Ibuprofen

Description

Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C. It is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. Ibuprofen tablets are available in strengths of 400 mg, 600 mg, and 800 mg for oral administration. Inactive ingredients include colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, and Opadry II, which 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, including flare-ups of chronic disease, the suggested dosage ranges from 1200 mg to 3200 mg daily. This can be administered as 400 mg, 600 mg, or 800 mg taken three to four times a day (tid or qid). 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, the recommended dosage is 400 mg every 4 hours as necessary for pain relief.

To minimize gastrointestinal discomfort, it is advised to administer ibuprofen tablets 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 documented in these patients. Furthermore, ibuprofen tablets are contraindicated in the context of coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

Patients receiving nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, should be closely monitored for various potential adverse effects.

Cardiovascular Effects NSAIDs are associated with an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. This risk may manifest early in treatment and is likely to escalate with prolonged use. Ibuprofen tablets are contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery. In the post-myocardial infarction (MI) period, patients treated with NSAIDs face a heightened risk of reinfarction, cardiovascular-related mortality, and all-cause mortality, beginning within the first week of treatment. Therefore, the use of ibuprofen tablets in patients with a recent MI should be avoided unless the anticipated benefits outweigh the risks of recurrent cardiovascular thrombotic events. If ibuprofen is administered, it is essential to monitor patients for signs of cardiac ischemia. Additionally, NSAIDs may induce new hypertension or exacerbate pre-existing hypertension; thus, blood pressure should be closely monitored during the initiation of NSAID therapy and throughout the treatment duration. The use of ibuprofen tablets in patients with severe heart failure should also be approached with caution, and if necessary, patients should be monitored for signs of worsening heart failure.

Gastrointestinal Effects NSAIDs can lead to serious gastrointestinal adverse events, including inflammation, bleeding, ulceration, and perforation of the gastrointestinal tract, which may be fatal. These events can occur at any time, with or without warning symptoms. Prescribing NSAIDs requires extreme caution in patients with a history of ulcer disease or gastrointestinal bleeding, as these individuals have over a tenfold increased risk of developing gastrointestinal bleeding. To mitigate the risk of adverse gastrointestinal events, the lowest effective dose should be utilized for the shortest duration possible. Both patients and healthcare providers should remain vigilant for signs and symptoms of gastrointestinal ulcerations and bleeding during NSAID therapy, and prompt evaluation and treatment should be initiated if a serious gastrointestinal event is suspected.

Renal Effects Long-term use of NSAIDs has been linked to renal papillary necrosis and other forms of renal injury. Patients at increased risk for renal toxicity include those with impaired renal function, heart failure, liver dysfunction, those on diuretics and ACE inhibitors, and the elderly. The use of ibuprofen tablets is not recommended in patients with advanced renal disease; if therapy is deemed necessary, close monitoring of renal function is advised.

Anaphylactoid Reactions Anaphylactoid reactions may occur in patients who have not previously been exposed to ibuprofen tablets. In the event of such a reaction, immediate medical assistance should be sought.

Serious Skin Reactions NSAIDs can cause severe skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs and symptoms of serious skin reactions and advised to discontinue ibuprofen tablets at the first appearance of a skin rash or any other indication of hypersensitivity.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) DRESS has been reported in patients taking NSAIDs, including ibuprofen tablets. If any signs or symptoms of DRESS are observed, ibuprofen tablets should be discontinued immediately, and the patient should be evaluated without delay.

Fetal Toxicity The use of NSAIDs, including ibuprofen tablets, is contraindicated in pregnant women at approximately 30 weeks gestation and later due to the risk of premature closure of the fetal ductus arteriosus. Additionally, NSAID use around 20 weeks gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some cases, neonatal renal impairment. If oligohydramnios occurs, ibuprofen tablets should be discontinued, and follow-up should be conducted according to clinical practice guidelines.

In summary, healthcare professionals must exercise caution when prescribing ibuprofen tablets, ensuring that patients are adequately monitored for the aforementioned risks and adverse effects.

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 use and can occur early in treatment. 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.

Common gastrointestinal adverse reactions reported include nausea, epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, and fullness of the gastrointestinal tract (bloating and flatulence). Less common but serious gastrointestinal events with a probable causal relationship include gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests, and pancreatitis, all with a precise incidence unknown but estimated to be less than 1%.

Central nervous system reactions may include dizziness, headache, and nervousness. Serious central nervous system events with a probable causal relationship include depression, insomnia, confusion, emotional liability, somnolence, and aseptic meningitis with fever and coma. Other central nervous system reactions, such as paresthesias, hallucinations, dream abnormalities, and pseudotumor cerebri, have an unknown causal relationship.

Dermatologic reactions may manifest as rash (including maculopapular type) and pruritus. Serious dermatologic events with a probable causal relationship include vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, and alopecia. Other dermatologic reactions, such as toxic epidermal necrolysis and photoallergic skin reactions, have an unknown causal relationship.

