{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "celecoxib",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1 ) • OA: 200 mg once daily or 100 mg twice daily ( 2.2 , 14.1 ) • RA: 100 mg to 200 mg twice daily ( 2.3 , 14.2 ) • JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg ( 2.4 , 14.3 ) • AS: 200 mg once daily single dose or 100 mg twice daily.",
        "source": "US FDA label for celecoxib (celecoxib), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit ( 2.5 , 14.4 ) • AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day.",
        "source": "US FDA label for celecoxib (celecoxib), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "For patients ≥10 kg to ≤25 kg the recommended dose is 50 mg twice daily.",
        "source": "US FDA label for celecoxib (celecoxib), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Celecoxib capsules are approved for relief of the signs and symptoms of Juvenile Rheumatoid Arthritis in patients 2 years and older. Safety and efficacy have not been studied beyond six months in children.",
        "source": "US FDA label for celecoxib (celecoxib), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1 ) • OA: 200 mg once daily or 100 mg twice daily ( 2.2 , 14.1 ) • RA: 100 mg to 200 mg twice daily ( 2.3 , 14.2 ) • JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg ( 2.4 , 14.3 ) • AS: 200 mg once daily single dose or 100 mg twice daily.",
        "source": "US FDA label for celecoxib (celecoxib), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "On subsequent days, 200 mg twice daily as needed ( 2.6 , 14.5 ) Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B).",
        "source": "US FDA label for celecoxib (celecoxib), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "The use of celecoxib capsules in patients with severe hepatic impairment is not recommended [ see Dosage and Administration ( 2.6 ) and Clinical Pharmacology ( 12.3 ) ]. 8.7 Renal Insufficiency Celecoxib capsules are not recommended in patients with severe renal insufficiency [ see Warnings and Precautions ( 5.6 ) and Clinical Pharmacology ( 12.3 ) ].",
        "source": "US FDA label for celecoxib (celecoxib), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "Hyperkalemia Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment.",
        "source": "US FDA label for celecoxib (celecoxib), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "On subsequent days, 200 mg twice daily as needed ( 2.6 , 14.5 ) Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B).",
        "source": "US FDA label for celecoxib (celecoxib), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "On subsequent days, the recommended dose is 200 mg twice daily as needed. 2.7 Special Populations Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%.",
        "source": "US FDA label for celecoxib (celecoxib), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "The use of celecoxib capsules in patients with severe hepatic impairment is not recommended [ see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 ) ].",
        "source": "US FDA label for celecoxib (celecoxib), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy category D from 30 weeks of gestation onward.",
        "source": "US FDA label for celecoxib (celecoxib), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "Risk Summary Use of NSAIDs, including celecoxib capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.",
        "source": "US FDA label for celecoxib (celecoxib), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "Avoid use of NSAIDs, including celecoxib capsules, in pregnant women starting at 30 weeks of gestation.",
        "source": "US FDA label for celecoxib (celecoxib), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including celecoxib capsules, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.",
        "source": "US FDA label for celecoxib (celecoxib), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin mediated follicular rupture required for ovulation.",
        "source": "US FDA label for celecoxib (celecoxib), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      },
      {
        "text": "Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation.",
        "source": "US FDA label for celecoxib (celecoxib), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/celecoxib.json",
        "verbatim": true
      }
    ]
  }
}