Budesonide

DRUG INFORMATION

  ADULT
    - Recommended Dosage: Mild to moderate active Crohn’s disease ( 2.2 ): Adults: 9 mg
      once daily for up to 8 weeks; repeat 8 week treatment courses for recurring
      episodes of active disease.
      Source: US FDA label for budesonide (Budesonide), section 'dosage and
      administration', retrieved 2026-08-29
    - Maintenance of clinical remission of mild to moderate Crohn’s disease ( 2.3 ):
      Adults: 6 mg once daily for up to 3 months; taper to complete cessation after 3
      months.
      Source: US FDA label for budesonide (Budesonide), section 'dosage and
      administration', retrieved 2026-08-29
    - Hepatic Impairment: Consider reducing the dosage to 3 mg once daily in adult
      patients with moderate hepatic impairment (Child-Pugh Class B).
      Source: US FDA label for budesonide (Budesonide), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of budesonide have been established in pediatric
      patients 8 to 17 years of age who weigh more than 25 kg for the treatment of mild
      to moderate active Crohn’s disease involving the ileum and/or the ascending colon.
      Source: US FDA label for budesonide (Budesonide), section 'pediatric use',
      retrieved 2026-08-29
    - Administration Instructions ( 2.1 ): Take once daily in the morning. Swallow
      whole. Do not chew or crush. For patients unable to swallow an intact capsule,
      open the capsules and empty the granules onto one tablespoonful of applesauce. Mix
      and consume the entire contents within 30 minutes. Do not chew or crush. Follow
      with 8 ounces of water. Avoid consumption of grapefruit juice for the duration of
      therapy.
      Source: US FDA label for budesonide (Budesonide), section 'dosage and
      administration', retrieved 2026-08-29
    - Pediatrics 8 to 17 years who weigh more than 25 kg: 9 mg once daily for up to 8
      weeks, followed by 6 mg once daily in the morning for 2 weeks.
      Source: US FDA label for budesonide (Budesonide), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for budesonide (Budesonide),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Hepatic Impairment: Consider reducing the dosage to 3 mg once daily in adult
      patients with moderate hepatic impairment (Child-Pugh Class B).
      Source: US FDA label for budesonide (Budesonide), section 'dosage and
      administration', retrieved 2026-08-29
    - Since prednisolone should not be stopped abruptly, tapering should begin
      concomitantly with initiating budesonide delayed-release capsules treatment. 2.4
      Dosage Adjustment in Adult Patients with Hepatic Impairment Consider reducing the
      dosage of budesonide delayed-release capsules to 3 mg once daily for adult
      patients with moderate hepatic impairment (Child-Pugh Class B).
      Source: US FDA label for budesonide (Budesonide), section 'dosage and
      administration', retrieved 2026-08-29
    - Avoid use in patients with severe hepatic impairment (Child-Pugh Class C) [see
      Warnings and Precautions (5.1) , Use in Specific Populations (8.6) ] .
      Source: US FDA label for budesonide (Budesonide), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Limited published studies report on the use of budesonide in pregnant
      women; however, the data are insufficient to inform a drug-associated risk for
      major birth defects and miscarriage.
      Source: US FDA label for budesonide (Budesonide), section 'pregnancy', retrieved
      2026-08-29
    - There are clinical considerations [see Clinical Considerations ] .
      Source: US FDA label for budesonide (Budesonide), section 'pregnancy', retrieved
      2026-08-29
    - In animal reproduction studies with pregnant rats and rabbits, administration of
      subcutaneous budesonide during organogenesis at doses approximately 0.5 times or
      0.05 times, respectively, the maximum recommended human dose, resulted in
      increased fetal loss, decreased pup weights, and skeletal abnormalities.
      Source: US FDA label for budesonide (Budesonide), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary Lactation studies have not been conducted with oral budesonide,
      including budesonide, and no information is available on the effects of the drug
      on the breastfed infant or the effects of the drug on milk production.
      Source: US FDA label for budesonide (Budesonide), section 'nursing mothers',
      retrieved 2026-08-29
    - One published study reports that budesonide is present in human milk following
      maternal inhalation of budesonide [see Data ] .
      Source: US FDA label for budesonide (Budesonide), 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 budesonide and any potential adverse effects
      on the breastfed infant from budesonide, or from the underlying maternal
      condition.
      Source: US FDA label for budesonide (Budesonide), section 'nursing mothers',
      retrieved 2026-08-29