Ibuprofen - an overview | ScienceDirect Topics (2022)

Ibuprofen is a widely used non-steroidal anti-inflammatory drug (NSAID) which is subject to extensive metabolism, via both Phase I (hydroxylation and oxidation) and Phase II (glucuronidation) pathways.

From: Handbook of Analytical Separations, 2003

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Drug Dosages

Keith Kleinman MD, in Harriet Lane Handbook, 2021


PO: Motrin, Advil, Children’s Advil, Children’s Motrin, and generics

IV: NeoProfen, Caldolor

Nonsteroidal anti-inflammatory agent


Oral suspension [OTC]: 100 mg/5 mL (60, 120, 480 mL)

Oral drops [OTC]: 40 mg/mL (15, 30 mL)

Chewable tabs [OTC]: 100 mg

Caplets [OTC]: 100, 200 mg

Tabs: 200 [OTC], 400, 600, 800 mg

Capsules [OTC]: 200 mg


NeoProfen and generic (lysine salt): 10 mg ibuprofen base/1 mL (2 mL)

Caldolor: 100 mg/mL (4, 8 mL); contains 78 mg/mL arginine


Infant and child (≥6 mo):

Analgesic/antipyretic: 5–10 mg/kg/dose Q6–8 hr PO;max. dose: 400 mg/dose or 40 mg/kg/24 hr

JRA (6 mo12 yr): 30–50 mg/kg/24 hr ÷ Q6 hr PO;max. dose: 800 mg/dose or 2400 mg/24 hr


Inflammatory disease: 400–800 mg/dose Q6–8 hr PO;max. dose: 800 mg/dose or 3.2 g/24 hr

Pain/fever/dysmenorrhea: 200–400 mg/dose Q4–6 hr PRN PO;max. dose: 3.2 g/24 hr

(Video) Could Ibuprofen Be Dangerous? - An Ibuprofen Overview (Advil/Motrin)


6 mo<12 yr:

Analgesic and antipyretic: 10 mg/kg/dose up to 400 mg/dose Q4–6 hr PRN;max. dose: the lesser of 40 mg/kg/24 hr or 2400 mg/24 hr

1217 yr:

Analgesic and antipyretic: 400 mg/dose Q4–6 hr PRN;max. dose: 2400 mg/24 hr

≥18 yr and adult:

Analgesic (see remarks): 400–800 mg/dose Q6 hr PRN;max. dose: 3200 mg/24 hr

Antipyretic (see remarks): 400 mg/dose Q4–6 hr or 100–200 mg/dose Q4 hr PRN;max. dose: 3200 mg/24 hr

Closure of ductus arteriosus:

<32 wk of gestation and 0.5–1.5 kg (use birth weight to calculate all doses and infuse all doses over 15 min; see remarks): 10 mg/kg/dose IV × 1 followed by two doses of 5 mg/kg/dose each, 24 and 48 hr after the initial dose. Hold second or third dose if urinary output is <0.6 mL/kg/hr; dosing should resume when laboratory studies indicate the return of normal renal function. If the ductus arteriosus fails to close or reopens, a second course of ibuprofen, the use of IV indomethacin, or surgery may be necessary.


