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 of 74-77°C. It is characterized by very slight solubility in water (less than 1 mg/mL) and is readily soluble 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 associated with rheumatoid arthritis and osteoarthritis. Additionally, these tablets are indicated for the relief of mild to moderate pain and for the treatment of primary dysmenorrhea.

Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in pediatric populations have not been conducted. Therefore, healthcare professionals should exercise caution when considering the use of ibuprofen in children.

Dosage and Administration

For the treatment of rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease, the suggested dosage ranges from 1200 mg to 3200 mg daily. Dosing may be administered as 300 mg four times a day, or as 400 mg, 600 mg, or 800 mg three to four times a day. It is imperative not to exceed a total daily dose of 3200 mg. The dosage should be individualized for each patient and may be adjusted according to the severity of symptoms.

For the management of mild to moderate pain, a dosage of 400 mg may be taken every 4 to 6 hours as needed for pain relief.

In cases of dysmenorrhea, a dosage of 400 mg may be administered every 4 hours as necessary for pain relief.

To minimize gastrointestinal discomfort, it is recommended that ibuprofen tablets be taken with meals or milk.

Contraindications

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

Warnings and Precautions

Increased risk of serious cardiovascular thrombotic events, including myocardial infarction (MI) and stroke, has been associated with the use of NSAIDs. These events can be fatal and may occur early in treatment, with the risk potentially increasing with prolonged use. It is recommended to use the lowest effective dose for the shortest duration possible. Healthcare professionals should monitor patients for symptoms indicative of serious cardiovascular events.

In patients who have undergone coronary artery bypass graft (CABG) surgery, there is an increased incidence of myocardial infarction and stroke associated with NSAID treatment. Therefore, NSAIDs are contraindicated in this patient population.

For patients with a history of myocardial infarction, NSAID use is linked to an elevated risk of reinfarction, cardiovascular-related death, and all-cause mortality. Close monitoring for signs of cardiac ischemia is advised when NSAIDs are administered to these individuals.

NSAIDs may also contribute to the development of new hypertension or exacerbate preexisting hypertension. Blood pressure should be monitored closely throughout the duration of NSAID therapy.

Patients with heart failure are at an increased risk of hospitalization and mortality when treated with NSAIDs. Monitoring for signs of worsening heart failure is essential in this group.

Serious gastrointestinal adverse events, such as inflammation, bleeding, ulceration, and perforation, can occur at any time during NSAID therapy. Caution is warranted in patients with a history of ulcer disease or gastrointestinal bleeding, and healthcare providers should monitor for signs and symptoms of gastrointestinal ulcerations and bleeding.

Long-term use of NSAIDs may lead to renal injury. It is advisable to closely monitor renal function, particularly in patients with impaired renal function, heart failure, liver dysfunction, or those concurrently taking diuretics and ACE inhibitors.

In cases of anaphylactoid reactions, emergency medical assistance should be sought immediately. Additionally, if any skin rash or signs of hypersensitivity appear, NSAID use should be discontinued.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a serious condition that necessitates the immediate discontinuation of ibuprofen tablets and prompt evaluation of the patient if signs or symptoms are present.

In pregnant women, particularly those at approximately 30 weeks gestation and later, NSAID use should be avoided due to the risk of premature closure of the fetal ductus arteriosus. Between 20 weeks and 30 weeks gestation, NSAIDs should be limited to the lowest effective dose for the shortest duration possible, and treatment should be discontinued if oligohydramnios occurs.

Healthcare professionals should ensure that patients are aware to seek emergency medical help in the event of an anaphylactoid reaction and to discontinue ibuprofen tablets and seek immediate evaluation if signs or symptoms of DRESS are present. Additionally, treatment should be stopped if oligohydramnios occurs, with follow-up conducted according to clinical practice guidelines.

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. The risk of these events may increase with the duration of treatment and can occur early in the course of therapy. Additionally, there is an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal. These gastrointestinal events may occur at any time during treatment and without warning symptoms, with elderly patients being at greater risk.

