Pediasure

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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 Pediasure

What is PediaSure? Foundational Definition and Composition

Property Description
Active Ingredient Comprehensive nutrient blend (Protein, Fat, Carbohydrate, 25+ Vitamins & Minerals)
Form Liquid Preparation
Pharmacological Class Enteral Nutrition Preparation For Children / Medical Food
Common Use Nutritional support and supplementation
Origin Derived/Formulated Combination Product

What Type of Product is PediaSure? (Identity, Class, and Form)

PediaSure is formally classified as an Enteral Nutrition Preparation For Children, which is broadly regulated as a medical food intended for the specific dietary management of nutritional inadequacy. It is not considered an over-the-counter drug, but rather a specialized nutritional combination product designed for the pediatric population (typically ages 2 to 13). The preparation is supplied as a shelf-stable liquid preparation intended for the enteral route of administration, meaning it is consumed orally or delivered via a feeding tube. Its core differentiation is its explicit formulation tailored to support catch-up growth and address inadequate oral intake in this specific age group.


Understanding the Full Composition of PediaSure (Macronutrients and Micronutrients)

This product's identity rests on its comprehensive and scientifically balanced composition, which supplies all essential macronutrients and a full profile of micronutrients. Its formula includes high-quality Protein, complex and simple Carbohydrate sources, and a lipid profile featuring essential fatty acids from oils like Safflower Oil and Coconut Oil. It is highly enriched with all necessary Vitamins (e.g., Vit D, Vit C) and a wide spectrum of Minerals (Calcium, Iron, Zinc). The product is distinct in that many variations feature Fructooligosaccharides (prebiotics) and beneficial cultures to support digestive health, a feature utilized for aiding nutrient assimilation. Specific versions are also developed as lactose-free options, broadening their suitability.


What is the General Purpose of Enteral Nutrition for Children? (Core Benefit)

The general purpose of this type of Enteral Nutrition Preparation is to provide reliable complete or supplemental nutrition to children who are unable to meet their dietary requirements through conventional food consumption. By delivering a dependable nutritional foundation, PediaSure ensures the child receives the necessary building blocks—Protein, Vitamins, and Minerals—to support healthy growth and development, particularly in scenarios of growth faltering or increased metabolic demand.

What side effects are possible with Pediasure?

Possible Side Effects and Safety Information

As a Medical Food regulated by the U.S. Food and Drug Administration (FDA) for use as an Enteral Nutrition Preparation, this product’s official safety profile is defined by necessary precautions, contraindications, and symptoms of intolerance, rather than a drug-style table of adverse reaction frequencies.

Administration and Composition Safety

The primary safety limitations are absolute prohibitions on use. The product is strictly contraindicated in individuals with galactosemia, a serious metabolic condition. Furthermore, it is explicitly labeled Not for Intravenous (IV) Use and must only be administered via the enteral (oral or tube) route. All varieties contain milk protein and soy and are therefore unsuitable for children with a known cow's milk protein allergy.


Potential Intolerance and Population Notes

The most commonly noted possible effects are symptoms of gastrointestinal intolerance related to the nutritional formula. These may involve gastrointestinal disorders such as diarrhea, constipation, vomiting, or stomach discomfort. While the product is often suitable for lactose intolerance due to low lactose content, this consideration is separate from the absolute contraindication in galactosemia.

Regarding the pediatric population, the preparation is not intended for use in infants under 1 year of age unless specific instruction is provided by a healthcare professional.

Overdose and Emergency Response

Overdose and when to seek help

The following statements reflect standard emergency guidance provided in official government-authorized materials for nutritional products, which do not typically contain a detailed toxicological overdose section found in prescription drug labeling.

Overdose Scope and Emergency Action

Feature Official Regulatory Information (Label-Derived Phrasing)
Documented overdose presentations No specific, named toxic syndrome or symptoms are detailed in official regulatory documents for over-ingestion of this nutritional product.
Dose-related factors No specific toxic dose thresholds or amounts associated with serious symptoms are cited in official labeling.
Emergency-response statements If someone has overdosed and is experiencing serious symptoms such as passing out or trouble breathing, call emergency services (e.g., 911) immediately.
When immediate medical help is required Required immediately upon the appearance of serious symptoms including loss of consciousness or respiratory difficulty.

Resulting Overdose Structure

The formal guidance instructs patients and caregivers to take specific emergency actions based on the severity of the symptoms, rather than a known toxic threshold. The primary actions are to contact emergency medical services if the individual shows signs of severe distress, such as inability to remain conscious or difficulty breathing, or to call the national poison control center right away for any suspected over-ingestion when serious symptoms are absent.

