Ibuprofen

Description

Ibuprofen tablets contain the active ingredient ibuprofen, which is chemically defined as (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen appears as a white powder with a melting point ranging from 74 to 77° C. It exhibits very slight solubility in water, quantified at less than 1 mg/mL, while demonstrating ready solubility in organic solvents such as ethanol and acetone. The structural formula of ibuprofen is provided below.

This nonsteroidal anti-inflammatory drug (NSAID) is formulated for oral administration and is available in tablet strengths of 400 mg, 600 mg, and 800 mg. The tablets also contain several inactive ingredients, including colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulfate, and titanium dioxide.

Uses and Indications

Ibuprofen tablets are indicated for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Additionally, these tablets are indicated for the relief of mild to moderate pain and for the treatment of primary dysmenorrhea.

Limitations of Use: Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. Therefore, the use of ibuprofen in pediatric populations should be approached with caution.

Dosage and Administration

Healthcare professionals should carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before initiating therapy. It is recommended to use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After assessing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to meet the specific needs of each patient. The total daily dose should not exceed 3200 mg. In cases where gastrointestinal complaints arise, ibuprofen tablets should be administered with meals or milk to mitigate discomfort.

For the management of rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease, the suggested dosage ranges from 1200 mg to 3200 mg daily. This can be achieved through various dosing regimens, such as 300 mg four times a day, or 400 mg, 600 mg, or 800 mg three to four times a day. The dosage should be tailored to each patient, with adjustments made based on the severity of symptoms at the initiation of therapy or in response to treatment.

It is noted that patients with rheumatoid arthritis may require higher doses of ibuprofen tablets compared to those with osteoarthritis. The smallest effective dose that provides acceptable control should always be employed.

For the treatment of mild to moderate pain, ibuprofen tablets may be administered at a dose of 400 mg every 4 to 6 hours as needed for pain relief. In the case of dysmenorrhea, treatment should begin at the earliest onset of pain, with ibuprofen tablets given at a dose of 400 mg every 4 hours as necessary for relief.

Contraindications

Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. They should not be administered to individuals who have experienced asthma, urticaria, or allergic-type reactions following the use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), as severe, potentially fatal, anaphylactic-like reactions have been reported in these patients. Additionally, the use of ibuprofen tablets is contraindicated in the context of coronary artery bypass graft (CABG) surgery.

Caution is advised when considering ibuprofen for patients with preexisting asthma, particularly those with aspirin-sensitive asthma.

Warnings and Precautions

Non-steroidal anti-inflammatory drugs (NSAIDs), including Ibuprofen Tablets, are associated with an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. This risk may manifest early in treatment and is likely to escalate with prolonged use. Ibuprofen Tablets are contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery.

Patients with a history of cardiovascular disease or risk factors are at a heightened risk for serious cardiovascular thrombotic events. Therefore, the use of Ibuprofen Tablets should be avoided in individuals with a recent myocardial infarction unless the anticipated benefits outweigh the risks of recurrent cardiovascular events. Additionally, NSAIDs may contribute to the onset of new hypertension or exacerbate existing hypertension. It is important to note that the use of Ibuprofen Tablets may interfere with the cardiovascular effects of certain therapeutic agents prescribed for heart failure.

Anaphylactoid reactions can occur in patients without prior exposure to ibuprofen. In such cases, immediate emergency medical assistance should be sought. Furthermore, NSAIDs have been linked to severe skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), all of which can be fatal. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has also been reported in patients taking NSAIDs, including ibuprofen, with some cases resulting in fatal or life-threatening outcomes. The use of NSAIDs in pregnant women, particularly after approximately 30 weeks of gestation, should be avoided due to the risk of premature closure of the fetal ductus arteriosus.

Patients should be informed that Ibuprofen Tablets are not a substitute for corticosteroids and cannot address corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of the underlying condition, and therefore, patients on prolonged corticosteroid therapy should have their medication tapered gradually if discontinuation is necessary.

For patients undergoing long-term NSAID treatment, it is recommended to monitor hemoglobin or hematocrit levels if any signs or symptoms of anemia arise. Additionally, those receiving Ibuprofen Tablets who may be affected by changes in platelet function should be closely monitored.

Regular monitoring for signs or symptoms of gastrointestinal (GI) bleeding is essential for patients on long-term NSAID therapy. Periodic checks of complete blood count (CBC) and chemistry profiles are also advised. If any clinical signs or symptoms indicative of liver or renal disease develop, Ibuprofen Tablets should be discontinued immediately.