Common gastrointestinal adverse reactions reported include nausea, epigastric pain, heartburn, diarrhea, abdominal distress, vomiting, indigestion, constipation, and abdominal cramps or pain. Patients may also experience fullness of the gastrointestinal tract, characterized by bloating and flatulence. Serious gastrointestinal complications, although occurring in less than 1% of patients, may include gastric or duodenal ulcers with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests, and pancreatitis.

Central nervous system reactions may manifest as dizziness, headache, and nervousness. Serious central nervous system effects, with a precise incidence unknown but estimated to be less than 1%, can include depression, insomnia, confusion, emotional liability, somnolence, and aseptic meningitis with fever and coma.

Dermatologic reactions are also noted, with common occurrences of rash (including maculopapular types) and pruritus. Serious skin reactions, although occurring in less than 1% of patients, may include vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, and alopecia. The causal relationship for toxic epidermal necrolysis and photoallergic skin reactions remains unknown.

Hematologic adverse reactions may include neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, and eosinophilia, all with a precise incidence unknown but estimated to be less than 1%. There is also an unknown causal relationship with bleeding episodes such as epistaxis and menorrhagia.

Metabolic and endocrine reactions may present as decreased appetite, with a causal relationship unknown for gynecomastia, hypoglycemic reactions, and acidosis.

Cardiovascular reactions may include edema and fluid retention, which generally respond promptly to drug discontinuation. Serious cardiovascular events, with a precise incidence unknown but estimated to be less than 1%, may include congestive heart failure in patients with marginal cardiac function, elevated blood pressure, and palpitations. The causal relationship for arrhythmias, such as sinus tachycardia and sinus bradycardia, remains unknown.

Allergic reactions may occur, with a precise incidence unknown but estimated to be less than 1%, including a syndrome characterized by abdominal pain, fever, chills, nausea, and vomiting, as well as anaphylaxis and bronchospasm. The causal relationship for serum sickness, lupus erythematous syndrome, Henoch-Schonlein vasculitis, and angioedema is also unknown.

Renal adverse reactions may include acute renal failure, decreased creatinine clearance, polyuria, azotemia, cystitis, and hematuria, with a precise incidence unknown but estimated to be less than 1%. The causal relationship for renal papillary necrosis remains unknown.

Miscellaneous reactions may include dry eyes and mouth, gingival ulcer, and rhinitis.

Drug Interactions

Concomitant use of certain medications with ibuprofen may lead to significant drug interactions, categorized primarily into pharmacodynamic and pharmacokinetic interactions.

Pharmacodynamic Interactions

ACE-Inhibitors Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may reduce the antihypertensive effect of ACE-inhibitors. Clinicians should consider this interaction in patients receiving both medications.

Aspirin Ibuprofen has been shown to interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered before aspirin. This interaction is significant with enteric-coated low-dose aspirin and persists even with a once-daily regimen of ibuprofen. To mitigate this risk, it is advisable to administer immediate-release low-dose aspirin at least 2 hours prior to ibuprofen. For patients taking low-dose aspirin for cardiovascular protection who require analgesics, alternative NSAIDs that do not affect aspirin's antiplatelet effect or non-NSAID analgesics should be considered.

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

Warfarin-type Anticoagulants While short-term studies have not demonstrated a significant effect of ibuprofen on prothrombin times in patients on coumarin-type anticoagulants, caution is warranted. The combination of ibuprofen and anticoagulants may increase the risk of gastrointestinal bleeding, which is synergistic. Therefore, careful monitoring is recommended for patients receiving both therapies.

Pharmacokinetic Interactions

Lithium Ibuprofen has been associated with increased plasma lithium levels and decreased renal clearance of lithium. In a study, the mean minimum lithium concentration rose by 15%, while renal clearance decreased by 19%. This interaction is attributed to the inhibition of renal prostaglandin synthesis. Patients receiving both ibuprofen and lithium should be closely monitored for signs of lithium toxicity.

