Ibuprofen

Description

Ibuprofen Tablets, USP 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, with a solubility of less than 1 mg/mL, but is readily soluble in organic solvents such as ethanol and acetone. The structural formula of ibuprofen is provided below.

These tablets are formulated as a nonsteroidal anti-inflammatory drug (NSAID) and are available in a dosage strength of 400 mg for oral administration. The formulation includes several inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Cellulose, Hypromellose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, and Titanium Dioxide.

Uses and Indications

Ibuprofen Tablets are indicated for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. This medication is also 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 this medication in pediatric populations is not recommended.

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 (qid) or as 400 mg, 600 mg, or 800 mg three to four times a day (tid or qid). Individual patient responses may vary, with some patients potentially benefiting from a total daily dose of 3200 mg compared to 2400 mg.

It is imperative that the total daily dose does not exceed 3200 mg. In cases where gastrointestinal complaints arise, it is recommended to administer Ibuprofen Tablets with meals or milk to mitigate these effects. The dosage should be individualized 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 the case of dysmenorrhea, a dosage of 400 mg every 4 hours may be administered as necessary for pain relief.

Contraindications

Ibuprofen Tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Additionally, the use of Ibuprofen Tablets 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 should not be administered in the context of coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

Nonsteroidal 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. Therefore, healthcare professionals should exercise caution when prescribing these medications, particularly in patients with a history of cardiovascular disease.

Ibuprofen Tablets are contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery. Additionally, NSAIDs can lead to the onset of new hypertension or exacerbate preexisting hypertension, potentially increasing the incidence of cardiovascular events. It is essential to monitor blood pressure closely during the initiation of therapy and throughout the treatment course.

Serious gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, can occur with NSAID use, sometimes without warning symptoms. Healthcare providers should remain vigilant for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and initiate further evaluation and treatment if a serious GI event is suspected.

Long-term use of NSAIDs has been linked to renal papillary necrosis and other forms of renal injury. Patients at heightened risk include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Close monitoring of renal function is advisable if Ibuprofen Tablets therapy is initiated in patients with advanced renal disease.

Anaphylactoid reactions may occur in patients without prior exposure to Ibuprofen Tablets. In such cases, emergency medical assistance should be sought immediately. Furthermore, NSAIDs can cause severe skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinuation of Ibuprofen Tablets is warranted at the first sign of a skin rash or any other indication of hypersensitivity.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs, including Ibuprofen Tablets. If any signs or symptoms of DRESS are observed, the medication should be discontinued, and the patient should be evaluated promptly.

In pregnant women, the use of NSAIDs, including Ibuprofen Tablets, should be avoided around 30 weeks of gestation and later due to the risk of premature closure of the fetal ductus arteriosus.

To minimize potential risks, it is recommended to use the lowest effective dose for the shortest duration necessary. Patients with a recent myocardial infarction should be monitored for signs of cardiac ischemia, while those with severe heart failure should be observed for signs of worsening heart failure.

Blood pressure should be monitored closely during the initiation of NSAID treatment and throughout therapy. Emergency medical help should be sought in cases of anaphylactoid reactions. Additionally, patients should discontinue Ibuprofen Tablets at the first appearance of a skin rash or any other sign of hypersensitivity, and if symptoms of DRESS are present, the medication should be stopped, and the patient evaluated immediately.

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. 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 can occur at any time during treatment and may present without warning symptoms, particularly in elderly patients who are at greater risk.

Common adverse reactions, occurring in greater than 1% but less than 3% of patients, primarily involve the gastrointestinal system. These include nausea, epigastric pain, heartburn, diarrhea, abdominal distress, vomiting, indigestion, constipation, abdominal cramps or pain, and a sensation of fullness in the gastrointestinal tract, such as bloating and flatulence.

Adverse reactions with a precise incidence unknown but likely related to the medication, occurring in less than 1% of patients, encompass a variety of systems. Gastrointestinal issues may include gastric or duodenal ulcers with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, and abnormal liver function tests, as well as pancreatitis.

Central nervous system effects may manifest as paresthesias, hallucinations, dream abnormalities, and pseudotumor cerebri. Dermatologic reactions can include toxic epidermal necrolysis and photoallergic skin reactions. Special senses may be affected, leading to hearing loss and amblyopia, which presents as blurred and/or diminished vision, scotomata, and/or changes in color vision.

Hematologic reactions may include neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, and decreases in hemoglobin and hematocrit. Metabolic and endocrine reactions may involve gynecomastia, hypoglycemic reactions, and acidosis.

Cardiovascular effects can include 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, bronchospasm, serum sickness, lupus erythematosus syndrome, Henoch-Schonlein vasculitis, and angioedema.

Renal adverse reactions may 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.

