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 (less than 1 mg/mL) but is readily soluble in organic solvents such as ethanol and acetone.

These tablets are classified as a nonsteroidal anti-inflammatory drug (NSAID) and are available in dosages of 400 mg, 600 mg, and 800 mg for oral administration. The formulation includes several inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, and an Opadry II coating that contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate, 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

For the treatment of rheumatoid arthritis and osteoarthritis, the suggested dosage ranges from 1200 mg to 3200 mg daily, administered as 400 mg, 600 mg, or 800 mg three to four times a day (tid or qid). The total daily dose should not exceed 3200 mg. Dosing should be individualized based on the severity of the patient's symptoms, allowing for adjustments as necessary.

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, the recommended dosage is 400 mg every 4 hours as necessary for pain relief.

To minimize gastrointestinal discomfort, it is advised that ibuprofen tablets be administered 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

Cardiovascular thrombotic events, including myocardial infarction (MI) and stroke, may occur with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), potentially leading to fatal outcomes. The risk of such events may increase with the duration of NSAID use. Ibuprofen is contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery. Furthermore, patients treated with NSAIDs during the post-MI period face an elevated risk of reinfarction, cardiovascular-related mortality, and all-cause mortality.

NSAIDs have been associated with the development of new hypertension or the exacerbation of pre-existing hypertension. Additionally, these medications can increase the risk of heart failure and edema. Serious gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation, can occur at any time during NSAID therapy, with or without prior warning symptoms. Long-term use of NSAIDs may lead to renal injury and renal papillary necrosis.

Anaphylactoid reactions can occur in patients who have not previously been exposed to ibuprofen. Serious skin adverse events, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), may arise without warning. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported and can be fatal or life-threatening. In pregnant women, the use of NSAIDs around 30 weeks of gestation and later increases the risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs at approximately 20 weeks of gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios and neonatal renal impairment.

To minimize risks, it is recommended to use the lowest effective dose of NSAIDs for the shortest duration necessary. Blood pressure should be monitored closely during NSAID treatment, particularly in patients with hypertension. Patients with a recent MI should be monitored for signs of cardiac ischemia if NSAIDs are administered. If a serious GI event is suspected, NSAID therapy should be discontinued, and the patient should be evaluated. Close monitoring of renal function is advisable for patients with advanced renal disease when initiating ibuprofen therapy.

Laboratory tests should include regular monitoring of blood pressure during the initiation of NSAID treatment and throughout the course of therapy. Additionally, renal function should be closely monitored in patients with advanced renal disease.

Emergency medical assistance should be sought immediately in the event of an anaphylactoid reaction. Patients should discontinue ibuprofen tablets at the first sign of a skin rash or any other indication of hypersensitivity. If symptoms suggestive of DRESS occur, ibuprofen therapy should be stopped, and the patient should be evaluated without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication, categorized by seriousness and frequency.

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

Renal effects may manifest as acute renal failure, decreased creatinine clearance, and renal papillary necrosis with long-term administration. Anaphylactoid reactions can occur in patients without prior exposure to the medication, and serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported.

Common adverse reactions observed in clinical trials and postmarketing experiences include gastrointestinal symptoms such as nausea, epigastric pain, heartburn, diarrhea, and abdominal distress. Other gastrointestinal issues may include constipation, abdominal cramps, and fullness of the gastrointestinal tract, as well as more severe conditions like gastritis, pancreatitis, and gastrointestinal hemorrhage.

Central nervous system effects may present as dizziness, headache, nervousness, depression, insomnia, confusion, and emotional liability. Somnolence and aseptic meningitis with fever and coma have also been reported.

Dermatologic reactions can include rash (including maculopapular types), pruritus, vesiculobullous eruptions, urticaria, and more severe reactions such as erythema multiforme and alopecia.

Patients may also experience adverse reactions affecting special senses, including tinnitus, hearing loss, amblyopia, conjunctivitis, diplopia, and optic neuritis.

Hematologic adverse reactions may include neutropenia, agranulocytosis, aplastic anemia, and various forms of anemia, as well as thrombocytopenia and bleeding episodes.

Metabolic and endocrine reactions can manifest as decreased appetite, gynecomastia, hypoglycemic reactions, and acidosis.

Cardiovascular reactions may include edema, fluid retention, congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations, and arrhythmias.

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

Renal adverse reactions may include polyuria, azotemia, cystitis, and hematuria.

