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Nurofen 400

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Nurofen 400

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Nurofen 400

Quick Facts

Property Description
Active ingredient Ibuprofen
Form Tablet (Oral solid dosage form)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Relief of pain, inflammation, and fever
Origin Synthetic (Propionic acid derivative)

What Type of Medicine is Nurofen 400?

Nurofen 400 is a pharmaceutical preparation classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), which belongs to a major drug class recognized for providing symptomatic relief. The medication's active ingredient is Ibuprofen, a synthetic Propionic acid derivative that acts systemically when taken via the oral route of administration as an oral solid dosage form. Ibuprofen is utilized for its anti-inflammatory and analgesic properties, which stem from the compound's mechanism for modulating the body's inflammatory process.


Composition and General Purpose of the 400 mg Tablet

The preparation contains a defined 400 mg strength of the sole active ingredient, Ibuprofen, making it a single active ingredient product (monotherapy). The core therapeutic purpose is to achieve pain relief, inflammation reduction, and fever reduction in adults and adolescents. As a medication for managing pain and inflammation, this high-strength tablet is engineered for efficient systemic uptake, delivering the necessary concentration of Ibuprofen to target body-wide discomfort effectively.


How Does Ibuprofen Differ from Other Pain Relievers?

Ibuprofen's key distinction among common pain relievers lies in its simultaneous capacity to reduce inflammation alongside its role as an analgesic and fever reducer. As an NSAID, it offers a broader scope of symptomatic treatment compared to purely analgesic compounds. Its ability to directly modulate the inflammatory cascade means it is effective not just for general aches, but specifically where swelling or localized irritation is contributing to the discomfort, thereby providing more complete relief.

Regulatory References

  1. MedlinePlus: Ibuprofen
  2. NIH: Ibuprofen Clinical Pharmacology
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What side effects are possible with Nurofen 400?

Possible Side Effects and Safety Information

The safety profile for this medicine is officially documented through classification of adverse reactions primarily by frequency and System-Organ Class (SOC). This information, derived from regulatory agencies, outlines the known risks associated with use.


Key Safety Domains

Adverse reactions are grouped by the body systems they affect, with major emphasis on:

  • Gastrointestinal Disorders: Reactions include common effects like nausea, vomiting, and dyspepsia, extending to serious risks such as ulceration, bleeding, and perforation of the stomach or intestines. The risk of these serious events increases with higher doses and prolonged use.
  • Cardiovascular and Thromboembolic Events: Regulatory information specifies an increased risk of serious events like myocardial infarction (heart attack) and stroke, particularly at higher daily doses (e.g., above 1,200 mg) and with long-term treatment.
  • Hypersensitivity Reactions: Allergic reactions can range from uncommon skin rashes and pruritus to very rare, severe systemic reactions, including anaphylactic shock and severe skin disorders (e.g., Stevens-Johnson syndrome).
  • Renal and Hepatic Impairment: Rare effects include kidney damage, acute renal failure, and liver dysfunction. Elderly patients and those who are dehydrated may be at a greater risk of kidney issues.

Safety Restrictions and Limitations

Specific conditions and populations are subject to Contraindications where the medicine should not be used due to heightened risk. These include:

  • Patients with active or a history of recurrent peptic ulcer or gastrointestinal bleeding.
  • Individuals with severe heart failure (NYHA Class IV), severe liver failure, or severe renal failure.
  • The third trimester of pregnancy.
  • Patients who have previously experienced asthma, angioedema, or hives after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).

To minimize risks, regulatory guidance emphasizes using the lowest effective dose for the shortest duration necessary.

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Overdose and Emergency Response

Overdose and When to Seek Help

This information is derived strictly from government regulatory documents and describes the officially documented manifestations and required emergency actions for an overdose of Ibuprofen (Nurofen 400).


Documented Overdose Presentations

Overdose may initially present with nausea, vomiting, diarrhea, and abdominal pain.

More severe manifestations documented in official labeling include Central Nervous System (CNS) effects such as drowsiness, confusion, agitation, headache, and potentially seizures or coma. Severe cases may also involve hypotension, metabolic acidosis, and acute renal failure.