Postmarketing experience has revealed additional skin and appendage reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).

Drug Interactions

Concomitant use of Ibuprofen Tablets with certain medications 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 consider this interaction in patients receiving both medications.

Aspirin Ibuprofen may interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered before aspirin. This interaction is noted with both enteric-coated and immediate-release low-dose aspirin. To mitigate this risk, it is advisable to administer immediate-release low-dose aspirin at least 2 hours prior to ibuprofen. Due to the potential for increased cardiovascular events, alternative analgesics that do not affect aspirin's antiplatelet effect should be considered for patients taking low-dose aspirin for cardioprotection.

Diuretics Ibuprofen may diminish the natriuretic effect of diuretics such as furosemide and thiazides, likely due to inhibition of renal prostaglandin synthesis. Patients on concomitant NSAID therapy should be monitored closely 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, 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 shown to elevate plasma lithium levels and decrease renal clearance of lithium. In a study, the mean minimum lithium concentration increased by 15%, and renal clearance decreased by 19% during concurrent administration. Patients should be closely monitored for signs of lithium toxicity 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.

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

Safety and effectiveness of Ibuprofen Tablets in pediatric patients have not been established. Therefore, caution should be exercised when considering the use of this medication in children. Further studies are needed to determine appropriate dosing and outcomes in this population.

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 NSAIDs, including Ibuprofen Tablets, during pregnancy is associated with significant risks, particularly when administered around 20 to 30 weeks of gestation. The use of these medications can lead to premature closure of the fetal ductus arteriosus and fetal renal dysfunction, which may result in oligohydramnios and, in some cases, neonatal renal impairment. Therefore, it is recommended to limit the dose and duration of Ibuprofen Tablets use between approximately 20 and 30 weeks of gestation, and to avoid their use at around 30 weeks of gestation and later in pregnancy.

Observational studies have indicated that the use of NSAIDs at about 30 weeks gestation or later increases the risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs at about 20 weeks gestation or later has been associated with fetal renal dysfunction leading to oligohydramnios, with some reports of neonatal renal impairment. These adverse outcomes typically occur after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after initiation of NSAID therapy. In many instances, the decrease in amniotic fluid was transient and reversible upon cessation of the drug.

Reproductive studies in rats and rabbits have not demonstrated evidence of developmental abnormalities; however, animal reproduction studies are not always predictive of human response. Prostaglandins play a crucial role in endometrial vascular permeability, blastocyst implantation, and decidualization, and their inhibition by NSAIDs like ibuprofen has been shown to impair kidney development in animal studies. Furthermore, there have been limited case reports of maternal NSAID use leading to neonatal renal dysfunction without oligohydramnios, some of which were irreversible and required invasive treatments.

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 background risk for the indicated population(s) 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. If NSAID use is deemed necessary at about 20 weeks gestation or later, it is crucial to limit the use to the lowest effective dose and shortest duration possible. If treatment extends beyond 48 hours, monitoring with ultrasound for oligohydramnios is advised, and if oligohydramnios occurs, discontinuation of Ibuprofen Tablets should be considered, with follow-up according to clinical practice.

The effects of Ibuprofen Tablets on labor and delivery in pregnant women are currently unknown, and methodological limitations in postmarketing studies hinder the establishment of a reliable estimate of the risk of adverse fetal and neonatal outcomes associated with maternal NSAID 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.

Discontinuation of NSAID therapy typically results in recovery to the pretreatment state. However, there is no available information from controlled clinical studies regarding the use of Ibuprofen Tablets in patients with advanced renal disease, and as such, treatment with Ibuprofen Tablets is not recommended in this population. If therapy with Ibuprofen Tablets 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 can 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 approximately 20 and 30 weeks of gestation, it is recommended 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 do not require specific dosage adjustments for the administration of Ibuprofen Tablets. However, caution is advised when prescribing this medication to individuals with liver dysfunction, as they may be at an increased risk for renal toxicity and other adverse effects associated with nonsteroidal anti-inflammatory drugs (NSAIDs).

It is important to monitor patients with compromised liver function closely, particularly those who also have impaired renal function, heart failure, or are taking diuretics and ACE inhibitors, as these populations are identified as being at the greatest risk for renal adverse effects from NSAIDs. Regular assessment of renal function and overall health status is recommended to mitigate potential risks in these patients.

Overdosage

In cases of ibuprofen overdosage, clinical manifestations can vary significantly based on the amount ingested and the time elapsed since ingestion.

Clinical Presentation

A notable case involved a 19-month-old child 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 this, the painful stimulus was sufficient to induce respiration. Initial management included the administration of oxygen and parenteral fluids, with a greenish-yellow fluid aspirated from the stomach, showing 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 responsive, able to sit independently and follow verbal commands. A blood level of ibuprofen measured at 102.9 mcg/mL approximately 8½ hours after ingestion indicated significant exposure. Remarkably, by 12 hours post-ingestion, the child appeared to have fully recovered.

