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The following adverse reactions have been observed and reported during treatment with fluconazole with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Blood and the lymphatic system disorders: Uncommon: Anaemia.
Rare: Agranulocytosis, leukopenia, thrombocytopenia, neutropenia.
Immune system disorders: Rare: Anaphylaxis.
Metabolism and nutrition disorders: Uncommon: Decreased appetite.
Rare: Hypercholesterolaemia, hypertriglyceridaemia, hypokalemia.
Psychiatric disorders: Uncommon: Somnolence, insomnia.
Nervous system disorders: Common: Headache.
Uncommon: Seizures, paraesthesia, dizziness, taste perversion.
Rare: Tremor.
Ear and labyrinth disorders: Uncommon: Vertigo.
Cardiac disorders: Rare: Torsades de pointes, QT prolongation.
Gastrointestinal disorders: Common: Abdominal pain, vomiting, diarrhoea, nausea.
Uncommon: Constipation, dyspepsia, flatulence, dry mouth.
Hepatobiliary disorders: Common: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased.
Uncommon: Cholestasis, jaundice, bilirubin increased.
Rare: Hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular damage.
Skin and subcutaneous tissue disorders: Common: Rash.
Uncommon: Drug eruption - including Fixed Drug Eruption, urticaria, pruritus, increased sweating.
Rare: Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis, dermatitis exfoliative, angioedema, face oedema, alopecia.
Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS).
Musculoskeletal and connective tissue disorders: Uncommon: Myalgia.
General disorders and administration site conditions: Uncommon: Fatigue, malaise, asthenia, fever.
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