{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "alendronate",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Treatment of osteoporosis in postmenopausal women and in men: 10 mg daily or 70 mg tablet once weekly.",
        "source": "US FDA label for alendronate (Alendronate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 , 2.3 ) Prevention of osteoporosis in postmenopausal women: 5 mg daily or 35 mg once weekly.",
        "source": "US FDA label for alendronate (Alendronate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) Glucocorticoid-induced osteoporosis: 5 mg daily; or 10 mg daily in postmenopausal women not receiving estrogen.",
        "source": "US FDA label for alendronate (Alendronate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Alendronate is not indicated for use in pediatric patients. The safety and efficacy of alendronate sodium were examined in a randomized, double-blind, placebo-controlled two-year study of 139 pediatric patients, aged 4-18 years, with severe osteogenesis imperfecta (OI).",
        "source": "US FDA label for alendronate (Alendronate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      },
      {
        "text": "In a pharmacokinetic study, 6 of 24 pediatric osteogenesis imperfecta patients who received a single oral dose of alendronate sodium 35 or 70 mg developed fever, flu-like symptoms, and/or mild lymphocytopenia within 24 to 48 hours after administration.",
        "source": "US FDA label for alendronate (Alendronate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "( 8.4 ) Alendronate sodium is not recommended in patients with renal impairment (creatinine clearance <35 mL/min).",
        "source": "US FDA label for alendronate (Alendronate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      },
      {
        "text": "No overall differences in efficacy or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 8.6 Renal Impairment Alendronate sodium is not recommended for patients with creatinine clearance less than 35 mL/min.",
        "source": "US FDA label for alendronate (Alendronate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      },
      {
        "text": "No dosage adjustment is necessary in patients with creatinine clearance values between 35-60 mL/min [see Clinical Pharmacology (12.3) ] . 8.7 Hepatic Impairment As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment.",
        "source": "US FDA label for alendronate (Alendronate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No dosage adjustment is necessary in patients with creatinine clearance values between 35-60 mL/min [see Clinical Pharmacology (12.3) ] . 8.7 Hepatic Impairment As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment.",
        "source": "US FDA label for alendronate (Alendronate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Available data on the use of Alendronate sodium in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes.",
        "source": "US FDA label for alendronate (Alendronate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      },
      {
        "text": "Discontinue Alendronate sodium when pregnancy is recognized.",
        "source": "US FDA label for alendronate (Alendronate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies, daily oral administration of alendronate to rats from before mating through the end of gestation or lactation showed decreased postimplantation survival and decreased pup body weight gain starting at doses equivalent to less than half of the highest recommended 40 mg clinical daily dose (based on body surface area, mg/m 2 ).",
        "source": "US FDA label for alendronate (Alendronate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary It is not known whether alendronate is present in human breast milk, affects human milk production, or has effects on the breastfed infant.",
        "source": "US FDA label for alendronate (Alendronate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for alendronate sodium and any potential adverse effects on the breastfed child from alendronate sodium or from the underlying maternal condition.",
        "source": "US FDA label for alendronate (Alendronate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies, daily oral administration of alendronate to rats from before mating through the end of gestation or lactation showed decreased postimplantation survival and decreased pup body weight gain starting at doses equivalent to less than half of the highest recommended 40 mg clinical daily dose (based on body surface area, mg/m 2 ).",
        "source": "US FDA label for alendronate (Alendronate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/alendronate.json",
        "verbatim": true
      }
    ]
  }
}