FDA label
What is cefixime used for?
The FDA-approved uses of cefixime, 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 for cefixime (capsule) lists 5 uses: Uncomplicated Urinary Tract Infections; Pharyngitis and Tonsillitis; Acute Exacerbations of Chronic Bronchitis; Uncomplicated Gonorrhea (cervical/urethral); and 1 more.
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Cefixime, capsule
Indications and Usage, quoted from the label by Ascend Laboratories, LLC (ANDA210574). Cross-references to other label sections are left out.
Uncomplicated Urinary Tract Infections
Cefixime is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis.
Pharyngitis and Tonsillitis
Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections.
Cefixime capsules are generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime capsules in the subsequent prevention of rheumatic fever is not available.)
Acute Exacerbations of Chronic Bronchitis
Cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated Gonorrhea (cervical/urethral)
Cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).
Usage to Reduce Development of Drug-Resistant Bacteria
To reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime capsules and other antibacterial drugs, cefixime capsules should be used only to treat 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Source: DailyMed label, set id 6f1df975-f825-4301-87da-d7eba56a6890, version 12, effective October 16, 2026. NDC 67877-584, one of 5 listings for this product.
Cefixime, powder, for suspension
Indications and Usage, quoted from the label by Lupin Pharmaceuticals, Inc. (ANDA065129). Cross-references to other label sections are left out.
Uncomplicated Urinary Tract Infections
Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis.
Otitis Media
Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.)
Note: For patients with otitis media caused by Streptococcus pneumoniae, overall response was approximately 10% lower for cefixime than for the comparator.
Pharyngitis and Tonsillitis
Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections.
Acute Exacerbations of Chronic Bronchitis
Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated Gonorrhea (cervical/urethral)
Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).
Usage to Reduce Development of Drug-Resistant Bacteria
To reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime for oral suspension and cefixime capsule should be used only to treat 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Source: DailyMed label, set id 6d68dbd9-7d75-4ff1-91db-79ff8ae879ec, version 14, effective October 14, 2025. NDC 68180-405, one of 4 listings for this product.
Cefixime, tablet
Indications and Usage, quoted from the label by Rising Pharma Holdings, Inc. (ANDA206358). Cross-references to other label sections are left out.
Uncomplicated Urinary Tract Infections
Cefixime tablets are indicated in the treatment of adults and pediatric patients weighing more than 45 kg or older than 12 years with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis.
Pharyngitis and Tonsillitis
Cefixime tablets are indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Cefixime tablets are generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime tablets in the subsequent prevention of rheumatic fever is not available.)
Acute Exacerbations of Chronic Bronchitis
Cefixime tablets are indicated in the treatment of adults and pediatric patients weighing more than 45 kg or older than 12 years with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated Gonorrhea (cervical/urethral)
Cefixime tablets are indicated in the treatment of adults and pediatric patients weighing more than 45 kg or older than 12 years with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).
Usage
To reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime tablets and other antibacterial drugs, cefixime tablets should be used only to treat 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Source: DailyMed label, set id b5a3c547-3bc7-4856-af9c-1bead294f5d9, version 3, effective April 6, 2026. NDC 64980-430, one of 1 listing for this product.
Questions
What is cefixime used for?
The FDA label for cefixime (capsule) lists 5 uses: Uncomplicated Urinary Tract Infections; Pharyngitis and Tonsillitis; Acute Exacerbations of Chronic Bronchitis; Uncomplicated Gonorrhea (cervical/urethral); and 1 more.
What drug class is cefixime?
FDA lists cefixime in the Cephalosporin 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.