Since fluconazole is used in patients with serious underlying diseases, there are some instances where causal relationship of the adverse event to the treatment is hard to establish.
Gastrointestinal effects: Gastrointestinal effects are the most common adverse reactions reported with fluconazole use. These reactions are usually mild to moderate in nature and do not usually require discontinuation of therapy. These adverse effects are nausea, vomiting, abdominal pain and diarrhea. Rarely, there have been reports of flatus, bloating, dry mouth, hiccups, heartburn and anorexia.
In patients with vulvovaginal candidiasis receiving single dose of fluconazole, abdominal pain, nausea, diarrhea, dyspepsia and dysgeusia have been reported.
Dermatologic and Hypersensitivity Reactions: Rare reports of anaphylaxis have occurred. Rash (including diffuse rash with eosinophilia) and pruritus were also reported. Stevens-Johnson syndrome has also occurred and may be fatal.
In patients with serious diseases such as autoimmune deficiency syndrome (AIDS) or malignancy, exfoliative skin disorders have occurred.
In patients with vulvovaginal candidiasis receiving single dose of fluconazole, angioedema and anaphylaxis were reported rarely.
Hepatic Effects: Rare but serious hepatoxicity (eg, necrosis, clinical hepatitis, cholestasis, fulminant hepatic failure) have been reported.
Although these events may be reversible, there have been reports of death, especially involving patients with serious underlying conditions.
Nervous System Effects: Dizziness and headache have occurred. Somnolence, delirium/coma, dysesthesia, psychiatric disturbances, malaise, paresthesia of hands and feet, fatigue and seizure have been reported rarely.
Hematologic Effects: Eosinophilia, anemia, leukopenia, neutropenia and thrombocytopenia have been reported. Although thrombocytopenia may be reversible after drug discontinuation, there were reports of severe cases necessitating treatment.
Endocrine Effects: Endocrine effects of fluconazole have not been studied. However, there have been reports of alterations on testosterone and endogenous corticosteroid concentrations, as well as changes in ACTH-stimulated cortisol response.
Other Adverse Effects: There have been rare reports of fever, edema, pleural effusion, oliguria, hypotension, arthralgia/myalgia and finger stiffness. Alopecia was also reported, occurring in both genders after 3 months of therapy. Alopecia may respond to either drug discontinuation or dose reduction. Fluconazole may also cause hair loss on the face, axillary, pubic, leg and chest area.
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