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Ibuprofen

Class: Other Nonsteroidal Anti-inflammatory Agents
CAS Number: 15687-271
Brands: Advil, Caldolor, Genpril, Haltran, IBU, Ibu-Tab, Menadol, Midol, Motrin, NeoProfen

Medically reviewed by Drugs.com. Last updated on Nov 9, 2020.

Warning

Special Alerts:

[Posted 10/15/2020]

AUDIENCE: Consumer, Patient, Health Professional, Pharmacy

ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.

For prescription NSAIDs, FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid.

For over-the-counter (OTC) NSAIDs intended for use in adults, FDA will also update the Drug Facts labels, available at: [Web]. These labels already warn to avoid using NSAIDs during the last 3 months of pregnancy because the medicines may cause problems in the unborn child or complications during delivery. The Drug Facts labels already advise pregnant and breastfeeding women to ask a health care professional before using these medicines.

BACKGROUND:

NSAIDs

  • are a class of medicines available by prescription and OTC. They are some of the most commonly used medicines for pain and fever.

  • are used to treat medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu.

  • work by blocking the production of certain chemicals in the body that cause inflammation.

  • are available alone and combined with other medicines. Examples of NSAIDs include aspirin, ibuprofen, naproxen, diclofenac, and celecoxib.

Common side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

RECOMMENDATION:

Consumers/Patients

  • If you are pregnant, do not use NSAIDs at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby.

  • Many OTC medicines contain NSAIDs, including those used for pain, colds, flu, and insomnia, so it is important to read the Drug Facts labels, available at: [Web], to find out if the medicines contain NSAIDs.

  • Talk to your health care professional or pharmacist if you have questions or concerns about NSAIDs or which medicines contain them.

  • Other medicines, such as acetaminophen, are available to treat pain and fever during pregnancy. Talk to your pharmacist or health care professional for help deciding which might be best.

Health Care Professionals

  • FDA recommends that health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. If NSAID treatment is determined necessary, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found. FDA is warning that use of NSAIDs around 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

  • These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.

  • Oligohydramnios is often, but not always, reversible with treatment discontinuation.

  • Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.

  • If NSAID treatment is deemed necessary between 20 to 30 weeks of pregnancy, limit use to the lowest effective dose and shortest duration possible. As currently described in the NSAID labels, avoid prescribing NSAIDs at 30 weeks and later in pregnancy because of the additional risk of premature closure of the fetal ductus arteriosus.

  • The above recommendations do not apply to low-dose 81 mg aspirin prescribed for certain conditions in pregnancy.

  • Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours. Discontinue the NSAID if oligohydramnios occurs and follow up according to clinical practice.

For information on the use of this drug in patients with coronavirus disease 2019 (COVID-19), see the document “Assessment of the Evidence for COVID-19-Related Treatments” on ASHP's COVID-19 Resource Center. To view this document, please click here: [Web]

Warning

    Cardiovascular Risk
  • Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke). Risk may occur early in treatment and may increase with duration of use. (See Cardiovascular Thrombotic Effects under Cautions.)

  • Contraindicated in the setting of CABG surgery.

    GI Risk
  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine). Serious GI events can occur at any time and may not be preceded by warning signs and symptoms. Geriatric individuals are at greater risk for serious GI events. (See GI Effects under Cautions.)

Introduction

Prototypical NSAIA; propionic acid derivative.

Uses for Ibuprofen

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

When used for inflammatory diseases, pain, dysmenorrhea, or fever, consider potential benefits and risks of ibuprofen therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Management of juvenile rheumatoid arthritis in children.

Pericarditis

Reduction of pain, fever, and inflammation of pericarditis; however, in the treatment of post-MI pericarditis, NSAIAs are potentially harmful and aspirin is the treatment of choice. (See Cardiovascular Thrombotic Effects under Cautions.)

Pain

Oral ibuprofen used for relief of mild to moderate pain in adults and children; IV ibuprofen used in adults for relief of mild to moderate pain and, in conjunction with opiates, for relief of moderate to severe pain.

NSAIAs considered first-line agents for mild to moderate migraine attacks or for severe attacks that have responded in the past to NSAIAs or nonopiate analgesics.

Self-medication in children and adults for the temporary relief of minor aches and pain associated with the common cold, influenza, or sore throat; headache (including migraine); toothache; muscular aches; backache; minor pain of arthritis.