Sarah Miles, in xPharm: The Comprehensive Pharmacology Reference, 2007

Ibuprofen; Benzeneacetic acid,alpha-methyl-4-(2-methylpropyl)-; advil; aktren; algifor; algofen; alpha (4isobutylphenyl)propionic acid; analgyl; anco; attritin; balkaprofen; brufen; brufort; bufohexal; burana; contraneural; dc 7034; dg 7034; dolgit; dolocyl; dolodolgit; ecoprofen; emflam; exidol; femapirin; fenalgic; fenbid; focus; halprin; haltran; ibofen; ibudak; ibufen; ibugel; ibugesic; ibulgan; ibumetin; ibuprin; ibuprofen klinge 600; ibu slow; ibusynth; ibutop; irfen; 2 (4isobutylphenyl)propionic acid; junifen; kontraneural; lidifen; maxagesic; mcnr 1451; medipren; mediprin; mensoton; 2 [4 (2 methylpropyl)phenyl]propionicacid; midol 200; motrin; neobrufen; nerofen; novogent n; nugin; nuprin; nureflex; nurofen; optifen; opturem; paduden; 2 (paraisobutylphenyl)propionic acid; proflex; rebugen; reuvol; rufen; seclodin; tabalon; trendar; unipro; urem; Benzeneacetic acid, alpha-methyl-4-(2-methylpropyl)-; 'focus'; 2 (4 isobutylphenyl)propionic acid; 2 (para isobutylphenyl)propionic acid; 2 [4 (2 methylpropyl)phenyl]propionic acid; alpha (4 isobutylphenyl)propionic acid; dc7034; dg7034; mcn r 1451; pedea

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Paul Rutter PhD, FRPharmS, FFRPS, SFHEA, in Community Pharmacy, 2021


Ibuprofen (e.g., Nurofen, Calprofen) can be given to children older than 3 months. Doses for ibuprofen, like paracetamol, are age-dependent. The dosing schedule that follows is taken from the British National Formulary (note that some OTC products’ dosing schedules are different than these):

Age, 3 to 5 months: 50mg, three times a day.

Age, 6 to 11 months: 50mg, three or four times a day.

Age, 1 to 3 years: 100mg, three times a day.

Age, 4 to 6 years: 150mg, three times a day.

Age, 7 to 9 years: 200mg, three times a day.

(Video) Ibuprofen: Important Warnings and Precautions

Age, 10 to 11 years: 300mg, three times a day.

Ibuprofen can cause gastrointestinal side effects, such as nausea and diarrhoea, and also interacts with many other medicines, although medicines that interact with ibuprofen are very unlikely to be taken by children. Any child who has previously taken a nonsteroidal antiinflammatory drug (NSAID) and had an allergic reaction to it should avoid ibuprofen.


Meremikwu, M. M., & Oyo-Ita, A. (2002). Paracetamol versus placebo or physical methods for treating fever in children.Cochrane Database System Review, 2:CD003676.https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003676/full.

Meremikwu, M., & Oyo-Ita, A. (2003). Paracetamol for treating fever in children.Cochrane Database System Review, 2:CD004264.https://doi.org/10.1002/14651858.CD004264.https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD004264/full.

Wong, T., Stang, A. S., Ganshorn, H., et al. (2013). Combined and alternating paracetamol and ibuprofen therapy for febrile children.Cochrane Database System Review, 2:CD009572.https://doi.org/10.1002/14651858.CD009572.pub2.https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009572.pub2/full.

Further reading

Dodd, S. R., Lancaster, G. A., Craig, J. V, et al. (2006). Sensitivity and specificity of aural compared with rectal thermometers: A meta-analysis.Journal of Clinical Epidemiology, 59(4), 354–357.

National Institute for Health and Care Excellence (NICE) Guidance. Fever in under 5's: Assessment and initial management. Available fromhttps://www.nice.org.uk/guidance/cg160.


Christopher P. Holstege, in Encyclopedia of Toxicology (Second Edition), 2005


Ibuprofen is rapidly absorbed after ingestion with peak plasma concentrations obtained within 1–2h. Ibuprofen is highly protein bound (99%) and occupies only a fraction of the total drug binding sites during therapeutic use. The volume of distribution is 0.1–0.2lkg−1. Ibuprofen passes slowly into synovial spaces and may remain there in higher concentration as the concentrations in plasma decline. Ibuprofen passes readily across the placenta. Ibuprofen is extensively metabolized, yielding four urinary metabolites formed by hydroxylation. The excretion of ibuprofen is rapid and complete. Ibuprofen's elimination half-life is 1–2h. Approximately 90% of an ingested dose is excreted in the urine as metabolites or their conjugates, and 10% is eliminated as free drug.

