Pedifen

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Pedifen

Property Description
Active Ingredient Ibuprofen
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common Use Analgesic, Antipyretic, Anti-inflammatory
Origin Synthetic, propionic acid derivative
Forms Oral Suspension, Syrup, Tablets

What Type of Medicine is Pedifen? (Identity and Classification)

Pedifen is a widely recognized pharmaceutical preparation whose active substance is Ibuprofen, firmly classifying it as a Nonsteroidal Anti-Inflammatory Drug (NSAID). This classification defines the medicine as a systemic, non-narcotic agent derived chemically from propionic acid.

Its designation as an NSAID reflects a mechanism that involves inhibiting the production of prostaglandins, the chemical mediators that trigger and sustain inflammatory responses. The World Health Organization (WHO) includes Ibuprofen on its List of Essential Medicines, a status that confirms its role as a clinically recognized compound for public health needs.


What is Pedifen Used for and How is it Supplied? (Purpose and Form)

The general purpose of Pedifen is to offer relief by providing three key therapeutic benefits: acting as an analgesic for pain relief, an antipyretic for reducing fever, and an anti-inflammatory agent for addressing swelling and redness. This reliable triple-action profile makes the drug suitable for managing generalized discomfort, such as fever or pain accompanying common symptoms.

Pedifen is prominently positioned for the pediatric audience, which influences its primary dosage forms for systemic (oral) administration. The medicine is supplied in liquid forms, notably oral suspension and syrup, which often feature flavorings to enhance acceptance, alongside solid tablets for adult and older patient use. The focused development of palatable liquid forms is a distinguishing factor tailored to this young target audience.

Regulatory References

  1. WHO Model List of Essential Medicines (Ibuprofen)

What side effects are possible with Pedifen?

Possible Side Effects and Safety Information

The official safety profile of Ibuprofen (Pedifen), an NSAID, is categorized by regulatory bodies based on the System Organ Class (SOC) and frequency of occurrence (e.g., Common, Uncommon, Rare). Adverse reactions most frequently reported relate to Gastrointestinal Disorders, often including nausea, vomiting, and abdominal pain.


Serious Adverse Reactions

Regulatory warnings explicitly highlight the potential for serious cardiovascular thrombotic events, such as myocardial infarction (heart attack) and stroke. These risks are noted to be dose- and duration-dependent, meaning the risk is higher with longer exposure and increased doses. A second major safety warning addresses serious gastrointestinal adverse events, including bleeding, ulceration, and perforation, which can be fatal. Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson Syndrome, are rare but documented risks, often appearing early in therapy.


Population-Specific Constraints

Safety statements identify specific populations with heightened risk or contraindications. Older adults have an officially increased frequency of adverse reactions, particularly fatal gastrointestinal complications. The drug is contraindicated during the last trimester of pregnancy. A specific safety note exists regarding the risk of renal impairment in dehydrated children and adolescents. Furthermore, the label states the drug may mask the signs of infection and can potentially interfere with the antiplatelet effect of low-dose aspirin.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Ibuprofen, the active ingredient in Pedifen, is addressed through symptomatic and supportive management, as no specific antidote is documented in regulatory prescribing information. The official overdose profile outlines manifestations ranging from common symptoms to severe, life-threatening complications.

Documented Manifestations and Severe Outcomes

Symptoms often involve the gastrointestinal (GI) and central nervous system (CNS). Common manifestations include abdominal pain, nausea, vomiting, drowsiness, and headache.

In cases of massive ingestion, severe and potentially fatal outcomes may affect multiple organ systems:

System Documented Severe Outcomes
Gastrointestinal Severe GI bleeding, ulceration, and perforation
Neurological Seizures, convulsions, and coma
Cardiovascular Hypotension (shock) and cardiac arrest
Renal/Metabolic Acute renal failure and metabolic acidosis

Required Emergency Action

Regulatory authorities explicitly require immediate action in case of suspected overdose. It is essential to seek immediate medical attention or get medical help right away. Users must also contact a Poison Control Center immediately for specific guidance and monitoring requirements.

Population Considerations: Higher risk of severe outcomes is noted for elderly patients and children who have ingested very large doses.

Therapeutic Uses of Pedifen

Pedifen (Ibuprofen) is used across several therapeutic domains to provide symptomatic relief and supportive assistance when symptoms that interfere with daily functioning become more noticeable. The medication is generally considered relevant when supportive symptom management is appropriate in situations involving acute discomfort and is applied in scenarios where additional management of discomfort is required.


