Bufen

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Medically reviewed

Rosario Oropesa

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.

Overview of Bufen

What is Ibuprofen? (Bufen)

Property Description
Active Ingredient Ibuprofen
Form Tablets, capsules, oral suspension, topical gel
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common Use Symptomatic relief of pain, fever, and inflammation
Chemical Family Propionic acid derivative

Ibuprofen is the International Nonproprietary Name (INN) for a medication widely relied upon for its analgesic (pain-relieving), antipyretic (fever-reducing), and anti-inflammatory effects. It is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID), which means it works by interfering with the body's production of chemicals that cause inflammation and pain.

The widespread trust in this active ingredient is underscored by its inclusion on the World Health Organization's (WHO) Model List of Essential Medicines. This recognition signifies that ibuprofen is considered one of the most effective and safe medicines required in a basic health system globally.

Chemically, ibuprofen is a propionic acid derivative. It is available both over-the-counter (OTC) and by prescription, marketed under various common brand names globally. The medication is versatile, manufactured in forms specifically designed for rapid absorption, as well as concentrated liquids tailored for pediatric use.

What side effects are possible with Bufen?

Possible Side Effects and Safety Information

The safety profile of Ibuprofen (Bufen), classified as a Nonsteroidal Anti-inflammatory Drug (NSAID), is documented by regulatory authorities (such as the FDA and EMA) with specific attention to adverse reactions classified by system and frequency.

Official Adverse Reaction Classification

The most significant risks are categorized around the Gastrointestinal and Cardiovascular systems. Gastrointestinal disorders, such as dyspepsia, abdominal pain, and nausea, are among the officially listed Common side effects. Uncommon events include gastrointestinal ulceration or hemorrhage.

System-Organ Class (SOC) Examples of Officially Documented Adverse Reactions
Gastrointestinal Disorders Dyspepsia, nausea, abdominal pain, ulceration, bleeding
Nervous System Disorders Headache, dizziness, aseptic meningitis (rare)
Cardiac/Vascular Disorders Hypertension, heart failure, thrombotic events
Skin Disorders Rash, pruritus, severe bullous reactions (very rare)

Serious Safety Considerations

Official labeling documents serious risks, including the potential for cardiovascular thrombotic events (such as myocardial infarction and stroke) and severe gastrointestinal bleeding, which can be fatal. These risks may increase with the duration of use and higher doses of the medicine. Severe hypersensitivity reactions, including anaphylaxis and severe skin conditions like Stevens-Johnson Syndrome, are also documented as rare but serious adverse reactions.

Population-Specific Safety Notes

Regulatory documents emphasize that older adults have an increased frequency and severity of adverse reactions, particularly gastrointestinal bleeding. The medicine is formally contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use is also restricted in individuals with severe, pre-existing heart, renal, or hepatic failure.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Ibuprofen (Bufen) outlines specific clinical signs and required emergency actions associated with overdosage. When an overdose is suspected, immediate medical attention must be sought or a Poison Control Center should be contacted right away, as stated in the official labeling.

Documented manifestations of overdosage often involve the Central Nervous System (CNS) and Gastrointestinal (GI) systems. Common signs may include nausea, vomiting, epigastric pain, drowsiness, dizziness, and tinnitus. Serious or life-threatening outcomes officially documented include profound CNS depression (seizures, coma), acute renal failure, metabolic acidosis, hypotension, shock, and severe GI bleeding.

Urgent medical help is specifically required if an individual experiences signs of internal bleeding, such as bloody or black stools, vomiting blood, or sudden faintness. The management protocol described in regulatory texts confirms that no specific antidote is known for Ibuprofen. Treatment is symptomatic and supportive, focusing on continuous monitoring of vital signs, procedures such as gastric lavage, and the use of activated charcoal to reduce drug absorption, where appropriate. Population-specific regulatory notes indicate that children who ingest amounts greater than 400 mg/kg are at higher risk of serious toxicity and require urgent evaluation.

Therapeutic Uses of Bufen

The medication Bufen (Ibuprofen) is used across therapeutic areas to provide key symptomatic support, which contributes to easing the overall symptom load and contributes to easing day-to-day comfort during periods of heightened symptoms. It is primarily relevant for conditions characterized by symptoms related to physical discomfort and systemic imbalance.

The medicine is applied across conditions presenting with localized discomfort, such as minor pain of arthritis, pain from sprains and strains, headaches, toothache, and the acute, cyclical discomfort of menstrual cramps. It is also used for managing systemic symptoms, including fever and body aches associated with the common cold or flu. This supportive relief may assist patients with maintaining functional stability during difficult episodes.

