Fluconazole
Tablet · Oral, Intravenous
Uses
Fluconazole is indicated for the treatment of: 1. Vaginal candidiasis (vaginal yeast infections due to Candida ). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. Prophylaxis Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Dosage and administration
Dosage and Administration in Adults Single Dose Vaginal candidiasis The recommended dosage of fluconazole for vaginal candidiasis is 150 mg as a single oral dose. Multiple Dose SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy. The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient's response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse. Oropharyngeal candidiasis The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse. Esophageal candidiasis The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms. Systemic Candida infections For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used. Urinary tract infections and peritonitis For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparative studies of small numbers of patients. Cryptococcal meningitis The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily. Prophylaxis in patients undergoing bone marrow transplantation The recommended fluconazole daily dosage for the prevention of candidiasis in patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils cells/mm 3 ) should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells/mm 3 . Dosage and Administration in Pediatric Patients Oropharyngeal candidiasis The recommended dosage of fluconazole for oropharyngeal candidiasis in pediatric patients 6 months and older is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse. Esophageal candidiasis For the treatment of esophageal candidiasis, the recommended dosage of fluconazole in pediatric patients 6 months and older is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used, based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least 2 weeks following the resolution of symptoms. Systemic Candida infections The following dosing regimens in Table 6 are recommended for pediatric patients to achieve systemic exposures similar to adults for the treatment of systemic Candida infections, i.e., to maintain an AUC 0-24 between 400-800 mg*h/L. Table 6: Recommended Dosing Regimens for the Treatment of Systemic Candida Infections in Pediatric Patients Patient Age Dosing Regimen 3 months and older A loading dose of 25-mg/kg on the first day (not to exceed 800 mg) followed by 12-mg/kg once daily (not to exceed 400 mg) Birth to 3 months postnatal age and gestational age 30 weeks and above 25-mg/kg on the first day, followed by 12-mg/kg once daily Birth to 3 months postnatal age and gestational age less than 30 weeks 25-mg/kg on the first day, followed by 9-mg/kg once daily Patients with systemic candidiasis should be treated for a minimum of 3 weeks and for at least 2 weeks following the resolution of symptoms. Dosing in Pediatric Patients on ECMO The recommended dosage of fluconazole in pediatric patients 3 months and older on ECMO is 35-mg/kg on the first day (not to exceed 800 mg) followed by 12-mg/kg once daily (not to exceed 400 mg). For patients from birth to 3 months postnatal age, and gestational age less than 30 weeks, a loading dose of 35-mg/kg on the first day followed by 9-mg/kg once daily is recommended. For patients from birth to 3 months postnatal age and gestational age 30 weeks and above, a loading dose of 35-mg/kg on the first day followed by 12-mg/kg once daily is recommended. Cryptococcal meningitis For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient's response to therapy.
Contraindications
Fluconazole is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies and PRECAUTIONS . )
Warnings
(1) Hepatic injury: Fluconazole should be administered with caution to patients with liver dysfunction. Fluconazole has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions. In cases of fluconazole associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex, or age of the patient has been observed. Fluconazole hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more severe hepatic injury. Fluconazole should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to fluconazole. (2) Anaphylaxis: In rare cases, anaphylaxis has been reported. (3) Dermatologic: Exfoliative skin disorders during treatment with fluconazole have been reported. Fatal outcomes have been reported in patients with serious underlying diseases. Patients with deep seated fungal infections who develop rashes during treatment with fluconazole should be monitored closely and the drug discontinued if lesions progress. Fluconazole should be discontinued in patients treated for superficial fungal infection who develop a rash that may be attributed to fluconazole. (4) Potential for fetal harm: There are no adequate and well-controlled clinical trials of fluconazole in pregnant women. Case reports describe a pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If fluconazole is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus. Effective contraceptive measures should be considered in women of child-bearing potential who are being treated with fluconazole 400 to 800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose. Epidemiological studies suggest a potential risk of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150 mg of fluconazole as a single or repeated dose in the first trimester, but these epidemiological studies have limitations and these findings have not been confirmed in controlled clinical trials. (See PRECAUTIONS: Pregnancy . )
Precautions
General Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. Fluconazole causes QT prolongation via the inhibition of Rectifier Potassium Channel current (Ikr). The QT prolongation caused by other medicinal products (such as amiodarone) may be amplified via the inhibition of cytochrome P450 (CYP) 3A4 (See PRECAUTIONS: Drug Interactions . ) During post-marketing surveillance, there have been rare cases of QT prolongation and torsade de pointes in patients taking fluconazole. 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. Patients with hypokalemia and advanced cardiac failure are at an increased risk for the occurrence of life-threatening ventricular arrhythmias and torsade de pointes. Fluconazole should be administered with caution to patients with these potentially proarrhythmic conditions. Concomitant use of fluconazole and erythromycin has the potential to increase the risk of cardiotoxicity (prolonged QT interval, torsade de pointes) and consequently sudden heart death. This combination should be avoided. Fluconazole should be administered with caution to patients with renal dysfunction. Adrenal insufficiency has been reported in patients receiving azoles, including fluconazole. Reversible cases of adrenal insufficiency have been reported in patients receiving fluconazole. Fluconazole Powder for Oral Suspension contains sucrose and should not be used in patients with hereditary fructose, glucose/galactose malabsorption, and sucrase-isomaltase deficiency. When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or seizures may occur. There have been reports of cases of superinfection with Candida species other than C. albicans , which are often inherently not susceptible to fluconazole (e.g., Candida krusei ). Such cases may require alternative antifungal therapy (See CLINICAL PHARMACOLOGY , Microbiology ). Single Dose The convenience and efficacy of the single dose oral tablet of fluconazole regimen for the treatment of vaginal yeast infections should be weighed against the acceptability of a higher incidence of drug related adverse events with fluconazole (26%) versus intravaginal agents (16%) in U.S. comparative clinical studies. (See ADVERSE REACTIONS and CLINICAL STUDIES . ) Drug Interactions (See CONTRAINDICATIONS . ) Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor. Fluconazole is also a strong inhibitor of CYP2C19. Patients treated with fluconazole, who are also concomitantly treated with drugs with a narrow therapeutic window metabolized through CYP2C9 and CYP3A4, should be monitored for adverse reactions associated with the concomitantly administered drugs. In addition to the observed /documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9, CYP2C19, and CYP3A4 coadministered with fluconazole. Therefore, caution should be exercised when using these combinations and the patients should be carefully monitored. The enzyme inhibiting effect of fluconazole persists 4 to 5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole. Clinically or potentially significant drug interactions between fluconazole and the following agents/classes have been observed and are described in greater detail below: Abrocitinib Drug interaction studies indicate that when coadministered with fluconazole (strong inhibitor of CYP2C19; moderate inhibitor of CYP2C9 and CYP3A4), the systemic exposure of abrocitinib and its active metabolites increased. (See CLINICAL PHARMACOLOGY . ) Avoid concomitant use of abrocitinib with fluconazole. Refer to the abrocitinib Prescribing Information for additional details. Alfentanil A study observed a reduction in clearance and distribution volume as well as prolongation of t ½ of alfentanil following concomitant treatment with fluconazole. A possible mechanism of action is fluconazole's inhibition of CYP3A4. Dosage adjustment of alfentanil may be necessary. Amiodarone Concomitant administration of fluconazole with amiodarone may increase QT prolongation. Caution must be exercised if the concomitant use of fluconazole and amiodarone is necessary, notably with high dose fluconazole (800 mg). Amitriptyline, nortriptyline Fluconazole increases the effect of amitriptyline and nortriptyline. 5-Nortriptyline and/or S-amitriptyline may be measured at initiation of the combination therapy and after 1 week. Dosage of amitriptyline/nortriptyline should be adjusted, if necessary. Amphotericin B Concurrent administration of fluconazole and amphotericin B in infected normal and immunosuppressed mice showed the following results: a small additive antifungal effect in systemic infection with Candida albicans , no interaction in intracranial infection with Cryptococcus neoformans , and antagonism of the two drugs in systemic infection with A. fumigatus . The clinical significance of results obtained in these studies is unknown. Azithromycin An open-label, randomized, three-way crossover study in 18 healthy subjects assessed the effect of a single 1200 mg oral dose of azithromycin on the pharmacokinetics of a single 800 mg oral dose of fluconazole as well as the effects of fluconazole on the pharmacokinetics of azithromycin. There was no significant pharmacokinetic interaction between fluconazole and azithromycin. Calcium channel blockers Certain calcium channel antagonists (nifedipine, isradipine, amlodipine, verapamil, and felodipine) are metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of the calcium channel antagonists. Frequent monitoring for adverse events is recommended.
Side effects
Fluconazole is generally well tolerated. In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain. In Patients Receiving a Single Dose for Vaginal Candidiasis During comparative clinical studies conducted in the United States, 448 patients with vaginal candidiasis were treated with fluconazole, 150 mg single dose. The overall incidence of side effects possibly related to fluconazole was 26%. In 422 patients receiving active comparative agents, the incidence was 16%. The most common treatment-related adverse events reported in the patients who received 150 mg single dose fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%). Other side effects reported with an incidence equal to or greater than 1% included diarrhea (3%), dyspepsia (1%), dizziness (1%), and taste perversion (1%). Most of the reported side effects were mild to moderate in severity. Rarely, angioedema and anaphylactic reaction have been reported in marketing experience. In Patients Receiving Multiple Doses for Other Infections Sixteen percent of over 4000 patients treated with fluconazole in clinical trials of 7 days or more experienced adverse events. Treatment was discontinued in 1.5% of patients due to adverse clinical events and in 1.3% of patients due to laboratory test abnormalities. Clinical adverse events were reported more frequently in HIV infected patients (21%) than in non-HIV infected patients (13%); however, the patterns in HIV infected and non-HIV infected patients were similar. The proportions of patients discontinuing therapy due to clinical adverse events were similar in the two groups (1.5%). The following treatment-related clinical adverse events occurred at an incidence of 1% or greater in 4048 patients receiving fluconazole for 7 or more days in clinical trials: nausea 3.7%, headache 1.9%, skin rash 1.8%, vomiting 1.7%, abdominal pain 1.7%, and diarrhea 1.5%. Hepato-biliary In combined clinical trials and marketing experience, there have been rare cases of serious hepatic reactions during treatment with fluconazole. (See WARNINGS ) The spectrum of these hepatic reactions has ranged from mild transient elevations in transaminases to clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities. Instances of fatal hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly AIDS or malignancy) and often while taking multiple concomitant medications. Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors. In each of these cases, liver function returned to baseline on discontinuation of fluconazole. In two comparative trials evaluating the efficacy of fluconazole for the suppression of relapse of cryptococcal meningitis, a statistically significant increase was observed in median AST (SGOT) levels from a baseline value of 30 IU/L to 41 IU/L in one trial and 34 IU/L to 66 IU/L in the other. The overall rate of serum transaminase elevations of more than 8 times the upper limit of normal was approximately 1% in fluconazole-treated patients in clinical trials. These elevations occurred in patients with severe underlying disease, predominantly AIDS or malignancies, most of whom were receiving multiple concomitant medications, including many known to be hepatotoxic. The incidence of abnormally elevated serum transaminases was greater in patients taking fluconazole concomitantly with one or more of the following medications: rifampin, phenytoin, isoniazid, valproic acid, or oral sulfonylurea hypoglycemic agents. Post-Marketing Experience In addition, the following adverse events have occurred during post-marketing experience. Immunologic: In rare cases, anaphylaxis (including angioedema, face edema, and pruritus) has been reported. Body as a Whole : Asthenia, fatigue, fever, malaise. Cardiovascular: QT prolongation, torsade de pointes. (See PRECAUTIONS . ) Central Nervous System: Seizures, dizziness. Hematopoietic and Lymphatic: Leukopenia, including neutropenia and agranulocytosis, thrombocytopenia. Metabolic: Hypercholesterolemia, hypertriglyceridemia, hypokalemia. Gastrointestinal: Cholestasis, dry mouth, hepatocellular damage, dyspepsia, vomiting. Other Senses: Taste perversion. Musculoskeletal System: myalgia. Nervous System: Insomnia, paresthesia, somnolence, tremor, vertigo. Skin and Appendages : Acute generalized exanthematous pustulosis, drug eruption including fixed drug eruption, increased sweating, exfoliative skin disorders including Stevens‑Johnson syndrome and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) (See WARNINGS ), alopecia. Adverse Reactions in Pediatric Patients The pattern and incidence of adverse events and laboratory abnormalities recorded during pediatric clinical trials are comparable to those seen in adults. In Phase II/III clinical trials conducted in the United States and in Europe, 577 pediatric patients, ages 1 day to 17 years were treated with fluconazole at doses up to 15 mg/kg/day for up to 1,616 days. Thirteen percent of pediatric patients experienced treatment-related adverse events. The most commonly reported events were vomiting (5%), abdominal pain (3%), nausea (2%), and diarrhea (2%). Treatment was discontinued in 2.3% of patients due to adverse clinical events and in 1.4% of patients due to laboratory test abnormalities. The majority of treatment-related laboratory abnormalities were elevations of transaminases or alkaline phosphatase.
Drug interactions
Drug Interactions (See CONTRAINDICATIONS . ) Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor. Fluconazole is also a strong inhibitor of CYP2C19. Patients treated with fluconazole, who are also concomitantly treated with drugs with a narrow therapeutic window metabolized through CYP2C9 and CYP3A4, should be monitored for adverse reactions associated with the concomitantly administered drugs. In addition to the observed /documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9, CYP2C19, and CYP3A4 coadministered with fluconazole. Therefore, caution should be exercised when using these combinations and the patients should be carefully monitored. The enzyme inhibiting effect of fluconazole persists 4 to 5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole. Clinically or potentially significant drug interactions between fluconazole and the following agents/classes have been observed and are described in greater detail below: Abrocitinib Drug interaction studies indicate that when coadministered with fluconazole (strong inhibitor of CYP2C19; moderate inhibitor of CYP2C9 and CYP3A4), the systemic exposure of abrocitinib and its active metabolites increased. (See CLINICAL PHARMACOLOGY . ) Avoid concomitant use of abrocitinib with fluconazole. Refer to the abrocitinib Prescribing Information for additional details. Alfentanil A study observed a reduction in clearance and distribution volume as well as prolongation of t ½ of alfentanil following concomitant treatment with fluconazole. A possible mechanism of action is fluconazole's inhibition of CYP3A4. Dosage adjustment of alfentanil may be necessary. Amiodarone Concomitant administration of fluconazole with amiodarone may increase QT prolongation. Caution must be exercised if the concomitant use of fluconazole and amiodarone is necessary, notably with high dose fluconazole (800 mg). Amitriptyline, nortriptyline Fluconazole increases the effect of amitriptyline and nortriptyline. 