Methotrexate NSAIDs, including ibuprofen, may competitively inhibit the accumulation of methotrexate, potentially enhancing its toxicity. Caution is advised when administering NSAIDs alongside methotrexate.

H-2 Antagonists Co-administration of ibuprofen with H-2 antagonists such as cimetidine or ranitidine has not shown any significant effect on ibuprofen serum concentrations, indicating that these combinations may not require dosage adjustments.

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

Safety and effectiveness of ibuprofen tablets in pediatric patients have not been established. Therefore, healthcare professionals should exercise caution 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, specifically those aged 65 years and older. Due to the potential for altered pharmacokinetics and increased sensitivity to medications in this population, careful consideration of dosage adjustments and monitoring is essential. Healthcare providers are advised to assess the individual health status and comorbidities of geriatric patients to ensure safe and effective treatment.

Pregnancy

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, during pregnancy is associated with significant risks, particularly when used in the later stages of gestation. Administration of NSAIDs around 30 weeks of gestation or later can lead to premature closure of the fetal ductus arteriosus, which may result in serious fetal complications. Additionally, the use of NSAIDs at approximately 20 weeks of gestation or later has been linked to fetal renal dysfunction, leading to oligohydramnios and, in some cases, neonatal renal impairment.

Due to these potential risks, it is recommended that the use of ibuprofen tablets be limited in dose and duration between approximately 20 and 30 weeks of gestation. Use should be avoided entirely at around 30 weeks of gestation and later. If NSAID treatment is deemed necessary after 20 weeks of gestation, it should be restricted to the lowest effective dose for the shortest duration possible. If treatment with ibuprofen tablets extends beyond 48 hours, monitoring with ultrasound for oligohydramnios is advised. Should oligohydramnios be detected, discontinuation of ibuprofen tablets is warranted, followed by appropriate clinical follow-up.

While reproductive studies in rats and rabbits have not shown evidence of developmental abnormalities, the predictive value of animal studies for human outcomes is limited. Prostaglandins play a crucial role in various reproductive processes, and inhibition of prostaglandin synthesis by NSAIDs has been associated with increased pre- and post-implantation loss in animal studies. Furthermore, there is evidence that prostaglandin synthesis inhibitors may impair fetal kidney development when administered at clinically relevant doses.

The estimated background risk of major birth defects and miscarriage in the general U.S. population is 2 to 4% and 15 to 20%, respectively. However, the specific background risk associated with ibuprofen tablets in pregnant patients remains unknown. There are no adequate, well-controlled studies in pregnant women, and ibuprofen tablets should only be used during pregnancy if the potential benefits justify the potential risks to the fetus.

Published literature indicates that adverse outcomes, such as fetal renal dysfunction and oligohydramnios, may occur after days to weeks of NSAID treatment, although oligohydramnios has been reported as early as 48 hours after initiation. Some cases of neonatal renal dysfunction have been reported without preceding oligohydramnios, and in certain instances, these conditions required invasive interventions. The methodological limitations of existing studies, including the lack of control groups and limited data on dosing and timing, hinder the ability to establish a reliable estimate of the risks associated with maternal NSAID use.

The effects of ibuprofen tablets on labor and delivery in pregnant women remain unknown, and caution is advised when considering NSAID use in this population.

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. The use of NSAIDs may lead to a dose-dependent reduction in prostaglandin formation, which can subsequently decrease renal blood flow and precipitate overt renal decompensation.

Patients at greatest risk for these adverse reactions include those with impaired renal function, heart failure, liver dysfunction, individuals taking diuretics and ACE inhibitors, and the elderly. In cases where NSAID therapy is initiated, close monitoring of renal function is advisable. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state.