Dysmenorrhea

Symptomatic management of primary dysmenorrhea.

Self-medication for the temporary relief of minor aches and pain associated with menstrual cramps.

Fever

Reduction of fever in adults (oral or IV ibuprofen) and children (oral ibuprofen).

Self-medication for reduction of fever in children and adults.

Patent Ductus Arteriosus (PDA)

Treatment of PDA in premature neonates (designated an orphan drug by FDA for this use). Used to promote closure of a clinically important PDA in premature neonates weighing 500–1500 g who are ≤32 weeks' gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support) is ineffective. Limited follow-up data available; reserve for neonates with clinically important PDA.

Ibuprofen Dosage and Administration

General

  • For inflammatory diseases, pain, dysmenorrhea, or fever, consider potential benefits and risks of ibuprofen therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Ibuprofen: Administer orally (for inflammatory diseases, pain, dysmenorrhea, or fever) or by IV infusion (for pain or fever).

Ibuprofen lysine: Administer by IV infusion (for PDA).

Oral Administration

If GI disturbances occur, administer with meals or milk.

Pediatric Administration

Ibuprofen oral drops generally used in infants 6–23 months of age. Use the calibrated dosing device provided by the manufacturer for measurement of the dose.

Pediatric oral suspension commonly used in children ≥2 years of age; 50-mg chewable tablets also may be used in this age group. Use the calibrated dosage cup provided by the manufacturer for measurement of the dose of the suspension.

The 100-mg chewable or film-coated tablets may be used in children ≥6 years of age.

IV Administration (Ibuprofen)

Ensure patient is well hydrated.

Must be diluted prior to IV administration.

Dilution

Dilute ibuprofen injection concentrate with an appropriate volume of 0.9% sodium chloride injection, 5% dextrose injection, or lactated Ringer’s injection to provide a solution containing ≤4 mg/mL.

Rate of Administration

Administer dose over ≥30 minutes.

IV Administration (Ibuprofen Lysine)

Administer by IV infusion using IV port nearest to the IV insertion site.

Do not infuse simultaneously through same line as parenteral nutrition solutions. If same line must be used, interrupt infusion of the nutrition solution for 15 minutes before and after administration of ibuprofen; maintain line patency by infusing dextrose injection or sodium chloride injection.

Avoid extravasation (irritating to extravascular tissues).

Dilution

Dilute ibuprofen lysine injection with an appropriate volume of dextrose injection or sodium chloride injection.

Administer within 30 minutes of preparation; discard any unused solution.

Rate of Administration

Administer dose over 15 minutes.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Dosage of ibuprofen lysine expressed in terms of ibuprofen.

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.

Pediatric Patients

Dosage in children should be guided by body weight.

Inflammatory Diseases
Juvenile Rheumatoid Arthritis
Oral

30–40 mg/kg daily divided into 3 or 4 doses. 20 mg/kg daily in divided doses may be adequate for children with mild disease.

Pain
Oral

For mild to moderate pain in children 6 months to 12 years of age, 10 mg/kg every 6–8 hours. (See Pediatric Use under Cautions.)

Dose may be administered every 6–8 hours.

Age- or Weight-Based Dosage for Self-medication of Minor Aches and Pain in Children 6 Months to 11 Years of Age164186

Age

Weight

Dose

6–11 months

12–17 pounds (approximately 5–8 kg)

50 mg

12–23 months

18–23 pounds (approximately 8–10 kg)

75 mg

2–3 years

24–35 pounds (approximately 11–16 kg)

100 mg

4–5 years

36–47 pounds (approximately 16–21 kg)

150 mg

6–8 years

48–59 pounds (approximately 22–27 kg)

200 mg

9–10 years

60–71 pounds (approximately 27–32 kg)

250 mg

11 years

72–95 pounds (approximately 33–43 kg)

300 mg

For self-medication of minor aches and pain in children ≥12 years of age, 200 mg every 4–6 hours; may increase dosage to 400 mg every 4–6 hours if needed.

Fever
Oral

For children 6 months to 12 years of age: 5 mg/kg for temperatures <39°C; 10 mg/kg for temperatures >39°C. (See Pediatric Use under Cautions.)

Dose may be administered every 6–8 hours.