5-Nortriptyline and/or S-amitriptyline may be measured at initiation of the combination therapy and after 1 week. Dosage of amitriptyline/nortriptyline should be adjusted, if necessary. Amphotericin B Concurrent administration of fluconazole and amphotericin B in infected normal and immunosuppressed mice showed the following results: a small additive antifungal effect in systemic infection with Candida albicans , no interaction in intracranial infection with Cryptococcus neoformans , and antagonism of the two drugs in systemic infection with A. fumigatus . The clinical significance of results obtained in these studies is unknown. Azithromycin An open-label, randomized, three-way crossover study in 18 healthy subjects assessed the effect of a single 1200 mg oral dose of azithromycin on the pharmacokinetics of a single 800 mg oral dose of fluconazole as well as the effects of fluconazole on the pharmacokinetics of azithromycin. There was no significant pharmacokinetic interaction between fluconazole and azithromycin. Calcium channel blockers Certain calcium channel antagonists (nifedipine, isradipine, amlodipine, verapamil, and felodipine) are metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of the calcium channel antagonists. Frequent monitoring for adverse events is recommended. Carbamazepine Fluconazole inhibits the metabolism of carbamazepine and an increase in serum carbamazepine of 30% has been observed. There is a risk of developing carbamazepine toxicity. Dosage adjustment of carbamazepine may be necessary depending on concentration measurements/effect. Celecoxib During concomitant treatment with fluconazole (200 mg daily) and celecoxib (200 mg), the celecoxib C max and AUC increased by 68% and 134%, respectively. Half of the celecoxib dose may be necessary when combined with fluconazole. Coumarin-type anticoagulants Prothrombin time may be increased in patients receiving concomitant fluconazole and coumarin-type anticoagulants. In post-marketing experience, as with other azole antifungals, bleeding events (bruising, epistaxis, gastrointestinal bleeding, hematuria, and melena) have been reported in association with increases in prothrombin time in patients receiving fluconazole concurrently with warfarin. Careful monitoring of prothrombin time in patients receiving fluconazole and coumarin-type anticoagulants is recommended. Dose adjustment of warfarin may be necessary. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies . ) Cyclophosphamide Combination therapy with cyclophosphamide and fluconazole results in an increase in serum bilirubin and serum creatinine. The combination may be used while taking increased consideration to the risk of increased serum bilirubin and serum creatinine. Cyclosporine Fluconazole significantly increases cyclosporine levels in renal transplant patients with or without renal impairment. Careful monitoring of cyclosporine concentrations and serum creatinine is recommended in patients receiving fluconazole and cyclosporine. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies . ) This combination may be used by reducing the dosage of cyclosporine depending on cyclosporine concentration. Fentanyl One fatal case of possible fentanyl-fluconazole interaction was reported. The author judged that the patient died from fentanyl intoxication. Furthermore, in a randomized crossover study with 12 healthy volunteers, it was shown that fluconazole delayed the elimination of fentanyl significantly. Elevated fentanyl concentration may lead to respiratory depression. HMG-CoA reductase inhibitors The risk of myopathy and rhabdomyolysis increases when fluconazole is coadministered with HMG-CoA reductase inhibitors metabolized through CYP3A4, such as atorvastatin and simvastatin, or through CYP2C9, such as fluvastatin (decreased hepatic metabolism of the statin).
Pregnancy
Pregnancy Teratogenic Effects Potential for Fetal Harm Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus. A few published case reports describe a pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. Effective contraceptive measures should be considered in women of child-bearing potential who are being treated with fluconazole 400 to 800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose. If fluconazole is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus. Spontaneous abortions and congenital abnormalities have been suggested as potential risks associated with 150 mg of fluconazole as a single or repeated dose in the first trimester of pregnancy based on retrospective epidemiological studies. There are no adequate and well-controlled studies of fluconazole in pregnant women. (See WARNINGS: Potential for Fetal Harm .) Human Data Case reports describe a distinctive and rare pattern of birth defects among infants whose mothers received high-dose (400 to 800 mg/day) fluconazole during most or all of the first trimester of pregnancy. The features seen in these infants include: brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease. These effects are similar to those seen in animal studies. Epidemiological studies suggest a potential risk of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150 mg of fluconazole as a single or repeated dose in the first trimester, but these epidemiological studies have limitations and these findings have not been confirmed in controlled clinical trials. Animal Data Fluconazole was administered orally to pregnant rabbits during organogenesis in two studies at doses of 5 mg/kg, 10 mg/kg, and 20 mg/kg and at 5 mg/kg, 25 mg/kg, and 75 mg/kg, respectively. Maternal weight gain was impaired at all dose levels (approximately 0.25 to 4 times the 400 mg clinical dose based on body surface area [BSA] comparison), and abortions occurred at 75 mg/kg (approximately 4 times the 400 mg clinical dose based on BSA); no adverse fetal effects were observed. In several studies in which pregnant rats received fluconazole orally during organogenesis, maternal weight gain was impaired and placental weights were increased at 25 mg/kg. There were no fetal effects at 5 mg/kg or 10 mg/kg; increases in fetal anatomical variants (supernumerary ribs, renal pelvis dilation) and delays in ossification were observed at 25 mg/kg and 50 mg/kg and higher doses. At doses ranging from 80 to 320 mg/kg (approximately 2 to 8 times the 400 mg clinical dose based on BSA), embryolethality in rats was increased and fetal abnormalities included wavy ribs, cleft palate, and abnormal craniofacial ossification. These effects are consistent with the inhibition of estrogen synthesis in rats and may be a result of known effects of lowered estrogen on pregnancy, organogenesis, and parturition.
