nervous System Disorders: Headache.
Gastrointestinal Disorders: Abdominal pain, diarrhea, flatulence and nausea.
Hepatobiliary Disorders: Hepatic toxicity including rare cases of fatalities, elevated alkaline phosphatase, elevated bilirubin, elevated SGOT and SGPT.
Skin and Subcutaneous Tissue Disorders: Rash.
In some patients, particularly those with serious underlying diseases eg, 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.
In addition, the following undesirable effects have occurred during post-marketing: Blood and Lymphatic System Disorders: Leukopenia including neutropenia and agranulocytosis, thrombocytopenia.
Immune System Disorders: Anaphylaxis (including angioedema, face edema, pruritus and urticaria).
Metabolism and Nutrition Disorders: Hypercholesterolemia, hypertriglyceridemia and hypokalemia.
Nervous System Disorders: Dizziness, seizures and taste perversion.
Cardiac Disorders: QT prolongation and torsade de pointes (see Precautions).
Gastrointestinal Disorders: Dyspepsia and vomiting.
Hepatobiliary Disorders: Hepatic failure, hepatitis, hepatocellular necrosis and jaundice.
Skin and Subcutaneous Tissue Disorders: Alopecia, exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis.
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