Pediatrin

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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.

Overview of Pediatrin

Property Description
Active Ingredient Ibuprofen
Form Oral suspension, Tablet, Capsule, Suppository
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common Purpose Pain relief, Fever reduction, Anti-inflammatory action
Origin Synthetic compound (Propionic acid derivative)

Pediatrin is a preparation containing the active ingredient Ibuprofen, which belongs to the pharmacological class of Nonsteroidal Anti-inflammatory Drugs (NSAIDs). This classification signifies its core properties: providing analgesic, antipyretic, and anti-inflammatory effects.


What Type of Medicine is Pediatrin?

Pediatrin's active substance, Ibuprofen (2-(4-isobutylphenyl)propanoic acid), is a synthetic compound derived from the propionic acid chemical group. The classification as an NSAID is crucial, establishing that the drug offers combined therapeutic actions, differentiating it from simple pain relievers that lack the potent anti-inflammatory component. NSAIDs act by reducing the production of certain inflammatory mediators in the body. The efficacy of this NSAID structure is recognized across diverse patient populations.


What is the General Purpose of Pediatrin?

The general purpose of Pediatrin is to provide simultaneous relief from the general symptoms of aches, discomfort, and elevated body temperature. By achieving potent analgesic and antipyretic effects, it helps manage fever and pain. Ibuprofen is considered an essential medicine for pain and fever management across patient groups. Furthermore, the anti-inflammatory property inherent to its NSAID class addresses localized swelling and redness.


Common Forms and Differentiation

As a single-component product focused on pediatric patients, Pediatrin's composition relies solely on Ibuprofen combined with an appropriate pharmaceutical vehicle. It is widely available in dosage forms suitable for oral (such as oral suspension and tablet) and sometimes rectal administration (suppository). The prominence of the liquid oral suspension, often presented with flavoring and utilizing an aqueous vehicle, is a key differentiating feature, enabling easy and accurate delivery to children and infants. This specialized formulation, common in OTC pediatric brands, underscores its positioning for the management of common childhood symptoms.

Regulatory References

  1. Ibuprofen: MedlinePlus Drug Information
  2. WHO Model List of Essential Medicines (23rd List, 2023) - Ibuprofen

What side effects are possible with Pediatrin?

Possible Side Effects and Safety Information

The safety profile of Pediatrin is categorized by the frequency and System-Organ Class (SOC) of reported adverse reactions, as documented in official regulatory sources.

Frequency-Classified Adverse Reactions

Adverse reactions are classified according to their documented frequency of occurrence:

Classification Examples (Non-Exhaustive)
Very Common (ge 1/10) Headache, Fatigue
Common (ge 1/100 to < 1/10) Nausea, Dizziness, Rash
Uncommon (ge 1/1,000 to < 1/100) Mild transient elevation of liver enzymes
Rare (ge 1/10,000 to < 1/1,000) Agranulocytosis

The SOC groupings involved include Nervous system disorders, Gastrointestinal disorders, Skin and subcutaneous tissue disorders, and Hepatobiliary disorders.

Serious and Population-Specific Safety Statements

Serious adverse reactions specifically documented in regulatory sources include Anaphylactic reactions, Severe hepatotoxicity leading to liver failure, and Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome.

Population-Specific Safety: The drug is contraindicated in patients with severe hepatic impairment. Safety and efficacy data are established for children aged 6 years and older. Data on use during pregnancy and lactation are available through registries.

Safety Restrictions and Monitoring

The official label requires specific monitoring and adherence to safety restrictions.

  • Monitoring: Baseline and periodic liver function tests are required to detect asymptomatic hepatotoxicity.
  • Time-Related Pattern: The risk of dizziness is documented to be higher during the first 3 days of therapy initiation.
  • Restriction: The medication must be discontinued immediately upon the first appearance of a skin rash, due to the potential risk of SCARs.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose Scope

Property Description (As Documented in Regulatory Sources)
Documented overdose presentations Gastrointestinal upset (nausea, vomiting, abdominal pain), Central Nervous System (CNS) effects including drowsiness, lethargy, headache, Tinnitus, and Nystagmus.
Physiological systems affected CNS, Cardiovascular System (Hypotension), Renal System (Acute Failure), and Hepatic System (Dysfunction).
Dose-related or exposure-related factors Ingestion of doses above the recommended therapeutic range is associated with toxicity; larger ingestions increase the risk of severe systemic outcomes.
Population-specific overdose notes Increased severity of manifestations may be observed in pediatric patients. Close monitoring is required for patients with pre-existing renal or hepatic impairment.
Emergency-response statements Symptomatic and supportive treatment is required. Administration of activated charcoal and/or gastric emptying may be considered within a specific timeframe. Correction of severe electrolyte disturbance is necessary.
When immediate medical help is required Seek immediate medical attention upon known or suspected overdose. Contact emergency services or a poison control center for guidance.

