Drug profile
Ibuprofen
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease
Suggested Dosage: 1200 mg-3200 mg daily (400 mg, 600 mg or 800 mg tid or qid).
Source: US FDA label for ibuprofen (Ibuprofen), section 'dosage and
administration', retrieved 2026-08-29
- Individual patients may show a better response to 3200 mg daily, as compared with
2400 mg, although in well-controlled clinical trials patients on 3200 mg did not
show a better mean response in terms of efficacy.
Source: US FDA label for ibuprofen (Ibuprofen), section 'dosage and
administration', retrieved 2026-08-29
- Therefore, when treating patients with 3200 mg/ day, the physician should observe
sufficient increased clinical benefits to offset potential increased risk.
Source: US FDA label for ibuprofen (Ibuprofen), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Safety and effectiveness of Ibuprofen tablets in pediatric patients have not been
established.
Source: US FDA label for ibuprofen (Ibuprofen), section 'pediatric use', 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 ibuprofen (Ibuprofen),
retrieved 2026-08-29
HEPATIC IMPAIRMENT
- No liver-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for ibuprofen (Ibuprofen),
retrieved 2026-08-29
PREGNANCY
- Risk Summary Use of NSAIDs, including Ibuprofen tablets, can cause premature
closure of the fetal ductus arteriosus and fetal renal dysfunction leading to
oligohydramnios and, in some cases, neonatal renal impairment.
Source: US FDA label for ibuprofen (Ibuprofen), section 'pregnancy', retrieved
2026-08-29
- Because of these risks, limit dose and duration of Ibuprofen tablets use between
about 20 and 30 weeks of gestation, and avoid Ibuprofen tablets use at about 30
weeks of gestation and later in pregnancy [see WARNINGS; Fetal Toxicity ].
Source: US FDA label for ibuprofen (Ibuprofen), section 'pregnancy', retrieved
2026-08-29
- Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including Ibuprofen
tablets, at about 30 weeks gestation or later in pregnancy increases the risk of
premature closure of the fetal ductus arteriosus.
Source: US FDA label for ibuprofen (Ibuprofen), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- It is not known whether this drug is excreted in human milk.
Source: US FDA label for ibuprofen (Ibuprofen), section 'nursing mothers',
retrieved 2026-08-29
- Because many drugs are excreted in human-milk and because of the potential for
serious adverse reactions in nursing infants from Ibuprofen tablets, a decision
should be made whether to discontinue nursing or discontinue the drug, taking into
account the importance of the drug to the mother.
Source: US FDA label for ibuprofen (Ibuprofen), section 'nursing mothers',
retrieved 2026-08-29