Therapeutic Focus and Symptom Relief

Pedifen is commonly used to help manage symptoms related to physical discomfort, systemic imbalance, and inflammatory or irritative states. It is applicable in conditions presenting with acute episodes, such as mild to moderate pain (including headache, dental pain, sprains and strains, and primary dysmenorrhea), as well as chronic manifestations of joint conditions like osteoarthritis and tendinitis. The medication is also utilized to help with controlling elevated body temperature (fever) and associated generalized body aches during seasonal illnesses like the common cold or flu. Addressing these symptoms helps improve day-to-day comfort during symptomatic periods and supports general well-being during symptomatic phases.

Quick Fact: Relief for Pain and Fever (The medication is generally applied in settings where symptoms become temporarily overwhelming and short-term symptomatic assistance is appropriate when symptoms disrupt daily stability.)


Easing Inflammatory Swelling

This therapeutic category is relevant for managing symptoms related to inflammatory or irritative states. Pedifen is generally applied when appropriate for conditions presenting with swelling, stiffness, and tenderness in joints or soft tissues. This supportive benefit contributes to easing the overall symptom load when symptoms become more noticeable and helps maintain a sense of stability when symptoms are more noticeable.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Pedifen — Official Regulatory Information

The eligibility for Pedifen (Ibuprofen) is strictly defined by regulatory authorities based on patient health status, age, and physiological condition.


Eligibility Scope
Populations for whom use is allowed (as stated in label): Adults and adolescents (ge 12 years). Children ge 3 months old and weighing ge 5 kg (minimum age may vary by formulation).
Populations for whom use is contraindicated: Patients with a known hypersensitivity to any NSAID (including aspirin-induced asthma); those with active or recurrent peptic ulceration or hemorrhage; patients with severe heart failure (NYHA Class IV), or severe renal/hepatic failure; and women in the third trimester of pregnancy (after 20 weeks gestation).
Age-related eligibility rules: Contraindicated for infants under 3 months or those weighing less than 5 kg. Older adults are considered a high-risk group and should use the lowest effective dose.
Pregnancy and lactation eligibility status: Contraindicated in the third trimester of pregnancy. Use in the first and second trimesters is restricted and generally not recommended. Use during lactation (breastfeeding) is generally considered compatible.
Eligibility-related restrictions: High doses (ge 2400 mg/day) must be avoided in patients with established cardiovascular disease. Caution is required for patients with mild to moderate organ impairment, uncontrolled hypertension, or a history of Crohn's disease/Ulcerative Colitis.

Resulting Eligibility Structure

Official eligibility statements:

  • Use is contraindicated in patients with severe organ impairment, active GI bleeding, or NSAID hypersensitivity.
  • The medicine is approved for use in children ge 3 months and ge 5 kg.
  • Use is strictly prohibited in pregnant women after 20 weeks gestation.

Connection to the overall eligibility profile: Official regulatory documents define who can and cannot use the medicine by establishing clear and absolute prohibitions (e.g., severe heart failure, third-trimester pregnancy) to mitigate known systemic risks. The structure also requires explicit caution and dose minimization for vulnerable groups like older adults or those with pre-existing mild-to-moderate organ impairment.

What should I know about interactions with other medicines?

Pedifen Interactions with other medicines and products

Pedifen (Ibuprofen) may interact with a range of other medicines, potentially affecting how both drugs work or increasing the risk of adverse events. Official documents advise against the concomitant use of Pedifen with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including selective COX-2 inhibitors and salicylates, due to a significantly increased risk of gastrointestinal bleeding and ulceration.

Documented Interactions and Required Precautions

Interacting Product Category Regulatory Constraint Mechanistic Basis (if stated in label)
Low-Dose Acetylsalicylic Acid (Aspirin) Generally not recommended due to increased adverse effects; potential for reduced anti-platelet effect with long-term, regular use. Competitive inhibition of the anti-platelet effect on cyclo-oxygenase.
Anticoagulants (e.g., Warfarin), Corticosteroids, SSRIs Use with caution; requires monitoring. Additive increase in the risk of serious bleeding or ulceration.
Diuretics and Anti-hypertensives Use with caution; monitoring of kidney function is required. Reduction of anti-hypertensive or diuretic effects; risk of worsening kidney function.
Digoxin, Lithium, Phenytoin Monitoring of plasma drug levels is required. Ibuprofen can increase the plasma concentrations of these drugs.
Mifepristone NSAIDs should not be used for 8–12 days after administration. Potential to reduce the effectiveness of Mifepristone.

For patients taking immediate-release low-dose aspirin for cardiovascular protection, regulatory agencies recommend taking Pedifen (Ibuprofen 400 mg) at least 30 minutes after, or more than 8 hours before, the aspirin dose to minimize the potential interference with the anti-platelet effect. Occasional use of Pedifen is considered less likely to cause a clinically relevant interaction.