Age- or Weight-Based Dosage for Self-medication of Fever in Children 6 Months to 11 Years of Age164186

Age

Weight

Dose

6–11 months

12–17 pounds (approximately 5–8 kg)

50 mg

12–23 months

18–23 pounds (approximately 8–10 kg)

75 mg

2–3 years

24–35 pounds (approximately 11–16 kg)

100 mg

4–5 years

36–47 pounds (approximately 16–21 kg)

150 mg

6–8 years

48–59 pounds (approximately 22–27 kg)

200 mg

9–10 years

60–71 pounds (approximately 27–32 kg)

250 mg

11 years

72–95 pounds (approximately 33–43 kg)

300 mg

For self-medication of fever in children ≥12 years of age, 200 mg every 4–6 hours; may increase dosage to 400 mg every 4–6 hours if needed.

PDA
IV

Each course of therapy consists of 3 doses administered at 24-hour intervals.

Base dosage on neonate’s birth weight.

First dose is 10 mg/kg; second and third doses are 5 mg/kg each.

If anuria or oliguria (urine output <0.6 mL/kg per hour) is present at the time of a second or third dose, withhold the dose until laboratory determinations indicate that renal function has returned to normal.

If ductus arteriosus closes or is substantially constricted after completion of the first course, no further doses are necessary.

If ductus arteriosus fails to close or reopens, a second course of ibuprofen, alternative pharmacologic therapy, or surgery may be needed.

Adults

Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis
Oral

1.2–3.2 g daily, given as 300 mg 4 times daily, or 400, 600, or 800 mg 3 or 4 times daily.

Pain
Oral

For mild to moderate pain, 400 mg every 4–6 hours as needed.

For self-medication of minor aches and pain, 200 mg every 4–6 hours; may increase dosage to 400 mg every 4–6 hours if needed.

For self-medication of migraine pain, 400 mg once in a 24-hour period.

IV

Individuals ≥17 years of age: 400–800 mg every 6 hours as needed.

Dysmenorrhea
Oral

400 mg every 4 hours as necessary; initiate at earliest onset of pain.

For self-medication, 200 mg every 4–6 hours; may increase to 400 mg every 4–6 hours if necessary.

Fever
Oral

For self-medication, 200 mg every 4–6 hours; may increase to 400 mg every 4–6 hours if needed.

IV

Individuals ≥17 years of age: 400 mg initially; then 400 mg every 4–6 hours or 100–200 mg every 4 hours.

Prescribing Limits

Pediatric Patients

Inflammatory Diseases
Juvenile Rheumatoid Arthritis
Oral

Maximum 50 mg/kg daily.

Pain
Oral

For mild to moderate pain in children 6 months to 12 years of age, maximum 40 mg/kg daily.

For self-medication of minor aches and pain in children 6 months to 11 years of age, do not exceed recommended dosage; do not administer recommended dose more than 4 times daily. (See Pediatric Use under Cautions.) Self-medication should not exceed 3 days unless otherwise directed by a clinician.

For self-medication of minor aches and pain in children ≥12 years of age, maximum 1.2 g daily. Self-medication should not exceed 10 days unless otherwise directed by a clinician.

Fever
Oral

Maximum 40 mg/kg daily in children 6 months to 12 years of age.

For self-medication in children 6 months to 11 years of age, do not exceed recommended dosage; do not administer recommended dose more than 4 times daily. (See Pediatric Use under Cautions.) Self-medication should not exceed 3 days unless otherwise directed by a clinician.

For self-medication in children ≥12 years of age, maximum 1.2 g daily. Self-medication should not exceed 3 days unless otherwise directed by a clinician.

Adults

Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis
Oral

Maximum 3.2 g daily.

Pain
Oral

For mild to moderate pain, maximum 3.2 g daily.

For self-medication of minor aches and pain, maximum 1.2 g daily. Self-medication should not exceed 10 days unless otherwise directed by a clinician.

For self-medication of migraine pain, maximum 400 mg in a 24-hour period unless otherwise directed by a clinician.

IV

Maximum 3.2 g in a 24-hour period.

Dysmenorrhea
Oral

Maximum 3.2 g daily.

For self-medication, maximum 1.2 g daily.

Fever
Oral

For self-medication, maximum 1.2 g daily. Self-medication should not exceed 3 days unless otherwise directed by a clinician.

IV

Maximum 3.2 g in a 24-hour period.

Special Populations

Renal Impairment

Consider dosage reduction in patients with substantial renal impairment.

Cautions for Ibuprofen

Contraindications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Known hypersensitivity to ibuprofen or any ingredient in the formulation.

