{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "nitrofurantoin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Adult Patients: 50 mg to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      },
      {
        "text": "(2.3) 2.1 Recommended Dosage and Administration in Adult Patients The recommended dosage is 50 mg to 100 mg of nitrofurantoin oral suspension four times a day.",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      },
      {
        "text": "For long-term suppressive therapy in adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate.",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Nitrofurantoin oral suspension is contraindicated in pediatric patients younger than 1 month of age because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability). [see Contraindications (4) and Warnings and Precautions (5.4) ] .",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      },
      {
        "text": "Adult Patients: 50 mg to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections. (2.2) Pediatric Patients: 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age). (2.3) 2.1 Recommended Dosage and Administration in Adult Patients The recommended dosage is 50 mg to 100 mg of nitrofurantoin oral suspension four times a day.",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      },
      {
        "text": "(2.2) Pediatric Patients: 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating disease may enhance the occurrence of peripheral neuropathy.",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.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 nitrofurantoin (Nitrofurantoin), retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Nitrofurantoin is contraindicated in pregnant women at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent because of the possibility of hemolytic anemia in the infant (see Clinical Considerations ).",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      },
      {
        "text": "Published epidemiological studies, including cohort studies and case control studies, have reported inconsistent findings related to nitrofurantoin use during the first trimester and risk of major birth defects.",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      },
      {
        "text": "These studies cannot definitively establish the presence or absence of risk due to several methodological limitations.",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Infertility Male Based on findings from a fertility study conducted in 36 healthy male volunteers and an animal fertility study, nitrofurantoin may reversibly decrease spermatogenesis [see Nonclinical Toxicology (13.1) ].",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      },
      {
        "text": "Nitrofurantoin doses of 10 mg/kg/day or greater in healthy human males may produce a slight to moderate spermatogenic arrest with a decrease in sperm count.",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      },
      {
        "text": "• Lactation: Breastfeeding is not recommended in infants under one month of age or with glucose-6-phosphate dehydrogenase (G6PD) deficiency.",
        "source": "US FDA label for nitrofurantoin (Nitrofurantoin), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/nitrofurantoin.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "avoid",
      "line": "The label says not to use it. Read the quote below before deciding.",
      "set_by": "Set from the label's own words, not from a reading of them: 'contraindicated in pregnan'."
    }
  }
}