{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "budesonide",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      },
      {
        "text": "There are clinical considerations [see Clinical Considerations ] .",
        "source": "US FDA label for budesonide (Budesonide), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/budesonide.json",
        "verbatim": true
      }
    ]
  }
}