Patients should be instructed to seek emergency medical help if an anaphylactoid reaction occurs. Moreover, if any clinical signs or symptoms consistent with liver disease or systemic manifestations such as eosinophilia or rash develop, the use of Ibuprofen Tablets should be halted. The drug should also be discontinued at the first appearance of any skin rash or other signs of hypersensitivity.

Side Effects

Patients may experience a range of adverse reactions while using this medication, categorized by seriousness and frequency.

Serious adverse reactions include cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. This risk may arise early in treatment and is known to increase with prolonged use. Additionally, there is a significant risk of serious gastrointestinal events, including bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal. These gastrointestinal complications can occur at any time during treatment, often without warning symptoms, and elderly patients are particularly at higher risk.

Gastrointestinal adverse reactions reported include nausea, epigastric pain, heartburn, diarrhea, abdominal distress, and constipation. More severe gastrointestinal issues such as gastric or duodenal ulcers with bleeding or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, and pancreatitis have also been observed.

Central nervous system effects may manifest as dizziness, headache, and nervousness. More serious symptoms can include depression, insomnia, confusion, emotional liability, somnolence, and rare occurrences of aseptic meningitis, which may present with fever and coma. Other neurological effects reported include paresthesias, hallucinations, dream abnormalities, and pseudo-tumor cerebri.

Dermatologic reactions can range from mild rashes and pruritus to more severe conditions such as vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Alopecia and photoallergic skin reactions have also been noted.

Hematologic adverse reactions include neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), and thrombocytopenia, with or without purpura. Patients may also experience bleeding episodes, such as epistaxis and menorrhagia.

Metabolic and endocrine reactions may involve decreased appetite, gynecomastia, hypoglycemic reactions, and acidosis. Cardiovascular effects can include edema, fluid retention, congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations, and arrhythmias such as sinus tachycardia and sinus bradycardia.

Allergic reactions may present as a syndrome of abdominal pain, fever, chills, nausea, and vomiting, as well as anaphylaxis and bronchospasm. Other allergic conditions reported include serum sickness, lupus erythematosus syndrome, Henoch-Schonlein vasculitis, and angioedema.

Renal adverse reactions can include acute renal failure, decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria, and renal papillary necrosis.

Miscellaneous reactions reported include dry eyes and mouth, gingival ulcers, and rhinitis.

It is important to note that aseptic meningitis with fever and coma has been observed on rare occasions in patients undergoing ibuprofen therapy. Anaphylactoid reactions may occur even in patients without prior exposure to ibuprofen. Serious skin adverse events, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal, may occur without warning.

Drug Interactions

Concomitant use of certain medications with ibuprofen may lead to significant drug interactions, which can affect therapeutic outcomes and patient safety. The following interactions have been identified:

Pharmacodynamic Interactions

ACE-Inhibitors Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may reduce the antihypertensive effect of ACE-inhibitors. Clinicians should monitor blood pressure in patients receiving both medications and consider alternative analgesics if necessary.

Aspirin Pharmacodynamic studies indicate that ibuprofen can interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered shortly before aspirin. This interaction is less pronounced if immediate-release low-dose aspirin is taken at least 2 hours prior to ibuprofen. However, this timing does not apply to enteric-coated low-dose aspirin. Patients using low-dose aspirin for cardiovascular protection should be advised to consider alternative analgesics that do not affect aspirin's antiplatelet effect. Additionally, the concomitant use of ibuprofen and aspirin may increase the risk of adverse effects, and thus, this combination is generally not recommended.

Diuretics Ibuprofen may diminish the natriuretic effect of diuretics such as furosemide and thiazides, likely due to inhibition of renal prostaglandin synthesis. Patients on these diuretics should be closely monitored for signs of renal impairment and to ensure diuretic efficacy.

Warfarin-type Anticoagulants While short-term studies have not shown significant effects of ibuprofen on prothrombin times in patients on coumarin-type anticoagulants, there is a risk of increased gastrointestinal bleeding when these medications are used together. Caution is advised when prescribing ibuprofen to patients on anticoagulants due to the synergistic risk of serious GI bleeding.

Pharmacokinetic Interactions

Lithium Ibuprofen has been shown to elevate plasma lithium levels and decrease renal clearance of lithium. Specifically, a study indicated a 15% increase in mean minimum lithium concentration and a 19% reduction in renal clearance during concurrent administration. Patients receiving both ibuprofen and lithium should be monitored for signs of lithium toxicity.