Required Emergency Action

Immediate medical attention is required in all suspected cases of overdose, even if the person appears well initially, as severe symptoms may be delayed. Individuals should contact a Poison Control Center or emergency services right away.

No specific antidote is known for Ibuprofen overdose. Management is officially classified as symptomatic and supportive, addressing the clinical signs that manifest. Procedures in a hospital setting may include the administration of activated charcoal and continuous observation with monitoring of vital signs.

Regulatory authorities note that children are more susceptible to severe toxicity, and ingestions above a specific threshold typically mandate hospitalization and monitoring.

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Therapeutic Uses of Nurofen 400

What Nurofen 400 Treats: Main Uses and Benefits

Nurofen 400 mg is commonly used to provide symptomatic relief across several therapeutic domains. The primary symptomatic benefit involves easing symptoms related to inflammatory or irritative states and managing pain where swelling may be a contributing factor.

The medication is applied in addressing pain and discomfort in conditions such as osteoarthritis flares, musculoskeletal injuries, dental pain, and the episodic manifestations of migraine attacks and primary dysmenorrhea (menstrual cramps). It also supports the management of symptoms related to heightened physiological activity by helping to moderate fever and generalized aches associated with acute episodes like the common cold or flu.

“This medication is considered relevant when supportive symptom management is appropriate, assisting with maintaining functional stability during difficult episodes.”

This application provides support that helps ease the overall symptom burden and contributes to improved comfort during phases when symptoms become more noticeable.


Quick Fact: Relief for Pain, Inflammation, and Fever
Symptom Scope Targets symptoms related to physical discomfort, inflammatory states, and heightened physiological activity.
Key Scenarios Acute episodic pain, rheumatic condition flares, acute symptomatic episodes.
Patient Benefit Supports the patient by easing distress and contributing to functional stability during symptomatic periods.

Regulatory References

  1. NIH DailyMed Labeling Information
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Eligibility and Restrictions for Use

Who Can and Cannot Use Nurofen 400?

The population eligibility for Nurofen 400 mg is determined by mandatory regulatory classifications, focusing on age, medical history, and physiological status. The medicine is primarily intended for Adults and Adolescents 12 years of age and 40 kg body weight [1.2, 2.2].

Contraindicated populations must not use the medicine, as documented in official labeling [1.1, 2.1]:

  • Patients with severe heart, hepatic, or renal failure (NYHA Class IV for heart failure).
  • Patients with active or recurrent gastrointestinal ulceration/haemorrhage or a history of bleeding related to previous NSAID therapy.
  • Individuals with known hypersensitivity to Ibuprofen, Aspirin, or other NSAIDs.
  • Patients in the last trimester of pregnancy (after 30 weeks gestation) [2.1].
  • Patients in the setting of coronary artery bypass graft (CABG) surgery [1.2].
Restricted Use Official Eligibility Status
Elderly patients (65 years) Use requires particular caution and monitoring; the lowest effective dose should be used [1.1, 2.1].
First/Second Trimester Pregnancy Use should be avoided unless clearly necessary; limit to lowest dose/shortest duration [1.5, 2.2].
Mild/Moderate Organ Impairment Use requires caution and monitoring; the lowest dose should be used [1.1, 2.1].
Women Attempting to Conceive Use is not recommended [1.5, 2.8].

This 400 mg tablet formulation is not recommended for children under 12 years of age [2.4].

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Nurofen 400 (Ibuprofen) is structured around official regulatory statements that define specific co-administration risks and constraints.

Contraindicated Combinations and Key Restrictions

Co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or high-dose Aspirin is prohibited due to an increased and cumulative risk of adverse events. Ibuprofen is also contraindicated for use during the setting of coronary artery bypass graft (CABG) surgery. Consumption of three or more alcoholic drinks daily while using Ibuprofen is officially associated with an increased risk of serious gastrointestinal bleeding.


