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Generic drug name:
fluconazole
(flew KON a zole)
Brand name(s):
DIFLUCAN
GENERIC:
available
FAMILY:
Drugs for Fungal Infection
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
Fluconazole has caused harm to developing fetuses in animal studies, including bone abnormalities of the skull. There have been reports of multiple congenital abnormalities in children born to mothers taking fluconazole. Because of the potential for serious adverse effects to the fetus, this drug should not be used by pregnant women.
The Food and Drug Administration (FDA) is informing the public that treatment with chronic, high doses (400-800 mg/day) of DIFLUCAN (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. This risk does not appear to be associated with a single, low dose of fluconazole (150 mg) to treat vaginal yeast infection (candidiasis).
Breast-feeding Warning
Fluconazole is excreted in human milk. Because of the potential for adverse effects in nursing infants, you should not take this drug while nursing.
Safety Warnings For This Drug [top]
Hepatic Effects
Itraconazole has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition, and some of these cases developed within the first week of treatment. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. Continued itraconazole use or reinstitution of treatment with itraconazole is strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk.[1]
Hepatotoxicity
Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Lamisil Tablets in individuals with and without preexisting liver disease.
In the majority of liver cases reported in association with use of Lamisil Tablets, the patients had serious underlying systemic conditions. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with Lamisil Tablets should be discontinued if biochemical or clinical evidence of liver injury develops.
Lamisil Tablets are not recommended for patients with chronic or active liver disease. Before prescribing Lamisil Tablets, liver function tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver disease. Periodic monitoring of liver function tests is recommended. Lamisil should be immediately discontinued in case of elevation of liver function tests. Patients prescribed Lamisil Tablets should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools. Patients with these symptoms should discontinue taking oral terbinafine, and the patient’s liver function should be immediately evaluated. [2]
Facts About This Drug [top]
Fluconazole is used to treat severe fungal infections (such as meningitis) and infections of the mouth or esophagus (such as candida).[3],[4] Often these infections occur when another condition (such as cancer, organ transplant or HIV infection) reduces immunity to infections. The drug should not be used to treat trivial fungal skin infections.
Fluconazole is also approved by the Food and Drug Administration (FDA) to treat vaginal yeast infections (vaginal candidiasis) in a single dose...
Fluconazole is used to treat severe fungal infections (such as meningitis) and infections of the mouth or esophagus (such as candida).[3],[4] Often these infections occur when another condition (such as cancer, organ transplant or HIV infection) reduces immunity to infections. The drug should not be used to treat trivial fungal skin infections.
Fluconazole is also approved by the Food and Drug Administration (FDA) to treat vaginal yeast infections (vaginal candidiasis) in a single dose of 150 milligrams (mg).[5]
Adverse effects
Some drugs in the azole family, including fluconazole, have been associated with the prolongation of the QT interval. QT prolongation is a change in the electrical activity of the heart that can lead to a fatal heart rhythm disturbance called torsades de pointes, resulting in sudden death. During postmarketing surveillance of fluconazole, there have been rare cases of QT prolongation and torsades de pointes. Most of these reports involved seriously ill patients with multiple confounding risk factors (such as structural heart disease, electrolyte abnormalities and concomitant medications) that may have been contributory.
Fluconazole should be administered with caution to patients with these potential pro-arrhythmic conditions. Also, other drugs known to cause QT interval prolongation, such as erythromycin, should not be administered to patients taking fluconazole.
Patients who develop a rash while being treated with fluconazole for deep-seated fungal infections should be monitored carefully, and the drug should be stopped if the rash progresses. The drug should be discontinued in patients who develop a rash while taking fluconazole for superficial fungal infections.
In 2020, BMJ published an article warning about a small increased risk of musculoskeletal (muscle and bone) malformations in children born to mothers who used fluconazole during the first trimester of pregnancy.
Regulatory actions surrounding fluconazole
2011: In August, the FDA issued a safety communication that long-term (chronic) high-dose (400-800 mg/day) use of fluconazole during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. (See warning box under “Safety Warnings for This Drug” section, at top of this page.)[6]
2016: The FDA is evaluating data from a Danish study on the possible increased risk of miscarriage associated with the use of oral fluconazole.[7]
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:
amitriptyline, CELEBREX, celecoxib, cilostazol, COUMADIN, cyclosporine, DECADRON, DETROL, dexamethasone, DILANTIN, DURAQUIN, ELAVIL, glipizide, GLUCOTROL, HEXADROL, lovastatin, MEVACOR, mizolastine, NEORAL, phenytoin, PLETAL, PRIFTIN, PROGRAF, QUINAGLUTE DURA-TABS, QUINIDEX, quinidine, RETROVIR, RIFADIN, rifampin, rifapentine, RIMACTANE, SANDIMMUNE, simvastatin, tacrolimus, tolterodine, warfarin, zidovudine, ZOCOR.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed October 31, 2020
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