Adverse reactions affecting special senses include tinnitus, with probable causal relationships to hearing loss and amblyopia (blurred and/or diminished vision, scotomata, and/or changes in color vision). Other reactions, such as conjunctivitis, diplopia, optic neuritis, and cataracts, have an unknown causal relationship.

Hematologic adverse reactions may include neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, and decreases in hemoglobin and hematocrit, all with a probable causal relationship. Bleeding episodes, such as epistaxis and menorrhagia, have an unknown causal relationship.

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

Cardiovascular reactions may include edema and fluid retention, which generally respond promptly to drug discontinuation. Serious cardiovascular events with a probable causal relationship include congestive heart failure in patients with marginal cardiac function, elevated blood pressure, and palpitations. Arrhythmias, such as sinus tachycardia and sinus bradycardia, have an unknown causal relationship.

Allergic reactions may present as a syndrome of abdominal pain, fever, chills, nausea, and vomiting, with probable causal relationships to anaphylaxis and bronchospasm. Other allergic reactions, including serum sickness, lupus erythematosus syndrome, Henoch-Schonlein vasculitis, and angioedema, have an unknown causal relationship.

Renal adverse reactions may include acute renal failure, decreased creatinine clearance, polyuria, azotemia, cystitis, and hematuria, with a probable causal relationship. Renal papillary necrosis has an unknown causal relationship.

Miscellaneous adverse reactions may include dry eyes and mouth, gingival ulcer, and rhinitis, all with a probable causal relationship.

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

Drug Interactions

The concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) and various other medications can lead to significant drug interactions that may affect therapeutic outcomes and safety.

Antihypertensive Agents NSAIDs may diminish the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibitors. Clinicians should monitor blood pressure closely in patients receiving both classes of medications.

Antiplatelet Agents Ibuprofen can interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered prior to aspirin. To mitigate this interaction, it is recommended that immediate-release low-dose aspirin be taken at least 2 hours before ibuprofen.

Diuretics Ibuprofen may reduce the natriuretic effect of furosemide and thiazide diuretics. Close observation for signs of renal failure is advised in patients taking these combinations.

Lithium The use of ibuprofen can elevate plasma lithium levels and decrease renal clearance of lithium, thereby increasing the risk of lithium toxicity. Regular monitoring of lithium levels is recommended for patients on this combination.

Methotrexate NSAIDs may enhance the toxicity of methotrexate by competitively inhibiting its accumulation. Caution is warranted when these agents are used together, and monitoring for signs of methotrexate toxicity is advised.

Anticoagulants Caution is advised when administering ibuprofen to patients on warfarin-type anticoagulants due to the increased risk of serious gastrointestinal bleeding. Regular monitoring of coagulation parameters is recommended.

Gastrointestinal Agents Co-administration of cimetidine or ranitidine with ibuprofen does not have a substantive effect on ibuprofen serum concentrations, and no dosage adjustments are necessary in this context.

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 (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 is recommended 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 is particularly concerning, as it can lead to premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs at approximately 20 weeks of gestation or later has been linked to fetal renal dysfunction, which may result in oligohydramnios and, in some cases, neonatal renal impairment.

To mitigate these risks, it is recommended that the use of ibuprofen tablets be limited to the lowest effective dose and the shortest duration possible if necessary after 20 weeks of gestation. If treatment extends beyond 48 hours, monitoring with ultrasound for oligohydramnios should be considered. In instances where oligohydramnios is detected, ibuprofen tablets should be discontinued, and follow-up should be conducted according to clinical practice guidelines.

Data from observational studies regarding the potential embryofetal risks of NSAID use during the first and second trimesters remain inconclusive. While reproductive studies in rats and rabbits have not shown evidence of developmental abnormalities, animal reproduction studies are not always predictive of human outcomes. Prostaglandins play a crucial role in endometrial vascular permeability, blastocyst implantation, and decidualization, and their inhibition by NSAIDs like ibuprofen has been associated with increased pre- and post-implantation loss and impaired kidney development at clinically relevant doses.

The estimated background risk of major birth defects and miscarriage in the general U.S. population is 2-4% and 15-20%, respectively. However, the specific background risk associated with ibuprofen tablets use in pregnant patients is 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 leading to oligohydramnios, may occur after days to weeks of NSAID treatment, although oligohydramnios has been reported as soon as 48 hours after initiation. While many cases of decreased amniotic fluid were transient and reversible upon cessation of the drug, some instances of neonatal renal dysfunction occurred without oligohydramnios and were irreversible, necessitating invasive treatments like exchange transfusion or dialysis.

It is important to note that methodological limitations in postmarketing studies, including the lack of control groups and limited information on dosing and timing, hinder the ability to establish a reliable estimate of the risks associated with maternal NSAID use. Furthermore, the safety data primarily involve preterm infants, raising uncertainty about the generalizability of reported risks to full-term infants exposed to NSAIDs through maternal use.

