Drug profile
Celecoxib
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- • 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
- 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
- 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
CHILD
- 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
- • 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
- 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
RENAL IMPAIRMENT
- 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
- 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
HEPATIC IMPAIRMENT
- 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
- 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
- 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
PREGNANCY
- Pregnancy category D from 30 weeks of gestation onward.
Source: US FDA label for celecoxib (celecoxib), section 'pregnancy', retrieved
2026-08-29
- 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
- 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
BREASTFEEDING
- 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
- 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
- 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