{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "prednisone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The timing of administration should take into account the delayed-release pharmacokinetics and the disease or condition being treated ( 2 , 12.1 ): Initial dose: Prednisone delayed-release tablets 5 mg administered once per day.",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      },
      {
        "text": "The initial dosage of prednisone delayed-release tablets may vary from 5 to 60 mg per day depending on the specific disease entity being treated.",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      },
      {
        "text": "Prednisone delayed-release tablets should be taken daily with food. [see Clinical Pharmacology (12.3) ] Prednisone delayed-release tablets should not be broken, divided, or chewed because the delayed release of prednisone is dependent on an intact coating [see Description (11)] .",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The efficacy and safety of prednisone in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (> 2 years of age), and aggressive lymphomas and leukemias (> 1 month of age).",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      },
      {
        "text": "Individualize dosing based on disease severity and patient response. The timing of administration should take into account the delayed-release pharmacokinetics and the disease or condition being treated ( 2 , 12.1 ): Initial dose: Prednisone delayed-release tablets 5 mg administered once per day.",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "These agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for prednisone (Prednisone delayed release), retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Based on findings from human and animal studies, corticosteroids, including prednisone delayed-release tablets, can cause fetal harm when administered to a pregnant woman (see Data ) [see Warnings and Precautions (5.10) ].",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      },
      {
        "text": "Published epidemiological studies suggest a small but inconsistent increased risk of orofacial clefts with use of corticosteroids during the first trimester.",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      },
      {
        "text": "Intrauterine growth restriction and decreased birth weight have also been reported with maternal use of corticosteroids during pregnancy; however, the underlying maternal condition may also contribute to these risks (see Clinical Considerations ).",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Prednisone delayed-release tablets was not formally evaluated in animal reproduction studies. 8.2 Lactation Risk Summary Prednisolone has been found to be present in human milk following administration to lactating women.",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      },
      {
        "text": "No adverse effects in the breastfed infant have been reported following maternal exposure of prednisolone during breastfeeding.",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      },
      {
        "text": "High doses of corticosteroids administered to lactating women for long periods could potentially produce problems in the breastfed infant including growth and development and interfere with endogenous corticosteroid production (see Clinical Considerations ) [see Use in Specific Populations (8.4) ].",
        "source": "US FDA label for prednisone (Prednisone delayed release), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/prednisone.json",
        "verbatim": true
      }
    ]
  }
}