Lactation

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

Renal Impairment

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

Discontinuation of NSAID therapy typically results in recovery to the pretreatment state. However, there is no information from controlled clinical studies regarding the use of ibuprofen tablets in patients with advanced renal disease, and treatment with ibuprofen tablets is not recommended in this population. If 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 initiation. If NSAID treatment is required between approximately 20 and 30 weeks of gestation, it is recommended to limit ibuprofen tablet use 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 compensatory 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 precipitate renal decompensation.

Patients at the highest risk for these adverse reactions include those with impaired renal function, heart failure, liver dysfunction, individuals 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 these patients. If the initiation of ibuprofen tablet therapy 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 timing of intervention.

A notable case involved a 19-month-old child who ingested between 7 to 10 ibuprofen tablets (400 mg). This child presented with apneic and cyanotic symptoms, necessitating oxygen supplementation and intravenous fluids. Blood analysis conducted approximately 8½ hours post-ingestion revealed a serum ibuprofen concentration of 102.9 mcg/mL.

Conversely, in two separate instances, children weighing around 10 kg ingested approximately 120 mg/kg of ibuprofen without exhibiting acute intoxication symptoms. Notably, one of these children had a blood level of 700 mcg/mL measured 90 minutes after ingestion, indicating that significant variability in response can occur.

In an adult case, a 19-year-old male consumed 8,000 mg of ibuprofen over several hours. He experienced dizziness but ultimately recovered following parenteral hydration and three days of bed rest, highlighting the importance of supportive care in managing ibuprofen overdose.

For the management of acute overdosage, it is critical to empty the stomach through vomiting or gastric lavage within one hour of ingestion, as little drug will likely be recovered after this period. The administration of alkali and the induction of diuresis may be beneficial due to the acidic nature of ibuprofen and its urinary excretion. Additionally, oral activated charcoal can be utilized to reduce further absorption of the drug.

Supportive measures are paramount in the management of ibuprofen overdose. Continuous monitoring for signs of toxicity is essential, and healthcare professionals should provide appropriate care based on the clinical presentation of the patient.

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, during pregnancy has been associated with several teratogenic effects. Administration of NSAIDs at approximately 30 weeks gestation or later increases the risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs from around 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.

In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has resulted in increased pre- and post-implantation loss. Prostaglandins play a crucial role in fetal kidney development, and published animal studies have indicated that prostaglandin synthesis inhibitors can impair kidney development when given at clinically relevant doses.

Due to the risks associated with NSAID use, it is advised to avoid the use of ibuprofen tablets 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 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 demonstrated evidence of developmental abnormalities. Nonetheless, it is important to note that animal reproduction studies are not always predictive of human responses.

Postmarketing Experience

During postapproval use of ibuprofen, the following adverse reactions have been identified. These reactions were reported voluntarily from a population of uncertain size, making it challenging to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and appendages-related adverse reactions include exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).

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 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 of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis. They should be encouraged to seek medical advice upon observing 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, such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which may also result in hospitalization or death. Although serious skin reactions may occur without warning, patients should be alert for signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity, such as itching. They should be instructed to seek medical advice if they observe 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 advised to be alert for symptoms of congestive heart failure, including 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, which may include nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms. If these occur, patients should be instructed to stop therapy and seek immediate medical attention.

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

Pregnant women should be informed 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 advised that monitoring for oligohydramnios may be required if treatment continues for longer than 48 hours.

Healthcare providers should monitor patients for signs or symptoms of gastrointestinal bleeding, as serious gastrointestinal tract ulcerations and bleeding can occur without warning symptoms. Patients on long-term treatment with NSAIDs 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 systemic manifestations occur (e.g., eosinophilia, rash, etc.), or if abnormal liver tests persist or worsen, ibuprofen tablets should be discontinued.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, may experience borderline elevations in liver tests, occurring in up to 15% of cases. Notable elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have been reported in approximately 1% of patients in clinical trials. Additionally, anemia can occur, and patients on long-term NSAID therapy should have their hemoglobin or hematocrit monitored if they show signs of anemia. Postmarketing studies have also indicated positive stool occult blood tests and elevated serum creatinine levels.

Clinicians should counsel patients prior to initiating NSAID therapy and periodically throughout treatment. Patients are encouraged to read the accompanying NSAID Medication Guide and to be vigilant for symptoms of cardiovascular thrombotic events, such as chest pain, shortness of breath, weakness, or slurred speech, which should be reported to a healthcare provider immediately. Furthermore, postmarketing clinical studies have revealed a higher incidence of decreased hemoglobin levels than previously documented, with significant decreases observed in 17.1% of patients taking 1600 mg daily for osteoarthritis and 22.8% of those taking 2400 mg daily for rheumatoid arthritis. Rare cases of aseptic meningitis with fever and coma have also been reported in patients undergoing ibuprofen therapy.

FDA Insert (PDF)

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

View full prescribing information (PDF)