Azithromycin

DRUG INFORMATION

  ADULT
    - Adult Patients ( 2.1 ) Infection Recommended Dose / Duration of Therapy Community-
      acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy)
      Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by
      250 mg once daily on Days 2 through 5.
      Source: US FDA label for azithromycin (azithromycin), section 'dosage and
      administration', retrieved 2026-08-29
    - Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 500 mg as a
      single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg
      once daily for 3 days.
      Source: US FDA label for azithromycin (azithromycin), section 'dosage and
      administration', retrieved 2026-08-29
    - Acute bacterial sinusitis 500 mg once daily for 3 days.
      Source: US FDA label for azithromycin (azithromycin), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - [see CLINICAL PHARMACOLOGY ( 12.3 ), INDICATIONS AND USAGE ( 1.2 ), and DOSAGE AND
      ADMINISTRATION ( 2.2 )] Safety and effectiveness in the treatment of pediatric
      patients with acute otitis media, acute bacterial sinusitis and community-acquired
      pneumonia under 6 months of age have not been established.
      Source: US FDA label for azithromycin (azithromycin), section 'pediatric use',
      retrieved 2026-08-29
    - Adult Patients ( 2.1 ) Infection Recommended Dose / Duration of Therapy Community-
      acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy)
      Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by
      250 mg once daily on Days 2 through 5.
      Source: US FDA label for azithromycin (azithromycin), section 'dosage and
      administration', retrieved 2026-08-29
    - Pediatric Patients ( 2.2 ) Infection Recommended Dose/Duration of Therapy Acute
      otitis media (6 months of age and older) 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 followed by 5
      mg/kg/day on Days 2 through 5.
      Source: US FDA label for azithromycin (azithromycin), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for azithromycin (azithromycin),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for azithromycin (azithromycin),
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Available data from published literature and postmarketing experience
      over several decades with azithromycin use in pregnant women have not identified
      any drug-associated risks for major birth defects, miscarriage, or adverse
      maternal or fetal outcomes (see Data) .
      Source: US FDA label for azithromycin (azithromycin), section 'pregnancy',
      retrieved 2026-08-29
    - Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed
      no drug-induced fetal malformations at doses up to 4, 2, and 2 times,
      respectively, an adult human daily dose of 500 mg based on body surface area.
      Source: US FDA label for azithromycin (azithromycin), section 'pregnancy',
      retrieved 2026-08-29
    - Decreased viability and delayed development were observed in the offspring of
      pregnant rats administered azithromycin from day 6 of pregnancy through weaning at
      a dose equivalent to 4 times an adult human daily dose of 500 mg based on body
      surface area (see Data).
      Source: US FDA label for azithromycin (azithromycin), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Risk Summary Azithromycin is present in human milk (see Data) .
      Source: US FDA label for azithromycin (azithromycin), section 'nursing mothers',
      retrieved 2026-08-29
    - Non-serious adverse reactions have been reported in breastfed infants after
      maternal administration of azithromycin (see Clinical Considerations) .
      Source: US FDA label for azithromycin (azithromycin), section 'nursing mothers',
      retrieved 2026-08-29
    - There are no available data on the effects of azithromycin on milk production.
      Source: US FDA label for azithromycin (azithromycin), section 'nursing mothers',
      retrieved 2026-08-29