Pediatric use
Pediatric Use Use in Pediatric Patients for the Treatment of Oropharyngeal Candidiasis An open-label, randomized, controlled trial has shown fluconazole to be effective in the treatment of oropharyngeal candidiasis in pediatric patients 6 months to 13 years of age. (See CLINICAL STUDIES . ) Use in Pediatric Patients for the Treatment of Candida Esophagitis, Systemic Candida Infections, or Cryptococcal Meningitis The use of fluconazole in pediatric patients with cryptococcal meningitis, Candida esophagitis, or systemic Candida infections is supported by the efficacy shown for these indications in adults and by the results from several small noncomparative pediatric clinical studies. In addition, pharmacokinetic studies in pediatric patients (See CLINICAL PHARMACOLOGY . ) have established a dose proportionality between pediatric patients and adults. (See DOSAGE AND ADMINISTRATION . ) In a noncomparative study of fluconazole administered to pediatric patients (from birth to less than 17 years) with serious systemic fungal infections, most of which were candidemia, the effectiveness of fluconazole was similar to that reported for the treatment of candidemia in adults. Of 17 subjects with culture-confirmed candidemia, 11 of 14 (79%) with baseline symptoms (3 were asymptomatic) had a clinical cure; 13/15 (87%) of evaluable patients had a mycologic cure at the end of treatment but two of these patients relapsed at 10 and 18 days, respectively, following cessation of therapy. The efficacy of fluconazole for the suppression of cryptococcal meningitis was successful in 4 of 5 pediatric patients (4 years to 10 years of age) treated in a compassionate-use study of fluconazole for the treatment of life-threatening or serious mycosis. There are limited clinical data to support the efficacy of fluconazole for the primary treatment of cryptococcal meningitis in pediatric patients. The safety profile of fluconazole has been studied in 577 pediatric patients 1 from 1 day to 17 years of age who received doses ranging from 1 to 15 mg/kg/day for 1 to 1,616 days. (See ADVERSE REACTIONS . ) Use in Pediatric Patients on Extracorporeal Membrane Oxygenation (ECMO) A prospective, open-label, single-center study was conducted to determine the PK and safety of fluconazole in pediatric patients (ages: from birth to 17 years of age) on ECMO (See CLINICAL PHARMACOLOGY ). A loading dose of 35-mg/kg is recommended in pediatric patients on ECMO due to increased volume of distribution (See DOSAGE AND ADMINISTRATION ). Use in Prophylaxis of Invasive Candida Infections in Pediatric Patients (premature infants weighing less than 750 grams at birth) Safety and effectiveness of fluconazole for the prophylaxis of invasive candidiasis in pediatric patients (premature infants weighing less than 750 grams at birth) have not been established. A prospective, randomized, double-blind, placebo-controlled, multicenter trial was conducted in premature infants weighing less than 750 grams at birth to evaluate the efficacy and safety of prophylactic fluconazole 6-mg/kg administered twice weekly for 6 weeks versus placebo (NCT00734539). Efficacy was assessed using the endpoint of death or candidiasis by study day 49. The results are summarized in Table 4 . Table 4: Death or Candidiasis by Day 49 in Premature Infants Receiving Fluconazole Prophylaxis Fluconazole (N=188) n (%) Placebo (N=173) n (%) P-value Difference (95% CI) Death or candidiasis* 33 (17.6) 38 (22.0) 0.2954 -4.4(-12.6, 3.8) Components of endpoint** Death Candidiasis Missing 27 (14.4) 6 (3.2) 2 (1.0) 25 (14.5) 16 (9.2) 1 (0.5) * Subjects with missing data are imputed as having candidiasis or died. **Subjects may be counted more than once as two fluconazole subjects and four placebo subjects diagnosed with candidiasis subsequently died by day 49. The most common fatal serious adverse reactions in the fluconazole vs placebo arms, respectively, were necrotizing enterocolitis (NEC), 9 (5%) vs 9 (5%); neonatal bacterial sepsis, 6 (3%) vs 7 (4%); and neonatal respiratory failure, 4 (2%) vs 2 (0.6%). The most common serious adverse reactions (>5%), reported in patients receiving fluconazole prophylaxis are displayed in Table 5. Table 5. Serious Adverse Reactions* Occurring in >5% of Infants Receiving Fluconazole Prophylaxis Adverse Reaction Fluconazole (N=188) n(%) Placebo (N=173) n (%) Necrotizing Enterocolitis (NEC) 27 (14) 28 (16) Intestinal Perforation (includes ileal/small intestinal perforation) 13 (7) 7 (4) Neonatal Respiratory Arrest/Neonatal Respiratory Failure 13 (7) 4 (2) Bacterial Sepsis, Neonatal 10 (5) 12 (7) *All serious adverse reactions were assessed and recorded up through 30 days after the final dose of study drug. Serious adverse reactions included both fatal and non-fatal outcomes.
