Alendronate

DRUG INFORMATION

  ADULT
    - 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
    - ( 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
    - ( 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

  CHILD
    - 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
    - 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

  RENAL IMPAIRMENT
    - ( 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
    - 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
    - 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

  HEPATIC IMPAIRMENT
    - 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

  PREGNANCY
    - 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
    - Discontinue Alendronate sodium when pregnancy is recognized.
      Source: US FDA label for alendronate (Alendronate), section 'pregnancy', retrieved
      2026-08-29
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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