  • History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.

  • In the setting of CABG surgery.

    IV Therapy for PDA
  • Known or suspected untreated infection.

  • Bleeding, especially active intracranial hemorrhage or GI bleeding; thrombocytopenia; coagulation defects.

  • Known or suspected necrotizing enterocolitis.

  • Substantial renal impairment.

  • Congenital heart disease if patency of the ductus arteriosus is necessary for pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta).

Warnings/Precautions

Warnings

Cardiovascular Thrombotic Effects

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.

Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.

Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.

Increased risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use.

In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.

In patients receiving NSAIAs following MI, increased risk of reinfarction and death observed beginning in the first week of treatment.

Increased 1-year mortality rate observed in patients receiving NSAIAs following MI; absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.

Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs. FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events throughout therapy, even in those without prior cardiovascular symptoms) and at the lowest effective dosage for the shortest duration necessary.

Some clinicians suggest that it may be prudent to avoid NSAIA use, whenever possible, in patients with cardiovascular disease. Avoid use in patients with recent MI unless benefits of therapy are expected to outweigh risk of recurrent cardiovascular thrombotic events; if used, monitor for cardiac ischemia. Contraindicated in the setting of CABG surgery.

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs. (See Specific Drugs under Interactions.)

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol; alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole) or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).

Contraindicated in neonates with necrotizing enterocolitis.

Hypertension

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events. Use with caution in patients with hypertension; monitor BP.

Impaired response to ACE inhibitors, angiotensin II receptor antagonists, β-blockers, and certain diuretics may occur. (See Specific Drugs under Interactions.)

Heart Failure and Edema

Fluid retention and edema reported.

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) may increase morbidity and mortality in patients with heart failure.

NSAIAs may diminish cardiovascular effects of diuretics, ACE inhibitors, or angiotensin II receptor antagonists used to treat heart failure or edema. (See Specific Drugs under Interactions.)

Manufacturer recommends avoiding use in patients with severe heart failure unless benefits of therapy are expected to outweigh risk of worsening heart failure; if used, monitor for worsening heart failure.

Some experts recommend avoiding use, whenever possible, in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.

Potential for overt renal decompensation. Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist. (See Renal Impairment under Cautions.)

Correct dehydration before initiating ibuprofen therapy.

Renal insufficiency (including oliguria), increases in BUN, increases in Scr, and renal failure reported in neonates. Decreases in urine output in ibuprofen-treated neonates noted on days 2–6 of life; compensatory increase in output noted on day 9.

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.

Immediate medical intervention and discontinuance for anaphylaxis.

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning. Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).

General Precautions

Do not use multiple ibuprofen-containing preparations concomitantly.

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.

Elevations of serum ALT or AST reported.

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results. Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.

Hematologic Effects

Anemia reported rarely. Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.

May inhibit platelet aggregation and prolong bleeding time.

Potential for spontaneous intraventricular hemorrhage in neonates. Observe premature infants for signs of bleeding.

Contraindicated in neonates who are bleeding and those with thrombocytopenia or coagulation defects.

Aseptic Meningitis

Aseptic meningitis reported rarely. Consider possibility that meningitis in a patient receiving ibuprofen is drug related.

Individuals with Phenylketonuria

Motrin chewable tablets contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 3 or 6 mg of phenylalanine for each 50- or 100-mg tablet, respectively.

Advil Children’s chewable tablets and Advil Junior Strength chewable tablets contain aspartame, which is metabolized to provide 2.1 and 4.2 mg of phenylalanine for each tablet, respectively.

Diabetic Patients

Some commercially available preparations of ibuprofen may contain sucrose.

Hyperbilirubinemia

Ibuprofen can displace bilirubin from serum albumin; caution in patients with elevated total bilirubin concentrations.

Ocular Effects

Visual disturbances reported: ophthalmic evaluation recommended if visual changes occur.

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.

May mask certain signs of infection.

Obtain CBC and chemistry profile periodically during long-term use.

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category C. Avoid use in third trimester because of possible premature closure of the ductus arteriosus.

Lactation

Not detected in milk; however, studies were limited. Use not recommended.

Pediatric Use

Safety and efficacy of ibuprofen lysine established in neonates receiving the drug for PDA. However, long-term follow-up (>36 weeks postconception age) of these neonates has not been conducted. Effects of ibuprofen on neurodevelopmental outcome, growth, and other complications of prematurity (e.g., retinopathy of prematurity, chronic lung disease) not assessed.