Methotrexate NSAIDs, including ibuprofen, may competitively inhibit the accumulation of methotrexate, potentially enhancing its toxicity. Caution is warranted when these medications are used together.

H-2 Antagonists Co-administration of ibuprofen with H-2 antagonists such as cimetidine or ranitidine does not appear to significantly affect ibuprofen serum concentrations, indicating no major pharmacokinetic interaction.

In summary, careful consideration and monitoring are essential when ibuprofen is used in conjunction with these medications to mitigate potential adverse effects and ensure therapeutic efficacy.

Packaging & NDC

The table below lists all NDC Code configurations of Ibuprofen, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The safety and effectiveness of ibuprofen tablets in pediatric patients have not been established. Therefore, caution is advised when considering the use of ibuprofen in this population. Further studies are needed to determine appropriate dosing and outcomes in children and adolescents.

Geriatric Use

Caution should be exercised when treating elderly patients (65 years and older) with this medication, as with any nonsteroidal anti-inflammatory drugs (NSAIDs). It is important for healthcare providers to consider the increased risk of adverse effects in this population. Monitoring for potential side effects and adjusting dosages as necessary may be warranted to ensure the safety and efficacy of treatment in geriatric patients.

Pregnancy

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, during pregnancy is associated with specific risks that healthcare professionals should consider. The use of NSAIDs, particularly after approximately 20 weeks of gestation, has been linked to fetal renal dysfunction, which can lead to oligohydramnios and, in some instances, neonatal renal impairment. The risk of these adverse outcomes increases significantly when NSAIDs are used around 30 weeks of gestation or later, as they may cause premature closure of the fetal ductus arteriosus.

Healthcare providers are advised to limit the dose and duration of ibuprofen tablets use between approximately 20 and 30 weeks of gestation. It is recommended to avoid the use of ibuprofen tablets at or beyond 30 weeks of gestation due to the heightened risk of ductus arteriosus closure. If the use of an NSAID is deemed necessary after 20 weeks of gestation, it should be restricted to the lowest effective dose for the shortest duration possible. Should treatment with ibuprofen tablets extend beyond 48 hours, monitoring with ultrasound for oligohydramnios is advisable. In cases where oligohydramnios is detected, ibuprofen tablets should be discontinued, and follow-up should be conducted according to clinical practice guidelines.

Data from observational studies regarding the potential risks of NSAID use during the first and second trimesters of pregnancy remain inconclusive. In the general U.S. population, the background rate of major malformations in clinically recognized pregnancies is estimated at 2-4%, with a pregnancy loss rate of 15-20%. Animal studies have not demonstrated developmental abnormalities associated with ibuprofen; however, animal reproduction studies may not accurately predict human outcomes. Therefore, ibuprofen should only be used in pregnancy if the potential benefits outweigh the risks to the fetus.

Furthermore, animal data suggest that prostaglandins play a critical role in endometrial vascular permeability, blastocyst implantation, and fetal kidney development. Inhibition of prostaglandin synthesis by NSAIDs like ibuprofen has been associated with increased pre- and post-implantation loss and impaired kidney development at clinically relevant doses.

While published literature indicates that maternal NSAID use around 30 weeks of gestation or later may lead to premature closure of the fetal ductus arteriosus, the methodological limitations of postmarketing studies—such as the absence of control groups and limited data on dosage and duration—hinder the establishment of a reliable risk estimate for adverse fetal and neonatal outcomes. Additionally, the majority of safety data concerning neonatal outcomes primarily involve preterm infants, raising questions about the applicability of these findings to full-term infants exposed to NSAIDs through maternal use.

Lactation

It is not known whether this drug is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from ibuprofen tablets, lactating mothers should consider the importance of the drug to their health when making a decision to either discontinue nursing or discontinue the drug.

Renal Impairment

Long-term administration of NSAIDs has been associated with renal papillary necrosis and other forms of renal injury. In patients with reduced kidney function, renal prostaglandins play a compensatory role in maintaining renal perfusion; therefore, the use of NSAIDs may lead to a dose-dependent reduction in prostaglandin formation and, subsequently, renal blood flow. This can precipitate overt renal decompensation, particularly in patients at greatest risk, including those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly.

In patients with advanced renal disease, the use of ibuprofen tablets is not recommended due to a lack of controlled clinical study data. If therapy with ibuprofen tablets is deemed necessary, close monitoring of renal function is advised. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state.