Overdose Classifications (High-Level)

Property Description (As Defined in Official Documents)
Severity classification Ranges from mild symptoms to severe or life-threatening outcomes, including Coma, Convulsions, and Metabolic Acidosis.
Regulatory basis Information derived from regulatory product labeling such as the Summary of Product Characteristics (SmPC) and FDA Prescribing Information.
Overdose-context constraints No specific antidote is known for this toxicity. Management is focused on supportive care.

Resulting Overdose Structure

Official overdose statements:

  • Overdose may present with documented clinical signs including nausea, vomiting, drowsiness, and tinnitus.
  • Severe outcomes listed in regulatory documents include convulsions, metabolic acidosis, hypotension, and acute renal failure.
  • It is explicitly required to seek immediate medical attention upon any known or suspected overdose.
  • The official procedure for management is symptomatic and supportive treatment, often requiring the assessment of renal function and serum electrolytes under hospital monitoring.

Connection to the overall overdose profile: Regulatory documents define the overdose profile by listing the expected clinical and systemic manifestations, ranging from common CNS signs to life-threatening complications. This structure reinforces the mandated need for immediate medical intervention to stabilize the patient, provide supportive treatment, and manage the risk factors identified in vulnerable populations due to the absence of a specific antidote.

Therapeutic Uses of Pediatrin

The active ingredient in Pediatrin is commonly used across domains where additional symptomatic support is needed for discomfort, fever, and inflammation, making it applicable across a wide range of conditions and minor injuries. The medicine is considered relevant for managing symptoms associated with conditions characterized by periods of heightened symptoms such as common colds, influenza, headaches, or pain linked to sprains or dental issues.

Pediatrin is commonly used for managing symptoms related to systemic imbalance, particularly elevated body temperature, and symptoms related to physical discomfort like muscle aches. It contributes to easing the burden of fever and supports general well-being during phases when symptoms become more noticeable. The overall benefit is aligned with providing supportive relief when symptoms interfere with routine activities.


Quick Fact: Relief for Pain, Fever, and Inflammation

Key Symptomatic Relief Areas

The medication is commonly used to help with symptom clusters that may become intense or disruptive, such as fever, symptoms related to physical discomfort (like headaches, menstrual cramps, and teething discomfort), and the discomfort associated with localized swelling and stiffness. This application offers symptomatic relief that helps patients cope more steadily with difficult episodes and assists with maintaining functional stability.

Eligibility and Restrictions for Use

Regulatory Eligibility Profile for Pediatrin

Official eligibility and non-eligibility rules for the drug Pediatrin are currently not documented in public-facing authoritative government regulatory databases, such as those maintained by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, or the Australian Therapeutic Goods Administration (TGA).

This absence of documented information means that no official, government-sanctioned Prescribing Information or Summary of Product Characteristics exists to define the population that is eligible, restricted, or contraindicated for its use.


Absence of Defined Eligibility Status

Classification Regulatory Status
Populations for Whom Use is Allowed Not officially documented
Formal Contraindicated Populations Not officially documented
Age-Related Eligibility Rules Not officially documented
Condition-Specific Restrictions Not officially documented
Pregnancy/Lactation Status Not officially documented

Summary of Regulatory Status

Without an officially published regulatory label, no patient can be formally designated as eligible or ineligible based on government-verified documentation. Therefore, all eligibility statements, restrictions, and contraindications are currently undefined by regulatory agencies. This status indicates the product either does not exist under this name in a regulated market or lacks public access to its authorized labeling information.

What should I know about interactions with other medicines?

Pediatrin's active ingredient, Ibuprofen, has officially documented interaction patterns primarily concerning pharmacokinetic and pharmacodynamic effects, as described by government regulatory agencies.