Safety and efficacy of oral ibuprofen not established in infants <6 months of age.

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Such preparations also may contain analgesics and antipyretics. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral OTC cough and cold preparations agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns.

Safety and efficacy of IV ibuprofen for relief of pain or reduction of fever not established in pediatric patients <17 years of age.

Geriatric Use

Geriatric patients appear to tolerate GI ulceration and bleeding less well than other individuals. Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.

Experience in those ≥65 years of age insufficient to determine whether they respond differently to IV ibuprofen than do younger adults. Select dosage with caution, starting at the low end of the dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.

Renal Impairment

Use with caution in patients with renal disease. Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.

Common Adverse Effects

With oral ibuprofen therapy, dizziness, epigastric pain, heartburn, nausea, rash.

With IV ibuprofen therapy, nausea, flatulence, vomiting, headache, hemorrhage, dizziness.

With IV ibuprofen lysine therapy, sepsis, anemia, bleeding, apnea, adverse GI effects, renal impairment, respiratory tract infection, dermatologic effects, hypoglycemia, hypocalcemia, respiratory failure.

Interactions for Ibuprofen

No evidence of enzyme induction.

Specific Drugs

Drug

Interaction

Comments

ACE inhibitors

Reduced BP response to ACE inhibitor

Possible deterioration of renal function in individuals with renal impairment

Monitor BP

Alcohol

Increased risk of GI bleeding

Angiotensin II receptor antagonists

Reduced BP response to angiotensin II receptor antagonist

Possible deterioration of renal function in individuals with renal impairment

Monitor BP

Antacids (aluminum- and magnesium-containing)

No effect on ibuprofen absorption

Aspirin

Antagonism of the irreversible platelet-aggregation inhibitory effect of aspirin; may limit the cardioprotective effects of aspirin

Increased risk of GI ulceration and other complications

No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs

Manufacturer states that concomitant use not recommended

Regular ibuprofen use not recommended in patients taking aspirin for cardiovascular prophylaxis

For occasional use with immediate-release low-dose aspirin: Administer single dose of ibuprofen 400 mg for self-medication at least 8 hours before or at least 30 minutes after aspirin

Enteric-coated low-dose aspirin: No recommendations regarding timing of administration with single dose of ibuprofen

Diuretics (furosemide, thiazides)

Reduced natriuretic effects

Monitor for diuretic efficacy and renal failure

Histamine H2-receptor antagonists (cimetidine, ranitidine)

Serum ibuprofen concentrations not appreciably altered

Lithium

Increased plasma lithium concentrations

Monitor for lithium toxicity; monitor lithium concentrations; lithium dosage reduction may be required

Methotrexate

Pharmacokinetics of methotrexate may be altered

Caution advised

Warfarin

Reports of bleeding

Caution advised

Ibuprofen Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration; peak plasma concentration usually attained within 1–2 hours.

Onset

Pain relief and/or antipyretic activity achieved within 1 hour.

Food

Food reduces peak plasma concentration by about 30–50% and delays time to reach peak plasma concentration by about 30–60 minutes but does not affect extent of absorption.

Distribution

Plasma Protein Binding

>99%.

Elimination

Metabolism

Extensively metabolized.

Elimination Route

Excreted mainly in urine as metabolites.

Half-life

1.8–2.4 hours.

Half-life 10-fold longer in neonates than in adults.

Stability

Storage

Oral

Capsules and Tablets

20–25°C.

Suspension

20–25°C.

Parenteral

Injection

20–25°C.

Actions

  • Inhibits cyclooxygenase-1 (COX-1) and COX-2.

  • Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.

  • Permits closure of the ductus arteriosus in premature neonates by inhibiting prostaglandin synthesis.

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.

  • When used for self-medication, importance of reading the product labeling.

  • When used for self-medication, importance of using the lowest effective dosage and of not exceeding the recommended dosage or duration of therapy.

  • When used for self medication, importance of reviewing the warning information provided by the manufacturer.

  • Risk of serious cardiovascular events (e.g., MI, stroke).

  • Risk of GI bleeding and ulceration.

  • Risk of serious skin reactions. Risk of anaphylactoid and other sensitivity reactions.

  • Risk of hepatotoxicity.

  • Importance of seeking immediate medical attention if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.

  • Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.

