Apirofeno

Quick links to important sections

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.

Overview of Apirofeno

Property Description
Active ingredient Ibuprofen
Form (High-level) Oral Suspension, Film-coated Tablets, Capsules
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
General purpose Pain relief, inflammation reduction, fever management
Origin Synthetic compound (Propionic acid derivative)

Apirofeno: Definition and Chemical Classification

Apirofeno is a pharmaceutical entity defined by its active ingredient, Ibuprofen, and is officially classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). This classification denotes its core function as an agent possessing analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) properties. Ibuprofen, the substance in Apirofeno, is chemically recognized as a propionic acid derivative, a characteristic placing it within a family of synthetic compounds. Apirofeno often differentiates itself in the market through its strong focus on Child Health, particularly as offered by its manufacturer, Laboratorios ERN, in specialized liquid formulations.

Composition, General Purpose, and Differentiation

The composition of Apirofeno is that of a single-ingredient product, consisting solely of Ibuprofen combined with pharmaceutical excipients. The drug’s mechanism centers on inhibiting cyclooxygenase (COX) enzymes, thereby limiting the production of prostaglandins, which are key chemical messengers in the body's pain and inflammatory pathways. This action directly supports the drug's general purpose: the reduction of pain, inflammation, and elevated body temperature. A specific differentiator for the oral suspension format is its common supply with a specialized oral syringe graduated by patient weight, which assists in precise administration for children.

Available Forms and Accessibility Status

Apirofeno is administered via the systemic oral route and is typically formulated into high-level dosage forms such as film-coated tablets, capsules, and oral suspensions. These forms ensure suitability across various patient age groups. The liquid suspension often features the higher 40 mg/mL concentration, distinguishing it from standard lower-strength pediatric liquids. Many formulations of Apirofeno are distributed as Prescription Drugs or carry strict dispensing controls, in contrast to widely available lower-dose over-the-counter (OTC) ibuprofen products, often reflecting its specialized concentration formats.

What side effects are possible with Apirofeno?

Possible Side Effects and Safety Information

The safety profile of Apirofeno, whose active ingredient is Ibuprofen, is based strictly on classifications found in government regulatory documents.

Frequency-Classified Adverse Reactions

Adverse reactions are formally grouped by frequency and are typically classified across several System-Organ Classes. Common reactions documented in official labels involve primarily Gastrointestinal Disorders (such as dyspepsia, abdominal pain, nausea) and Nervous System Disorders (such as headache and dizziness). More severe effects, including certain haematological disorders and aseptic meningitis, are listed within Rare or Very Rare frequency tiers.

Serious Adverse Reactions and Safety Constraints

Regulatory documents emphasize the risk of serious adverse reactions that, though often rare, are clinically significant. These include potentially fatal gastrointestinal bleeding, ulceration, and perforation. The labeling also documents the risk of serious arterial thrombotic events (e.g., Myocardial Infarction and Stroke), noting that this risk is higher with longer treatment duration and higher daily doses.

Severe Hypersensitivity Reactions (such as anaphylactic shock and angioedema) and Severe Cutaneous Adverse Reactions (SCARs) are also listed as documented serious effects, with SCARs often noted to occur early in therapy. Use of the medicine is formally contraindicated for the treatment of peri-operative pain following Coronary Artery Bypass Graft (CABG) surgery and in patients with active peptic ulceration or severe, uncontrolled cardiac failure.

Population-Specific Safety Notes

The official safety information highlights specific considerations for certain patient groups. Older adults are documented to be at an increased frequency of adverse reactions, particularly serious GI bleeding. In the pediatric population, there is a noted risk of renal impairment in cases of dehydration, and the medication is contraindicated during the third trimester of pregnancy.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Apirofeno overdose describes a range of documented clinical manifestations. Common presentations often involve the Gastrointestinal system, presenting as nausea, vomiting, or abdominal pain, and the Central Nervous System (CNS), with symptoms such as headache, dizziness, lethargy, somnolence, tinnitus, or nystagmus.

