Famotidine

DRUG INFORMATION

  ADULT
    - May increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily Maximum of
      40 mg per day 8 weeks b GERD Birth to less than 3 months Starting dosage 0.5 mg/kg
      once daily.
      Source: US FDA label for famotidine (Famotidine), section 'dosage and
      administration', retrieved 2026-08-29
    - May increase to 1 mg/kg once daily b Up to 8 weeks b,c,d 3 months to less than 1
      year Starting dosage 0.5 mg/kg twice daily.
      Source: US FDA label for famotidine (Famotidine), section 'dosage and
      administration', retrieved 2026-08-29
    - May increase to 1 mg/kg twice daily c Maximum of 40 mg per day GERD with or
      without esophagitis and ulcerations 1 year to less than 17 years 0.5 mg/kg twice
      daily Maximum of 40 mg twice daily 6 to 12 weeks b a After preparation, the
      concentration of famotidine oral suspension is 8 mg/mL [see DOSAGE AND
      ADMINISTRATION (2.3)] b Treatment duration based on adult recommendations (see
      Table 1).
      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 famotidine (Famotidine),
      section 'dosage and administration', retrieved 2026-08-29

  CHILD
    - Peptic Ulcer Disease and GERD With or Without Esophagitis and Ulcerations
      Pediatric Patients One Year to Less than 17 Years of Age: The safety and
      effectiveness of famotidine for oral suspension have been established in pediatric
      patients 1 year to less than 17 years of age for the treatment of peptic ulcer
      disease and GERD with or without esophagitis and ulcerations.
      Source: US FDA label for famotidine (Famotidine), section 'pediatric use',
      retrieved 2026-08-29
    - Table 2: Recommended Dosage and Duration of Famotidine for Oral Suspension a in
      Pediatric Patients with Normal Renal Function Indication Pediatric Age Range
      Recommended Dosage a Duration Peptic Ulcer Disease 1 year to less than 17 years
      Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily.
      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 famotidine (Famotidine),
      section 'dosage and administration', retrieved 2026-08-29
    - May increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily Maximum of
      40 mg per day 8 weeks b GERD Birth to less than 3 months Starting dosage 0.5 mg/kg
      once daily.
      Source: US FDA label for famotidine (Famotidine), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Consider an additional 4 weeks of treatment if treatment benefit outweighs
      potential risks. 2.3 Recommended Dosage in Adults with Renal Impairment
      Recommended dosage adjustments for adults with moderate to severe renal impairment
      (creatinine clearance less than 60 mL/min) by indication are shown in Table 3.
      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 famotidine (Famotidine),
      section 'dosage and administration', retrieved 2026-08-29
    - A safe and effective dosage has not been established in pediatric patients with
      renal impairment.
      Source: US FDA label for famotidine (Famotidine), section 'dosage and
      administration', retrieved 2026-08-29
    - (2.2, 5.1, 8.5) Renal Impairment: Risk of CNS adverse reactions and QT
      prolongation in patients with moderate and severe renal impairment; reduce the
      dosage in adults.
      Source: US FDA label for famotidine (Famotidine), section 'use in specific
      populations', 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 famotidine (Famotidine),
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Available data with H 2 -receptor antagonists, including famotidine,
      in pregnant women are insufficient to establish a drug-associated risk of major
      birth defects, miscarriage or adverse maternal or fetal outcomes.
      Source: US FDA label for famotidine (Famotidine), section 'pregnancy', retrieved
      2026-08-29
    - In animal reproduction studies, no adverse development effects were observed with
      oral administration of famotidine at doses up to approximately 243 and 122 times,
      respectively, the recommended human dose of 80 mg per day for the treatment of
      erosive esophagitis (see Data) .
      Source: US FDA label for famotidine (Famotidine), section 'pregnancy', retrieved
      2026-08-29
    - The estimated background risk for major birth defects and miscarriage for the
      indicated population is unknown.
      Source: US FDA label for famotidine (Famotidine), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Because animal reproductive studies are not always predictive of human response,
      this drug should be used during pregnancy only if clearly needed. 8.2 Lactation
      Risk Summary There are limited data available on the presence of famotidine in
      human breast milk.
      Source: US FDA label for famotidine (Famotidine), section 'use in specific
      populations', retrieved 2026-08-29
    - There were no effects on the breastfed infant.
      Source: US FDA label for famotidine (Famotidine), section 'use in specific
      populations', retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother's clinical need for famotidine and any potential adverse effects
      on the breastfed child from famotidine for oral suspension or from the underlying
      maternal condition.
      Source: US FDA label for famotidine (Famotidine), section 'use in specific
      populations', retrieved 2026-08-29