FDA label
What is micafungin used for?
The FDA-approved uses of micafungin, 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: “Micafungin for injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older; Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age; Treat...”
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Micafungin Sodium, injection, powder, lyophilized, for solution
Indications and Usage, quoted from the label by Sagent Pharmaceuticals (ANDA213363). Cross-references to other label sections are left out.
Micafungin for injection is indicated for:
- Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.
- Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.
- Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.
- Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation.
Limitations of Use
- The safety and effectiveness of micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed.
- Micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida.
- The efficacy of micafungin for injection against infections caused by fungi other than Candida has not been established.
Source: DailyMed label, set id 33e579c1-b315-44cb-a690-e2dd2cdf44ee, version 4, effective November 8, 2025. NDC 25021-190, one of 13 listings for this product.
Questions
What is micafungin used for?
The FDA label says: “Micafungin for injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older; Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age; Treat...”
What drug class is micafungin?
FDA lists micafungin in the Echinocandin 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.