Geriatric use
Geriatric Use In non-AIDS patients, side effects possibly related to fluconazole treatment were reported in fewer patients aged 65 and older (9%, n =339) than for younger patients (14%, n=2240). However, there was no consistent difference between the older and younger patients with respect to individual side effects. Of the most frequently reported (>1%) side effects, rash, vomiting, and diarrhea occurred in greater proportions of older patients. Similar proportions of older patients (2.4%) and younger patients (1.5%) discontinued fluconazole therapy because of side effects. In post-marketing experience, spontaneous reports of anemia and acute renal failure were more frequent among patients 65 years of age or older than in those between 12 and 65 years of age. Because of the voluntary nature of the reports and the natural increase in the incidence of anemia and renal failure in the elderly, it is however not possible to establish a causal relationship to drug exposure. Controlled clinical trials of fluconazole did not include sufficient numbers of patients aged 65 and older to evaluate whether they respond differently from younger patients in each indication. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Fluconazole is primarily cleared by renal excretion as unchanged drug. Because elderly patients are more likely to have decreased renal function, care should be taken to adjust dose based on creatinine clearance. It may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION . )
Overdosage
There have been reports of overdose with fluconazole accompanied by hallucination and paranoid behavior. In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if clinically indicated) should be instituted. Fluconazole is largely excreted in urine. A 3-hour hemodialysis session decreases plasma levels by approximately 50%. In mice and rats receiving very high doses of fluconazole, clinical effects in both species included decreased motility and respiration, ptosis, lacrimation, salivation, urinary incontinence, loss of righting reflex, and cyanosis; death was sometimes preceded by clonic convulsions.
Description
Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension. Fluconazole is designated chemically as 2,4-difluoro-α,α 1 -bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C 13 H 12 F 2 N 6 O and molecular weight of 306.3. The structural formula is: Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Tablets contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Fluconazole for Oral Suspension contains 350 mg or 1400 mg of fluconazole and the following inactive ingredients: sucrose, sodium citrate dihydrate, citric acid anhydrous, sodium benzoate, titanium dioxide, colloidal silicon dioxide, xanthan gum, and natural orange flavor. After reconstitution with 24 mL of distilled water or Purified Water (USP), each mL of reconstituted suspension contains 10 mg or 40 mg of fluconazole. Chemical Structure
Mechanism of action
Mechanism of Action Fluconazole is a highly selective inhibitor of fungal cytochrome P450 dependent enzyme lanosterol 14-α-demethylase. This enzyme functions to convert lanosterol to ergosterol. The subsequent loss of normal sterols correlates with the accumulation of 14-α-methyl sterols in fungi and may be responsible for the fungistatic activity of fluconazole. Mammalian cell demethylation is much less sensitive to fluconazole inhibition.
How supplied
Fluconazole Tablets Pink trapezoidal tablets containing 50, 100, or 200 mg of fluconazole are packaged in bottles or unit dose blisters. The 150 mg fluconazole tablets are pink and oval shaped, packaged in a single dose unit blister. Fluconazole Tablets are supplied as follows: Fluconazole 50 mg Tablets: Embossed with "FLZ 50" on one side with no markings on the other side. NDC 59762-5015-1 Bottles of 30 Fluconazole 100 mg Tablets: Embossed with "FLZ 100" on one side with no markings on the other side. NDC 59762-5016-1 Bottles of 30 Fluconazole 150 mg Tablets: Embossed with "FLZ 150" on one side with no markings on the other side. NDC 59762-5017-1 Unit dose package of 12 Fluconazole 200 mg Tablets: Embossed with "FLZ 200" on one side with no markings on the other side. NDC 59762-5018-1 Bottles of 30 Storage Store tablets below 30°C (86°F). Fluconazole for Oral Suspension Fluconazole for Oral Suspension is supplied as an orange-flavored powder to provide 35 mL per bottle as follows: NDC 59762-5029-1 Fluconazole 350 mg per bottle NDC 59762-5030-1 Fluconazole 1400 mg per bottle Storage Store dry powder below 30°C (86°F). Store reconstituted suspension between 30°C (86°F) and 5°C (41°F) and discard unused portion after 2 weeks. Protect from freezing.
Storage
Storage Store tablets below 30°C (86°F). Storage Store dry powder below 30°C (86°F). Store reconstituted suspension between 30°C (86°F) and 5°C (41°F) and discard unused portion after 2 weeks. Protect from freezing.
Label text from the FDA structured product label by Mylan Pharmaceuticals Inc. (revised Apr 2, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Fluconazole in 160 products
Fluconazole NDC products (160)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6842 | Fluconazole 150 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6751 | Fluconazole 200 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6733 | Fluconazole 100 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5764 | Fluconazole 150 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5299 | Fluconazole 100 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-4864 | Fluconazole 200 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-4425 | Fluconazole 150 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-2195 | Fluconazole 150 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-1429 | Fluconazole 100 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 68084-735 | Fluconazole 200 mg/1 Tablet | American Health Packaging | ANDA |
| 68084-728 | Fluconazole 100 mg/1 Tablet | American Health Packaging | ANDA |
| 62559-990 | Fluconazole 50 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 62559-991 | Fluconazole 100 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 62559-992 | Fluconazole 150 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 62559-993 | Fluconazole 200 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 87063-206 | Fluconazole 200 mg/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-205 | Fluconazole 150 mg/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-204 | Fluconazole 100 mg/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-203 | Fluconazole 50 mg/1 Tablet | ASCLEMED USA INC. | ANDA |
