Fluconazole is generally well tolerated. The most common undesirable effects observed during clinical trials and associated with fluconazole are: Central and Peripheral Nervous System: Headache.
Gastrointestinal: Abdominal pain, diarrhoea, flatulence, nausea.
In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and haematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain (see Precautions).
Liver/Biliary: Hepatic toxicity including rare cases of fatalities, elevated alkaline phosphatase, elevated bilirubin, elevated SGOT, elevated SGPT.
In addition, the following undesirable effects have occurred during post-marketing: Central and Peripheral Nervous System: Dizziness, seizures.
Skin/Appendages: Alopecia, exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrosis.
Gastrointestinal: Dyspepsia, vomiting.
Haematopoietic and Lymphatic: Leukopenia including neutropenia and agranulocytosis, thrombocytopenia.
Body As A Whole: Allergic reaction: Anaphylaxis (including angioedema, face oedema, pruritus), urticaria.
Liver/Biliary: Hepatic failure, hepatitis, hepatocellular necrosis, jaundice.
Metabolic/Nutritional: Hypercholesterolaemia, hypertriglyceridaemia, hypokalaemia.
Other senses: Taste pervesion.
Cardiac Disorders: QT prolongation, torsade de pointes.