Pharmacodynamic and Pharmacokinetic Interactions

Ibuprofen interacts with several medicinal product classes through two main mechanisms documented in regulatory labels:

Interaction Type Interacting Agents Officially Documented Outcome
Pharmacodynamic Anticoagulants (e.g., Warfarin), Oral Corticosteroids, SSRIs Increased risk of serious bleeding or gastrointestinal damage.
Pharmacodynamic Low-Dose Aspirin (Cardioprotective) Interference with the antiplatelet effect of Aspirin.
Pharmacokinetic Lithium, Digoxin, Methotrexate Increased plasma concentration (exposure) of the co-administered drug due to reduced renal clearance.

Efficacy and Timing Constraints

Ibuprofen may diminish the antihypertensive and natriuretic effects of Diuretics and ACE Inhibitors (angiotensin-converting enzyme inhibitors), particularly in patients with pre-existing renal impairment. To minimize interference with immediate-release low-dose Aspirin, the regulatory label advises a timing separation rule: Ibuprofen should be administered at least 2 hours before or 8 hours after the aspirin dose. Taking Ibuprofen with food may delay the rate of absorption but does not alter the overall extent of absorption.

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Mechanism of Action

The mechanism of Nurofen 400, centered on Ibuprofen, is defined by its ability to influence specific biological pathways through the reversible inhibition of the Cyclooxygenase (COX) enzymes.

Molecular Blockade of Inflammatory Mediators

The drug's core molecular action is the competitive inhibition of both COX-1 and COX-2 enzymes. By occupying the active site, Ibuprofen halts the conversion of Arachidonic Acid, restricting the synthesis of inflammatory mediators like prostaglandins. This action modifies the early molecular steps that shape the subsequent systemic physiological outcomes.

Modulation of Nociceptive and Thermoregulatory Pathways

This functional domain connects the molecular blockade to system-level effects. The reduction in prostaglandins diminishes the sensitization of peripheral nociceptors, which is the physiological basis for altered signaling. Simultaneously, the suppression of prostaglandin E2 specifically in the hypothalamus allows the central control of body temperature to reset. These combined effects contribute to the physiological adjustments associated with altered nociceptive and thermoregulatory responses.

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Dosage and Administration Information

How to Use Nurofen 400

The administration of 400 mg Ibuprofen follows the oral route for solid dosage forms, such as tablets and capsules. This involves a standardized procedural approach for use, distinct from clinical guidance.

General Administration Guidelines

Parameter Guideline
Route of administration Oral route (swallowed).
Dosing schedule Initial dose is typically 400 mg. Subsequent doses may be 200 mg to 400 mg. The maximum dose for short-term, non-prescription use is restricted to 1200 mg in 24 hours.
Frequency and timing Doses are taken as needed with a minimum interval of 4 to 6 hours required between administrations.
Context of intake The tablet should be swallowed whole with water and is often recommended to be taken with or immediately after food or a meal.
Duration of use For acute, non-prescription use, duration is typically restricted to 3 days for fever and 7 days for pain without medical consultation.

Administration Principles

Administration involves using the lowest effective dose for the shortest necessary duration, particularly in populations like older adults. The procedural structure requires that the tablet must not be crushed, chewed, or broken, ensuring the product is administered exactly as formulated. If a dose is missed, a double dose is not taken; instead, the next dose is taken at the next scheduled time, maintaining the required interval.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Nurofen 400

This summary describes the types of clinical evaluations conducted for Ibuprofen, the active ingredient in Nurofen 400 mg, focusing on how research has explored its use and what is still uncertain. It is strictly a review of the available evidence structure and does not determine whether an individual will respond similarly or provide treatment instructions.


## Evidence Supporting Acute Pain Relief

Research has extensively explored Ibuprofen for outcomes related to physical discomfort, particularly those associated with acute or disruptive episodes like headaches, dental pain, and musculoskeletal injuries. The primary evidence base consists of short-term Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies typically measured changes using standardized pain scales to see how research highlights changes measured during the study period over defined time intervals, such as one and two hours post-administration.

Findings describe patterns observed in the studies regarding reported changes in pain intensity over the study period. However, data show patterns related to an analgesic ceiling in the study populations, where increases in the dose beyond 400 mg was observed in some studies to not consistently yield substantial additional measurements of symptom change for mild-to-moderate pain. Furthermore, the evidence structure is heavily reliant on follow-up durations were limited, meaning that the research provides limited information for long-term outcomes or for the repeated use during extended periods of acute pain.