| 76420-587 | Fluconazole 150 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-164 | Fluconazole 150 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 65862-060 | Fluconazole 150 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-300 | Fluconazole 40 mg/mL Powder, For Suspension | Aurobindo Pharma Limited | ANDA |
| 65862-299 | Fluconazole 10 mg/mL Powder, For Suspension | Aurobindo Pharma Limited | ANDA |
| 65862-058 | Fluconazole 50 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-059 | Fluconazole 100 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-061 | Fluconazole 200 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 50268-337 | Fluconazole 100 mg/1 Tablet | AvPAK | ANDA |
| 50268-339 | Fluconazole 200 mg/1 Tablet | AvPAK | ANDA |
| 0338-6046 | Fluconazole 200 mg/100mL Injection, Solution | Baxter Healthcare Company | ANDA |
| 0338-6045 | Fluconazole 400 mg/200mL Injection, Solution | Baxter Healthcare Company | ANDA |
| 68001-251 | Fluconazole 50 mg/1 Tablet | BluePoint Laboratories | ANDA |
| 68001-252 | Fluconazole 100 mg/1 Tablet | BluePoint Laboratories | ANDA |
| 68001-253 | Fluconazole 150 mg/1 Tablet | BluePoint Laboratories | ANDA |
| 68001-254 | Fluconazole 200 mg/1 Tablet | BluePoint Laboratories | ANDA |
| 71335-1895 | Fluconazole 200 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1448 | Fluconazole 150 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1948 | Fluconazole 100 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2235 | Fluconazole 200 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2268 | Fluconazole 150 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-9134 | Fluconazole 100 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-9091 | Fluconazole 200 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8970 | Fluconazole 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0686 | Fluconazole 100 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0769 | Fluconazole 200 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1268 | Fluconazole 150 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1776 | Fluconazole 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 55154-3400 | Fluconazole 100 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-7875 | Fluconazole 200 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 62135-132 | Fluconazole 150 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-130 | Fluconazole 50 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-131 | Fluconazole 100 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-133 | Fluconazole 200 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 67046-1546 | Fluconazole 50 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-2000 | Fluconazole 100 mg/1 Tablet | Coupler LLC | ANDA |
| 72189-143 | Fluconazole 150 mg/1 Tablet | direct rx | ANDA |
| 72189-149 | Fluconazole 150 mg/1 Tablet | direct rx | ANDA |
| 72189-342 | Fluconazole 150 mg/1 Tablet | Direct Rx | ANDA |
| 61919-493 | Fluconazole 200 mg/1 Tablet | Direct Rx | ANDA |
| 72189-140 | Fluconazole 100 mg/1 Tablet | direct rx | ANDA |
| 72189-516 | Fluconazole 200 mg/1 Tablet | Direct_Rx | ANDA |
| 55111-146 | Fluconazole 200 mg/1 Tablet | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-145 | Fluconazole 150 mg/1 Tablet | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-144 | Fluconazole 100 mg/1 Tablet | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-143 | Fluconazole 50 mg/1 Tablet | Dr. Reddy's Laboratories Limited | ANDA |
| 68462-119 | Fluconazole 150 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-104 | Fluconazole 200 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-102 | Fluconazole 100 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-101 | Fluconazole 50 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 51407-425 | Fluconazole 100 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-424 | Fluconazole 50 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-426 | Fluconazole 150 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-427 | Fluconazole 200 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 85534-0049 | Fluconazole 150 mg/1 Tablet | HAWAII REPACK, INC. | ANDA |
| 0143-9666 | Fluconazole 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9667 | Fluconazole 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9899 | Fluconazole 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9669 | Fluconazole 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9668 | Fluconazole 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0409-4321 | Fluconazole 400 mg/200mL Injection, Solution | Hospira, Inc | ANDA |
| 0409-3435 | Fluconazole 200 mg/100mL Injection, Solution | Hospira, Inc | ANDA |
| 0904-6501 | Fluconazole 200 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6500 | Fluconazole 100 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 16714-694 | Fluconazole 50 mg/1 Tablet | NorthStar Rx LLC | ANDA |
| 16714-693 | Fluconazole 200 mg/1 Tablet | NorthStar Rx LLC | ANDA |
| 16714-692 | Fluconazole 150 mg/1 Tablet | NorthStar Rx LLC | ANDA |
| 16714-691 | Fluconazole 100 mg/1 Tablet | NorthStar Rx LLC | ANDA |
| 16714-695 | Fluconazole 10 mg/mL Powder, For Suspension | NorthStar Rx LLC | ANDA |
| 16714-696 | Fluconazole 40 mg/mL Powder, For Suspension | NorthStar Rx LLC | ANDA |
| 82868-033 | Fluconazole 150 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-889 | Fluconazole 100 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-435 | Fluconazole 150 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 68071-3768 | Fluconazole 100 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3547 | Fluconazole 200 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4501 | Fluconazole 100 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2557 | Fluconazole 150 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3428 | Fluconazole 200 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3474 | Fluconazole 150 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3515 | Fluconazole 150 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3578 | Fluconazole 150 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 43063-645 | Fluconazole 100 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-642 | Fluconazole 150 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 55289-824 | Fluconazole 200 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 82982-070 | Fluconazole 150 mg/1 Tablet | Pharmasource Meds, LLC | ANDA |