Overdose carries a documented risk of severe systemic outcomes, including Metabolic acidosis, Acute renal failure, and critical Cardiovascular effects such as hypotension or cardiac arrest. Severe CNS events like seizures and coma are also documented. Regulatory notes highlight that pediatric patients are a vulnerable population with increased risk for severe CNS depression and apnea, and patients with pre-existing renal issues face an increased susceptibility to acute renal failure.

Immediate Medical Attention is Required:

Regulators explicitly state that immediate medical attention must be sought upon suspected overdose, and Emergency Services must be contacted immediately. Hospital observation and monitoring of vital signs are required to manage potential complications. The regulatory basis for managing this toxicity emphasizes symptomatic and supportive treatment, as officially stated in the prescribing information that no specific antidote is known for Ibuprofen overdose. Management may include procedures like gastric decontamination or activated charcoal, administered based on clinical assessment.

Therapeutic Uses of Apirofeno

What Apirofeno Treats: Main Uses and Benefits

Apirofeno is commonly used to provide symptomatic relief across several key areas of physical discomfort. The medication is considered relevant for managing symptoms that interfere with daily comfort, such as those related to physical discomfort and systemic imbalance.

Supportive Relief for Acute and Inflammatory Symptoms

This medication is applied in addressing mild to moderate symptoms related to physical discomfort, such as tension headaches, muscular aches, dental pain, and the tenderness associated with minor sprains and strains. It is generally used when groups of symptoms appear suddenly or fluctuate in conditions involving episodic or fluctuating manifestations, including primary dysmenorrhea and common childhood illnesses. Concurrently, it is relevant for easing symptoms related to systemic imbalance by helping to lower elevated body temperature.

The medication is commonly used across conditions presenting with acute episodes, and may be part of symptomatic management when symptoms create noticeable functional strain. Its applications include: pain management (headache, toothache, menstrual cramps), fever reduction, and alleviation of swelling in inflammatory disorders like osteoarthritis.

“This application supports the patient during difficult episodes by helping to ease distress and contributing to improved comfort during symptomatic periods.”

The medication provides supportive relief when symptoms interfere with routine activities. This targeted use is relevant when short-term symptomatic assistance is needed for symptoms of fever and pain, and is commonly used in pediatric patient groups (infants and children).

Quick Fact: Relief for Fever and Pain.

Eligibility and Restrictions for Use

This section outlines the official population eligibility and non-eligibility rules for Apirofeno (Ibuprofen), strictly based on governmental regulatory documentation.

Population Status Official Regulatory Classification
Allowed Adults and teenagers with established safety and efficacy. Pediatric patients 6 months of age for specific, weight-based indications.
Contraindicated Patients with known hypersensitivity to Ibuprofen or other NSAIDs (including aspirin-sensitive asthma). History of active gastrointestinal bleeding or recurrent ulceration. Severe heart failure (NYHA Class IV), severe renal failure, or severe hepatic failure. Treatment of peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Age-Related Eligibility and Condition-Based Restrictions

Use is contraindicated during the third trimester of pregnancy (starting at \approx 30 weeks gestation) due to the documented risk of fetal harm. Use is generally not established for infants younger than 6 months of age. Older adults are documented to be at an increased risk of serious adverse gastrointestinal and renal events, requiring careful consideration. Conditional use is required for patients with mild to moderate organ impairment, uncontrolled hypertension, or a history of cardiovascular disease. The official regulatory classification for use in these groups is "use with caution" and requires specific monitoring.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation for Apirofeno (Ibuprofen) identifies specific interactions with other medicinal products and product classes that require careful consideration.


Documented Interacting Medicinal Products and Classes

Category or Specific Medicine Interaction Constraint or Condition
Other NSAIDs (e.g., other Ibuprofen products) Co-administration should be avoided due to the increased risk of adverse effects.
Diuretics May reduce the diuretic effect; requires monitoring of renal function, especially in dehydrated patients.
Low-dose Acetylsalicylic Acid (Aspirin) Long-term daily use of Ibuprofen may reduce the cardioprotective antiplatelet effect of Aspirin by competitive inhibition. Occasional Ibuprofen use is not expected to significantly affect this.
Amikacin (an Aminoglycoside) Decreased clearance of Amikacin has been documented, which can lead to increased concentrations of Amikacin.

