CHILDREN'S 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, which mediates inflammation, pain, and fever.
| Metabolism | Primarily hepatic via CYP2C9 and glucuronidation. |
| Excretion | Renal: 90% (primarily as conjugated metabolites, <10% unchanged); biliary/fecal: minor |
| Half-life | 2-4 hours (terminal elimination half-life in children; may be prolonged in neonates or hepatic impairment) |
| Protein binding | 99% (primarily albumin) |
| Volume of Distribution | 0.1-0.2 L/kg (low Vd, consistent with high protein binding and limited tissue distribution) |
| Bioavailability | Oral: 80-100% (well-absorbed; food may delay absorption but not extent) |
| Onset of Action | Oral: 30-60 minutes (analgesic/antipyretic effect begins) |
| Duration of Action | Oral: 4-6 hours (dose-dependent; antipyretic effect may last up to 8 hours at higher doses) |
Oral: 200-400 mg every 6-8 hours as needed; maximum daily dose: 1200 mg (OTC) or 3200 mg (prescription).
| Dosage form | SUSPENSION |
| Renal impairment | GFR 30-59 mL/min: Reduce dose by 25-50%; avoid if GFR <30 mL/min due to increased risk of nephrotoxicity. |
| Liver impairment | Child-Pugh A: No adjustment; Child-Pugh B: Reduce dose by 50%; Child-Pugh C: Avoid use. |
| Pediatric use | Oral suspension (100 mg/5 mL): 5-10 mg/kg/dose every 6-8 hours; maximum 40 mg/kg/day. For fever or mild pain: 5-10 mg/kg/dose; for inflammatory conditions: up to 10 mg/kg/dose. |
| Geriatric use | Use lowest effective dose for shortest duration; start at 200 mg every 8 hours; monitor renal function and gastrointestinal bleeding risk. |
| 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 in breast milk in very low concentrations (M/P ratio <0.1). Typically considered compatible with breastfeeding; use lowest effective dose for shortest duration. |
| Teratogenic Risk | First trimester: Avoid unless benefit outweighs risk; risk of spontaneous abortion and congenital malformations (cardiac, gastroschisis) based on case-control studies. Second trimester: No clear association with major malformations at standard doses. Third trimester (especially after 30 weeks): Avoid due to risk of premature closure of ductus arteriosus, oligohydramnios, and necrotizing enterocolitis. |
■ FDA Black Box Warning
No FDA black box warning.
| Common Effects | fever |
| Serious Effects |
["Hypersensitivity to ibuprofen or NSAIDs","Active or history of gastrointestinal bleeding","Severe renal impairment","Premature infants","Concomitant use of other NSAIDs or anticoagulants"]
| Precautions | ["Risk of gastrointestinal bleeding/ulceration","Renal toxicity in dehydrated patients","Cardiovascular thrombotic events (with prolonged use)","Exacerbation of asthma","Avoid in children with varicella due to increased risk of severe skin infections"] |
| Food/Dietary | Alcohol should be avoided due to increased risk of GI bleeding. No significant food interactions, but administering with food or milk can reduce GI irritation. Caffeine may increase stimulatory effects, but interaction is minimal in children. |
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| Fetal Monitoring | Monitor fetal growth, amniotic fluid volume, and ductus arteriosus patency via ultrasound if prolonged use in third trimester. For maternal monitoring: assess renal function, signs of bleeding, and gastrointestinal side effects. |
| Fertility Effects | May reversibly impair female fertility by inhibiting prostaglandin synthesis affecting ovulation and implantation. Effect resolves upon discontinuation. Limited data on male fertility. |
| Clinical Pearls | Ibuprofen is an NSAID; contraindicated in children with active bleeding, history of GI perforation, or severe renal impairment. Use lowest effective dose for shortest duration to minimize adverse effects. Monitor for signs of allergic reactions, GI upset, and renal dysfunction. Avoid use in dehydrated or hypovolemic children due to increased risk of acute kidney injury. |
| Patient Advice | Give with food or milk to reduce stomach upset. · Do not exceed recommended dose based on weight; use weight-based dosing, not age. · Do not use for more than 10 days for fever or 3 days for pain unless directed by a doctor. · Avoid taking with other NSAIDs or acetaminophen unless instructed by a healthcare provider. · Stop use and seek medical help if allergic reactions occur (rash, facial swelling, trouble breathing). · Keep out of reach of children; use child-resistant packaging. |