Fluconazole is generally well tolerated. The most common side effects associated with fluconazole are symptoms related to the gastrointestinal tract. These include nausea, headache, abdominal pain, diarrhea and flatulence.
After gastro-intestinal symptoms, the second most commonly observed side effect was rash. 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.
Patients with AIDS are more prone to the development of severe cutaneous reactions to many drugs. A small number of AIDS patients have developed such reaction, usually while receiving fluconazole concomitantly with other agents known to be associated with exfoliative cutaneous reactions. However, a definite causal relationship between exfoliative skin eruptions and the drug has not been established, since most patients were receiving multiple drugs concomitantly with fluconazole. 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.