Regulatory Constraints

The interaction profile imposes practical constraints on concurrent use. Use with diuretics necessitates monitoring for renal function impairment. The effect on low-dose Aspirin is conditionally relevant; the risk of reducing its cardioprotective benefit pertains specifically to long-term co-administration rather than occasional use. The entire class of other NSAIDs is restricted from concomitant use. These documented interactions reflect official regulatory requirements to ensure appropriate management when multiple medications are used.

Mechanism of Action

Apirofeno (Ibuprofen) modulates specific biological pathways, with its physiological profile emerging from two key mechanistic domains.


Non-Selective Inhibition of Cyclooxygenase (COX) Enzymes

This domain covers the primary molecular action: the reversible inhibition of both COX-1 and COX-2 enzymes. This enzymatic blockade restricts the conversion of arachidonic acid into prostaglandins ( PGE2 and PGI2) . The mechanism modifies this early molecular step, resulting in the suppression of chemical mediators that regulate nociceptive signaling and local vascular permeability in tissue.


Central and Peripheral Pathway Modulation

This domain describes the resulting physiological cascade that follows the molecular mechanism. Peripherally, the suppression of prostaglandins reduces the sensitization threshold of nociceptors (pain-sensing neurons) within affected areas. Centrally, the inhibitory action in the hypothalamus prevents PGE2 from elevating the body's thermoregulatory set-point, which facilitates heat dissipation mechanisms. This dual-action pathway modulation results in the simultaneous systemic alteration of nociceptive and thermoregulatory signaling.

Dosage and Administration Information

How to use Apirofeno

Apirofeno (Ibuprofen) is administered systemically via the oral route as tablets, capsules, or oral suspension, or via the intravenous (IV) route as a solution for infusion, based on the clinical setting. The fundamental principle for use is to apply the lowest effective dose for the shortest duration necessary to manage symptoms.


Dosing and Frequency

Adult dosing for acute relief typically ranges from 200 mg to 400 mg per dose, usually repeated every 4 to 6 hours as required. For chronic conditions, such as certain inflammatory disorders, the total daily dose is commonly administered in divided doses (3 or 4 times per day), not to exceed the maximum prescription strength of 3200 mg daily. Pediatric dosing of the oral suspension is calculated based on the child’s body weight (5 mg/ kg to 10 mg/ kg per dose), with the maximum daily limit being 40 mg/ kg.


Administration Requirements

Administration Aspect Official Label Instruction
With Food May be taken with food or milk to potentially lessen gastrointestinal discomfort.
Solid Forms (Tablets) Must be swallowed whole with water; chewing or crushing is not permitted.
Liquid Forms (Suspension) Must be shaken well before use and measured using the specialized device provided (e.g., syringe).
IV Infusion Must be administered via controlled intravenous infusion over a specified duration by a qualified healthcare professional.

For older adult patients, the lowest possible effective dose should be selected and used for the shortest possible duration. If a dose is missed, a double dose should not be taken to catch up.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Apirofeno

Evidence for use in Chronic Pain Management

Apirofeno was evaluated in studies exploring its use for conditions characterized by fluctuating or episodic manifestations of pain. The research primarily was studied for short-term durations, such as randomized controlled trials (RCTs), typically lasting between four and twelve weeks. These studies applied in studies examining patient-reported experiences of pain. Research described outcomes related to physical discomfort, which were measured using tools like pain intensity rating scales, and also described outcomes reflecting daily functioning or activity level. The populations included were generally adults with localized or generalized chronic non-cancer pain.

The findings describe patterns observed in the studies where measurements in groups assigned to Apirofeno were numerically distinct from those in control groups. Some trials reported patterns related to measured outcomes for daily function. However, the magnitude of these reported differences was modest, and findings were mixed across the small number of existing studies. The existing evidence helps contextualize reported symptom patterns over the short-term study periods, but the overall evidence base remains limited and heterogeneous.

