IBU

Clinical safety rating: caution

Comprehensive clinical and safety monograph for IBU (IBU).

How it works

Non-selective inhibitor of cyclooxygenase (COX-1 and COX-2), decreasing prostaglandin synthesis, thereby reducing inflammation, pain, and fever.

What the body does with it

Metabolism	Hepatic metabolism primarily via CYP2C9 to inactive metabolites; minor pathways include CYP2C8.
Excretion	Renal (90% as conjugated metabolites, 10% unchanged), biliary/fecal (minor, <5%)
Half-life	Terminal elimination half-life: 2-4 hours in adults; prolonged in neonates (30 hours) and elderly (up to 6 hours). No accumulation with recommended dosing due to short t½.
Protein binding	99% bound primarily to albumin
Volume of Distribution	0.1-0.2 L/kg, indicating low tissue distribution; predominantly confined to plasma and extracellular fluid.
Bioavailability	Oral: 80-100% (immediate-release), 70-90% (extended-release); Topical: approximately 5-10% systemic absorption; Intravenous: 100%.
Onset of Action	Oral immediate-release: 30-60 minutes; Oral extended-release: 1-2 hours; Topical: 1-2 hours; Intravenous: 5-10 minutes.
Duration of Action	Oral immediate-release (analgesic/antipyretic): 4-6 hours; Anti-inflammatory effect: requires multiple doses over days; Topical: approximately 4-6 hours; Intravenous: 4-6 hours.

Classification & Brands

Action Class	NSAID's- Non-Selective COX 1&2 Inhibitors (propionic acid)
Brand Substitutes	Ibupal 400mg Tablet, Bruriff 400mg Tablet, IBUFLAMAR 400MG TABLET, ALFAM 400MG TABLET, NORSWEL 400MG TABLET, Multigon Tablet, Ibuwin 400 mg/500 mg Tablet, Tolfen Tablet, Ibuflam 400 mg/500 mg Tablet, Arden Plus 400 mg/500 mg Tablet

Dosing & administration

200-800 mg orally every 6-8 hours as needed; maximum 3200 mg/day. For OTC use: 200-400 mg every 4-6 hours; max 1200 mg/day.

Dosage form	TABLET
Renal impairment	CrCl >30 mL/min: no adjustment. CrCl 10-30 mL/min: 200 mg every 12 hours; avoid if CrCl <10 mL/min.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50% or avoid. Child-Pugh C: contraindicated due to risk of hepatotoxicity.
Pediatric use	6 months to 12 years: 5-10 mg/kg/dose every 6-8 hours; max 40 mg/kg/day. For juvenile idiopathic arthritis: 30-40 mg/kg/day divided every 6-8 hours; max 50 mg/kg/day.
Geriatric use	Initiate at lowest effective dose; consider 200 mg every 8-12 hours; monitor renal function and GI bleeding risk.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for IBU (IBU).

Breastfeeding	Ibuprofen is excreted into breast milk in low concentrations (M/P ratio approximately 0.01-0.03). Considered compatible with breastfeeding by the American Academy of Pediatrics; use lowest effective dose for shortest duration.
Teratogenic Risk	First and second trimester: Increased risk of miscarriage and congenital malformations (particularly cardiac defects) associated with NSAID use. Third trimester: Known risk of premature closure of ductus arteriosus, oligohydramnios, and neonatal renal impairment; contraindicated after 30 weeks gestation.

Warnings & precautions

■ FDA Black Box Warning

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Contraindicated for treatment of peri-operative pain in coronary artery bypass graft (CABG) surgery.

Side Effect Profile

Serious Effects

Absolute Contraindications

["History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs","Peri-operative pain in CABG surgery","Active gastrointestinal bleeding","Advanced renal disease","Third trimester of pregnancy"]

Clinical Precautions

Precautions

["Cardiovascular thrombotic events","Gastrointestinal bleeding, ulceration, and perforation","Hypertension","Heart failure exacerbation","Renal toxicity","Anaphylactic reactions","Serious skin reactions (e.g., Stevens-Johnson syndrome)","Hematologic effects (anemia, bleeding)"]

Clinical Tips & Counseling

Drug interactions

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IBU

Clinical safety rating: caution

Comprehensive clinical and safety monograph for IBU (IBU).

How it works

Non-selective inhibitor of cyclooxygenase (COX-1 and COX-2), decreasing prostaglandin synthesis, thereby reducing inflammation, pain, and fever.

What the body does with it

Metabolism	Hepatic metabolism primarily via CYP2C9 to inactive metabolites; minor pathways include CYP2C8.
Excretion	Renal (90% as conjugated metabolites, 10% unchanged), biliary/fecal (minor, <5%)
Half-life	Terminal elimination half-life: 2-4 hours in adults; prolonged in neonates (30 hours) and elderly (up to 6 hours). No accumulation with recommended dosing due to short t½.
Protein binding	99% bound primarily to albumin
Volume of Distribution	0.1-0.2 L/kg, indicating low tissue distribution; predominantly confined to plasma and extracellular fluid.
Bioavailability	Oral: 80-100% (immediate-release), 70-90% (extended-release); Topical: approximately 5-10% systemic absorption; Intravenous: 100%.
Onset of Action	Oral immediate-release: 30-60 minutes; Oral extended-release: 1-2 hours; Topical: 1-2 hours; Intravenous: 5-10 minutes.
Duration of Action	Oral immediate-release (analgesic/antipyretic): 4-6 hours; Anti-inflammatory effect: requires multiple doses over days; Topical: approximately 4-6 hours; Intravenous: 4-6 hours.

Classification & Brands

Action Class	NSAID's- Non-Selective COX 1&2 Inhibitors (propionic acid)
Brand Substitutes	Ibupal 400mg Tablet, Bruriff 400mg Tablet, IBUFLAMAR 400MG TABLET, ALFAM 400MG TABLET, NORSWEL 400MG TABLET, Multigon Tablet, Ibuwin 400 mg/500 mg Tablet, Tolfen Tablet, Ibuflam 400 mg/500 mg Tablet, Arden Plus 400 mg/500 mg Tablet

Dosing & administration

200-800 mg orally every 6-8 hours as needed; maximum 3200 mg/day. For OTC use: 200-400 mg every 4-6 hours; max 1200 mg/day.

Dosage form	TABLET
Renal impairment	CrCl >30 mL/min: no adjustment. CrCl 10-30 mL/min: 200 mg every 12 hours; avoid if CrCl <10 mL/min.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50% or avoid. Child-Pugh C: contraindicated due to risk of hepatotoxicity.
Pediatric use	6 months to 12 years: 5-10 mg/kg/dose every 6-8 hours; max 40 mg/kg/day. For juvenile idiopathic arthritis: 30-40 mg/kg/day divided every 6-8 hours; max 50 mg/kg/day.
Geriatric use	Initiate at lowest effective dose; consider 200 mg every 8-12 hours; monitor renal function and GI bleeding risk.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for IBU (IBU).

Breastfeeding	Ibuprofen is excreted into breast milk in low concentrations (M/P ratio approximately 0.01-0.03). Considered compatible with breastfeeding by the American Academy of Pediatrics; use lowest effective dose for shortest duration.
Teratogenic Risk	First and second trimester: Increased risk of miscarriage and congenital malformations (particularly cardiac defects) associated with NSAID use. Third trimester: Known risk of premature closure of ductus arteriosus, oligohydramnios, and neonatal renal impairment; contraindicated after 30 weeks gestation.