In two additional cases involving children weighing approximately 10 kg who 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 but recovered fully after receiving parenteral hydration and three days of bed rest, with no 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.

Healthcare professionals should remain vigilant for potential symptoms and manage accordingly, ensuring that supportive care is provided throughout the treatment process.

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including Ibuprofen Tablets, during pregnancy has been associated with teratogenic effects, particularly when administered around 20 weeks gestation or later. Notably, there is an increased risk of premature closure of the fetal ductus arteriosus and cases of fetal renal dysfunction leading to oligohydramnios, which may result in neonatal renal impairment. If NSAID treatment is deemed necessary between approximately 20 and 30 weeks of gestation, it is recommended to limit the use of Ibuprofen Tablets to the lowest effective dose for the shortest duration possible. Additionally, ultrasound monitoring of amniotic fluid is advised if treatment extends beyond 48 hours, with discontinuation of Ibuprofen Tablets if oligohydramnios is detected, followed by appropriate clinical follow-up.

Non-teratogenic effects have also been observed, with fetal renal dysfunction leading to oligohydramnios occurring after days to weeks of NSAID treatment. Instances of oligohydramnios have been infrequently reported as early as 48 hours after initiation of NSAID therapy. Prolonged oligohydramnios may lead to complications such as limb contractures and delayed lung maturation.

Reproductive studies conducted in rats and rabbits have not indicated any evidence of developmental abnormalities. However, animal data suggest that prostaglandins play a crucial role in endometrial vascular permeability, blastocyst implantation, and decidualization. In studies involving animal models, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has been linked to increased pre- and post-implantation loss. Furthermore, prostaglandins are essential for fetal kidney development, and published animal studies have reported that prostaglandin synthesis inhibitors can impair kidney development when administered at clinically relevant doses.

Postmarketing Experience

Anemia has been reported in patients receiving NSAIDs, including Ibuprofen Tablets. This condition may arise from fluid retention, occult or gross gastrointestinal blood loss, or an incompletely characterized effect on erythropoiesis. It is recommended that patients undergoing long-term treatment with NSAIDs, including Ibuprofen Tablets, have their hemoglobin or hematocrit levels monitored if they exhibit any signs or symptoms of anemia.

In two postmarketing clinical studies, the incidence of decreased hemoglobin levels was found to be higher than previously documented. A decrease in hemoglobin of 1 gram or more was observed 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 noted in these studies.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients using NSAIDs such as Ibuprofen Tablets. Some cases of DRESS have resulted in fatal or life-threatening outcomes. This syndrome typically presents with symptoms including fever, rash, lymphadenopathy, and/or facial swelling, although other clinical manifestations may occur, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Symptoms of DRESS may sometimes mimic those of an acute viral infection, and eosinophilia is frequently observed.

A limited number of case reports have documented maternal NSAID use associated with neonatal renal dysfunction in the absence of oligohydramnios, with some cases resulting in irreversible damage. Certain instances of neonatal renal dysfunction necessitated invasive treatments, including exchange transfusion or dialysis.

Patient Counseling

Patients should be informed of the symptoms associated with cardiovascular thrombotic events, which include chest pain, shortness of breath, weakness, or slurring of speech. They should be advised to report any of these symptoms to their healthcare provider immediately.

It is important to communicate that Ibuprofen Tablets 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. 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 these occur.

Patients should be instructed 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 made aware of the symptoms of congestive heart failure, which include shortness of breath, unexplained weight gain, or edema. They should be encouraged to contact their healthcare provider if such symptoms arise.

Healthcare providers should inform patients about the warning signs and symptoms of hepatotoxicity, such as nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms. Patients should be instructed to stop therapy and seek immediate medical attention if these symptoms occur.

Patients should also be educated on the signs of an anaphylactoid reaction, including 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 closing 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.

Physicians should monitor patients on long-term treatment with NSAIDs for signs or symptoms of gastrointestinal bleeding. Furthermore, patients on long-term NSAID therapy should have their complete blood count (CBC) and chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, or if abnormal liver tests persist or worsen, Ibuprofen Tablets should be discontinued.

Storage and Handling

The product is supplied in a tight, light-resistant container as defined by the United States Pharmacopeia (USP). It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F).

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. Immediate discontinuation of Ibuprofen Tablets 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 and hepatotoxicity, and seek emergency help for signs of an anaphylactoid reaction. Pregnant women should avoid Ibuprofen Tablets 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 gestation 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 Amneal Pharmaceuticals of New York LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)