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Women’s health

Paul Rutter PhD, FRPharmS, FFRPS, SFHEA, in Community Pharmacy, 2021


There is a plethora of marketed ibuprofen products, all of which have a standard dose for the relief of PD. Adults should take 200 to 400 mg (one or two tablets) three times a day, although most patients will need the higher dose of 400 mg three times a day. Because ibuprofen is only used for a few days during each cycle, it is generally well tolerated. However, gastric irritation is possible, and bronchospasm can be triggered in asthmatics who have a history of hypersensitivity to aspirin or NSAIDs. Ibuprofen can interact with many medicines, although most are not clinically significant (see Table 6.19).


A. Garrard, in Encyclopedia of Toxicology (Third Edition), 2014

Exposure Routes and Pathways

Ibuprofen is available in tablet and liquid dosage forms. Ingestion is the most common route of both accidental and intentional exposures to ibuprofen. Exposure to ibuprofen through wastewater, surface water, and even drinking water occurs, although no adverse human health effects have been reported at the low levels ibuprofen is detected. In wastewater treatment a significant amount of ibuprofen is degraded; however, the primary route by which ibuprofen enters surface waters is still through wastewater treatment plant effluent. Ibuprofen also enters the sewage system through incompletely absorbed drug and through the disposal of unused drugs into toilets and down drains. Potential exposure through runoff from landfill sites and from agricultural land to which biosolids have been applied and through discharges into wastewater from hospitals and through manufacturing processes also occurs.

(Video) IBUPROFEN - Overview and Side effects

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In Meyler's Side Effects of Drugs (Sixteenth Edition), 2016

Urinary tract

Ibuprofen can cause renal impairment, ranging from an insignificant reduction to an acute fall in creatinine clearance associated with a general hypersensitivity reaction, especially in patients with systemic lupus erythematosus or acute tubular necrosis [43]. The nephrotic syndrome without renal insufficiency and acute interstitial nephritis without the nephrotic syndrome have been described after self-administration of over-the-counter ibuprofen [44,45].

Irreversible renal insufficiency due to acute cortical necrosis triggered by severe renal hypoperfusion has been reported [46]. A pharmacokinetic study showed that conversion of inactive R-ibuprofen to active S-ibuprofen was greater in patients with renal impairment than in healthy controls; this may aggravate renal insufficiency [47].

Acute deterioration in renal function can occur also in other at-risk patients, such as those with renal transplants [48,49].

Reports of acute renal insufficiency in children taking ibuprofen as an analgesic or antipyretic continue to appear [50,51]. In most cases dehydration was the main precipitating cause. Ibuprofen and other NSAIDs should be avoided in dehydrated patients.

Acute papillary necrosis causing bilateral ureteric obstruction has been attributed to ibuprofen in an 8-year-old boy [52].

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John D. Higgins, ... Harry G. Brittain, in Analytical Profiles of Drug Substances and Excipients, 2001

3.3.1 Melting Behavior

Rac-ibuprofen exists as a stable crystalline solid, and exhibits a typical melting range of 75-77°C [22]. Interestingly, if the molten solid is allowed to cool from the melting point to room temperature without vibration in a smooth-lined container, rac-ibuprofen can exist as an oil phase for several hours to a few days. If disturbed, an exothermic recrystallization proceeds and a bulk crystal rapidly grows vertically out of the oil phase [23].

The combination of low melting point and slow recrystallization kinetics should be considered when formulating the substance, since even minor frictional heating during compression can melt the material. Furthermore, rac-ibuprofen has been shown to have a propensity toward sublimation, which also should be considered when designing manufacturing processes or stability protocols [24].

Finally, it should also be noted that rac-ibuprofen is known to form eutectic mixtures with a variety of excipients, which can result in a significant lowering of the melting point [25].