  • Importance of discontinuing ibuprofen and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop. Importance of seeking immediate medical attention if an anaphylactic reaction occurs.

  • Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.

  • Risk of heart failure or edema; importance of reporting dyspnea, unexplained weight gain, or edema.

  • Potential for ibuprofen to interfere with antiplatelet effect of low-dose aspirin. Importance of consulting clinician prior to taking low-dose aspirin concomitantly.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Importance of avoiding ibuprofen in late pregnancy (third trimester).

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ibuprofen

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, liquid-filled

200 mg

Advil Liqui-Gels

Wyeth

equivalent to 200 mg ibuprofen (as free acid and ibuprofen potassium)

Advil Migraine

Wyeth

Suspension

40 mg/mL*

Advil Infants’ Concentrated Drops

Wyeth

Ibuprofen Oral Suspension

Motrin Drops

McNeil

Motrin Infants’ Concentrated Drops

McNeil

100 mg/5 mL*

Advil Children’s

Wyeth

Ibuprofen Oral Suspension

Motrin Children’s

McNeil

Tablets

200 mg*

Ibuprofen Tablets

Motrin IB Gelcaps

McNeil

400 mg*

Ibuprofen Tablets

600 mg*

Ibuprofen Tablets

800 mg*

Ibuprofen Tablets

Tablets, chewable

50 mg

Advil Children’s

Wyeth

Motrin Children’s

McNeil

100 mg

Advil Junior Strength Chewable Tablets

Wyeth

Motrin (scored)

McNeil

Motrin Junior Strength

McNeil

Tablets, film-coated

100 mg

Advil Junior Strength Tablets

Wyeth

Motrin Caplets (scored)

McNeil

Motrin Junior Strength Caplets

McNeil

200 mg*

Advil Caplets

Wyeth

Advil Gel Caplets

Wyeth

Advil Tablets

Wyeth

Genpril Caplets

Teva

Genpril Tablets

Teva

Haltran

Lee

Ibu-Tab

Alra

Ibuprofen Tablets

Menadol Captabs

Watson

Midol Cramp

Bayer

Motrin IB Caplets

McNeil

Motrin IB Tablets

McNeil

Motrin Migraine Pain Caplets

McNeil

400 mg*

IBU

Par

Ibu-Tab

Alra

Ibuprofen Tablets

Motrin

Pharmacia

600 mg*

IBU

Par

Ibu-Tab

Alra

Ibuprofen Tablets

Motrin

Pharmacia

800 mg*

IBU

Par

Ibuprofen Tablets

Ibu-Tab

Alra

Motrin

Pharmacia

Parenteral

Injection concentrate, for IV use

100 mg/mL

Caldolor

Cumberland

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ibuprofen Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

100 mg with Pseudoephedrine Hydrochloride 15 mg/5 mL

Motrin Children’s Cold

McNeil

Tablets

200 mg with Pseudoephedrine Hydrochloride 30 mg

Dristan Sinus Caplets

Wyeth

Tablets, film-coated

200 mg with Hydrocodone Bitartrate 2.5 mg*

Hydrocodone Bitartrate and Ibuprofen Film-coated Tablets (C-II)

Reprexain (C-II)

Gemini

200 mg with Hydrocodone Bitartrate 5 mg*

Hydrocodone Bitartrate and Ibuprofen Film-coated Tablets (C-II)

Reprexain (C-II)

Gemini

200 mg with Hydrocodone Bitartrate 7.5 mg*

Hydrocodone Bitartrate and Ibuprofen Film-coated Tablets (C-II)

Vicoprofen (C-II)

AbbVie

200 mg with Hydrocodone Bitartrate 10 mg*

Hydrocodone Bitartrate and Ibuprofen Film-coated Tablets (C-II)

Reprexain (C-II)

Gemini

200 mg with Pseudoephedrine Hydrochloride 30 mg

Advil Cold & Sinus Caplets

Wyeth

Advil Cold & Sinus Tablets

Wyeth

Advil Flu & Body Ache Caplets

Wyeth

Motrin Sinus Headache Caplets

McNeil

400 mg with Oxycodone Hydrochloride 5 mg*

Oxycodone Hydrochloride and Ibuprofen Tablets (C-II)

Ibuprofen Lysine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV use only

10 mg/mL(of ibuprofen)

NeoProfen

Lundbeck

AHFS DI Essentials™. © Copyright 2021, Selected Revisions November 9, 2020. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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