{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "finasteride",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Finasteride may be administered with or without meals ( ). 2 Monotherapy: One tablet (5 mg) taken once a day ( ). 2.1 Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin ( ). 2.2 2.1 Monotherapy The recommended dose of finasteride tablets USP, 5 mg is one tablet (5 mg) taken once a day .",
        "source": "US FDA label for finasteride (Finasteride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      },
      {
        "text": "Finasteride tablets USP, 5 mg may be administered with or without meals. Finasteride may be administered with or without meals ( ). 2 Monotherapy: One tablet (5 mg) taken once a day ( ). 2.1 Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin ( ). 2.2 2.1 Monotherapy The recommended dose of finasteride tablets USP, 5 mg is one tablet (5 mg) taken once a day .",
        "source": "US FDA label for finasteride (Finasteride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Finasteride is not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for finasteride (Finasteride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No dosage adjustment is necessary in the elderly . [see and ] Clinical Pharmacology (12.3) Clinical Studies (14) 8.6 Hepatic Impairment Caution should be exercised in the administration of finasteride in those patients with liver function abnormalities, as finasteride is metabolized extensively in the liver . [see ] Clinical Pharmacology (12.3) 8.7 Renal Impairment No dosage adjustment is necessary in patients with renal impairment .",
        "source": "US FDA label for finasteride (Finasteride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No dosage adjustment is necessary in the elderly . [see and ] Clinical Pharmacology (12.3) Clinical Studies (14) 8.6 Hepatic Impairment Caution should be exercised in the administration of finasteride in those patients with liver function abnormalities, as finasteride is metabolized extensively in the liver . [see ] Clinical Pharmacology (12.3) 8.7 Renal Impairment No dosage adjustment is necessary in patients with renal impairment .",
        "source": "US FDA label for finasteride (Finasteride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Category X. [See .] Contraindications (4) Finasteride is contraindicated for use in women who are or may become pregnant.",
        "source": "US FDA label for finasteride (Finasteride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      },
      {
        "text": "Finasteride is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia.",
        "source": "US FDA label for finasteride (Finasteride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      },
      {
        "text": "In animal studies, finasteride caused abnormal development of external genitalia in male fetuses.",
        "source": "US FDA label for finasteride (Finasteride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Finasteride is not indicated for use in women.",
        "source": "US FDA label for finasteride (Finasteride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      },
      {
        "text": "It is not known whether finasteride is excreted in human milk.",
        "source": "US FDA label for finasteride (Finasteride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      },
      {
        "text": "Slightly decreased fertility was observed in male offspring after administration of about 3 times the MRHD (based on AUC at animal dose of 3 mg/kg/day) to female rats during late gestation and lactation.",
        "source": "US FDA label for finasteride (Finasteride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/finasteride.json",
        "verbatim": true
      }
    ]
  }
}