There is no available information from controlled clinical studies regarding the use of ibuprofen tablets in patients with advanced renal disease; therefore, treatment with ibuprofen tablets is not recommended in this population. If NSAID treatment is deemed necessary during pregnancy, particularly between 20 and 30 weeks gestation, it is important to limit the use of 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

In cases of ibuprofen overdosage, clinical manifestations can vary significantly based on the amount ingested and the patient's age and weight.

Clinical Presentation

A notable case involved a 19-month-old child weighing 12 kg, who ingested between 7 to 10 ibuprofen tablets (400 mg). Approximately 1½ hours post-ingestion, the child presented to the emergency department in an apneic and cyanotic state, responding only to painful stimuli. Despite the severity of the symptoms, this stimulus was sufficient to induce respiration. Initial management included the administration of oxygen and parenteral fluids, alongside gastric aspiration, which revealed a greenish-yellow fluid with no evidence of ibuprofen. Two hours after ingestion, the child's condition stabilized, although she continued to respond solely to painful stimuli and experienced intermittent apnea lasting 5 to 10 seconds. Following admission to intensive care, sodium bicarbonate, dextrose, and normal saline infusions were administered. By four hours post-ingestion, the child was more alert, able to sit independently, and responsive to verbal commands. A blood level of ibuprofen measured 102.9 mcg/mL approximately 8½ hours after ingestion, and by 12 hours, the child appeared to have fully recovered.

In two additional cases involving children weighing approximately 10 kg who accidentally ingested about 120 mg/kg of ibuprofen, no signs of acute intoxication or late sequelae were observed. One child exhibited a blood level of 700 mcg/mL 90 minutes after ingestion, which is approximately ten times the peak levels noted in absorption-excretion studies.

Another case involved a 19-year-old male who ingested 8,000 mg of ibuprofen over several hours. He presented with dizziness and nystagmus. After hospitalization, he received parenteral hydration and was placed on bed rest for three days, ultimately recovering without any reported sequelae.

Management Recommendations

In instances of acute ibuprofen overdosage, it is recommended to empty the stomach through vomiting or gastric lavage; however, it is important to note 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 beneficial. Supportive measures should be prioritized, and the use of oral activated charcoal may assist in reducing both absorption and reabsorption of ibuprofen tablets.

Healthcare professionals should remain vigilant for potential symptoms and manage each case based on the individual patient's presentation and clinical status.

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, during pregnancy has been associated with several teratogenic effects. Administration of NSAIDs around 30 weeks gestation or later increases the risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs from approximately 20 weeks gestation onward has been linked to fetal renal dysfunction, which can lead to oligohydramnios and, in some instances, neonatal renal impairment. Observational studies regarding other potential embryofetal risks associated with NSAID use during the first or second trimesters have yielded inconclusive results.

Reproductive studies conducted in rats and rabbits have not shown evidence of developmental abnormalities; however, it is important to note that animal reproduction studies may not always predict human responses. 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.

Due to the potential for non-teratogenic effects, it is advised to avoid the use of NSAIDs, including ibuprofen tablets, in pregnant women at approximately 30 weeks gestation and later. If NSAID treatment is deemed necessary between 20 and 30 weeks gestation, it is recommended to limit the use of ibuprofen tablets to the lowest effective dose for the shortest duration possible. Oligohydramnios, which may occur as a result of NSAID use, is often reversible upon discontinuation of treatment; however, complications from prolonged oligohydramnios can include limb contractures and delayed lung maturation.

The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies carry a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is between 2 to 4% and 15 to 20%, respectively.

In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has been associated with increased pre- and post-implantation loss. Additionally, published animal studies have reported that these inhibitors can impair kidney development when given at clinically relevant doses.

