Acute oral toxicity (LD50): 1271 mg/kg (rat) MSDS

Overdose information

Fluconazole overdoses have been associated with hallucination and paranoia, sometimes in combination.^L11043 In cases of overdose, employ supportive treatment. Gastric lavage may be necessary.^L11043 Other modalities such as forced diuresis or hemodialysis may also be used.^L11043

A note on liver toxicity

The FDA label warns that this drug carries a risk of hepatotoxicity. Rare but serious cases of serious hepatic toxicity have been reported, especially in patients with serious underlying medical conditions using fluconazole. This group of patients has an increased risk of fatality when using fluconazole.^L11043 In patients with existing liver dysfunction, use caution during fluconazole therapy. Those who are found to have abnormal liver function tests during therapy should be carefully monitored for the development of increasingly severe injury to the liver. Fluconazole should be stopped if its use is likely to be the underlying cause of liver injury, and medical attention should be sought.L11043,L6505 Fluconazole induced hepatotoxicity is usually reversible.^L11043

Carcinogenesis, mutagenesis, and impairment of fertility

Fluconazole demonstrated no evidence of carcinogenic risk in mice and rats treated orally for 24 months at doses equivalent to approximately 2-7 time the recommended human dose). Male rats given fluconazole at doses equivalent to supratherapeutic human doses showed an increased incidence of hepatocellular adenomas. Cytogenetic studies in vivo and in vitro demonstrated no sign of chromosomal mutation. The significance of these findings for humans is unknown.^L11043

Use in pregnancy

There are no sufficient and well-controlled studies of fluconazole use in pregnant women. Available human data do not show an increased risk of congenital anomalies after pregnant women were treated with standard doses (<200 mg/day) of fluconazole, either in a single dose or multiple doses in the first trimester did not appear to impact the fetus negatively.^L11043 Several case reports describe rare but striking congenital anomalies observed in infants who were exposed to fluconazole at high doses reaching 400-800 mg/day, primarily in the first trimester of pregnancy. Similar findings were observed in animal studies. If this drug is administered during pregnancy, or if the patient becomes pregnant while taking fluconazole, the risk should be discussed thoroughly.^L11043

Use in nursing

Fluconazole is secreted in breastmilk at high concentrations. Exercise caution if this drug is used during nursing.^L11043