This structure defines the overdose profile through an emergency directive focusing on immediate life-saving procedures, reflecting its classification as a nutritional product that lacks the explicit overdose toxicology data found in standard drug monographs.

Therapeutic Uses of Pediasure

What PediaSure Treats: Main Uses and Benefits

This preparation is generally applied in situations involving symptoms related to systemic imbalance and may assist with promoting appropriate physical development. It is commonly used for managing growth faltering, chronic nutritional inadequacy, and supporting patients during conditions marked by increased physiological stress.


Supporting Growth and Nutritional Status

This preparation is used in situations involving symptoms related to physical discomfort such as poor weight gain and where nutritional intake is insufficient. The core benefit may assist with providing supportive caloric and nutrient levels relevant for catch-up growth and supports patients whose goal is to manage symptoms that interfere with daily functioning (e.g., poor weight status). This focus is considered relevant for those with restrictive diets, including selective eating behaviors and those with chewing or swallowing difficulties (dysphagia).

“It is applied in addressing symptom clusters that may become disruptive by offering nutritional support to mitigate systemic deficits.”

Its application is considered relevant for easing the overall symptom load by providing a reliable, high-density source of nutrition, which contributes to improved comfort during symptomatic periods and helps the body manage the increased physiological stress from illness or surgery.


Quick Fact: Relief for Nutritional Strain

PediaSure supports patients across a range of conditions characterized by periods of heightened symptoms related to nutritional deficits, ensuring continuous access to complete macro- and micronutrient support.

Eligibility and Restrictions for Use

PediaSure is officially classified by regulatory agencies as a medical food or therapeutic nutritional product, not a prescription medication. Its eligibility profile is based on mandatory safety precautions and nutritional suitability for the target population.

Populations that Must Not Use PediaSure

Official labeling defines specific absolute exclusions:

  • Galactosemia: The product is contraindicated for individuals diagnosed with this metabolic disorder.
  • Intravenous (IV) Use: The product is strictly not for IV use or parenteral administration.
  • Severe Cow's Milk Allergy: As the product generally contains milk protein ingredients, it is not appropriate for those with a confirmed, severe cow’s milk allergy.

Eligibility and Restricted Use

Eligibility Group Regulatory Rule/Constraint
Target Age Group Primarily formulated for children 1 to 13 years of age as a nutritional supplement.
Infants Under 1 Year Not intended for infants under one year of age unless use is explicitly directed and supervised by a qualified physician.
Lactose Intolerance Generally suitable for individuals with lactose intolerance, as most formulations are low in lactose.

The regulatory structure mandates that use be limited to the oral or enteral (tube) feeding route, and eligibility is strictly tied to the pediatric age group for which the nutritional adequacy is established.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory profile for this Enteral Nutrition Preparation focuses on physical interference and nutritional content rather than conventional drug metabolism. Official regulatory documents define three main domains of interaction constraints.

Documented Interaction Patterns

Interaction Type Interacting Substance/Condition Constraint as Documented by Regulators
Product-Condition Prohibition Galactosemia Use is strictly contraindicated due to the formula’s composition.
Pharmacodynamic Antagonism Vitamin K-dependent Anticoagulants (e.g., Warfarin) The formula's Vitamin K content may counteract the anticoagulant effect.
Pharmaceutical Interference Specific Oral Medications (e.g., Phenytoin, Carbamazepine) Co-administration may reduce drug absorption and bioavailability due to physical binding.
Nutrient Accumulation Risk Other Vitamin/Mineral Supplements Risk of exceeding official Upper Intake Limits for certain micronutrients (e.g., Iron, Zinc).

These constraints establish mandatory requirements for the product's use. The interference with oral medications requires mandatory time separation during administration to mitigate the risk of reduced drug exposure. Additionally, caution is officially noted for use in individuals with Severe Renal Impairment due to the high electrolyte and fluid load inherent to the complete formula.

Mechanism of Action

The formulation provides a specific blend of macronutrients that function as primary substrates for the anabolic synthesis of body tissues, including both muscle and bone. Protein components are hydrolyzed, yielding free amino acids that serve as direct molecular precursors for the synthesis of lean tissue structures.

Concurrently, key vitamins and minerals function as essential cofactors, modulating the activity of various intracellular enzymatic reactions and contributing directly to the structural integrity of cell membranes. Calcium, a major mineral component, undergoes integration into the bone matrix following absorption, enabling the specific biochemical process of mineral incorporation into the skeletal structure. Furthermore, the specialized lipids present are efficiently hydrolyzed within the small intestine, facilitating the transport and absorption of fat-soluble nutrients.