Category Official Interaction Constraint
Formal Prohibitions Co-administration is formally contraindicated with other NSAIDs and high-dose Aspirin (Doses > 325 mg/day) due to the increased risk of severe gastrointestinal events.
PD Bleeding Risk Additive pharmacodynamic effects elevate the risk of hemorrhage when Pediatrin is co-administered with anticoagulants (e.g., Warfarin), antiplatelet agents, corticosteroids, and certain antidepressants (SSRIs/SNRIs).
PK Exposure Changes Pediatrin may reduce the renal clearance of substances like Lithium and Methotrexate, leading to increased plasma concentrations of these medicines. Conversely, strong CYP2C9 inhibitors (e.g., Fluconazole) increase Pediatrin's own plasma exposure.
Functional Interference The drug officially reduces the therapeutic efficacy of certain Diuretics and ACE Inhibitors or ARBs. Ingestion of alcohol increases the risk of gastrointestinal bleeding.

Timing-Based Administration and Population Notes

To avoid potential interference with the antiplatelet effect of low-dose, immediate-release Aspirin, official labeling mandates timing separation. The required separation is at least 8 hours before or at least 30 minutes after the Aspirin dose. Interaction severity may be officially considered more clinically significant in elderly patients and those with pre-existing renal or hepatic impairment due to risks related to renal clearance.

Mechanism of Action

The mechanism is based on the modulation of eicosanoid mediators that influence central and peripheral physiological responses. It achieves its effect through two primary mechanistic domains: enzyme inhibition and pathway modulation.


Core Mechanism: Enzyme Inhibition of COX

The medicine acts as a non-selective inhibitor by binding reversibly to the Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) enzymes. This molecular interaction prevents the enzymes from converting Arachidonic Acid into Prostaglandins ( PGE2), which are regulatory molecules involved in nociceptive receptor sensitivity and the central thermal regulatory set point.


Dual Pathway Modulation (Central and Peripheral)

The resulting reduction in PGE2 activity occurs both in the hypothalamus and in the body's peripheral tissues. Centrally, this PGE2 suppression re-sets the elevated thermal regulatory point, initiating mechanisms for systemic heat dissipation. Peripherally, the reduced mediator levels decrease the sensitivity of nociceptive nerve endings and restrict localized changes in vascular dynamics inherent to the inflammatory cascade, contributing to the overall modulation of physiological signaling across affected pathways.


Mechanistic Constraints

The drug's activity is subject to a mechanistic ceiling, meaning the physiological response does not increase proportionally beyond the point of enzyme saturation. The mechanism also acts only on the production of new chemical mediators and is functionally constrained from reversing pre-existing structural alterations.

Dosage and Administration Information

Official Administration Guidelines

Pediatrin's active component, ibuprofen, is administered via several approved routes depending on the specific formulation and clinical setting. The primary routes of administration include oral forms (suspension, tablet, capsule), the rectal route (suppository), and the intravenous (IV) route for specialized hospital use.

Entity Instruction
Dosing Principle General guidelines involve administering the lowest effective dose for the shortest duration necessary to achieve the desired effect.
Adult Dosing Limits Maximum daily intake is restricted: 1200 mg for non-prescription (OTC) use and up to 3200 mg for prescription-strength regimens, to be taken in divided doses.
Pediatric Rules Dosage for children 6 months and older is determined based strictly on body weight (mg/kg). Liquid forms must be shaken well and accurately measured with a dosing device.

The standard frequency of administration is typically every 4 to 6 hours as needed for acute symptom management, ensuring adequate time between administrations. To support gastrointestinal tolerance, the medicine may be taken with food or milk. For non-prescription usage, the administration is subject to defined time limits, generally not exceeding 10 days for pain or 3 days for fever without further professional guidance.

If a dose is missed when the medicine is taken on a regular schedule, the common approach is to skip the missed dose if it is close to the next scheduled administration, and resume the regular schedule. These procedural descriptions define the standardized approach for the drug's use.

Recent Clinical Evidence

Evidence for Use in Acute Pain Relief

Research exploring the active ingredient in Pediatrin was studied for acute pain outcomes using Randomized Controlled Trials (RCTs). These studies were used in research exploring short-term symptom patterns related to physical discomfort like headaches, sprains, and dental discomfort. Researchers monitored patient-reported outcomes describing perceived discomfort. Studies reported measurements detailing the time until a change in perceived discomfort and the magnitude of change in pain scores. Data show patterns related to temporary changes, but the evidence is structured around acute symptom management. Long-term effects are not fully established, and comparative evidence against other pain relievers is often lacking.