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

Patients should be monitored for these adverse reactions, and appropriate measures should be taken to manage any that occur.

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 when prescribing NSAIDs to patients who are concurrently taking ACE-inhibitors.

Aspirin Pharmacodynamic studies indicate that ibuprofen can interfere with the antiplatelet activity of aspirin. Specifically, when ibuprofen 400 mg is administered three times daily, it diminishes the effect of enteric-coated low-dose aspirin, even if ibuprofen is taken once daily. 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 formulations. Due to the potential increased risk of cardiovascular events from this interaction, it is advisable to consider alternative analgesics that do not affect aspirin's antiplatelet effect for patients using low-dose aspirin for cardioprotection.

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

Lithium Concomitant administration of 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. Careful monitoring for signs of lithium toxicity is recommended when these drugs are used together.

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

Warfarin-type Anticoagulants While short-term studies have not demonstrated significant effects of ibuprofen on prothrombin times or clotting factors in patients on coumarin-type anticoagulants, there is a documented risk of bleeding when these medications are used together. The combined use of warfarin and NSAIDs may increase the risk of serious gastrointestinal bleeding. Physicians should exercise caution when prescribing ibuprofen to patients on anticoagulants.

Pharmacokinetic Interactions

H-2 Antagonists Studies involving cimetidine or ranitidine co-administered with ibuprofen have shown no significant impact on ibuprofen serum concentrations. Therefore, no dosage adjustments are necessary when these medications are used together.

In summary, careful consideration and monitoring are essential when ibuprofen is prescribed alongside these medications to mitigate potential adverse effects and interactions.

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 should be exercised when considering the use of ibuprofen in this population. Further studies are needed to determine appropriate dosing and outcomes in children.

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 around 30 weeks of gestation or later can lead to premature closure of the fetal ductus arteriosus, which may have significant implications for fetal cardiovascular health. Additionally, NSAID use at approximately 20 weeks of gestation or later has been linked to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment. These adverse outcomes may occur after days to weeks of treatment, although oligohydramnios has been reported as early as 48 hours following NSAID initiation.

Given these risks, it is recommended that the use of ibuprofen tablets be limited to the lowest effective dose and shortest duration possible if treatment is deemed necessary after 20 weeks of gestation. If treatment extends beyond 48 hours, monitoring with ultrasound for oligohydramnios is advised. Should oligohydramnios be detected, discontinuation of ibuprofen tablets and appropriate follow-up according to clinical practice is warranted.

There are no adequate, well-controlled studies in pregnant women, and the estimated background risk of major birth defects and miscarriage in the general population is 2-4% and 15-20%, respectively. While animal studies have not demonstrated developmental abnormalities, they have shown that prostaglandins play a crucial role in fetal kidney development and implantation processes. Prostaglandin synthesis inhibitors, such as ibuprofen, have been associated with increased pre- and post-implantation loss in animal models.

Healthcare professionals should be aware that the published literature on NSAID use in pregnancy is limited, with methodological constraints in postmarketing studies, including the absence of control groups and insufficient data on dosage and duration of exposure. Consequently, the generalizability of reported risks to full-term infants remains uncertain, particularly as most safety data involve preterm infants. Therefore, ibuprofen tablets should only be used during pregnancy if the potential benefits justify the potential risks to the fetus.

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 breastfeeding 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. 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 initiation of ibuprofen tablet therapy is deemed necessary, close monitoring of the patient's renal function is advised.

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 NSAID initiation. While oligohydramnios is often reversible upon treatment discontinuation, 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 may experience altered pharmacokinetics and increased risk of adverse effects when treated with NSAIDs. Long-term administration of NSAIDs has been associated with renal papillary necrosis and other forms of renal injury, particularly in individuals where renal prostaglandins play a critical role in maintaining renal perfusion. In patients with compromised liver function, the administration of NSAIDs may lead to a dose-dependent reduction in prostaglandin formation, which can subsequently decrease renal blood flow and potentially precipitate renal decompensation.

Patients at heightened risk for these adverse reactions include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Therefore, it is crucial to exercise caution when considering NSAID therapy in this population.

Currently, there is no available information from controlled clinical studies regarding the use of ibuprofen tablets in patients with advanced renal disease. Consequently, treatment with ibuprofen tablets is not recommended for patients with advanced renal disease. If therapy with ibuprofen tablets is deemed necessary, close monitoring of renal function is advised to mitigate potential risks. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state, underscoring the importance of careful patient management.

