Biozole Warnings

Very rarely, patients who died with severe underlying disease and who had received multiple-dose fluconazole had post-mortem findings which included hepatic necrosis. These patients were receiving multiple concomitant medications, some known to be potentially hepatotoxic and/or had underlying diseases which could have caused the hepatic necrosis. Consequently, because a causal relationship with fluconazole cannot be excluded, in those patients in whom a significant rise of liver enzymes occurs, the risk-benefit ratio of continued fluconazole treatment should be assessed. In rare cases, as with other azoles, anaphylaxis has been reported.
Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson Syndrome and toxic epidermal necrolysis, during treatment with fluconazole. AIDS patients are more prone to the development of severe cutaneous reactions to many drugs. If a rash, which is considered attributable to fluconazole, develops in patients treated for a superficial fungal infection, 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.
The coadministration of fluconazole at doses lower than 400 mg per day with terfenadine should be carefully monitored.
Azole antifungal, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram.
During post-marketing surveillance, there have been rare cases of QT prolongation and torsades de pointes in patients taking fluconazole. Most reported cases involved seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant drugs that may have been contributed to these events. Fluconazole should be administered with caution to patients with these potentially proarrhythmic conditions.