Postmarketing Experience

Anaphylactoid reactions have been reported in patients without known prior exposure to ibuprofen tablets. It is advised that ibuprofen tablets not be administered to patients with the aspirin triad, a symptom complex that typically occurs in asthmatic patients who may experience rhinitis with or without nasal polyps, or who may exhibit severe, potentially fatal bronchospasm after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Serious skin adverse events, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal, have been documented. These serious events may occur without warning.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has also been reported in patients taking NSAIDs such as ibuprofen tablets. Some instances of DRESS have been fatal or life-threatening, typically presenting with fever, rash, lymphadenopathy, and/or facial swelling.

In two postmarketing clinical studies, a higher incidence of decreased hemoglobin levels was observed than previously reported. A decrease in hemoglobin of 1 gram or more was noted in 17.1% of 193 patients taking 1600 mg of ibuprofen daily for osteoarthritis, and in 22.8% of 189 patients taking 2400 mg of ibuprofen daily for rheumatoid arthritis. Additionally, positive stool occult blood tests and elevated serum creatinine levels were recorded in these studies.

Observational studies conducted within the Danish National Registry indicated that patients treated with NSAIDs in the post-myocardial infarction (MI) period faced an increased risk of reinfarction, cardiovascular-related death, and all-cause mortality beginning in the first week of treatment.

A limited number of case reports have described maternal NSAID use associated with neonatal renal dysfunction without oligohydramnios, some of which were irreversible. Certain cases of neonatal renal dysfunction necessitated treatment through invasive procedures, such as exchange transfusion or dialysis.

Patient Counseling

Patients should be informed of essential information before initiating therapy with an NSAID, such as ibuprofen, and periodically throughout the course of treatment. It is important for patients to read the NSAID Medication Guide that accompanies each prescription dispensed.

Healthcare providers should advise patients to be vigilant 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. Patients should be made aware that ibuprofen, like other NSAIDs, may cause serious cardiovascular side effects, such as myocardial infarction or stroke, which could lead to hospitalization or even death. Although serious cardiovascular events can occur without warning, patients should be alert for signs and symptoms and seek medical advice if they observe any indicative signs.

Additionally, patients should be informed that ibuprofen can cause gastrointestinal discomfort and, in rare cases, serious gastrointestinal side effects, such as ulcers and bleeding, which may also result in hospitalization or death. Patients should be vigilant for signs and symptoms of gastrointestinal ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis, and should seek medical advice if they experience any of these symptoms.

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

It is crucial for patients to be informed about the warning signs and symptoms of hepatotoxicity, including nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and flu-like symptoms. If these occur, patients should be instructed to discontinue therapy and seek immediate medical attention.

Patients should also be made aware of the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat, and should be instructed to seek immediate emergency help if these symptoms arise.

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

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature of 20º to 25ºC (68º to 77ºF), as defined by the United States Pharmacopeia (USP) guidelines. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Physicians should monitor patients on long-term NSAID treatment for signs or symptoms of gastrointestinal (GI) bleeding and periodically check complete blood count (CBC) and chemistry profiles. If patients exhibit clinical signs consistent with liver or renal disease, systemic manifestations such as eosinophilia or rash, or if abnormal liver tests persist or worsen, ibuprofen tablets should be discontinued.

Patients should be counseled to remain vigilant for symptoms of cardiovascular thrombotic events, including chest pain and shortness of breath, and to report these to their healthcare provider immediately. They should also be aware of signs of GI tract ulcerations and bleeding, such as epigastric pain and melena, and seek medical advice if these occur. Immediate cessation of ibuprofen is advised if any rash or fever develops, and patients should contact their healthcare provider. Additionally, they should monitor for symptoms of congestive heart failure, hepatotoxicity, and anaphylactoid reactions, seeking immediate medical attention if these symptoms arise. Pregnant women should avoid ibuprofen and other NSAIDs starting at 30 weeks gestation due to the risk of premature closure of the fetal ductus arteriosus, and those requiring treatment between 20 to 30 weeks should be monitored for oligohydramnios if treatment exceeds 48 hours.

FDA Insert (PDF)

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

View full prescribing information (PDF)