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, along with gastric aspiration, which revealed a greenish-yellow fluid but no evidence of ibuprofen. Two hours after ingestion, the child's condition stabilized, although she continued to respond solely to painful stimuli and experienced 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 reported dizziness, and nystagmus was observed. After hospitalization, he received parenteral hydration and underwent three days of bed rest, 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, use of these medications at approximately 20 weeks gestation or later 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. Animal studies have demonstrated that the administration of prostaglandin synthesis inhibitors, such as ibuprofen, can result in increased pre- and post-implantation loss. Furthermore, prostaglandins play a crucial role in fetal kidney development, and published animal studies indicate that prostaglandin synthesis inhibitors may impair kidney development when administered at clinically relevant doses.

Due to the risk of premature closure of the fetal ductus arteriosus, the use of NSAIDs, including ibuprofen tablets, is advised against in pregnant women at approximately 30 weeks gestation and later. If NSAID treatment is deemed necessary between 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. 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.

Reproductive studies conducted in rats and rabbits have not shown evidence of developmental abnormalities; however, it is important to note that animal reproduction studies are not always predictive of human responses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) remains 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 approximately 2-4% and 15-20%, respectively.

In animal pharmacology and toxicology studies involving NSAIDs, including ibuprofen, there has been an increased incidence of dystocia, delayed parturition, and decreased pup survival observed in rats. The effects of ibuprofen tablets on labor and delivery in pregnant women have not been established.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with ibuprofen tablets, reported voluntarily or through surveillance programs. Anaphylactoid reactions may occur in patients without known prior exposure to ibuprofen, necessitating 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 occurring without 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 two postmarketing clinical studies, a higher incidence of decreased hemoglobin levels was observed than previously reported, with a decrease of 1 gram or more noted in 17.1% of 193 patients on 1600 mg daily for osteoarthritis and in 22.8% of 189 patients taking 2400 mg daily for rheumatoid arthritis. Positive stool occult blood tests and elevated serum creatinine levels were also reported in these studies.

Reports indicate that NSAIDs may reduce the antihypertensive effect of ACE inhibitors. While several short-term controlled studies did not demonstrate significant effects of ibuprofen on prothrombin times or other clotting factors in individuals on coumarin-type anticoagulants, instances of bleeding have been noted when ibuprofen and other NSAIDs were administered concurrently with these anticoagulants.

Furthermore, maternal use of NSAIDs around 20 weeks of gestation or later has been associated with fetal renal dysfunction leading to oligohydramnios, with some cases of neonatal renal impairment reported. These adverse outcomes typically manifest after days to weeks of treatment, although oligohydramnios has been infrequently observed as soon as 48 hours after NSAID initiation. In certain postmarketing cases of impaired neonatal renal function, invasive interventions such as exchange transfusion or dialysis were required.

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, which may include chest pain, shortness of breath, weakness, or slurring of speech. Patients should be instructed to report any of these symptoms to their healthcare provider immediately.

Patients should be made aware that ibuprofen tablets, like other NSAIDs, can cause gastrointestinal discomfort and, in rare cases, serious gastrointestinal side effects such as ulcers and bleeding, which may lead to hospitalization or even death. Although serious gastrointestinal tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for signs and symptoms such as epigastric pain, dyspepsia, melena, and hematemesis. They should be encouraged to seek medical advice if they observe any indicative signs or symptoms and understand the importance of follow-up.

Additionally, patients should be informed that ibuprofen tablets can cause serious skin side effects, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which may also result in hospitalization or death. Patients should be vigilant for signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching. They should be advised to seek medical advice if they notice any indicative signs or symptoms and to stop taking ibuprofen tablets immediately if they develop any type of rash or fever, contacting their healthcare provider as soon as possible.

Patients should also be alerted to the symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema, and should contact their healthcare provider if such symptoms occur.

It is crucial for patients to be informed 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 symptoms occur, patients should be instructed to stop therapy and seek immediate medical attention.

Patients should be made aware of the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat. In such cases, 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, 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 20° to 25°C (68° to 77°F), as defined by the United States Pharmacopeia (USP) guidelines. 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 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 ulcerations and bleeding, such as epigastric pain and melena, and seek medical advice if these occur. Patients must stop taking ibuprofen if they develop any rash or fever and contact their healthcare provider promptly. Additionally, they should be informed about the symptoms of congestive heart failure, hepatotoxicity, and anaphylactoid reactions, and instructed to seek immediate help 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.

FDA Insert (PDF)

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

View full prescribing information (PDF)