{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "esomeprazole",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Population Recommended Adult (2.1) and Pediatric Dosage (2.2) Healing of EE (1 year and older) Adults 20 mg or 40 mg 1 once daily for 4 to 8 weeks; some patients may require an additional 4 to 8 weeks 12 years to 17 years 20 mg or 40 mg 1 once daily for 4 to 8 weeks Maintenance of Healing of EE Adults 20 mg once daily.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      },
      {
        "text": "Controlled studies do not extend beyond 6 months Treatment of Symptomatic GERD Adults 20 mg once daily once daily for 4 weeks some patients may require an additional 4 weeks 12 years to 17 years 20 mg once daily for 4 weeks Risk Reduction of NSAID-Associated Gastric Ulcer Adults 20 mg or 40 mg 1 once daily for up to 6 months 2 H.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      },
      {
        "text": "Dosages of up to 240 mg/day have been administered [see Clinical Studies (14.7)].",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Healing of EE Pediatric Patients 1 Year to 17 Years of Age The safety and effectiveness of esomeprazole magnesium delayed-release capsules and NEXIUM for delayed-release oral suspension have been established in pediatric patients 12 years to 17 years for short-term treatment (4 to 8 weeks) for healing of EE.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      },
      {
        "text": "Population Recommended Adult (2.1) and Pediatric Dosage (2.2) Healing of EE (1 year and older) Adults 20 mg or 40 mg 1 once daily for 4 to 8 weeks; some patients may require an additional 4 to 8 weeks 12 years to 17 years 20 mg or 40 mg 1 once daily for 4 to 8 weeks Maintenance of Healing of EE Adults 20 mg once daily.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      },
      {
        "text": "Controlled studies do not extend beyond 6 months Treatment of Symptomatic GERD Adults 20 mg once daily once daily for 4 weeks some patients may require an additional 4 weeks 12 years to 17 years 20 mg once daily for 4 weeks Risk Reduction of NSAID-Associated Gastric Ulcer Adults 20 mg or 40 mg 1 once daily for up to 6 months 2 H.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.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 esomeprazole (Esomeprazole magnesium), retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "Controlled studies do not extend beyond 6 months Treatment of Symptomatic GERD Adults 20 mg once daily once daily for 4 weeks some patients may require an additional 4 weeks 12 years to 17 years 20 mg once daily for 4 weeks Risk Reduction of NSAID-Associated Gastric Ulcer Adults 20 mg or 40 mg 1 once daily for up to 6 months 2 H.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      },
      {
        "text": "A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations ( 8.6 )]. 2.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      },
      {
        "text": "A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations ( 8.6 )] . 2.2 Recommended Dosage in Pediatric Patients by Indication Table 2 shows the recommended dosage of esomeprazole magnesium in pediatric patients by indication.",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for esomeprazole (Esomeprazole magnesium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary There are no adequate and well-controlled studies with esomeprazole in pregnant women.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      },
      {
        "text": "Esomeprazole is the S-isomer of omeprazole.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      },
      {
        "text": "Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use (see Data) .",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      },
      {
        "text": "There are no clinical data on the effects of esomeprazole on the breastfed infant or on milk production.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for esomeprazole magnesium and any potential adverse effects on the breastfed infant from esomeprazole magnesium or from the underlying maternal condition.",
        "source": "US FDA label for esomeprazole (Esomeprazole magnesium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/esomeprazole.json",
        "verbatim": true
      }
    ]
  }
}