Risedronate

DRUG INFORMATION

  ADULT
    - Do not chew or suck the tablet because of a potential for oropharyngeal
      ulceration. • Do not eat or drink anything except plain water, or take other
      medications for at least 30 minutes after taking risedronate sodium tablets.
      Source: US FDA label for risedronate (Risedronate Sodium), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Risedronate sodium tablets are not indicated for use in pediatric patients. The
      safety and effectiveness of risedronate was assessed in a one-year, randomized,
      double-blind, placebo-controlled study of 143 pediatric patients (94 received
      risedronate) with osteogenesis imperfecta (OI).
      Source: US FDA label for risedronate (Risedronate Sodium), section 'pediatric
      use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No overall differences in safety between geriatric and younger patients were
      observed in the risedronate sodium trials, but greater sensitivity of some older
      individuals cannot be ruled out. 8.6 Renal Impairment Risedronate sodium tablets
      are not recommended for use in patients with severe renal impairment (creatinine
      clearance less than 30 mL/min) because of lack of clinical experience.
      Source: US FDA label for risedronate (Risedronate Sodium), section 'use in
      specific populations', retrieved 2026-08-29
    - No dosage adjustment is necessary in patients with a creatinine clearance greater
      than or equal to 30 mL/min. 8.7 Hepatic Impairment No studies have been performed
      to assess risedronate's safety or efficacy in patients with hepatic impairment.
      Source: US FDA label for risedronate (Risedronate Sodium), section 'use in
      specific populations', retrieved 2026-08-29
    - Interruption of bisphosphonate therapy should be considered, pending a
      risk/benefit assessment, on an individual basis. 5.7 Renal Impairment Risedronate
      sodium tablets are not recommended for use in patients with severe renal
      impairment (creatinine clearance less than 30 mL/min).
      Source: US FDA label for risedronate (Risedronate Sodium), section 'warnings and
      cautions', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No dosage adjustment is necessary in patients with a creatinine clearance greater
      than or equal to 30 mL/min. 8.7 Hepatic Impairment No studies have been performed
      to assess risedronate's safety or efficacy in patients with hepatic impairment.
      Source: US FDA label for risedronate (Risedronate Sodium), section 'use in
      specific populations', retrieved 2026-08-29
    - Dosage adjustment is unlikely to be needed in patients with hepatic impairment.
      Source: US FDA label for risedronate (Risedronate Sodium), section 'use in
      specific populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Available data on the use of risedronate sodium tablets in pregnant
      women are insufficient to inform a drug-associated risk of adverse maternal or
      fetal outcomes.
      Source: US FDA label for risedronate (Risedronate Sodium), section 'pregnancy',
      retrieved 2026-08-29
    - Discontinue risedronate sodium tablets when pregnancy is recognized.
      Source: US FDA label for risedronate (Risedronate Sodium), section 'pregnancy',
      retrieved 2026-08-29
    - In animal reproduction studies, daily oral administration of risedronate to
      pregnant rats during organogenesis decreased neonatal survival and body weight at
      doses approximately 5 and 26 times, respectively, the highest recommended human
      daily dose of 30 mg (based on body surface area, mg/m 2 ).
      Source: US FDA label for risedronate (Risedronate Sodium), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Periparturient mortality due to maternal hypocalcemia occurred in dams and
      neonates when pregnant rats were treated daily during mating and/or gestation with
      oral doses equivalent to the human dose or higher. 8.2 Lactation Risk Summary
      There are no data on the presence of risedronate in human milk, the effects on the
      breastfed infant, or the effects on milk production.
      Source: US FDA label for risedronate (Risedronate Sodium), section 'use in
      specific populations', retrieved 2026-08-29
    - A small degree of lacteal transfer occurred in nursing rats.
      Source: US FDA label for risedronate (Risedronate Sodium), section 'use in
      specific populations', retrieved 2026-08-29
    - The concentration of the drug in animal milk does not necessarily predict the
      concentration of drug in human milk.
      Source: US FDA label for risedronate (Risedronate Sodium), section 'use in
      specific populations', retrieved 2026-08-29