{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "famotidine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      },
      {
        "text": "(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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      }
    ],
    "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 famotidine (Famotidine), retrieved 2026-08-29",
        "cached_file": "labels/famotidine.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      },
      {
        "text": "There were no effects on the breastfed infant.",
        "source": "US FDA label for famotidine (Famotidine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/famotidine.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "lactation": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'should be used during pregnancy only if'."
    }
  }
}