Clinical safety rating: avoid
Positive evidence of fetus risks but benefits may outweigh risks in some cases
Non-selective inhibition of cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis, leading to anti-inflammatory, analgesic, and antipyretic effects.
| Metabolism | Primarily hepatic via CYP2C9 (major) and CYP2C8 (minor); also undergoes glucuronidation. Metabolites are inactive. |
| Excretion | Renal excretion of conjugated metabolites (about 90% as glucuronide and sulfate conjugates, <10% as unchanged drug); minor biliary/fecal elimination (<5%). |
| Half-life | Terminal elimination half-life is 2-4 hours; no accumulation with repeated dosing in normal renal function. |
| Protein binding | 99% bound primarily to 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% (rapidly and completely absorbed). |
| Onset of Action | Oral: 30-60 minutes (analgesic/antipyretic); Topical: 1-2 hours for local analgesia; IV: within minutes. |
| Duration of Action | Oral: 4-6 hours for analgesia/antipyretic; Topical: 4-6 hours; IV: 4-6 hours. Duration prolonged with sustained-release formulations. |
| Molecular Weight | 206.28 |
200-800 mg orally every 6-8 hours; maximum 3200 mg/day.
| Renal impairment | GFR 30-60 mL/min: no adjustment needed; GFR 15-29 mL/min: 200 mg every 12 hours; GFR <15 mL/min: avoid use. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: use with caution, reduce dose by 50%; Child-Pugh C: avoid use. |
| Pediatric use | 5-10 mg/kg/dose orally every 6-8 hours; maximum 40 mg/kg/day. |
| Geriatric use | Start at lowest effective dose (200 mg every 8-12 hours); maximum 400 mg/day due to increased risk of GI bleeding and renal impairment. |
| 1st trimester | Avoid use during first trimester due to potential risk of miscarriage and congenital malformations; use only if clearly needed. |
| 2nd trimester | Use with caution; associated with oligohydramnios and premature ductus arteriosus constriction; avoid prolonged use. |
| 3rd trimester | Contraindicated after 30 weeks gestation due to risk of premature closure of ductus arteriosus and oligohydramnios; avoid use. |
Clinical note
Avoid, especially after 20 weeks gestation. Associated with premature closure of the ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. The FDA strengthened its warning in 2020 to include all NSAIDs from 20 weeks onward. Some studies suggest a modest increase in early miscarriage risk with first-trimester use, though evidence is not definitive.
| Placental transfer | Ibuprofen crosses the placenta, but fetal concentrations are low (about 1-2% of maternal levels). |
| Breastfeeding |
■ FDA Black Box Warning
NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. Risk may increase with duration of use. Contraindicated for treatment of perioperative pain in coronary artery bypass graft surgery.
| Serious Effects |
History of hypersensitivity to ibuprofen or any NSAIDActive peptic ulcer disease or gastrointestinal bleedingSevere heart failure (NYHA class III-IV)History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDsPerioperative pain in the setting of coronary artery bypass graft (CABG) surgeryThird trimester of pregnancy (after 30 weeks)Significant renal impairment (eGFR <30 mL/min/1.73 m²)Severe hepatic impairment (Child-Pugh class C)
| Precautions | Cardiovascular thrombotic events, Gastrointestinal ulceration, bleeding, perforation, Hypertension, Heart failure exacerbation, Renal toxicity (including acute renal failure, interstitial nephritis), Anaphylactoid reactions, Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), Hematologic effects (e.g., anemia, prolonged bleeding time), Hepatic impairment, Asthmatic reactions in aspirin-sensitive patients |
Loading safety data…
| Ibuprofen is excreted into breast milk in very small amounts (0.0008% of maternal dose) and is considered compatible with breastfeeding. It has a short half-life and low risk to the infant. However, use the lowest effective dose for the shortest duration. |
| Lactation Rating | L1 (Compatible) |
| Teratogenic Risk | First trimester: NSAID use associated with increased risk of miscarriage and congenital anomalies (e.g., cardiac defects, gastroschisis). Second trimester: Avoid due to potential oligohydramnios and fetal renal impairment. Third trimester: Contraindicated; risk of premature ductus arteriosus closure, persistent pulmonary hypertension, oligohydramnios, and fetal nephrotoxicity. |
| Fetal Monitoring | During pregnancy: Monitor amniotic fluid volume via ultrasound if prolonged use; fetal echocardiography if exposed in third trimester. Monitor maternal renal function and blood pressure. In neonates: Assess for patent ductus arteriosus, pulmonary hypertension, and renal function if exposed near term. |
| Fertility Effects | Reversible impairment of female fertility due to inhibition of prostaglandin synthesis, affecting ovulation and implantation. Effects resolve upon discontinuation. No known adverse effect on male fertility. |
| Food/Dietary |
| Alcohol: increases GI irritation and bleeding risk. Grapefruit juice: no significant interaction. High-fat meals may delay absorption but do not reduce overall bioavailability. |
| Clinical Pearls | Ibuprofen has a ceiling effect for analgesia; exceeding 400 mg per dose provides minimal additional pain relief but increases GI and cardiovascular risks. Avoid use in patients with severe renal impairment (CrCl <30 mL/min) or active peptic ulcer disease. In asthma patients, note that NSAIDs can trigger bronchospasm in approximately 10% of aspirin-sensitive individuals. For acute pain, a single dose of 400-800 mg is effective; for chronic use, use the lowest effective dose for the shortest duration. Ibuprofen is highly protein-bound and may displace warfarin, increasing INR; monitor closely. |
| Patient Advice | Take with food or milk to reduce stomach upset. · Do not exceed 1200 mg per day without a doctor's approval; maximum OTC dose is 400 mg every 4-6 hours. · Avoid alcohol while taking ibuprofen to reduce the risk of stomach bleeding. · Stop taking and contact your doctor if you experience signs of stomach bleeding: black or bloody stools, vomiting blood, or severe abdominal pain. · Ibuprofen can increase risk of heart attack or stroke, especially with long-term use or high doses; discuss your cardiovascular risk with your doctor. · Do not take ibuprofen if you are pregnant (especially in the third trimester) unless directed by your doctor, as it can harm the unborn baby. |