What is azithromycin used for?

Indications and Usage, quoted from the label by Sandoz Inc (ANDA065211). Cross-references to other label sections are left out.

Indications in Adult Patients

• Azithromycin is indicated in adult patients for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:
• Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
• Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
• Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
• Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
• Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.
• Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
• Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

Indications in Pediatric Patients

Azithromycin is indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:.

• Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae, in pediatric patients 6 months of age and older.
• Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in pediatric patients 6 months of age and older appropriate for oral therapy.
• Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy in pediatric patients 2 years of age and older.

Limitations of Use

Azithromycin is not recommended in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:

• patients with cystic fibrosis,
• patients with nosocomial infections,
• patients with known or suspected bacteremia,
• patients requiring hospitalization,
• elderly or debilitated patients, or
• patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin 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.

Source: DailyMed label, set id ec619299-e0ef-44dd-acdb-8c53bbfc5b8a, version 5, effective July 30, 2026. NDC 0781-8089, one of 114 listings for this product.

Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA065246). Cross-references to other label sections are left out.

Indications in Adult Patients

Azithromycin is indicated in adult patients for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:

• Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
• Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
• Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
• Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
• Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.
• Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
• Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

Indications in Pediatric Patients

Azithromycin is indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:.

• Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae, in pediatric patients 6 months of age and older.
• Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in pediatric patients 6 months of age and older appropriate for oral therapy.
• Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy in pediatric patients 2 years of age and older.

Limitations of Use

Azithromycin is not recommended in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:

• patients with cystic fibrosis,
• patients with nosocomial infections,
• patients with known or suspected bacteremia,
• patients requiring hospitalization,
• elderly or debilitated patients, or
• patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension and other antibacterial drugs, azithromycin for oral suspension 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.

Source: DailyMed label, set id 3209b147-11ce-4eeb-8427-5f8e6fb2c83d, version 17, effective August 31, 2026. NDC 0093-2026, one of 24 listings for this product.