elemental infant formula

Medically Reviewed on 1/18/2023

Generic Name: elemental infant formula

Brand and Other Names: Neocate Infant Formula, amino acid-based infant formula

Drug Class: Food, Supplements

What is elemental infant formula, and what is it used for?

Elemental infant formula is a special hypoallergenic formula used to feed infants who are allergic to or unable to digest cow’s milk, soy-based, or pre-digested protein formulas.

Elemental infant formula contains free amino acids without any protein particles (peptides), in order to prevent protein-based allergic reactions. Elemental infant formula also contains vitamins, minerals, fats, and carbohydrates required for a baby’s growth and development. 

Breast milk is considered to be the best and only source of nutrition required for infants up to 4 or 6 months of age when they can begin to eat soft solid foods. In addition to nutrition, breast milk has other biologic substances that are important for the development of the baby’s intestinal function, immune system, and brain development.

Although breastfeeding is highly recommended, infant formula is used because breastfeeding may not always be possible, suitable, or fully adequate by itself. Elemental infant formula is a specialized formula used only under medical supervision for infants with certain medical conditions. The different types of infant formulas available include:

  • Standard Infant formula: Special dried cow’s milk powder made to resemble breast milk as closely as possible in an attempt to provide all the nutrition a baby needs.
  • Soy-based formula: Used to feed infants who cannot tolerate sugars and/or proteins found in cow’s milk or breastmilk.
  • Protein hydrolysate hypoallergenic formula: Contain proteins that have been broken down or predigested (hydrolyzed), used for infants who cannot tolerate or are allergic to both cow’s milk and soy formulas.
  • Elemental infant formula: Contains free amino acids without peptides and is used for infants who cannot have any of the above types of formulas.

Elemental infant formulas are typically used in the following conditions:

  • Cow milk allergy
  • Multiple protein intolerance
  • Short bowel syndrome
  • Eosinophilic esophagitis
  • Gastroesophageal reflux
  • Transition from intravenous (parenteral) to enteral nutrition
  • Other medical conditions for which an amino acid-based diet is required


  • Elemental infant formula is not for intravenous (parenteral) use.
  • Elemental infant formula should be used only under strict medical supervision.
  • Clinicians should monitor the infant’s serum levels of micronutrients, particularly phosphorous, especially when elemental (Neocate brand) infant formula is the sole source of nutrition.
  • There have been recent reports of broken bones, rickets, and other bone disorders in infants fed with Neocate infant formula. Recent studies have discovered a link between Neocate formula and low blood phosphate levels (hypophosphatemia) and have recommended further investigation to establish the exact mechanism.
  • There is an ongoing class suit action against the Neocate brand of infant formula to investigate potential side effects of hypophosphatemia and associated bone conditions.

What are the side effects of elemental infant formula?

Side effects linked to Neocate infant formula include:

  • Low phosphate levels in the blood (hypophosphatemia)
  • Rickets
  • Fractures
  • Nutritional deficiencies
  • Stunted growth
  • Skeletal deformities
  • Long-term skeletal damage

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.


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What are the dosages of elemental infant formula?


  • Dependent upon age, body weight, and medical condition; use under medical supervision


  • Not indicated for use


  • Babies naturally refuse to feed and turn their faces away when they are full, and overfeeding is uncommon.
  • Overfeeding an infant can make them spit up or vomit the infant formula and get gassy, fussy, and irritable.
  • Overfeeding can be avoided by watching for cues as to how the baby responds before, during, and after feeding.

What drugs interact with elemental infant formula?

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

  • Elemental infant formula has no listed severe, serious, moderate, or mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider about all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or healthcare provider if you have any questions about the medication.

What else should I know about elemental infant formula?

  • Prepare elemental infant formula exactly as per directions.
  • Do not boil formula and do not use a microwave oven to prepare or warm the formula.
  • Before feeding, ensure that the formula is at the correct temperature by placing a few drops on the wrist
  • Discard unused formula remaining in the bottle after feeding. Use the prepared formula within 24 hours of preparation. Shake immediately before use.
  • While buying infant formula, check the label for content and make sure it is not expired.
  • Make sure the container is sealed and in good condition. Do not buy it if there are any leaks, puffy ends, or rust spots.
  • Before switching the formula brand, check with the pediatrician.
  • All infant formulas legally sold in the U.S., whether made locally or imported from other countries must be reviewed by the FDA. Do not use illegally imported infant formulas.
  • There is an ongoing investigation on potential hypophosphatemia and related bone disorders associated with the Neocate brand of amino-acid based infant formula. Parents and clinicians should monitor the infant being fed with Neocate infant formula and keep alert for symptoms related to hypophosphatemia and bone disorders.


Elemental infant formula is a special hypoallergenic formula used to feed infants who are allergic to or unable to digest cow’s milk, soy-based, or pre-digested protein formulas. There have been recent reports of broken bones, rickets, and other bone disorders in infants fed with Neocate infant formula. Side effects linked to Neocate infant formula include low phosphate levels in the blood (hypophosphatemia), rickets, fractures, nutritional deficiencies, stunted growth, skeletal deformities, and long-term skeletal damage.

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Medically Reviewed on 1/18/2023