“This medication is commonly used across conditions presenting with acute episodes where supportive symptom management is appropriate.”


Quick Fact: Symptomatic Support for Inflammation
Bufen is applied to ease symptoms related to inflammatory or irritative states, and may help reduce localized swelling and joint tenderness.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Bufen? — Official Regulatory Information

Official regulatory documents define specific populations who are restricted from using Bufen (Ibuprofen) due to documented health risks, primarily listed as contraindications.


Eligibility Scope

Classification Population Restrictions
Populations for whom use is contraindicated Known hypersensitivity or allergic-type reactions (e.g., asthma, urticaria) to Ibuprofen, aspirin, or other NSAIDs. Active gastrointestinal (GI) bleeding or peptic ulceration, or a history of recurrent ulcer/GI haemorrhage. Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Severe heart failure (NYHA Class IV), severe hepatic failure, and severe renal failure (GFR < 30mL/min).
Pregnancy and Lactation Status Contraindicated from the start of the third trimester (30 weeks gestation) due to risk of premature closure of the fetal ductus arteriosus. Use should generally be avoided from 20 weeks gestation due to the risk of fetal renal dysfunction leading to low amniotic fluid. Generally considered compatible with breastfeeding by regulatory bodies.
Age-Related Rules OTC formulations have specific minimum age requirements (e.g., often not for children under 6 months of age). Pediatric use for some prescription forms may not be established. Use in elderly patients (over 65) requires caution due to increased risk of GI ulceration, bleeding, and adverse cardiovascular effects.

Resulting Eligibility Structure

Official labeling determines who must not use the medicine by explicitly prohibiting use in high-risk scenarios defined by organ function severity (severe heart, liver, or kidney failure) and specific clinical history (known hypersensitivity, active GI issues). The most strict prohibitions apply to patients immediately following CABG surgery and those in the third trimester of pregnancy. Individuals with pre-existing conditions like hypertension or moderate organ impairment are categorized for use with caution, indicating restricted but not absolutely prohibited eligibility.

What should I know about interactions with other medicines?

Bufen Interactions with other medicines and products

This section outlines interactions with other medicines and products as officially documented in government regulatory sources.

Official Contraindicated Combinations and Restrictions

  • Other NSAIDs: The concomitant use of Ibuprofen with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including COX-2 selective inhibitors, is officially advised against due to the documented increased risk of gastrointestinal bleeding or ulceration.
  • High-Dose Aspirin: Combining Ibuprofen with high-dose Acetylsalicylic Acid (Aspirin) is not generally recommended as it increases the risk of adverse reactions.
  • Surgical Setting: Ibuprofen is formally contraindicated for the management of peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Clinically Significant Interactions

Ibuprofen has documented interactions that can alter the effects or clearance of co-administered medicines:

  • Increased Bleeding Risk: Ibuprofen can enhance the effects of anticoagulants (e.g., Warfarin) and, with co-administration of oral corticosteroids or SSRIs, significantly increases the risk of bleeding [2.4].
  • Altered Clearance: Regulatory documents state that Ibuprofen can reduce the renal clearance of drugs such as Lithium and Methotrexate, which may result in increased plasma levels of these medicines [2.4].
  • Antagonistic Effects: Ibuprofen may officially diminish the therapeutic effect of certain Anti-hypertensives (ACE inhibitors, ARBs) and Diuretics [1.7, 2.4].

Timing and Population Constraints

  • Timing Separation: To avoid competitive inhibition of the cardioprotective effect of low-dose, immediate-release Aspirin, specific regulatory instructions require dose separation [3.3].
  • Mifepristone: Official constraints state that Ibuprofen should not be used for 8–12 days following Mifepristone administration [2.4].
  • Alcohol: Official labeling notes that consuming three or more alcoholic drinks daily may increase the risk of gastrointestinal bleeding when combined with Ibuprofen [1.5].

Mechanism of Action

Bufen's primary biological target is the family of cyclooxygenase (COX) enzymes, specifically acting as a non-selective, reversible inhibitor of both COX-1 (PTGS1) and COX-2 (PTGS2) isoforms.

Within the cell, this interaction prevents the COX enzymes from catalyzing the conversion of arachidonic acid into prostaglandin H₂ (PGH2). This molecular action is the initial step in the eicosanoid pathway leading to the synthesis of various prostanoids, including prostaglandins (e.g., PGE2, PGI2, PGF2alpha) and thromboxane A₂ (TXA2).

The intracellular consequence is a dose-dependent reduction in the overall biosynthesis and subsequent release of these bioactive lipid mediators. Downstream cascades of reduced prostaglandin and thromboxane signaling modulate several system-level physiological processes. Specifically, the diminished PGE2 concentration in the central nervous system contributes to the modulation of hypothalamic temperature regulation, leading to increased heat dissipation. Furthermore, the overall systemic reduction of prostanoid concentrations modifies processes such as vasodilation, vascular permeability, and the excitation threshold of nociceptor sensory neurons, as well as altering platelet aggregation dynamics.

Dosage and Administration Information

The usage of Bufen (Ibuprofen) is governed by distinct dosing regimens, minimum time intervals, and a core principle of minimizing exposure. The medication is administered via the Oral route (tablets, suspension), as a Solution for Intravenous (IV) Infusion, and via Topical application.


Official Dosing Protocols

Use Context Maximum Daily Dose Frequency Pattern
Non-Prescription (OTC) 1200 mg 200 mg to 400 mg every 4 to 6 hours
Prescription (Inflammatory) 3200 mg Administered in three or four divided doses

The foundational instruction for all use is to employ the lowest effective dose for the shortest duration necessary. Doses must be separated by a minimum interval of four hours. Continuous non-prescription use should not exceed 10 days for pain without professional guidance.

Administration Specifics

Oral formulations are recommended to be taken with food or milk to help mitigate gastrointestinal discomfort. Liquid suspensions must be shaken well and measured using a proper dosing device. The IV form is administered as a short infusion over a minimum time period (e.g., 15 minutes) when used in specialized settings. For pediatric patients, the dose is determined using weight-based calculations, adhering to the official maximum daily limit. If a scheduled dose is missed, it should be skipped if the next dose is nearly due, and doses must not be doubled.

Recent Clinical Evidence

Bufen: Recent Clinical Evidence

Clinical research consistently supports the use of Bufen (a fixed-dose combination of ibuprofen and paracetamol/acetaminophen) for the effective management of acute, mild-to-moderate pain and fever. The combination is grounded in the complementary mechanisms of action of its two components: ibuprofen provides analgesic, anti-inflammatory, and antipyretic effects, while paracetamol offers its own distinct analgesic and antipyretic action. This dual approach is often cited as the reason for its superior efficacy compared to using either drug alone (monotherapy).


Efficacy Data

Multiple randomized, double-blind trials, particularly those focusing on postoperative dental pain (a highly sensitive pain model), have demonstrated that the fixed-dose combination provides significantly greater and longer-lasting pain relief than monotherapies of ibuprofen or paracetamol at equivalent doses. Pooled analyses and systematic reviews confirm that the combination is an effective analgesic in various acute pain states, including:

  • Headache and earache
  • Dental pain (odontalgia)
  • Musculoskeletal injuries

In studies focusing on fever reduction, the combination has been shown to provide longer fever-free periods than paracetamol monotherapy alone, suggesting enhanced antipyretic action.


Safety and Tolerability Profile

Bufen’s use of fixed-dose combination allows for lower dosages of each active ingredient compared to the maximum non-prescription dose of each monotherapy, which is hypothesized to contribute to its favorable tolerability profile. In clinical trials and meta-analyses, the fixed-dose combination has generally been shown to be well tolerated, with a safety profile comparable to its individual components when used at standard non-prescription doses.

Reported adverse events are typically mild and transient. No significant increase in the risk of severe gastrointestinal or hepatic events has been confirmed with the short-term use of the combination at recommended doses. Patients should, however, be aware of the same precautions and contraindications that apply to ibuprofen (risk of gastrointestinal side effects and cardiovascular events) and paracetamol (risk of hepatotoxicity) when they are taken individually.

Frequently Asked Questions (FAQ)

Common questions about Bufen (FAQ)

Q: How quickly should I expect Bufen to start working?

Studies of the fixed-dose combination indicate that the active ingredients are generally absorbed and reach their peak levels in the bloodstream relatively quickly after being taken orally. The onset of action, or the rate at which the medication’s effect becomes noticeable, may vary among individuals. Absorption is described in product information as potentially being affected when the medicine is taken with food.


Q: Can Bufen make existing stomach problems worse?

Official warnings state that the medicine should be used with caution in individuals who have a history of gastrointestinal diseases, such as Crohn's disease or ulcerative colitis. Regulatory documents mention the risk of the medicine causing an exacerbation (worsening) of these pre-existing conditions.


Q: Is Bufen safe to take with common cold or flu medicines?

Official restrictions strongly advise against combining Bufen with any other products that already contain paracetamol, ibuprofen, or other Nonsteroidal Anti-inflammatory Drugs (NSAIDs). The official warning is that combining these products carries an increased risk of serious side effects, including the potential for an overdose of the active ingredients.


Q: What is the difference between the uses of Bufen versus ibuprofen?

Bufen is specifically a fixed-dose combination of two active ingredients: ibuprofen and paracetamol. This formulation is designed to provide complementary analgesic (pain-relieving) and antipyretic (fever-reducing) actions. The product called 'ibuprofen' alone refers only to the single, individual Nonsteroidal Anti-inflammatory Drug (NSAID) ingredient.


Q: Can Bufen be crushed or split?

Regulatory documentation does not provide instructions for altering the standard solid dosage form (tablets) of Bufen. Official instructions generally apply to the specific formulation. Specific formulations, such as those designed to be dissolved, will have explicit instructions for their preparation.


Q: Can Bufen cause trouble sleeping?

Official safety documents for the medicine's active ingredients, which work on the central nervous system, have documented effects such as somnolence (drowsiness) and confusion. While difficulty sleeping (insomnia) is not frequently documented, related neurological effects have been documented as possible undesirable effects.


Q: Why do some people say Bufen made them feel dizzy?

Dizziness is documented as a common undesirable effect of the ibuprofen component of the medicine and is officially listed under Nervous System Disorders. Like other side effects, this reaction may occur following the administration of Nonsteroidal Anti-inflammatory Drugs (NSAIDs).


Q: Can Bufen be taken on an empty stomach?

Regulatory texts officially advise taking the medicine with food or milk. This administration method is advised to help minimize the risk of gastrointestinal (stomach-related) side effects, such as abdominal discomfort, which is a common effect of the ibuprofen component.


Q: Does Bufen affect the ability to drive?

Official warnings state that certain undesirable effects such as dizziness, fatigue, and visual disturbances are possible after taking the medicine. If an individual is affected by these reactions, official warnings state they should refrain from driving or operating machinery.


Q: Is it safe to use Bufen if I have high blood pressure?

Official documentation states that the medicine should be used with caution in individuals with pre-existing hypertension (high blood pressure) or a history of heart failure. The ibuprofen component can potentially cause or worsen fluid retention and hypertension.


Q: Can Bufen interact with dietary supplements?

Regulatory guidance generally advises informing a healthcare provider about all concomitant products, including vitamins, dietary supplements, and herbal remedies. Official documentation notes there is often insufficient information to confirm the safety of complementary products when taken with the drug’s active ingredients.


Q: Is it possible for Bufen to cause changes in mood?

Official adverse reaction reports for the medicine's components have rarely included psychiatric disorders. These reactions, which relate to changes in mental state or mood, have included reports of confusion, depression, and hallucinations.


Q: Does Bufen have any long-term effects on the liver or kidneys?

Regulatory warnings indicate that prolonged use, particularly at high doses, has been associated with risks to the liver and kidneys. The paracetamol component carries a known risk of liver damage (hepatotoxicity), and the ibuprofen component carries a risk of kidney damage (renal impairment), especially in at-risk individuals.


Q: Is Bufen approved for children or teenagers?

Official regulatory approval for the fixed-dose combination generally covers use in adults and adolescents aged 12 years and older. The use of this medicine in younger pediatric populations depends on completed safety and efficacy studies for the specific formulation.


Q: What if I take Bufen and then feel sick to my stomach?

Nausea, vomiting, and abdominal discomfort are listed as common gastrointestinal side effects of the medicine. Official guidance documents require seeking immediate attention if severe symptoms occur, such as signs of bleeding, perforation, or a serious allergic reaction.


Q: Can men and women use Bufen differently?

Official regulatory documents do not specify differences in use based on sex. The only population-specific restrictions and cautions apply to individuals who are or may become pregnant, which relates to the third trimester contraindication.


Q: Is Bufen known to cause allergic reactions?

Hypersensitivity (severe allergy) to the active ingredients or other NSAIDs is a formal contraindication. Serious skin reactions, including rash, blistering, and swelling of the face, are documented as rare but potentially fatal adverse events, requiring immediate discontinuation.


Q: Can I take Bufen with caffeine?

