FDA approved Zithromax (azithromycin) for Mild to Moderate Bacterial InfectionsFDA approved Zithromax to treat bacterial infections in adults and children.

FDA From the archive Source published July 18, 1996 Summary added July 15, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider azithromycin for mild to moderate bacterial infections in appropriate patients, but avoid in pneumonia requiring oral therapy.

The FDA has approved Zithromax (azithromycin), a macrolide antibacterial drug, for the treatment of mild to moderate infections caused by susceptible strains of designated microorganisms in adults and pediatric patients. Indications include acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, and genital ulcer disease in men. In pediatric patients, it is also indicated for acute otitis media. The approval emphasizes that azithromycin should not be used in patients with pneumonia who are inappropriate for oral therapy due to moderate to severe illness or risk factors. This approval provides clinicians with an oral option for various infections, with dosing tailored to specific indications and patient populations.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Azithromycin is a macrolide antibacterial drug. The mechanism of action is not detailed in the label.

Indication & Patient Population

Zithromax is indicated for mild to moderate infections caused by susceptible bacteria in adults and pediatric patients. Adult indications: acute bacterial exacerbations of chronic bronchitis (due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae); acute bacterial sinusitis (due to H. influenzae, M. catarrhalis, or S. pneumoniae); community-acquired pneumonia (due to Chlamydophila pneumoniae, H. influenzae, Mycoplasma pneumoniae, or S. pneumoniae) in patients appropriate for oral therapy; pharyngitis/tonsillitis (due to Streptococcus pyogenes) as alternative to first-line therapy; uncomplicated skin and skin structure infections (due to Staphylococcus aureus, S. pyogenes, or Streptococcus agalactiae); urethritis and cervicitis (due to Chlamydia trachomatis or Neisseria gonorrhoeae); genital ulcer disease in men (due to Haemophilus ducreyi). Pediatric indications (age 6 months and older): acute otitis media (due to H. influenzae, M. catarrhalis, or S. pneumoniae); community-acquired pneumonia (due to C. pneumoniae, H. influenzae, M. pneumoniae, or S. pneumoniae) in patients appropriate for oral therapy; pharyngitis/tonsillitis (age 2 years and older) due to S. pyogenes as alternative to first-line therapy.

Dosing & Administration

Adult patients: For community-acquired pneumonia (mild severity), pharyngitis/tonsillitis (second-line therapy), and uncomplicated skin/skin structure infections: 500 mg as a single dose on Day 1, then 250 mg once daily on Days 2-5. For acute bacterial exacerbations of chronic bronchitis (mild to moderate): 500 mg as a single dose on Day 1, then 250 mg once daily on Days 2-5, or 500 mg once daily for 3 days. For acute bacterial sinusitis: 500 mg once daily for 3 days. For genital ulcer disease (chancroid), non-gonococcal urethritis and cervicitis: single 1 gram dose. For gonococcal urethritis and cervicitis: single 2 gram dose. Pediatric patients: Acute otitis media (≥6 months): 30 mg/kg as a single dose, or 10 mg/kg once daily for 3 days, or 10 mg/kg as a single dose on Day 1 then 5 mg/kg/day on Days 2-5. Acute bacterial sinusitis (≥6 months): 10 mg/kg once daily for 3 days. Community-acquired pneumonia (≥6 months): 10 mg/kg as a single dose on Day 1 then 5 mg/kg once daily on Days 2-5. Pharyngitis/tonsillitis (≥2 years): 12 mg/kg once daily for 5 days.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Limitations of use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as cystic fibrosis, nosocomial infections, known or suspected bacteremia, requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to illness (including immunodeficiency or functional asplenia). To reduce development of drug-resistant bacteria, Zithromax should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria.

Place in Therapy

Azithromycin is a macrolide antibacterial drug for mild to moderate infections. It is an alternative to first-line therapy for pharyngitis/tonsillitis. It should not be used in patients with pneumonia who are inappropriate for oral therapy.

The FDA has approved Zithromax, also known as azithromycin, to treat certain bacterial infections. It is a macrolide antibiotic that works by stopping the growth of bacteria. Zithromax is approved for mild to moderate infections in adults and children, including acute bacterial sinusitis, community-acquired pneumonia, bronchitis, strep throat, skin infections, and some sexually transmitted infections. In children, it is also approved for ear infections.

This approval means doctors now have an oral antibiotic option for these conditions. The dosing depends on the specific infection and the patient's age. Zithromax is not for everyone. It should not be used in patients with pneumonia who are too sick for oral therapy or who have risk factors for severe illness.

If you think you have a bacterial infection, talk to your doctor. They can decide if Zithromax is right for you. Remember, antibiotics like Zithromax do not work against viruses, such as those that cause colds or the flu. Taking antibiotics when they are not needed can lead to antibiotic resistance.

What this means for you:

Zithromax is a new oral antibiotic for bacterial infections; always talk to your doctor to see if it is right for you.

Study Details

Study typeFda approval

PublishedJul 1996

View Original Abstract ↓

1 INDICATIONS AND USAGE ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) ] ZITHROMAX is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1 ) Acute bacterial sinusitis in adults ( 1.1 ) Uncomplicated skin and skin structure infections in adults ( 1.1 ) Urethritis and cervicitis in adults ( 1.1 ) Genital ulcer disease in men ( 1.1 ) Acute otitis media in pediatric patients (6 months of age and older) ( 1.2 ) Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1 , 1.2 ) Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1.1 , 1.2 ) Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. ( 1.3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.4 ) 1.1 Adult Patients 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. 1.2 Pediatric Patients [see Use in Specific Populations (8.4) and Clinical Studies (14.2) ] Acute otitis media ( >6 months of age) caused by Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae. Community-acquired pneumonia ( >6 months of age) due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae , or Streptococcus pneumoniae in patients appropriate for oral therapy. Pharyngitis/tonsillitis ( >2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. 1.3 Limitations of Use Azithromycin should not be used 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). 1.4 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

FDA approved Zithromax (azithromycin) for Mild to Moderate Bacterial InfectionsFDA approved Zithromax to treat bacterial infections in adults and children.

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

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FDA approved Zithromax (azithromycin) for Mild to Moderate Bacterial InfectionsFDA approved Zithromax to treat bacterial infections in adults and children.

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

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