## Research on Fever Reduction and Inflammation-Related Pain

Ibuprofen was evaluated in studies focused on outcomes related to systemic or functional imbalance, specifically temporary physiological imbalance (fever) and outcomes linked to inflammatory or irritative states. For fever, studies explored conditions where symptoms may vary in intensity, including children, adolescents, and adults. These research scenarios monitored changes in temperature and the duration of the effect, with data show patterns related to a time-dependent change in outcomes monitoring physiological strain or stress across these patient groups.

For pain related to inflammation, such as in primary dysmenorrhea (menstrual cramps) and osteoarthritis flares, studies monitored outcomes reflecting daily functioning or activity level. The research describes that in these acute or episodic settings, studies measured changes in patient-reported outcomes describing perceived discomfort and functional measures. However, certainty remains low when considering efficacy over extended periods, as the follow-up durations were limited to the acute phase of these conditions characterized by fluctuating or episodic manifestations.

Key Studies & References

  1. DailyMed Labeling Information: Ibuprofen
  2. MedlinePlus: Ibuprofen
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Frequently Asked Questions (FAQ)

Common questions about Nurofen 400 (FAQ)

Q: What is the difference between Nurofen 400 and regular ibuprofen tablets?

Regulatory guidance defines generic equivalents as having the same active ingredient (Ibuprofen) and yielding the same therapeutic effect as the brand-name version. While both Nurofen 400 and generic 400 mg Ibuprofen are considered therapeutically equivalent, they may differ in their inactive ingredients, such as coloring agents, preservatives, or fillers.

Q: Are generic 400mg ibuprofen tablets the same as brand-name Nurofen 400?

Regulatory agencies generally classify all approved generic products containing 400 mg of Ibuprofen as therapeutically equivalent to the brand-name product. This means the products are expected to work in the same way and provide the same benefit.

Q: What signs might indicate a stomach or gastrointestinal side effect while taking Nurofen 400?

Official warnings state that patients should be alert for symptoms that may suggest a serious gastrointestinal side effect. These indicative signs include severe pain in the upper abdomen (epigastric pain), persistent upset stomach (dyspepsia), and any evidence of bleeding, such as black stools (melena) or vomiting blood (hematemesis).

Q: Does taking Nurofen 400 occasionally still carry a risk of cardiovascular issues?

Official warnings state that the increased risk of serious cardiovascular events may occur early in treatment, not only after long-term use. Regulatory guidance describes that to minimize potential risk, the drug should be used at the lowest effective dose for the shortest possible duration.

Q: What specific symptoms related to heart or stroke risk are mentioned in warnings for Nurofen 400?

Regulatory guidance states that specific symptoms related to serious cardiovascular thrombotic events are listed, and patients should be alert for them. These include sudden chest pain, shortness of breath, weakness on one side of the body, or slurring of speech.

Q: What is the significance of the warning about Nurofen 400 and high blood pressure?

Official regulatory documents state that Ibuprofen, like other Non-Steroidal Anti-Inflammatory Drugs, can lead to the onset of new high blood pressure or worsen existing high blood pressure. This effect is a documented concern because hypertension is a risk factor for cardiovascular events.

Q: What are the risks of Nurofen 400 for a person with asthma?

Ibuprofen is contraindicated for individuals who have previously experienced asthma, swelling (angioedema), or hives after taking aspirin or other NSAIDs. This is due to the potential risk of cross-reactivity, which can lead to severe breathing difficulties, known as bronchospasm.

Q: Is Nurofen 400 absorbed faster than other forms of ibuprofen?

The Pharmacokinetics section of official product information may indicate that certain formulations of Ibuprofen, such as liquid-filled capsules, may be absorbed at a faster rate compared to standard oral tablets. This difference in absorption rate relates to the time it takes for the active ingredient to enter the bloodstream.

Q: Does Nurofen 400 have a potential effect on fertility in women?