Dosage and Administration Information

How to Use PediaSure: Official Administration Principles

The standardized use of PediaSure, categorized as a medical food, is strictly defined by protocols governing its route, preparation, dose volume, and the age of the patient. The administration is exclusively through the enteral route, meaning the preparation is delivered either by oral ingestion or via an enteral tube feeding. The product is explicitly not intended for parenteral (IV) use.


Official Dosing and Frequency

The regimen for PediaSure is determined by the child's age and nutritional requirement. It is designed for use in children aged 1 to 13 years; it is not intended for infants under one year of age. The preparation is administered daily, either with or between meals, as part of a sustained, long-term nutritional plan.

Supplemental Use is based on providing up to 2 or 3 servings per day, depending on the child's age group. When used as the sole source of nutrition, the required daily volume is substantial and calculated to meet 100% of the Daily Reference Intakes (DRIs) for protein and essential micronutrients, such as 1000 mL for younger children.


Preparation and Contextual Constraints

Proper use requires specific handling: the ready-to-use liquid form must be shaken well before opening. The powder form necessitates precise reconstitution with a specified volume of water, and the water used must be below 35 C to maintain product integrity. Consistent with guidelines for medical foods, the use of PediaSure as a sole source of nutrition requires professional oversight and must occur under medical supervision.

Recent Clinical Evidence

Recent Clinical Evidence Summary

Research on the use of balanced oral nutritional supplements (ONS), such as Pediasure, primarily focuses on children identified as being at risk for undernutrition, often due to selective or 'picky' eating habits, or those experiencing growth faltering.

Clinical studies, frequently conducted as randomized controlled trials (RCTs), suggest that incorporating ONS alongside dietary counseling may be associated with improvements in key nutritional indicators compared to dietary counseling alone in this specific pediatric population. These indicators commonly relate to growth and health outcomes, particularly in children aged 2 to 10 years.

Key Findings from Research Trials

Outcome Category Observed Study Results (Compared to Dietary Counseling Alone)
Anthropometric Growth Some trials observed statistically greater increases in weight-for-age and body mass index (BMI)-for-age z-scores within a few months of intervention. Improvements in linear catch-up growth (height-for-age z-scores) have also been reported over longer intervention periods (e.g., 4 to 12 months).
Nutritional Adequacy Studies indicate an increase in the proportion of children achieving adequate daily intake of essential macronutrients (protein, fat) and micronutrients (e.g., calcium, iron, vitamins A, C, D) following ONS supplementation.
Health Outcomes A reduced incidence of upper respiratory tract infections (URTIs) and fewer sick days were reported in some trials involving children at nutritional risk. Other noted secondary outcomes include parent-reported improvements in appetite, physical activity, and sleep habits.

It is important to note that the primary aim of these supplements, in a clinical context, is to provide energy, protein, and micronutrients to address dietary gaps and support growth when a child's intake of whole foods is inadequate.

Frequently Asked Questions (FAQ)

Common questions about Pediasure (FAQ)

Q: How long is Pediasure intended to be used as a supplement (e.g., short-term vs. long-term)?

Official guidance indicates that the product is designed to be administered as part of a sustained, long-term nutritional plan for children. It is generally part of a nutritional plan intended to be sustained to provide ongoing nutritional support and address dietary gaps.

Q: What types of feeding tubes can the Pediasure Peptide products be administered through?

The product is approved for the enteral (tube) feeding route. For certain specialized formulas, product information indicates that specific tube sizes are necessary for proper administration, such as 10 French (Fr) for gravity feeding or 8 Fr for an enteral feeding pump.

Q: Does Pediasure contain any ingredients derived from soy?

Yes, the official labeling for many varieties indicates the presence of soy. This includes ingredients derived from soy, such as soy oil or soy protein isolate.

Q: Is Pediasure appropriate for a child who is following a vegetarian diet?

Some PediaSure products are indicated as suitable for lacto-vegetarians. This is because the protein sources within the formula are derived from cow’s milk.

Q: Is there a version of Pediasure that is certified vegan or plant-based?

The product is generally not classified as suitable for a vegan diet. This is due to the presence of milk protein concentrate in many of the standard varieties.

Q: Does Pediasure contain gluten or is it considered a gluten-free product?

According to the official product characteristics and labeling, the majority of PediaSure formulations are explicitly classified as gluten-free.

Q: Are there any versions of Pediasure that contain a reduced sugar formula?

Yes, official product information confirms that there are specialized versions available. These include products such as PediaSure Complete Reduced Sugar, which contain a lower total sugar content than the standard formulations.

Q: Does Pediasure contain DHA Omega-3 fatty acids?

