Omeprazole

DRUG INFORMATION

  ADULT
    - Reduce the dosage to 10 mg once daily for patients with hepatic impairment (Child
      Pugh Class A, B, or C) and Asian patients ( 8.6 , 8.7 ) 2.1 Recommended Adult
      Dosage Regimen by Indication Table 1 shows the recommended dosage of omeprazole
      delayed-release capsules in adult 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 omeprazole (Omeprazole),
      section 'dosage and administration', retrieved 2026-08-29
    - Dual Therapy Omeprazole 40 mg once daily Clarithromycin 500 mg three times daily
      14 days In patients with an ulcer present at the time of initiation of therapy, an
      additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing
      and symptom relief.
      Source: US FDA label for omeprazole (Omeprazole), section 'dosage and
      administration', retrieved 2026-08-29
    - Active Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks Treatment of Symptomatic
      GERD 20 mg once daily Up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20
      mg once daily 4 to 8 weeks† Maintenance of Healing of EE due to Acid-Mediated GERD
      20 mg once daily‡ Controlled studies do not extend beyond 12 months.
      Source: US FDA label for omeprazole (Omeprazole), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of omeprazole delayed-release capsules have been
      established in pediatric patients 2 to 16 years for the treatment of symptomatic
      GERD, treatment of EE due to acid-mediated GERD, and maintenance of healing of EE
      due to acid-mediated GERD.
      Source: US FDA label for omeprazole (Omeprazole), section 'pediatric use',
      retrieved 2026-08-29
    - A 28-day toxicity study with a 14-day recovery phase was conducted in juvenile
      rats with esomeprazole magnesium at doses of 70 to 280 mg/kg/day (about 17 to 68
      times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body
      surface area basis).
      Source: US FDA label for omeprazole (Omeprazole), section 'pediatric use',
      retrieved 2026-08-29
    - An increase in the number of deaths at the high dose of 280 mg/kg/day was observed
      when juvenile rats were administered esomeprazole magnesium from postnatal day 7
      through postnatal day 35.
      Source: US FDA label for omeprazole (Omeprazole), section 'pediatric use',
      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 omeprazole (Omeprazole),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Reduce the dosage to 10 mg once daily for patients with hepatic impairment (Child
      Pugh Class A, B, or C) and Asian patients ( 8.6 , 8.7 ) 2.1 Recommended Adult
      Dosage Regimen by Indication Table 1 shows the recommended dosage of omeprazole
      delayed-release capsules in adult 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 omeprazole (Omeprazole),
      section 'dosage and administration', retrieved 2026-08-29
    - If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8
      week courses of omeprazole delayed-release capsules may be considered. ‡ Dosage
      reduction to 10 mg once daily is recommended for patients with hepatic impairment
      (Child-Pugh Class A, B or C) and Asian patients when used for the maintenance of
      healing of EE [see Use in Specific Populations ( 8.6 , 8.7 ) and Clinical
      Pharmacology ( 12.3 , 12.5 ) ] .
      Source: US FDA label for omeprazole (Omeprazole), section 'dosage and
      administration', retrieved 2026-08-29
    - However, no dosage adjustment is necessary in the elderly [see Clinical
      Pharmacology ( 12.3 )]. 8.6 Hepatic Impairment In patients with hepatic impairment
      (Child-Pugh Class A, B, or C) exposure to omeprazole substantially increased
      compared to healthy subjects.
      Source: US FDA label for omeprazole (Omeprazole), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are no adequate and well-controlled studies with omeprazole in
      pregnant women.
      Source: US FDA label for omeprazole (Omeprazole), 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.
      Source: US FDA label for omeprazole (Omeprazole), section 'pregnancy', retrieved
      2026-08-29
    - Reproduction studies in rats and rabbits resulted in dose-dependent embryo-
      lethality at omeprazole doses that were approximately 3.4 to 34 times an oral
      human dose of 40 mg (based on a body surface area for a 60 kg person).
      Source: US FDA label for omeprazole (Omeprazole), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary Limited data suggest omeprazole may be present in human milk.
      Source: US FDA label for omeprazole (Omeprazole), section 'nursing mothers',
      retrieved 2026-08-29
    - There are no clinical data on the effects of omeprazole on the breastfed infant or
      on milk production.
      Source: US FDA label for omeprazole (Omeprazole), 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 omeprazole and any potential adverse effects
      on the breastfed infant from omeprazole or from the underlying maternal condition.
      Source: US FDA label for omeprazole (Omeprazole), section 'nursing mothers',
      retrieved 2026-08-29