Esomeprazole

DRUG INFORMATION

  ADULT
    - 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
    - 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
    - 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

  CHILD
    - 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
    - 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
    - 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

  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 esomeprazole (Esomeprazole
      magnesium), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - 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
    - 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
    - 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

  PREGNANCY
    - 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
    - Esomeprazole is the S-isomer of omeprazole.
      Source: US FDA label for esomeprazole (Esomeprazole magnesium), section
      'pregnancy', retrieved 2026-08-29
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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