FDA label

What is fluconazole used for?

The FDA-approved uses of fluconazole, quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label says: “Fluconazole tablets are indicated for the treatment of:”

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Fluconazole, tablet

Indications and Usage, quoted from the label by Sportpharm LLC (ANDA076658). Cross-references to other label sections are left out.

Fluconazole tablets are 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 tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candidainfections including candidemia, disseminated candidiasis, and pneumonia.

3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.

Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.

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.

Source: DailyMed label, set id 8a4d6d9e-02ae-42e4-83ec-f5c4e135273b, version 2, effective April 24, 2026. NDC 85766-101, one of 140 listings for this product.

Fluconazole, powder, for suspension

Indications and Usage, quoted from the label by Slate Run Pharmaceuticals (ANDA215738). Cross-references to other label sections are left out.

Fluconazole for oral suspension is indicated for the treatment of: 1. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole for oral suspension was also effective for the treatment of Candidaurinary tract infections, peritonitis, and systemic Candidainfections including candidemia, disseminated candidiasis, and pneumonia. 2. Cryptococcal meningitis. Before prescribing fluconazole for oral suspension for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole for oral suspension to amphotericin B in non-HIV infected patients have not been conducted.

Prophylaxis: Fluconazole for oral suspension is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.

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.

Source: DailyMed label, set id 13804efd-7cb3-431f-a6a7-bd6d1da5889e, version 2, effective January 21, 2025. NDC 70436-227, one of 8 listings for this product.

Fluconazole, injection, solution

Indications and Usage, quoted from the label by Sagent Pharmaceuticals (ANDA079104). Cross-references to other label sections are left out.

Fluconazole in Sodium Chloride Injection, USP is indicated for the treatment of:

  • 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.
  • 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.

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.

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.

Source: DailyMed label, set id 02f74fe7-0649-46c5-a06a-0700cd265773, version 9, effective August 17, 2026. NDC 25021-184, one of 6 listings for this product.

Questions

What is fluconazole used for?

The FDA label says: “Fluconazole tablets are indicated for the treatment of:”

What drug class is fluconazole?

FDA lists fluconazole in the Azole Antifungal established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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