Additionally, the use of NSAIDs, including ibuprofen tablets, during pregnancy, particularly around 20 weeks gestation or later, may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes may occur after days to weeks of treatment, although oligohydramnios has been infrequently reported as early as 48 hours after initiation. If NSAID treatment is required between 20 and 30 weeks of gestation, it is recommended to limit ibuprofen tablets to the lowest effective dose and shortest duration possible. Ultrasound monitoring of amniotic fluid should be considered if treatment extends beyond 48 hours, and ibuprofen tablets should be discontinued if oligohydramnios occurs, with follow-up according to clinical practice.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

Approximately 1½ hours following the ingestion of 7 to 10 ibuprofen tablets (400 mg) by a 19-month-old child weighing 12 kg, the child presented to the hospital emergency room in a state of apnea and cyanosis, responding only to painful stimuli. This stimulus was sufficient to induce respiration. Upon admission, the child received oxygen and parenteral fluids, and a greenish-yellow fluid was aspirated from the stomach, with no evidence of ibuprofen detected. Two hours post-ingestion, the child's condition appeared stable; however, she continued to respond solely to painful stimuli and experienced periods of apnea lasting 5 to 10 seconds. The child was subsequently admitted to intensive care, where sodium bicarbonate, along with infusions of dextrose and normal saline, was administered. By four hours after ingestion, the child could be easily aroused, sit independently, and respond to verbal commands. A blood level of ibuprofen measured 102.9 mcg/mL approximately 8½ hours post-ingestion, and by 12 hours, the child appeared to have fully recovered.

In two additional reported cases involving children, each weighing approximately 10 kg, accidental acute ingestion of approximately 120 mg/kg of ibuprofen resulted in no signs of acute intoxication or late sequelae. Notably, one child's blood level was recorded at 700 mcg/mL 90 minutes after ingestion, which is about ten times the peak levels observed in absorption-excretion studies.

A case involving a 19-year-old male who ingested 8,000 mg of ibuprofen over several hours presented with dizziness, and nystagmus was noted. Following hospitalization, the patient received parenteral hydration and underwent three days of bed rest, ultimately recovering without any reported sequelae.

In instances of acute overdosage, it is recommended that the stomach be emptied through vomiting or gastric lavage; however, it should be noted that minimal drug recovery is expected if more than one hour has passed since ingestion. Given the acidic nature of ibuprofen and its urinary excretion, administering alkali and inducing diuresis may be theoretically beneficial. Supportive measures should be employed, and the use of oral activated charcoal may assist in reducing both the absorption and reabsorption of ibuprofen tablets.

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, during pregnancy has been associated with teratogenic effects, particularly concerning fetal renal function and ductus arteriosus closure. Specifically, NSAID use can lead to premature closure of the fetal ductus arteriosus and fetal renal dysfunction, which may result in oligohydramnios and, in some instances, neonatal renal impairment. Observational studies regarding other potential embryo-fetal risks associated with NSAID use in women during the first or second trimesters of pregnancy have yielded inconclusive results.

Animal reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities; however, it is important to note that animal reproduction studies are not always predictive of human response. Prostaglandins play a critical role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has resulted in increased pre- and post-implantation loss. Furthermore, prostaglandins are essential for fetal kidney development, and published animal studies indicate that prostaglandin synthesis inhibitors can impair kidney development when administered at clinically relevant doses.

The use of NSAIDs, including ibuprofen tablets, is advised against in pregnant women at approximately 30 weeks gestation and later due to the increased risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs at around 20 weeks gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes typically manifest after days to weeks of treatment, although oligohydramnios has been infrequently reported as early as 48 hours after the initiation of NSAID therapy. While oligohydramnios is often reversible upon discontinuation of treatment, prolonged oligohydramnios can lead to complications such as limb contractures and delayed lung maturation. In certain postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.

If NSAID treatment is deemed necessary between approximately 20 weeks and 30 weeks gestation, it is recommended to limit the use of ibuprofen tablets to the lowest effective dose for the shortest duration possible. Ultrasound monitoring of amniotic fluid should be considered if treatment with ibuprofen tablets extends beyond 48 hours. Discontinuation of ibuprofen tablets is advised if oligohydramnios occurs, with follow-up conducted according to clinical practice.

No information is available from controlled clinical studies regarding the use of ibuprofen tablets in patients with advanced renal disease. Therefore, treatment with ibuprofen tablets is not recommended for these patients. If therapy must be initiated, close monitoring of renal function is advisable.