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(Video) Ibuprofen: Pain Mechanism, Dose Safety and Drug Interactions

Acute Pain

Benjamin J. Walker, ... Charles B. Berde, in A Practice of Anesthesia for Infants and Children (Sixth Edition), 2019

Nonsteroidal Antiinflammatory Drugs

NSAIDs provide excellent analgesia for mild to moderate pain resulting from surgery, injury, and disease. Their principal mechanism of action is via inhibition of the enzyme prostaglandin H2 synthetase at the COX site, causing a reduction in the production of prostaglandins at the site of tissue injury and attenuation of the inflammatory cascade. In addition to their peripheral effects, the NSAIDs have also been shown to exert a direct spinal action by blocking the hyperalgesic response induced by activation of spinal glutamate and substance P receptors.144 Decreased production of leukotrienes, activation of serotonin pathways, and inhibition of excitatory amino acids, NMDA-mediated hyperalgesia, and central inhibition of prostaglandin biosynthesis have been proposed as additional mechanisms of action.145,146 The COX-1 enzyme is present in the brain, gastrointestinal tract, kidneys, and platelets and is expressed constitutively. It preserves gastric mucosal integrity and function, platelet aggregation, and renal perfusion. COX-2 expression is induced by inflammation or tissue injury. Selective COX-2 inhibitors reduce inflammation but have less effect on gastric mucosal function and have fewer effects on platelet aggregation, thereby resulting in fewer adverse effects. Their deleterious effects on renal perfusion, however, are no different than the nonselective COX drugs, because COX-2 is constitutively expressed in renal tissues and may be involved in prostaglandin-dependent renal homeostatic processes.147 The risks of renal toxicity increase in the presence of hypovolemia, cardiac failure, preexisting renal dysfunction, or with the concurrent use of other nephrotoxic drugs. Reports of thrombotic cardiovascular and CNS events after both long-term and short-term use in adults led to withdrawal of two of the COX-2 inhibitors, rofecoxib and valdecoxib, from the market148,149; the risk of these agents causing thrombotic complications in children remains unknown. Most pediatric studies have evaluated the use of nonselective COX medications. In adult studies, COX-2 inhibitors have generally, but not always, produced analgesia roughly equivalent to that of traditional NSAIDs.

Ibuprofen, one of the oldest orally administered NSAIDs, has been used extensively for treatment of fever and pain related to surgery, trauma, arthritis, menstrual cramps, and sickle cell disease. A large, controlled, randomized, double-blind study reported a greater decrease in VAS pain scores with ibuprofen than with acetaminophen or codeine in children presenting to the emergency department with acute pain after musculoskeletal trauma.150 Additionally, more children who received ibuprofen had VAS scores less than 30 on a 0-to-100-mm VAS scale than in the other two groups. The recommended dose of ibuprofen is 5 to 10 mg/kg every 6 hours. Like acetaminophen, ibuprofen is available in a variety of formulations and concentrations, placing children at risk for an overdose. For pediatric use, ibuprofen is available as follows:

Concentrated drops containing 50 mg ibuprofen in 1.25 mL

Oral suspension containing 100 mg of ibuprofen in 5 mL

Junior Strength chewable tablets or caplets containing 100 mg of ibuprofen in each

