FDA approved Zithromax (azithromycin) for Mild to Moderate Bacterial InfectionsFDA approved new antibiotic Zithromax for bacterial infections

FDA From the archive Source published October 19, 1995 Summary added July 15, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Zithromax for mild to moderate bacterial infections in appropriate patients, but avoid in those with pneumonia requiring hospitalization or risk factors for severe illness.

The FDA has approved Zithromax (azithromycin), a macrolide antibacterial drug, for the treatment of mild to moderate infections caused by susceptible strains of designated bacteria. The approval covers a range of indications in both adult and pediatric populations, including 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. For pediatric patients aged 6 months and older, indications include acute otitis media and community-acquired pneumonia. The drug is also approved for pharyngitis/tonsillitis in children aged 2 years and older as an alternative to first-line therapy. Clinicians should note 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 such as cystic fibrosis, nosocomial infections, or bacteremia. The approval is based on efficacy data from clinical trials demonstrating bacterial eradication and clinical cure rates.

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

Mechanism of Action

Azithromycin is a macrolide antibacterial drug that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby preventing peptide chain elongation.

Indication & Patient Population

Zithromax is indicated for mild to moderate infections caused by susceptible bacteria in adults and pediatric patients. Adult indications include 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), 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), and genital ulcer disease in men (due to Haemophilus ducreyi). Pediatric indications (6 months and older) include 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), and pharyngitis/tonsillitis (2 years and older, due to S. pyogenes as alternative).

Dosing & Administration

Adult dosing: For community-acquired pneumonia, pharyngitis/tonsillitis (second-line), 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: 500 mg once daily for 3 days or 500 mg on Day 1 then 250 mg on Days 2-5. For acute bacterial sinusitis: 500 mg once daily for 3 days. For genital ulcer disease and non-gonococcal urethritis/cervicitis: single 1 g dose. For gonococcal urethritis/cervicitis: single 2 g dose. Pediatric dosing: For acute otitis media (6 months+): 30 mg/kg as single dose, or 10 mg/kg once daily for 3 days, or 10 mg/kg on Day 1 then 5 mg/kg on Days 2-5. For acute bacterial sinusitis (6 months+): 10 mg/kg once daily for 3 days. For community-acquired pneumonia (6 months+): 10 mg/kg on Day 1 then 5 mg/kg once daily on Days 2-5. For pharyngitis/tonsillitis (2 years+): 12 mg/kg once daily for 5 days.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Azithromycin should not be used in patients with pneumonia who are inappropriate for oral therapy due to moderate to severe illness or risk factors including cystic fibrosis, nosocomial infections, known or suspected bacteremia, need for hospitalization, elderly or debilitated patients, or significant underlying health problems compromising response to illness (e.g., immunodeficiency, functional asplenia). Use only for infections proven or strongly suspected to be caused by susceptible bacteria to reduce drug resistance.

Place in Therapy

Zithromax is a macrolide antibiotic option for mild to moderate bacterial infections in adults and children. It is particularly useful as an alternative to first-line therapy for pharyngitis/tonsillitis due to S. pyogenes and for respiratory infections. Its once-daily dosing and short-course regimens may improve adherence. However, it is not recommended for patients with pneumonia requiring hospitalization or with risk factors for severe illness.

The FDA has approved a new antibiotic called Zithromax (azithromycin) to treat certain bacterial infections. It is a macrolide drug that works by stopping bacteria from growing. Zithromax is approved for mild to moderate infections in adults, including bronchitis, sinusitis, pneumonia, strep throat, skin infections, and some sexually transmitted infections. For children aged 6 months and older, it can treat ear infections and pneumonia. It is also approved for strep throat in children aged 2 years and older as an alternative treatment.

This approval is based on studies that showed Zithromax effectively kills bacteria and cures infections. The drug is taken by mouth, usually as a tablet or liquid. It is important to note that Zithromax should not be used in patients with pneumonia who are too sick for oral therapy or who have certain risk factors like cystic fibrosis or hospital-acquired infections.

What does this mean for you? If you or your child has a bacterial infection, your doctor may consider prescribing Zithromax. However, this antibiotic will not work for viral infections like the common cold or flu. Always take antibiotics exactly as prescribed and never share them with others.

If you have questions about Zithromax or whether it is right for your condition, talk to your doctor. They can help you understand the benefits and risks based on your health history.

What this means for you:

Zithromax is a new antibiotic for bacterial infections; it does not treat viruses.

Study Details

Study typeFda approval

PublishedOct 1995

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 new antibiotic Zithromax for bacterial infections

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 new antibiotic Zithromax for bacterial infections

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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