Biozole

Biozole Adverse Reactions

fluconazole

Manufacturer:

Biolab

Distributor:

Biopharm
Full Prescribing Info
Adverse Reactions
Fluconazole is generally well tolerated. The most common side effects associated with fluconazole are symptoms related to the gastrointestinal tract. These include nausea, 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 Warnings) 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. 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.
The most common undesirable effects observed with fluconazole are: Nervous System Disorders: Headache, dizziness, somnolence, seizures.
Hepatic Disorders: Hepatotoxicity including rare cases of fatalities, elevated alkaline phosphatase, elevated bilirubin, elevated SGOT, elevated SGPT, transient hepatic reactions, including hepatitis and jaundice. In addition, the following undesirable effects have occurred.
Hematologic/Lymphatic Disorders: Leukopenia, including neutropenia and agranulocytosis, thrombocytopenia.
Metabolic Disorders: Hypercholesterolemia, hypertriglyceridemia, hypokalemia.
Gastrointestinal Disorders: Nausea, abdominal pain, diarrhea, flatulence.
Dermatologic and Sensitivity Reaction Disorders: Rash, exfoliative skin disorders including Steven-Johnson Syndrome and toxic epidermal necrolysis, anaphylaxis, angioedema, pruritus, alopecia.
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