Studies and official product information indicate that Ibuprofen belongs to a class of medicines that may temporarily impair female fertility by interfering with the process of ovulation. This effect is described as reversible upon stopping the medicine.

Q: How quickly should the pain relief effect of Nurofen 400 be felt?

For standard oral tablet formulations, the onset of pain relief is generally expected to begin within 30 minutes of administration, although maximum effect may take longer.

Q: How long is Nurofen 400 expected to provide pain relief?

The analgesic effects of a single dose are typically expected to last for approximately 4 to 6 hours. The minimum time interval required between doses is based on this typical duration of action, according to official administration guidelines.

Q: Is there a risk of stomach irritation from Nurofen 400 even when taken with food?

Taking the tablet with or immediately after food is generally recommended as it can help reduce minor stomach upset. However, official warnings state that the overall risk of serious gastrointestinal events, such as ulceration or bleeding, is still present and increases with the dose and duration of use.

Q: Can Nurofen 400 cause dizziness or drowsiness?

Official documents list central nervous system effects such as dizziness and headache as potential side effects. Due to these potential effects, official guidance includes a caution regarding operating vehicles or machinery if impairment is experienced.

Q: Is a headache a listed side effect of taking Nurofen 400?

Yes, headache is officially listed as a possible side effect of Ibuprofen use in regulatory product information.

Q: What is the concern about Nurofen 400 and kidney function?

The primary concern with Non-Steroidal Anti-Inflammatory Drugs like Ibuprofen is their ability to affect blood flow to the kidneys. In rare instances, this can lead to kidney damage or acute renal failure. This effect is often temporary and reversible once the medicine is stopped.

Q: Are there specific patient groups where the risk of kidney problems with Nurofen 400 is higher?

Official warnings identify certain patient groups as having a greater risk of kidney issues. These groups include older adults, patients who are dehydrated, and those with pre-existing kidney or heart problems.

Q: What is the recommendation for taking Nurofen 400 if a person has a history of stomach ulcers?

Official regulatory documents list an active or recurrent history of peptic ulcer or gastrointestinal bleeding as a definitive contraindication. The existence of this contraindication means the medicine is generally not recommended for use by individuals with these conditions.

Q: Is there a link between Nurofen 400 and the worsening of IBD symptoms (Crohn’s/Colitis)?

Official warnings regarding the serious risk of gastrointestinal bleeding and ulceration are highly relevant for individuals with Inflammatory Bowel Disease (IBD). NSAID use may be associated with exacerbations of conditions like Crohn’s disease or ulcerative colitis.

Q: What is Tinnitus, and is it a possible side effect of Nurofen 400?

Tinnitus is the term for a persistent ringing, buzzing, or hissing sound in the ears. Official product information lists tinnitus as an uncommon adverse reaction associated with Ibuprofen use.

Q: Are there any known concerns about using Nurofen 400 while breastfeeding?

Official information notes that Ibuprofen may be present in human milk. Due to the potential for adverse reactions in nursing infants, official guidance states that a choice must be made between discontinuing breastfeeding or discontinuing the medicine.

Q: Is there a specific warning about allergic reactions to Nurofen 400 for people allergic to aspirin?

Regulatory alerts state that Ibuprofen may cause a severe allergic reaction, particularly in people who have a known hypersensitivity or allergy to aspirin or other Non-Steroidal Anti-Inflammatory Drugs. This is due to a risk of cross-reactivity.

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How should Nurofen 400 be stored and disposed of?

How to Store and Dispose of Nurofen 400?

This section outlines the official regulatory requirements for storing and disposing of Nurofen 400 (Ibuprofen).


Storage Requirements

  • Temperature: Store below 25 C or 30 C (varies by formulation/label).
  • Protection: Keep the product in its original package to protect it from moisture.
  • Safety: Keep out of reach of children. The shelf-life is typically 2 to 3 years, as indicated by the expiry date.

Disposal Requirements

  • Method: Unused or expired medication must be disposed of in accordance with local requirements, which often involves returning it to a pharmacy.
  • Environmental: The product should not be allowed to enter drains, water courses, or the soil to prevent environmental contamination.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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