FDA label
What is trimethoprim used for?
The FDA-approved uses of trimethoprim, 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: “To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or...”
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Trimethoprim, tablet
Indications and Usage, quoted from the label by Lupin Pharmaceuticals,Inc. (ANDA091437). Cross-references to other label sections are left out.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species, and coagulase-negative Staphylococcus species, including S. saprophyticus.
Cultures and susceptibility tests should be performed to determine the susceptibility of the bacteria to trimethoprim. Therapy may be initiated prior to obtaining the results of these tests.
Source: DailyMed label, set id 249e938d-f181-47c4-a082-372d65462f33, version 6, effective June 4, 2024. NDC 43386-330, one of 4 listings for this product.
Questions
What is trimethoprim used for?
The FDA label says: “To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or...”
What drug class is trimethoprim?
FDA lists trimethoprim in the Dihydrofolate Reductase Inhibitor Antibacterial 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.
More on Trimethoprim
- Is Trimethoprim a controlled substance?Federal schedule
- Generic for ProloprimFDA Orange Book
- Generic for TrimpexFDA Orange Book
- Dihydrofolate Reductase Inhibitor Antibacterials listFDA drug class
- NDC 75907-043Trimethoprim NDC record
- NDC 40032-330Trimethoprim NDC record
- NDC 43386-330Trimethoprim NDC record