| 68788-4163 | Fluconazole 200 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7293 | Fluconazole 150 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8526 | Fluconazole 200 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 82804-218 | Fluconazole 100 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-146 | Fluconazole 200 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-030 | Fluconazole 200 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-878 | Fluconazole 200 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-584 | Fluconazole 150 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-796 | Fluconazole 150 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-650 | Fluconazole 100 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-563 | Fluconazole 150 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-283 | Fluconazole 200 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-081 | Fluconazole 150 mg/1 Tablet | Proficient Rx LP | ANDA |
| 77771-399 | Fluconazole 200 mg/1 Tablet | Radha Pharmaceuticals Inc | ANDA |
| 77771-398 | Fluconazole 150 mg/1 Tablet | Radha Pharmaceuticals Inc | ANDA |
| 77771-397 | Fluconazole 100 mg/1 Tablet | Radha Pharmaceuticals Inc | ANDA |
| 77771-396 | Fluconazole 50 mg/1 Tablet | Radha Pharmaceuticals Inc | ANDA |
| 67296-2274 | Fluconazole 150 mg/1 Tablet | Redpharm Drug | ANDA |
| 70518-3901 | Fluconazole 100 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4020 | Fluconazole 200 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4242 | Fluconazole 100 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4332 | Fluconazole 150 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4336 | Fluconazole 150 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4413 | Fluconazole 100 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2415 | Fluconazole 100 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4723 | Fluconazole 50 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 57237-003 | Fluconazole 50 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 57237-004 | Fluconazole 100 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 57237-005 | Fluconazole 150 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 57237-150 | Fluconazole 40 mg/mL Powder, For Suspension | Rising Pharma Holdings, Inc. | ANDA |
| 57237-149 | Fluconazole 10 mg/mL Powder, For Suspension | Rising Pharma Holdings, Inc. | ANDA |
| 57237-006 | Fluconazole 200 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 25021-184 | Fluconazole 2 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA |
| 70436-227 | Fluconazole 40 mg/mL Powder, For Suspension | Slate Run Pharmaceuticals | ANDA |
| 85766-101 | Fluconazole 50 mg/1 Tablet | Sportpharm LLC | ANDA |
| 85766-102 | Fluconazole 100 mg/1 Tablet | Sportpharm LLC | ANDA |
| 85766-103 | Fluconazole 150 mg/1 Tablet | Sportpharm LLC | ANDA |
| 85766-104 | Fluconazole 200 mg/1 Tablet | Sportpharm LLC | ANDA |
| 85766-156 | Fluconazole 50 mg/1 Tablet | Sportpharm LLC | ANDA |
| 85766-157 | Fluconazole 100 mg/1 Tablet | Sportpharm LLC | ANDA |
| 85766-158 | Fluconazole 150 mg/1 Tablet | Sportpharm LLC | ANDA |
| 85766-159 | Fluconazole 200 mg/1 Tablet | Sportpharm LLC | ANDA |
| 85766-167 | Fluconazole 150 mg/1 Tablet | Sportpharm LLC | ANDA |
| 60760-950 | Fluconazole 150 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-803 | Fluconazole 150 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA |
| 72673-091 | Fluconazole 40 mg/mL Powder, For Suspension | Zhejiang Poly Pharm. Co., Ltd. | ANDA |
| 70771-1064 | Fluconazole 100 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70771-1063 | Fluconazole 50 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70771-1065 | Fluconazole 150 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70771-1066 | Fluconazole 200 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70710-1140 | Fluconazole 200 mg/1 Tablet | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 70710-1139 | Fluconazole 150 mg/1 Tablet | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 70710-1138 | Fluconazole 100 mg/1 Tablet | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 70710-1137 | Fluconazole 50 mg/1 Tablet | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 59762-5029 | Fluconazole 10 mg/mL Powder, For Suspension | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
| 59762-5030 | Fluconazole 40 mg/mL Powder, For Suspension | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
Fluconazole recalls
- D-0788-2017 May 24, 2017 · Class II · Terminated
Lack of assurance of sterility: customer complaints received for the presence of leaks. - D-0688-2017 May 10, 2017 · Class II · Terminated
Failed Dissolution Specifications - D-0689-2017 May 10, 2017 · Class II · Terminated
Failed Dissolution Specifications - D-0449-2017 Feb 8, 2017 · Class II · Terminated
Failed Dissolution Specifications; 18 month stability time point - D-0450-2017 Feb 8, 2017 · Class II · Terminated
Failed Dissolution Specifications; 18 month stability time point - D-0451-2017 Feb 8, 2017 · Class II · Terminated
Failed Dissolution Specifications; 18 month stability time point - D-0452-2017 Feb 8, 2017 · Class II · Terminated
Failed Dissolution Specifications; 18 month stability time point - D-0206-2017 Dec 28, 2016 · Class II · Terminated
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. - D-0380-2015 Feb 4, 2015 · Class II · Terminated
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. - D-1356-2014 Jun 11, 2014 · Class II · Terminated
Defective Container: Tamper evident ring failures discovered on some bottles.
Frequently asked questions
What is Fluconazole used for?
Fluconazole is indicated for the treatment of: 1. Vaginal candidiasis (vaginal yeast infections due to Candida ). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated…
What are the side effects of Fluconazole?
Fluconazole is generally well tolerated. In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain. In Patients Receiving a… See the full label for the complete list.
Who makes Fluconazole?
Fluconazole is listed by 43 labelers in the FDA NDC directory, including A-S Medication Solutions, American Health Packaging, ANI Pharmaceuticals, Inc., ASCLEMED USA INC..
Has Fluconazole been recalled?
The FDA enforcement database lists 10 recalls for Fluconazole, most recently D-0788-2017 (class ii): Lack of assurance of sterility: customer complaints received for the presence of leaks.