FDA label
What is fosfomycin used for?
The FDA-approved uses of fosfomycin, 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: “Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.”
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Fosfomycin Tromethamine, granule, for solution
Indications and Usage, quoted from the label by Ascend Laboratories, LLC (ANDA214554). Cross-references to other label sections are left out.
Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.
If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)
Source: DailyMed label, set id 48e352bc-52ea-4778-905a-60ef38a5c18a, version 5, effective December 17, 2025. NDC 67877-749, one of 8 listings for this product.
Granules For Oral Solution, powder
Indications and Usage, quoted from the label by XIROMED LLC (ANDA212548). Cross-references to other label sections are left out.
Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess.
If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)
Source: DailyMed label, set id c3ba67e7-aaca-e682-277a-94e20b0abad7, version 9, effective November 11, 2020. NDC 70700-268, one of 2 listings for this product.
Fosfomycin Tromethamine, granule
Indications and Usage, quoted from the label by Precision Dose, Inc. (ANDA217187). Cross-references to other label sections are left out.
Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine Granules for Oral Solution is not indicated for the treatment of pyelonephritis or perinephric abscess.
If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)
Source: DailyMed label, set id f44b79d0-a789-46cb-ab70-7eb33a7debaf, version 1, effective December 23, 2025. NDC 68094-064, one of 1 listing for this product.
Questions
What is fosfomycin used for?
The FDA label says: “Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.”
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.