Diclofenac provides effective analgesia after minor surgical procedures in children. It is available only as an oral tablet in the United States, but it is available as a suppository and in the injectable form in several countries. The pediatric dose of diclofenac is 1 mg/kg every 8 hours orally, 0.5 mg/kg rectally, and 0.3 mg/kg IV.151 The oral and rectal doses reflect bioavailabilities of 0.36, 0.35, and 0.6 for suspension, dispersible tablets, and suppository forms, respectively. When diclofenac was administered rectally, the relative bioavailability was greater and the peak concentration was reached earlier than after enteric-coated tablets administered orally.152 Children who received diclofenac experienced analgesia comparable to those who received caudal bupivacaine or IV ketorolac for inguinal hernia repair.153–155 In children undergoing tonsillectomy and/or adenoidectomy, diclofenac yielded superior analgesia with less supplemental opioid dosing, less nausea and vomiting, and earlier resumption of oral intake compared with acetaminophen.156,157 Although there are occasional reports of increased bleeding and restlessness in the recovery room in children who received diclofenac compared with those who had received papaveretum during tonsillectomy,158 a Cochrane review established that NSAIDs did not cause any increase in bleeding that required a return to the operating room (OR) for children. However, when examining the bleeding risk with different types of NSAIDS, ketorolac (but not other NSAIDS) was associated with a statistically significant increase in bleeding after tonsillectomy.159,160 Overall, there was less nausea and vomiting with NSAIDs compared with alternative analgesics, suggesting their benefits outweigh their negative aspects. A prospective, randomized trial assigned 91 children with sleep-disordered breathing to acetaminophen with ibuprofen or morphine for analgesia after tonsillectomy. There was an almost 4-fold increase in the number of desaturation events (from preoperative levels) during the first postoperative night in the morphine group, and a decrease in the number of desaturation events during the same period in the ibuprofen group. Overall, the pain scores in the morphine group were less, but there was no statistically significant difference. The study was terminated early as a result of preliminary results and an incident of respiratory depression at home, resulting in admission to the pediatric intensive care unit (ICU) in the morphine group.161

Ketorolac, indomethacin, and ibuprofen are the only injectable NSAIDs available in the United States. Indomethacin is the most commonly used NSAID used for closure of patent ductus arteriosus in preterm neonates. The IV formulation of ibuprofen is labeled for children and adults in the United States. Ketoprofen, parecoxib, and diclofenac are other injectable NSAIDs that are available outside the United States. A large multicenter study compared the risks of serious adverse events from IV ketorolac, ketoprofen, and diclofenac in more than 11,000 adults undergoing major surgery.162 The results indicated that 1.4% of adults experienced a serious adverse outcome, including surgical site bleeding (1%), death (0.17%), severe allergic reactions (0.12%), renal failure (0.09%), and gastrointestinal bleeding (0.04%), with no differences in outcomes among the groups. Similar large-scale studies are not available for children, but one placebo-controlled study of 161 children undergoing tonsillectomy who received IV ibuprofen (10 mg/kg IV) (n = 82) demonstrated an opioid-sparing effect without an increase in bleeding,163 consistent with the findings of larger reviews.160

Ketorolac has been shown to provide postoperative analgesia similar to opioids in children of all ages.164–167 Its benefits include lack of opioid adverse effects (respiratory depression, sedation, nausea, and pruritus), making it an attractive choice for the treatment of postoperative pain. However, in common with all NSAIDs, it carries risks of platelet dysfunction, gastrointestinal bleeding, and renal dysfunction. Ketorolac (1 mg/kg) given to 18 preterm and term neonates undergoing painful procedures in the OR or the neonatal ICU,165 revealed reduced pain scores (Neonatal Infant Pain Scale) with no incidents of systemic or local bleeding and no hematologic, hepatic, or renal complications (note that this dose is twice the usually recommended dose of 0.5 mg/kg). Similarly, no adverse effects on surgical drain output, renal or hepatic function tests, or oxygen saturation after major surgery were noted in 37 infants and toddlers between 6 and 18 months of age.168 Children in that study received continuous morphine infusions postoperatively, confounding the evaluation of the analgesic efficacy of ketorolac. In single dose studies, the pharmacokinetics (PK) of ketorolac in infants and small children (2–18 months of age) appear to be homogeneous and show a relatively rapid elimination of the analgesic S enantiomer, with slower clearance of the R enantiomer.168,169 Finally, ketorolac has been used to supplement opioid analgesia, with no increase in renal or bleeding complications in infants and children after open heart surgery.170–172 Nevertheless, because ketorolac can reduce renal blood flow, many recommend that its course be limited to 48 to 72 hours, and that renal function be checked if a course of administration greater than 72 hours is required.168,169

