{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "azithromycin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "[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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Azithromycin is present in human milk (see Data) .",
        "source": "US FDA label for azithromycin (azithromycin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azithromycin.json",
        "verbatim": true
      }
    ]
  }
}