In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has been associated with increased pre- and post-implantation loss. Additionally, the critical role of prostaglandins in fetal kidney development has been highlighted, with evidence from published animal studies indicating that prostaglandin synthesis inhibitors can impair kidney development when administered at clinically relevant doses.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of ibuprofen tablets, reported voluntarily or through surveillance programs. Anaphylactoid reactions may occur in patients without known prior exposure to ibuprofen, necessitating immediate emergency assistance in such cases.

Serious skin adverse events, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported, with the potential for fatal outcomes. These events may arise without prior warning. Additionally, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been documented in patients taking NSAIDs, including ibuprofen, with some cases resulting in fatal or life-threatening conditions.

In pregnant women, the use of NSAIDs, such as ibuprofen tablets, around 30 weeks gestation and later has been associated with premature closure of the fetal ductus arteriosus. Furthermore, the use of NSAIDs at approximately 20 weeks gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment. In cases of impaired neonatal renal function, invasive interventions such as exchange transfusion or dialysis have been required.

Postmarketing data also indicate an increased incidence of decreased hemoglobin levels, with a reduction of 1 gram or more observed in 17.1% of patients taking 1600 mg of ibuprofen daily and in 22.8% of those on 2400 mg daily. Positive stool occult blood tests and elevated serum creatinine levels have been noted in these studies.

Serious gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, have been reported, with the potential for fatal outcomes. These serious events can occur at any time, with or without warning symptoms. The risk of serious GI events is heightened with prolonged NSAID therapy, particularly in patients with a history of peptic ulcer disease and/or gastrointestinal bleeding, who face more than a tenfold increased risk of developing a GI bleed compared to those without these risk factors.

Patient Counseling

Patients should be informed of essential information before initiating therapy with an NSAID, such as ibuprofen, and periodically during the course of ongoing therapy. Healthcare providers should encourage patients to read the NSAID Medication Guide that accompanies each prescription dispensed.

Patients should be advised to be alert for symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately. It is important to communicate that ibuprofen tablets, like other NSAIDs, may cause serious cardiovascular side effects, such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular events can occur without warning symptoms, patients should be vigilant for signs and symptoms such as chest pain, shortness of breath, weakness, and slurring of speech, and should seek medical advice upon observing any indicative signs or symptoms.

Patients should also be apprised of the potential gastrointestinal discomfort associated with ibuprofen tablets, as well as the risk of serious gastrointestinal side effects, such as ulcers and bleeding, which may lead to hospitalization and even death. Serious gastrointestinal tract ulcerations and bleeding can occur without warning symptoms; therefore, patients should be alert for signs and symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis, and should seek medical advice if they experience any of these symptoms. The importance of follow-up in these cases should be emphasized.

Patients should be advised to stop taking ibuprofen tablets immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible. Additionally, patients should be alert for symptoms of congestive heart failure, such as shortness of breath, unexplained weight gain, or edema, and should contact their healthcare provider if such symptoms occur.

It is crucial to inform patients about the warning signs and symptoms of hepatotoxicity, which may include nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms. If these occur, patients should be instructed to stop therapy and seek immediate medical attention.

Patients should also be informed of the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat. If these symptoms occur, patients should be instructed to seek immediate emergency help.

Pregnant women should be advised to avoid the use of ibuprofen tablets and other NSAIDs starting at 30 weeks gestation due to the risk of premature closure of the fetal ductus arteriosus. If treatment with ibuprofen tablets is necessary for a pregnant woman between approximately 20 to 30 weeks gestation, it should be communicated that she may need to be monitored for oligohydramnios if treatment continues for longer than 48 hours.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20º to 25ºC (68º to 77ºF), in accordance with USP Controlled Room Temperature guidelines. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF), to maintain product integrity.

Additional Clinical Information

Physicians are advised to monitor patients for any signs or symptoms indicative of gastrointestinal (GI) bleeding. For patients undergoing long-term treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), it is recommended that complete blood counts (CBC) and chemistry profiles be assessed periodically to ensure safety and efficacy.

In cases where patients exhibit clinical signs and symptoms suggestive of liver or renal disease, or if systemic manifestations such as eosinophilia or rash occur, ibuprofen tablets should be discontinued. Additionally, if abnormal liver test results persist or worsen, immediate cessation of the medication is warranted.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Ibuprofen as submitted by Ascend Laboratories, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)