Another contentious issue regarding NSAIDs relates to their effects on bone healing and their use in children undergoing spinal fusion. Prostaglandins play an integral role in bone metabolism and significantly influence bone resorption and formation; however, their effects on bone formation predominate. NSAIDs inhibit the formation of prostaglandins, thereby raising the concern that they could promote nonunion after spinal fusion. Studies in rabbits and some studies in adults have reported a greater incidence of nonunion or pseudarthrosis, particularly with the use of large doses of ketorolac.173,174 However, no differences in curve progression, hardware failure, pseudarthrosis, or need for reoperation have been found in children and adolescents who received ketorolac in the immediate postoperative period compared with those who did not.175–177 Of note, the majority of the pediatric data are from otherwise healthy children with idiopathic scoliosis, making it problematic to extrapolate these data to children with comorbidities or those with neuromuscular scoliosis. There is no unique advantage of the IV route with NSAIDs. There is also no evidence that IV ketorolac is a more potent analgesic than comparable (i.e., equipotent) doses of a number of other NSAIDs administered by oral or rectal routes.178

A meta-analysis of the use of NSAIDs for postoperative pain that included 27 studies compared 567 children who received NSAIDs with 418 children who did not.179 The coadministration of NSAIDs and opioids during the perioperative period decreased opioid requirement in the postanesthesia care unit (PACU) and the first 24 hours after surgery, decreased pain intensity in the PACU, and reduced postoperative nausea and vomiting (PONV) during the first 24 hours postoperatively. Although NSAIDS appear to be more effective than acetaminophen for acute pain,180 modeling studies show that combination therapy prolongs the duration of analgesia of both drugs.181 Many studies have also demonstrated the benefits of scheduled combination therapy in children, often performing better than either drug alone.182,183 Therefore these two medications are part of the World Health Organization global guidelines on treating pain in children184 and should serve as the foundation of a safe, effective, and opioid-sparing analgesic regimen.

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Therapeutic Uses of Non-Opioid Analgesics


Ibuprofen Plus Hydrocodone

Ibuprofen plus hydrocodone reportedly produced an additive effect at the marketed doses according to studies conducted for the manufacturer. However, no information is available, comparing the combination of ibuprofen 200 mg plus hydrocodone 7.5 mg with ibuprofen 400 to 600 mg alone. Demonstration of superiority for the combination to either hydrocodone 7.5 mg alone or ibuprofen 200 mg alone is insufficient evidence that the marketed combination is superior to OTC NSAIDs (ibuprofen, naproxen, ketoprofen), aspirin, acetaminophen, or prescription doses of ibuprofen or other NSAIDs. Even if analgesic equivalency was established for the combination compared with ibuprofen 400 to 600 mg or its equivalent, it is likely that a greater incidence of CNS and GI side effects would occur in the opioid-containing combination.

The therapeutic advantage for the use of an ibuprofen-hydrocodone combination rests in adding a normal therapeutic dose of ibuprofen (400 to 600 mg) with a dose of the opioid that produces additive analgesia with a tolerable incidence of side effects. Combining one tablet of the marketed fixed dose combination with one to two tablets of nonprescription ibuprofen would result in a combination containing ibuprofen 400 to 600 mg and hydrocodone 7.5 mg. Extrapolating from a doseresponse comparison of ibuprofen and oxycodone,67 it is likely that hydrocodone 7.5 mg would result in a marginal additive analgesic effect in combination with ibuprofen 400 mg but with a greater incidence of side effects than use of the ibuprofen alone (Fig. 7–6). The use of two tablets of the marketed, fixed-dose formulation in an ambulatory patient population would likely result in additive analgesia that would be greater than either drug alone but would also likely produce an excessive amount of adverse effects. The currently marketed, fixed-dose combination of ibuprofen and hydrocodone should be reserved for clinical situations where ibuprofen 400 to 600 mg provides inadequate pain relief. Patients should be instructed to take one tablet of the combination with one 200-mg OTC tablet of ibuprofen every 4 to 6 hours, not to exceed the recommended maximum dosage of the combination or the recommended daily maximum dosage for ibuprofen (2400 mg/24-hour period) (Box 7–5).

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(Video) Regular Ibuprofen Use May Contribute To Male Infertility According To New Research | TIME


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