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. |
| Molecular Weight | 206.28 |
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 | Avoid use during first trimester; associated with increased risk of miscarriage and congenital malformations (cardiac defects, gastroschisis). Use only if potential benefit outweighs risk. |
| 2nd trimester | Use with caution; lowest effective dose for shortest duration. Risk of oligohydramnios and fetal renal dysfunction with prolonged use. |
| 3rd trimester | Contraindicated after 30 weeks gestation due to risk of premature ductus arteriosus closure, oligohydramnios, and neonatal complications including pulmonary hypertension. |
Clinical note
ACE inhibitors and ARBs may have diminished antihypertensive effect Increases risk of serious cardiovascular thrombotic events and GI bleeding.
| FDA category | Positive |
| Placental transfer | Ibuprofen crosses the placenta, with cord blood levels approximately 5-20% of maternal plasma levels. Transfer is detectable. |
■ 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 NSAIDsActive peptic ulcer disease or gastrointestinal bleedingSevere renal impairment (CrCl <30 mL/min)Severe hepatic insufficiencyThird trimester of pregnancy (after 30 weeks)History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDsPerioperative pain in the setting of coronary artery bypass graft (CABG) surgery
| 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 |
Loading safety data…
| Breastfeeding | Ibuprofen is excreted into breast milk in very low concentrations (milk:plasma ratio ~0.01). No adverse effects reported in infants. Preferred NSAID during lactation due to short half-life and low infant exposure. |
| Lactation Rating | L1 - Safest |
| 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. |
| 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. |
| Food/Dietary |
| Administration with food or milk reduces gastric irritation. Avoid alcohol use as it increases risk of GI bleeding. No significant food-drug interactions beyond standard NSAID precautions. |
| Clinical Pearls | Weight-based dosing (5-10 mg/kg/dose) is essential; use the lowest effective dose for shortest duration. Avoid in confirmed or suspected varicella due to increased risk of invasive group A streptococcal infections. Contraindicated in third trimester of pregnancy due to risk of premature ductus arteriosus closure. Monitor for GI bleeding, renal impairment, and hypersensitivity reactions, especially in children with asthma. |
| Patient Advice | Give with food or milk to reduce stomach upset. · Measure dose carefully using the provided dosing device, not a kitchen spoon. · Do not exceed 4 doses in 24 hours unless directed by a doctor. · Stop use and consult a doctor if pain worsens or lasts more than 3 days, or if fever lasts more than 3 days. · Do not use with other NSAID-containing products (e.g., ibuprofen, naproxen). · Seek medical attention for signs of allergic reaction (rash, hives, itching, swelling of face/tongue, trouble breathing), stomach bleeding (black/bloody stools, vomiting blood), or kidney problems (decreased urination, swelling). |