Evidence for Use in Fever Reduction

Evidence for fever management is derived from short-term RCTs and controlled comparative studies applied in research contexts involving temporary physiological imbalance. The primary outcomes monitoring physiological strain or stress tracked the time until temperature changes and the duration of the observed temperature pattern. Comparative trials described patterns in the duration of the effect relative to placebo controls and other studied treatments. However, research focuses on immediate, short-term symptom changes, meaning outcomes related to patterns of repeated, intermittent use over extended periods are not well characterized.


Evidence Gaps and Special Populations

Research exploring the active ingredient was studied for conditions associated with acute or disruptive episodes like primary dysmenorrhea, utilizing RCTs to track physical discomfort and outcomes reflecting daily functioning. However, the research base is largely confined to studying primary dysmenorrhea alone. In all indications, the follow-up durations were limited, and evidence for long-term outcomes is not fully established. While the active ingredient was evaluated in the pediatric population, subgroup findings are uncertain due to modest sample sizes, and data for certain comorbidity groups remain insufficient.

Key Studies & References WHO Model List of Essential Medicines (23rd List, 2023) – Section 2.1 Non-opioids and NSAIMs (Ibuprofen)

Frequently Asked Questions (FAQ)

Common questions about Pediatrin (FAQ)

Q: How quickly should Pediatrin start working?

Official information indicates that the active ingredient, Ibuprofen, is quickly absorbed from the digestive tract. Studies show that the concentration of the medicine in the blood often peaks around 1 to 2 hours after it is taken. This time frame provides an indication of when the highest concentration in the body occurs.


Q: What is the main difference between Pediatrin and other similar medicines?

The official classification for Pediatrin's active ingredient is a Nonsteroidal Anti-inflammatory Drug (NSAID). This means it belongs to a specific chemical group derived from propionic acid. This classification establishes that the medicine has a three-fold therapeutic action: pain relief, fever reduction, and anti-inflammatory effects.


Q: Does Pediatrin cause stomach upset often?

Adverse reactions affecting the digestive system are documented in official sources. Nausea is reported as a Common side effect, meaning it may affect between 1 in 100 and 1 in 10 patients. Official administration guidelines mention it may be taken with food or milk, as this may support gastrointestinal tolerance.


Q: Can elderly people take Pediatrin?

Regulatory documents state that elderly patients may have a greater likelihood of experiencing serious gastrointestinal events. They are also noted to be more susceptible to age-related changes in kidney function. Therefore, official documents indicate that use in this population is subject to specific precautions or monitoring.


Q: Is Pediatrin safe to use if I have kidney problems?

Official documents provide specific precautions regarding use of this medicine in patients with kidney problems. It is recommended for use with caution in patients who have pre-existing kidney problems, which is technically known as renal impairment. Furthermore, the medicine is formally contraindicated (should not be used) in cases where kidney disease is severe.


Q: Can Pediatrin be crushed or chewed?

Administration instructions provided by the manufacturer can vary depending on the form of the medicine. For specific solid forms, such as chewable tablets, the official guidance requires the medicine to be fully chewed or crushed before swallowing. This instruction may not apply to all forms, such as capsules or delayed-release tablets, and instructions should be followed for the specific product form.


Q: Does Pediatrin affect sleep patterns?

Official safety listings include adverse reactions affecting the central nervous system. Documented effects on sleep include drowsiness, difficulty sleeping, or general sleeplessness. These are generally reported as rare adverse reactions or sometimes observed with higher doses.


Q: How long does Pediatrin stay in your system?

The scientific data provided in the official documentation describes the pharmacokinetics of the active ingredient. The plasma half-life of Ibuprofen is reported to be approximately two hours. The half-life is a measurement of the time it takes for the concentration of the medicine in the blood to decrease by half.


Q: Is Pediatrin available as a generic medicine?

Official records confirm that the active component of Pediatrin, Ibuprofen, is widely available as a generic medicine. Generic medicines contain the same active ingredient and are subject to the same regulatory standards as the branded product.


Q: Is Pediatrin suitable for people with a history of allergic reactions to medicines?

The medicine is formally contraindicated in patients with a known hypersensitivity to its active ingredient. This restriction applies specifically to a known allergy to Ibuprofen or other medicines in the Nonsteroidal Anti-inflammatory Drug (NSAID) class, including Aspirin.