Evidence for use in Sleep Disturbance

Research explored Apirofeno's use in individuals with conditions involving periods of heightened symptoms related to sleep difficulties. The studies conducted were observed in small groups using short-duration, crossover study designs. Researchers monitored both subjective metrics, such as questionnaires about overall sleep quality, and objective metrics, like measurements taken during polysomnography (e.g., total sleep time and sleep latency).

Studies reported measurements of how symptoms changed in the observed populations, specifically measuring changes in the time it took for participants to fall asleep. Some trials observed numerical differences in these objective measurements. However, similar to the pain research, sample sizes were modest, and evidence is limited, primarily focusing on temporary changes. Overall, the research provides insight into short-term changes, but the consistency of the findings certainty remains low due to the size and design limitations of the research.

Frequently Asked Questions (FAQ)

Common questions about Apirofeno (FAQ)

Q: How quickly does Apirofeno start working?

Official information on how Apirofeno (Ibuprofen) works shows it is rapidly absorbed into the body after taking it orally. The time to reach peak concentrations is typically reported to be within one to two hours, which is when the therapeutic effects generally begin to be noted.

Q: How long do the effects of Apirofeno usually last?

The effects of Apirofeno are generally considered short-acting. The medicine's half-life (the time it takes for half of the drug to be eliminated from the body) is approximately two hours. This short half-life is consistent with the general recommendation for periodic redosing as needed.

Q: Can Apirofeno be taken on an empty stomach?

The administration instructions state that Apirofeno may be taken with food or milk. This is typically advised to potentially lessen gastrointestinal discomfort. However, the primary instruction is that it 'may' be taken with food, which is often done to help minimize potential stomach irritation.

Q: What are the most common side effects of Apirofeno?

The most frequently documented side effects in official labels relate primarily to the digestive system and the nervous system. These commonly include issues such as indigestion (dyspepsia), abdominal pain, nausea, headache, and dizziness.

Q: Does Apirofeno cause drowsiness or make you tired?

While regulatory documents commonly list dizziness as a side effect, specific mentions of drowsiness or fatigue are sometimes included under less frequent or higher-dose adverse reactions. If you experience any new side effects such as drowsiness or dizziness, it is important to be aware of how they affect daily activities.

Q: Is it normal to feel a mild stomach upset after taking Apirofeno?

Mild stomach upset is a commonly reported experience. Official safety documentation classifies gastrointestinal disorders, such as dyspepsia, abdominal pain, and nausea, as frequent adverse reactions. Taking the medicine with food or milk may help mitigate these symptoms.

Q: What are the benefits of Apirofeno over standard over-the-counter options?

Apirofeno is often distributed with a prescription or strict dispensing controls, offering specialized formulations like higher-concentration oral suspensions. This contrasts with common lower-strength over-the-counter Ibuprofen products and reflects its specialized uses and dosages.

Q: Are there any common foods or drinks to avoid while taking Apirofeno?

Official regulatory documents caution against the use of Apirofeno with alcohol, as combining the two may increase the risk of serious gastrointestinal bleeding. The primary interaction warning is related to alcohol.

Q: What does the research say about the effectiveness of Apirofeno?

Studies evaluated Apirofeno for short-term pain relief and inflammation. Findings generally showed that treated groups reported outcomes distinct from control groups. However, official summaries note that the overall evidence base remains limited and often varied across different studies.

Q: Are there generic versions of Apirofeno available?

Since the active ingredient in Apirofeno is Ibuprofen, which is the established generic name for the compound, many products containing this drug are available on the market under various brand and generic labels.

Q: What age group is Apirofeno mainly intended for?

Apirofeno is eligible for use across multiple age groups, including adults, teenagers, and pediatric patients six months of age and older. Specific formulations, such as the oral suspension, are focused on Child Health to facilitate precise weight-based dosing for children.

Q: What is the main difference between Apirofeno and ibuprofen?

Apirofeno is a specific brand name product whose active ingredient is Ibuprofen. The core difference is typically found in the exact formulation, such as the concentration of the liquid forms or the type of excipients used. These specialized formulations often require strict dispensing control.

Q: Does Apirofeno work for muscle aches?

