JUNIOR STRENGTH IBUPROFEN
Clinical safety rating: avoid
ACE inhibitors and ARBs may have diminished antihypertensive effect Increases risk of serious cardiovascular thrombotic events and GI bleeding.
Non-selective cyclooxygenase (COX-1 and COX-2) inhibitor, reducing prostaglandin synthesis involved in pain, inflammation, and fever.
| Metabolism | Hepatic metabolism primarily via CYP2C9; minor pathways via CYP2C8 and CYP2C19. |
| Excretion | Renal excretion of conjugated metabolites (approximately 70-90%) and unchanged drug (<10%). Biliary/fecal excretion accounts for <10%. |
| Half-life | Terminal elimination half-life is 2-4 hours in children; prolonged in neonates or hepatic impairment. |
| Protein binding | Approximately 99% bound to albumin. |
| Volume of Distribution | 0.1-0.2 L/kg; low Vd consistent with extensive plasma protein binding. |
| Bioavailability | Oral: 80-100% (rapidly absorbed); rectal: approximately 70-80%. |
| Onset of Action | Oral: 30-60 minutes; onset of analgesia is typically within 30 minutes. |
| Duration of Action | Duration of analgesia is 4-6 hours; antipyretic effect lasts 6-8 hours. |
Oral: 200-400 mg every 4-6 hours as needed; maximum single dose 400 mg, maximum daily dose 1200 mg for OTC use.
| Dosage form | TABLET |
| Renal impairment | eGFR 30-59 mL/min: No adjustment generally, but use lowest effective dose. eGFR 15-29 mL/min: Avoid or use with caution, maximum 400 mg/day. eGFR <15 mL/min: Contraindicated. |
| Liver impairment | Child-Pugh Class A: No adjustment. Child-Pugh Class B: Use with caution; reduce dose by 50%. Child-Pugh Class C: Avoid use (risk of GI bleeding and hepatotoxicity). |
| Pediatric use | For infants ≥6 months: 5-10 mg/kg/dose every 6-8 hours; maximum 40 mg/kg/day. For children: 5-10 mg/kg/dose every 6-8 hours; maximum 40 mg/kg/day (up to 1200 mg/day). |
| Geriatric use | Use lowest effective dose (200 mg) every 6-8 hours; maximum 600 mg/day. Increased risk of GI bleeding and renal impairment; monitor renal function and avoid if CrCl <30 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
ACE inhibitors and ARBs may have diminished antihypertensive effect Increases risk of serious cardiovascular thrombotic events and GI bleeding.
| FDA category | Positive |
| Breastfeeding | Ibuprofen is excreted into breast milk in very low concentrations (M/P ratio approximately 0.01-0.1). Considered compatible with breastfeeding; use lowest effective dose for shortest duration. No evidence of adverse effects on infant. |
| Teratogenic Risk | First trimester: Limited data suggest a small increased risk of cardiac malformations and gastroschisis; avoid use especially between weeks 20-30 due to risk of oligohydramnios or premature ductus arteriosus closure. Second trimester: Risk of fetal renal impairment and oligohydramnios; avoid prolonged use. Third trimester: Contraindicated due to risk of premature closure of ductus arteriosus, persistent pulmonary hypertension, oligohydramnios, and impaired platelet function with bleeding risk. |
■ FDA Black Box Warning
None listed for OTC ibuprofen products. Prescription NSAIDs carry a black box warning for cardiovascular and gastrointestinal risks.
| Common Effects | fever |
| Serious Effects |
["History of hypersensitivity to ibuprofen or other NSAIDs","Active peptic ulcer disease or bleeding","History of gastrointestinal bleeding or perforation","Severe renal impairment (glomerular filtration rate <30 mL/min)","Perioperative pain in coronary artery bypass graft (CABG) surgery","Avoid in third trimester of pregnancy"]
| Precautions | ["Risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation","Increased risk of cardiovascular thrombotic events with prolonged use","Renal toxicity including papillary necrosis and acute interstitial nephritis","Anaphylactoid reactions","Use caution in patients with asthma, hypertension, or fluid retention"] |
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| Fetal Monitoring | Monitor fetal ultrasound for oligohydramnios if used >48 hours in second trimester. Monitor ductus arteriosus and amniotic fluid index if used near term. Assess maternal renal function and blood pressure. |
| Fertility Effects | Reversible inhibition of prostaglandin synthesis may impair ovulation and luteal function; effect is short-term and not associated with permanent infertility. Use may delay conception. |