Yes, according to the official ingredient and nutrition panels, many PediaSure formulas contain DHA (Docosahexaenoic Acid). DHA is an Omega-3 fatty acid.

Q: How much fiber is contained in Pediasure products?

The amount of fiber varies significantly by product formulation. For example, the PediaSure Grow & Gain with Fiber formulation contains 3 grams of dietary fiber per serving, as listed on the Nutrition Facts panel.

Q: What is the Potential Renal Solute Load (PRSL) of Pediasure?

The Renal Solute Load (RSL) is a technical characteristic provided in the product information. For certain PediaSure products, such as PediaSure Peptide, the RSL value is listed (e.g., 275 mOsm/L).

Q: Is Pediasure intended to support a child's immune system health?

Yes, the product claims indicate that many formulations contain a blend of nutrients intended to support the immune system. These typically include ingredients such as protein, zinc, and antioxidants.

Q: Do the powder and liquid forms of Pediasure have the same exact list of ingredients?

No, the ingredient lists are not identical. The powder requires reconstitution with water, while the ready-to-drink liquid contains water, stabilizers, and potentially different oil sources required for its shelf-stable liquid preparation.

Q: What are the storage limits for an unopened container of Pediasure product?

Official storage instructions state the unopened container must be stored at room temperature. The time limit, or shelf life, is marked as the expiration date printed on the packaging.

Q: What is the primary difference between Pediasure powder and the ready-to-drink liquid?

The ready-to-drink liquid is ready for consumption after shaking and requires refrigeration after opening. In contrast, the powder form requires reconstitution with water upon use and should be stored re-sealed in a cool, dry place without refrigeration.

Q: Is it safe to freeze Pediasure products and consume them as a frozen treat?

Official storage instructions indicate that the unopened liquid product must not be frozen because this can compromise the product's stability and nutritional integrity. The label does not contain specific guidance on freezing the product for consumption as a treat once it has been opened or prepared.

Q: Can Pediasure be warmed up, and is it safe to use a microwave for heating it?

Regulatory information notes that the water used to mix the powder form must be kept below 35°C to maintain the formula's integrity. While this suggests heat sensitivity, the official label does not provide specific safety instructions regarding warming the ready-to-drink liquid or using a microwave.

Q: Why does Pediasure contain added sugar, and how much is in a single serving?

The amount of added sugar per serving is listed on the Nutrition Facts panel (e.g., some shakes contain 8 to 12 grams of added sugars). The label does not explicitly state the formulation purpose for the added sugar.

Q: Can Pediasure be given to children who have been diagnosed with diabetes?

The product label specifies that use should occur under medical supervision, particularly when used as the sole source of nutrition. Children with conditions like diabetes require management of their nutritional intake by a healthcare professional.

Q: What is the shelf-life of a mixed Pediasure shake if it is refrigerated?

A PediaSure shake prepared from the powder has a stability limit of 24 hours after mixing, provided it is refrigerated.

Q: What is the difference in calories and protein between PediaSure Grow & Gain and PediaSure SideKicks?

The official Nutrition Facts panel for each product provides the exact details. PediaSure SideKicks typically contains a lower caloric and fat content compared to PediaSure Grow & Gain, which is designed to support growth.

Q: How is the Pediasure Peptide formula different from the standard Pediasure formula?

The Peptide formula is a specialized product that differs in its protein source. It contains hydrolyzed protein (peptides) and is designed specifically for children with conditions resulting in malabsorption or other gastrointestinal difficulties.

Q: What is the standard recommended serving size for children in different age brackets (e.g., 1–3 years vs. 4–10 years)?

For supplemental use, the recommendation is typically 2 or 3 servings per day. The daily volume required to meet 100% of nutritional needs is higher for older children (9–13 years) than for younger children (1–8 years).

Q: Why do some formulations of Pediasure contain artificial sweeteners?

Some reduced-sugar formulations utilize non-nutritive sweeteners, such as Stevia leaf extract. These ingredients are added to maintain or enhance the flavor of the product while reducing the total sugar content.

How should Pediasure be stored and disposed of?

Storage and Disposal of PediaSure

Official labeling defines strict conditions for storing PediaSure, which is regulated as a medical food. Unopened liquid product must be stored at room temperature, in a cool, dry place, and must not be frozen.

Stability and Handling

Product State Required Storage Condition Stability Limit
Opened Liquid Must be refrigerated Use within 48 hours
Opened Powder Store in a cool, dry place (re-sealed) Use within three weeks

Opened powder requires the can to be re-sealed with the original lid or an airtight container and should not be refrigerated. All containers must be stored out of the reach of children.

Disposal

Unused or expired product and empty containers should be disposed of in household trash.

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

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