Mechanism of Action

The mechanism of action for Pedifen relies on its active ingredient, Ibuprofen, which selectively and reversibly interferes with specific enzyme systems that govern pathways associated with nociception, thermoregulation, and inflammatory processes.

Modulation of Local Inflammatory Mediators

Ibuprofen's primary action is the non-selective, reversible inhibition of Cyclooxygenase (COX) enzymes ( COX-1 and COX-2) in peripheral tissues. By blocking COX activity, Pedifen suppresses the synthesis of prostaglandins, which are key chemical messengers that mediate nociceptor sensitization and vascular permeability.

Central Correction of Thermoregulatory Signaling

Within the central nervous system, Ibuprofen's mechanism extends to the hypothalamus, the brain's temperature control center. Here, it suppresses the formation of prostaglandins that mediate the thermoregulatory set-point elevation. This central action results in the correction of the elevated body temperature set-point, initiating processes for heat dissipation.

Transient Influence on Platelet Signaling

This domain relates to the effect of COX-1 inhibition on cellular processes. The mechanism temporarily reduces the production of Thromboxane A2 ( TxA2), a signaling molecule that promotes platelet aggregation. This results in a transient, concentration-dependent influence on platelet function.

Dosage and Administration Information

How Pedifen (Ibuprofen) is Used: Administration Guidelines

The usage of Pedifen, which contains the active ingredient Ibuprofen, is based on established methods for administration and dosing. The primary route is oral, available in forms like tablets and liquid suspension. For specific clinical needs, an Intravenous (IV) solution is also used under professional supervision.

Oral administration is typically timed with food or milk to mitigate potential gastrointestinal discomfort. When using the oral suspension, the liquid must be shaken well and measured using a calibrated device provided with the product to ensure dose accuracy.

Dosing and Frequency Principles

A core principle of use is employing the lowest effective dosage for the shortest duration necessary. For general adult use, doses are administered every 4 to 6 hours as needed, with a maximum daily limit of 3200 mg. The minimum interval between doses should be strictly maintained.

Population-Specific Rules

For pediatric patients (typically 6 months and older), the oral dose is calculated based on the child's weight (5 mg/ kg to 10 mg/ kg) rather than a fixed standard, with a maximum daily cap. In older adults, administration patterns involve starting at the lower end of the dosing range due to increased sensitivity, reflecting the need for cautious use. Intravenous administration, when used, requires a minimum infusion time of 30 minutes for adults and 10 minutes for children and adolescents.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Clinical research for this study drug has focused on two primary areas: treatment-resistant depression and chronic pain management, alongside ongoing safety monitoring. Study results are descriptive of observed effects and trial characteristics.


1. Severe, Refractory Depression

Several placebo-controlled, double-blind, randomized controlled trials (RCTs) evaluated the potential of the drug to address symptoms in patients diagnosed with severe, refractory depression. This population included individuals who had not responded adequately to two or more prior courses of standard antidepressant therapy.

  • Primary Focus: Main studies examined the effect on scores using validated rating scales, such as the Montgomery-Åsberg Depression Rating Scale (MADRS).
  • Related Research: Other studies explored the potential effect on suicidal ideation in patients with a primary diagnosis of major depressive disorder.

2. Chronic Pain Management

Research explored whether the drug may be associated with changes in pain over the long term, specifically in patients with complex regional pain syndrome (CRPS). These phase III trials were designed to observe outcomes over periods up to six months.

  • Outcomes Measured: Trials focused on changes in the frequency of pain episodes and the dosage of rescue medication required by participants.
  • Comparative Studies: Research also compared the drug with standard antidepressants for treatment-resistant depression in open-label trials, examining differences in the number of participants who were classified as non-responders at the conclusion of the trial.

3. Safety Monitoring (Observed Events)

During the clinical trials, research documented the most commonly reported adverse events observed in the study population. These generally included temporary dissociation and elevated blood pressure. Other recorded events included dizziness and nausea. Monitoring was conducted in a clinical setting to observe participants immediately following administration and to record any delayed effects.

Key Studies & References

  1. Rapid-acting NMDA and GABAergic Modulators in Mood Disorders: From Synaptic Mechanisms to Clinical Practice - PubMed Central (Review of RCTs for TRD and Suicidal Ideation)
  2. Efficacy and Safety of Ketamine in Patients with Complex Regional Pain Syndrome: A Systematic Review
  3. Long-term Pain Modulation by Intravenous Esketamine in Complex Regional Pain Syndrome: a Non-inferiority Study (ClinicalTrials.gov ID: NCT05212571 - Example Trial for CRPS)

Frequently Asked Questions (FAQ)

Common questions about Pedifen (FAQ)


Q: Is Pedifen the same as ibuprofen or another common pain reliever?

A: Pedifen is a specific pharmaceutical product whose active ingredient is Ibuprofen. Ibuprofen is the compound that provides the therapeutic effects, and it belongs to a widely known class of pain relievers called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).


Q: What types of pain is Pedifen typically used for?

A: According to official product information, Pedifen is indicated for the relief of mild to moderate pain and the symptomatic treatment of fever. It is also officially indicated for the management of pain associated with specific conditions, such as primary dysmenorrhea (menstrual pain).


Q: Does Pedifen help with inflammation or just pain and fever?

A: Official information confirms that the active ingredient in Pedifen, Ibuprofen, has a triple action. It works as an analgesic (for pain), an antipyretic (for fever), and an anti-inflammatory agent (for addressing swelling and redness).


Q: What should be done if the fever or pain returns quickly after a dose?

A: Regulatory guidelines emphasize the importance of maintaining the minimum interval between doses, which is often 4 to 6 hours. Official instructions state that the subsequent dose should not be administered before this specific time interval has been strictly completed, even if symptoms return sooner.


Q: Is it possible to take Pedifen on an empty stomach?

A: The active ingredient is absorbed rapidly whether it is taken on an empty stomach or with food. However, official product information indicates the medicine is often taken with food or milk. This practice is intended to potentially mitigate the possibility of gastrointestinal discomfort.


Q: Can Pedifen cause drowsiness or make a person feel dizzy?

A: Official adverse reaction lists have documented both dizziness and, less commonly, drowsiness as potential effects associated with the use of this medicine. These are typically listed among the central nervous system-related events.


Q: Is it safe to use Pedifen at the same time as paracetamol/acetaminophen?

A: Regulatory documents advise caution or prohibition when combining Pedifen with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Paracetamol (acetaminophen) is not an NSAID; however, the official product information does not explicitly list required cautions for using the two together.


Q: Does Pedifen affect blood pressure?

-A: Official warnings note that NSAIDs, including Ibuprofen, have the potential to cause the onset of new high blood pressure (hypertension) or worsen pre-existing high blood pressure. Fluid retention and edema have also been observed as associated effects.


Q: Why do official documents advise caution when using Pedifen for dehydrated individuals?

A: A specific safety note exists regarding the risk of renal impairment (problems with kidney function) when the medicine is used in dehydrated children and adolescents. Caution is generally advised for any patient with pre-existing kidney function issues.


Q: Is it safe to use Pedifen while breastfeeding?

A: Official regulatory information generally considers the use of Ibuprofen (Pedifen) during lactation (breastfeeding) to be compatible. Limited studies indicate that only a small amount of the active ingredient is excreted into breast milk.


Q: Can Pedifen interact with medicines used for mental health conditions like SSRIs?

A: Official documents indicate that the co-administration of Ibuprofen (Pedifen) with certain antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), requires caution. This is due to a potential additive risk of serious bleeding or ulceration in the stomach or intestines.


Q: Why is Pedifen available as a pediatric suspension (syrup)?

A: Pedifen is often supplied in liquid forms, such as an oral suspension or syrup, because these formulations are specifically tailored for the pediatric audience. The liquid form is developed to be compatible with weight-based dosing and to facilitate administration in the pediatric audience.


Q: How quickly can a person expect Pedifen to start working for fever?

A: Official clinical pharmacology information indicates that peak plasma levels of the active ingredient are typically reached within one to two hours after a dose. Studies in children have shown that the maximum fever-reducing effect is usually observed between two and four hours.


Q: How long does the effect of one dose of Pedifen generally last?

A: Official dosing guidelines typically recommend administration every 4 to 6 hours as needed for symptoms, which reflects the expected duration of the primary therapeutic effect. Clinical studies in children have shown that significant fever reduction may last up to 8 hours at higher prescribed doses.


Q: Can Pedifen be used for teething pain in infants over 6 months?

A: The medicine is generally indicated for the symptomatic treatment of pain and fever in children, typically those over 6 months of age and weighing at least 5 kg. The product label should be reviewed for specific age restrictions.


Q: What is the risk of stomach irritation when taking Pedifen?

A: Gastrointestinal complaints are the most frequently reported type of adverse reaction associated with the use of Ibuprofen. These reactions often include stomach pain and heartburn. The risk of serious gastrointestinal events, such as bleeding, is noted to be higher with longer duration and increased doses.


Q: Are there different formulations (suspension vs. tablet) of Pedifen for different ages?

A: Yes, regulatory product information indicates that liquid forms, like oral suspension or syrup, are generally provided for the pediatric audience, while solid tablets are the typical formulation available for adult and older patient use.


Q: Does Pedifen have an orange flavor to help with compliance?

A: Official drug labels list all components of the medicine, including inactive ingredients. Liquid suspensions are often formulated with flavoring agents (such as fruit flavors) to improve compliance and acceptance, particularly in children.


Q: What is the risk of an allergic reaction to Pedifen?

A: Ibuprofen is strictly contraindicated for individuals with a known hypersensitivity to NSAIDs. Severe, rarely fatal, anaphylactic-like reactions have been reported, and these can occur in patients even if they have not used the drug before.


Q: Is a persistent rash a known side effect of Pedifen?

A: Yes, official safety warnings document that serious cutaneous (skin) adverse events can occur, which may manifest as a rash or blistering. These warnings include severe conditions such as Stevens-Johnson Syndrome (SJS).


Q: Can taking Pedifen for a long time lead to any specific health concerns?

A: Official warnings state that the risks of serious cardiovascular (CV) and gastrointestinal (GI) adverse events are dose- and duration-dependent. This means that the risk is noted to be higher with longer periods of use and increased doses.


Q: Is Pedifen known to cause issues with the liver or kidneys?

A: Regulatory documents indicate that long-term use of NSAIDs can result in kidney injury, and severe hepatic reactions (liver problems) have been reported rarely. Pre-existing severe liver or kidney failure is a specific contraindication for use.


Q: Is there a known link between Pedifen use and hearing changes like tinnitus?

A: Official reports on undesirable effects have documented tinnitus (a persistent ringing or buzzing in the ears) as a potential effect associated with the use of the active ingredient, Ibuprofen.


Q: What is the general information about Pedifen's effect on fertility in women?

A: Official documents state that NSAIDs are associated with reversible infertility in women. Therefore, regulatory advice suggests considering the withdrawal of Ibuprofen (Pedifen) if a woman is experiencing difficulties conceiving.


Q: What types of allergic reactions are most concerning when using Pedifen?

A: The most concerning allergic reactions warned about include severe symptoms such as hives, facial swelling, asthma (wheezing), rash, blisters, or shock. Serious skin reactions like Stevens-Johnson Syndrome are also explicitly highlighted in regulatory warnings.


Q: Is Pedifen safe for someone who has a history of stomach problems like Crohn's disease?

A: Official product labels advise that caution is required when the medicine is used in individuals who have a history of certain gastrointestinal disorders, including Crohn's disease or Ulcerative Colitis. This is due to the potential for the condition to be exacerbated.


Q: How long can Pedifen typically be used before consulting a healthcare provider?

A: For over-the-counter use, instructions generally advise use is limited to 10 days for pain or 3 days for fever unless otherwise directed.


Q: Is the adult formulation of Pedifen used for menstrual pain (primary dysmenorrhea)?

A: Official product information indicates that the medicine is used for the treatment of primary dysmenorrhea (painful menstrual periods).


Q: What information is available about the long-term use of Pedifen?

A: Official guidance is centered on using the lowest effective dose for the shortest duration possible. Higher risk is associated with longer duration and increased doses regarding serious cardiovascular and gastrointestinal adverse events, as documented in regulatory warnings.


Q: Does Pedifen contain common allergens like phenylalanine or certain dyes?

A: Official drug labels are required to list all inactive ingredients, which may include components like specific dyes or preservatives. Individuals are advised to review the specific product label to identify all listed inactive ingredients.

How should Pedifen be stored and disposed of?

Official Storage and Disposal Requirements

Official regulatory guidelines strictly define the conditions necessary to maintain the integrity and safety of Pedifen (Ibuprofen) formulations.

Storage Conditions

The medication must be kept at controlled room temperature, typically 15 C to 30 C, and stored away from excess heat and moisture. The product must remain in its original container, which should be kept tightly closed and secured with a child-resistant cap.

Storage Component Requirement
Temperature Controlled room temperature (Do not freeze or refrigerate)
Handling Shake oral suspension well before using
Protection Store away from moisture and excess heat
Child Safety Must be kept out of the sight and reach of children

Disposal Instructions

Official instructions mandate that unused or expired Pedifen should not be flushed down the toilet or sink. The preferred method of disposal is through a recognized drug take-back program or utilizing the household trash disposal method: mixing the product with an undesirable substance (e.g., dirt) and placing it in a sealed bag.

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

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