Official regulatory documents do not specifically prohibit the combination of Bufen with caffeine. While caffeine is sometimes included in other analgesic products, there are no specific warnings or restrictions about consuming caffeine while taking Bufen.


Q: Is there a generic version of Bufen available?

Official regulatory approvals confirm that the fixed-dose combination of ibuprofen and paracetamol is available under various brand names and as generic medications. Availability is subject to the specific marketing and regulatory status in each country.


Q: Are headaches a common side effect of Bufen?

Yes, headache is listed as a common undesirable effect of the medicine's components in official safety documents. It is categorized under Nervous System Disorders.


Q: Can Bufen interact with herbal teas or remedies?

Regulatory guidance generally advises informing a healthcare provider of all herbal remedies and supplements being taken. Official documentation notes there is often insufficient information to confirm the safety of these products when combined with the active ingredients in Bufen.


Q: Is Bufen considered addictive?

The active ingredients in Bufen are ibuprofen and paracetamol, which are officially classified as non-narcotic analgesics. They are not listed as controlled substances by regulatory agencies, meaning they are not associated with a defined potential for dependence or abuse.


Q: What kind of research has been done on Bufen in older adults?

Official warnings state that older adults have an increased frequency and severity of adverse reactions, particularly serious gastrointestinal and cardiovascular events. Official documentation includes a recommendation to use the lowest effective dose for the shortest duration possible in this population to help mitigate documented risks.


Q: How long does the effect of Bufen typically last?

The duration of the medicine’s effect is aligned with its recommended dosing frequency. Non-prescription use generally suggests a dose interval of every 4 to 6 hours, which is based on maintaining adequate levels of the medication in the body to control symptoms.


Q: Is Bufen effective for nerve pain?

Official indications for Bufen relate to the short-term management of mild-to-moderate acute pain, such as headache, dental, and musculoskeletal pain. The efficacy of the combination for specific conditions like nerve (neuropathic) pain is not detailed in the general regulatory documentation defining its approved uses.


Q: Why is Bufen a regulated substance?

Bufen is regulated due to its classification as a Nonsteroidal Anti-inflammatory Drug (NSAID) and the potential for serious adverse effects with misuse. Its components are often included on the World Health Organization’s (WHO) Model List of Essential Medicines, confirming its therapeutic value and the necessity for safety controls.


Q: Can Bufen cause hair loss?

Hair loss (alopecia) has been documented in rare post-marketing reports for the medicine's ibuprofen component. However, it is not listed as a common or frequent side effect in primary regulatory safety documents.


Q: What do official sources say about taking Bufen for non-approved conditions?

Official regulatory documents define the approved uses (indications) for the medicine. The regulatory label does not provide information or guidance for the use of the drug for any purpose outside of its officially approved indications.


Q: Does Bufen cause water retention or swelling in the feet?

Official safety data lists fluid retention (edema) and swelling as possible common side effects of the ibuprofen component. This is specifically noted as a concern for individuals who have pre-existing hypertension (high blood pressure) or heart failure.


Q: Why do some people need to adjust their diet while on Bufen?

Official documentation advises taking the medicine with food or milk to minimize gastrointestinal discomfort. Regulatory warnings also note that consuming three or more alcoholic drinks daily may increase the risk of gastrointestinal bleeding, which implies a necessary dietary adjustment related to alcohol intake.


Q: What is the common reason people stop using Bufen?

Official documentation indicates that gastrointestinal side effects like abdominal pain, nausea, and dyspepsia (indigestion) are common. Adverse events are a factor in discontinuation, and official trials suggest the tolerability profile is comparable to its individual components.


Q: Does Bufen affect blood clotting?

Yes, the ibuprofen component of Bufen is officially known to inhibit platelet aggregation, which is a process involved in blood clotting. This effect is documented in product labeling and contributes to interactions with blood-thinning medicines (anticoagulants).

How should Bufen be stored and disposed of?

Storage and Protection Requirements

Official regulations require Bufen (ibuprofen) to be stored in a dry environment at controlled room temperature, typically between 20 C and 25 C (68 F and 77 F). The product must be kept in its original container and protected from excessive heat, moisture, and direct light to maintain its stability. It is strictly required that the medicine is kept out of the sight and reach of children.

Disposal Instructions

Expired or unused Bufen should be disposed of via an authorized drug take-back program. If a take-back option is unavailable, the official procedure is to mix the product with an undesirable substance, such as used coffee grounds, place the mixture in a sealed container, and then discard it in the household trash. This method prevents accidental ingestion and misuse. Disposal into wastewater is generally prohibited.

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

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