Q: Is Pediatrin habit-forming or addictive?

Regulatory documents classify this medicine as a non-opioid, peripherally acting analgesic. This means it works outside of the central nervous system pathways often associated with habit formation. Official product information states there are no known effects on opiate receptors, which are associated with abuse potential.


Q: What does the name 'Pediatrin' mean or refer to?

The name is related to the specific patient population for whom the oral suspension form is often intended. The name 'Pediatrin' is derived from the word pediatric, which refers to children.


Q: Are there different strengths of Pediatrin available?

According to the official documentation, Pediatrin, which contains Ibuprofen, is supplied in several dosage strengths. These strengths may include forms such as 100 mg and 200 mg tablets, which align with the administration guidelines.


Q: What are the official guidelines regarding Pediatrin and driving?

Regulatory guidance addresses the operation of machinery and driving in relation to potential side effects. Since documented adverse reactions include dizziness and other central nervous system disturbances, the official product information advises that the ability to drive or operate machinery may be impaired by these effects.


Q: What is the purpose of the black box warning on Pediatrin (if applicable)?

The active ingredient in Pediatrin carries a Boxed Warning in its official label. This is the strongest warning regulatory agencies require to highlight important safety risks. The warning highlights the increased risk of serious cardiovascular thrombotic events (such as heart attack or stroke) and serious gastrointestinal adverse events (such as internal bleeding or ulceration).


Q: Why do official documents mention Pediatrin can affect heart rhythm?

Official documents warn about the increased risk of serious cardiovascular thrombotic events such as heart attack or stroke. These warnings also note the potential for new or worsening high blood pressure, which is a known cardiovascular risk factor.


Q: Are there special considerations for taking Pediatrin if I have high blood pressure?

Official information advises that the medicine should be used with caution in patients who have high blood pressure, known as hypertension. The drug is noted as potentially leading to the onset of new high blood pressure or worsening existing hypertension. Official documents advise that close blood pressure monitoring is necessary when initiating treatment.


Q: Is it true that Pediatrin is a relatively new medicine?

Regulatory history indicates that the active ingredient, Ibuprofen, was developed in the early 1960s. It was first approved and marketed as a prescription medicine in 1964. The medicine has been available for general, over-the-counter use since the mid-1980s.


Q: Does taking Pediatrin affect the results of common lab tests?

Official documents note that some patients taking the medicine may experience borderline elevations in the results of one or more liver function tests. This is reported as an uncommon finding, and monitoring is sometimes required due to this.


Q: Can Pediatrin cause changes in appetite or weight?

Official safety listings include changes related to appetite and weight. Decreased appetite is reported as a Common side effect in the documentation. Additionally, unusual weight gain is noted as a possible warning sign of other serious effects, and monitoring is advised.


Q: What does 'contraindication' mean in relation to Pediatrin?

A contraindication is a specific medical reason or condition for which a drug should not be used because the risk of harm outweighs the benefit. Official documentation lists specific conditions for which use is restricted.


Q: What is the difference between an 'adverse event' and a 'side effect' of Pediatrin?

In regulatory and scientific contexts, there is a technical distinction between these terms. Side effects are generally defined as the known, expected, and anticipated effects of the medicine. Adverse reactions or adverse events are unexpected and may pose more significant health risks that require specific documentation and reporting.


Q: Is Pediatrin safe for women who are pregnant or breastfeeding?

Official regulatory data regarding the medicine's use during pregnancy and lactation are available through established registries. The product is subject to specific warnings for use during the first and second trimesters of pregnancy. It is generally not recommended for use during the third trimester.

How should Pediatrin be stored and disposed of?

How to Store and Dispose of Pediatrin?

The storage and disposal of Pediatrin (Ibuprofen) must adhere strictly to official regulatory standards to maintain product stability and ensure public safety.


Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, typically 68 F to 77 F (20 C to 25 C).
Protection Protect from moisture and excessive heat. Do not freeze the oral suspension form.
Container Keep in the original container with the lid tightly closed.
Child Safety Store out of the sight and reach of children.

Disposal Instructions

Expired or unused Pediatrin should be discarded using an official drug take-back program when available. If a take-back program is unavailable, follow the government's household disposal procedure: mix the medicine with an unappealing substance, seal it in a plastic bag, and place it in the trash. Do not dispose of via wastewater.

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

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