As a Nonsteroidal Anti-inflammatory Drug (NSAID), Apirofeno's general purpose is the reduction of pain and inflammation. The drug's general mechanism is consistent with addressing various types of mild to moderate musculoskeletal pain, such as muscle aches.

Q: What is the half-life of Apirofeno?

According to the official pharmacokinetic data, the elimination half-life of the active ingredient (Ibuprofen) is typically in the range of 1.9 to 2.2 hours. This figure describes the rate at which the body processes and clears the medicine from the system.

Q: Can Apirofeno affect fertility in men or women?

Regulatory warnings mention that the use of NSAIDs, including Ibuprofen, has been associated with the potential to temporarily impair female fertility by interfering with ovulation. This effect is generally considered reversible upon stopping the medication.

Q: Does Apirofeno cause any long-term effects on the liver or kidneys?

The official label notes a risk of renal impairment, particularly in dehydrated patients. Regulatory documents also state that the risk of serious cardiovascular and gastrointestinal adverse events is documented to be higher with longer treatment duration and higher daily doses.

Q: Can I take Apirofeno if I am currently taking an antidepressant?

Official drug interaction warnings caution that taking an NSAID, such as Apirofeno, concurrently with certain antidepressants, specifically SSRIs, may increase the risk of serious gastrointestinal bleeding. It is important to ensure all healthcare providers are aware of all medicines being taken concurrently.

Q: How does the mechanism of action of Apirofeno compare to aspirin?

Both Apirofeno (Ibuprofen) and Aspirin work by inhibiting COX enzymes, which reduces pain and inflammation. However, Ibuprofen is a reversible inhibitor of COX, whereas Aspirin is an irreversible inhibitor, which accounts for its sustained antiplatelet effect.

Q: Can Apirofeno be used for period pain?

Official regulatory documents indicate that Apirofeno (Ibuprofen) is a formally established option for the symptomatic relief of primary dysmenorrhea (commonly known as period pain).

Q: Can Apirofeno affect sleep patterns?

Studies have explored the use of Apirofeno in individuals experiencing sleep difficulties. Researchers observed changes in some objective sleep measurements, such as the time taken to fall asleep, but the overall research evidence on the consistency of this effect is currently limited.

Q: What is the purpose of the specialized device (e.g., syringe) provided with the oral suspension?

The specialized measuring device, often a syringe graduated by patient weight, is included with the oral suspension to ensure the precise delivery of the dose. This level of precision is crucial for accurate administration, especially when treating children.

Q: Is it normal for Apirofeno to cause mild constipation?

While official labels list common gastrointestinal issues like nausea and abdominal pain, constipation is also sometimes reported as a side effect within the class of NSAIDs, including Ibuprofen. It is typically considered a less frequent gastrointestinal reaction.

Q: Does Apirofeno interact with low-dose aspirin for occasional use?

Regulatory documents explicitly state that occasional use of Apirofeno (Ibuprofen) is not expected to significantly interfere with the antiplatelet effect of low-dose Aspirin. The primary concern regarding competitive inhibition applies to long-term daily co-administration.

Q: Does Apirofeno help with tension headaches?

Apirofeno is indicated for the general management of mild to moderate pain. Its general indication and anti-inflammatory mechanism suggest its relevance to various types of acute pain, such as tension headaches.

How should Apirofeno be stored and disposed of?

Storage and Disposal Requirements

The official requirements for storing and disposing of Apirofeno (Ibuprofen) are defined by the regulatory label to ensure product integrity and safety.

Classification Regulatory Requirement
Storage Temperature Store at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F).
Handling Constraints Do not freeze the oral suspension. Keep the product in its original, well-closed container and protect from moisture.
In-Use Stability The oral suspension may have a stability limit; for some formulations, discard any unused product 6 months after opening.
Child Safety Mandatory instruction: Keep this medicine out of the sight and reach of children.
Disposal Method Unused or expired product should be disposed of using a drug take-back program. Do not flush the medicine down the toilet or throw it into wastewater.

These statements define how the medicine must be protected and handled according to the official labeling.

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

Available in countries:

Equivalent of Apirofeno found in:

A-Z Index: