Hypoallergenic Formula: Everything You Need to Know

Hypoallergenic Formula: Everything You Need to Know

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Article last updated: September 23, 2023

Some babies are born with or can develop allergies to food and food intolerances. For breastfed babies, a mother may avoid eating the allergens, and a baby can continue to breastfeed safely. For those infants whose symptoms do not improve or whose mothers are unable to tolerate a restricted diet, the best way is to find hypoallergenic formula as an alternative. 

If your baby has been diagnosed with a food allergy or you suspect they have an allergy, you may have many questions about how to feed your baby. There are a variety of hypoallergenic formulas on the market to choose from. Each formula has its own unique nutritional profile to ensure your baby’s safety and growth.

What’s the difference between a food allergy and food intolerance?

An allergy is an overzealous immune response. It occurs when your baby’s immune system attacks a food, incorrectly thinking that the food is an invader. 

In an effort to defend the body, the immune system will produce histamine, which causes a variety of symptoms including swelling, itchiness, and gastrointestinal discomfort. This allergic response to foods can affect many parts of the body and, if severe, can be life-threatening. 

Ninety percent of allergies to food in children are caused by just six foods or food groups, including milk, eggs, peanuts, tree nuts, soy including soy formula, and wheat. This is why it is important to know the sustainability formula used and the ingredient mixed in your child’s milk or food alternative.

An intolerance occurs when the body lacks one or more digestive enzymes needed to break down a particular food. This can irritate your baby’s digestive system and cause symptoms like diarrhea, gas, and bloating. So be sure to have a stock of foods with healthy fats for toddlers, an alternative to cow’s milk for babies, or a gentle formula in case allergies or lactose intolerance develops. Although an intolerance to food is not life-threatening, it can lead to dehydration and even impaired growth.

What is a hypoallergenic formula?

According to the research, the prevalence of allergy to cow’s milk affects roughly 2 to 3% of infants. The symptoms of allergy to cow’s milk typically appear between the first 3 to 6 months of life. If breastfeeding isn’t an option, the next step after a diagnosis is finding the best hypoallergenic formula for your baby.

You may come across a variety of hypoallergenic baby formulas in your quest for a safe and tolerable formula for your baby.  Hypoallergenic formulas are designed for babies who can’t tolerate cow’s milk-based formulas. The term “hypoallergenic” means that the formula contains protein that has been hydrolyzed or broken down into very small proteins. These tiny proteins are less likely to cause an allergic reaction.

The extent of the allergy will determine how small the proteins need to be in order for a baby to tolerate the standard formula. For example, a baby with a very severe allergy may not be able to tolerate any protein particles and therefore will require an “elemental” formula. This type of formula contains only amino acids, the building blocks of protein.

Specific criteria have to be met before an infant formula can be labeled as “hypoallergenic”. According to the American Academy of Pediatrics (AAP), hypoallergenic infant formula must be:

  • Studied in a clinical trial
  • Studied children with allergy to cow’s milk
  • Tolerated (no signs of an allergic reaction) by at least 90% of the patients

    Types of hypoallergenic formulas for babies

    The type of hypoallergenic formula you choose for your baby will depend on a variety of factors, including allergy severity. The following are various formulas available to choose from:

    Soy-based formulas: While these kinds of formulas are an alternative to cow’s milk formulas, they aren’t considered hypoallergenic. According to the literature, up to 50% of children with a cow's milk protein intolerance also develop soy protein intolerance if fed with soy-based alternatives. Consequently, soy-based formulas are not usually a viable formula option for babies with a cow's milk protein allergy or intolerance.

    Partially hydrolyzed: In a partially hydrolyzed formula, the proteins are only partially broken down. These formulas are not used for babies with a milk protein allergy

    because they aren’t considered truly hypoallergenic. Babies can still have a reaction to this sized protein molecule.

    Extensively hydrolyzed: The formula contains protein that is extensively broken down into smaller pieces. Babies won’t typically have a reaction to this type of formula due to the tiny milk protein size. Approximately 90% of babies with an allergy to cow’s milk can tolerate considerably hydrolyzed formulas.

    Amino acid-basedAmino acid–based formulas, also known as elemental formulas, contain no large or small protein molecules. Instead, the proteins are broken down into their building blocks, called amino acids. These formulas are considered 100% non-allergenic and are used for the roughly 10% of babies who are unable to tolerate extensively hydrolyzed formulas.

    Is hypoallergenic formula safe?

    Hypoallergenic formulas must meet strict standards of safety to ensure optimal growth and development. To be labeled hypoallergenic, these formulas must prove that they don’t cause reactions in 90% of infants or children with confirmed allergy to cow’s milk.

    For a baby with a severe allergy who isn’t breastfed, hypoallergenic formula is the only safe way to feed your baby. Even when a severe allergy isn’t present, babies with mild allergies and intolerances to milk protein may benefit from a hypoallergenic formula.

    Allergies to food and intolerances can wreak havoc on your baby’s comfort. They can cause pain, distress, and may even lead to additional health complications if not treated. This type of formula is considered a safe and effective treatment option for babies with a milk protein allergy. 

    Baby Formula Shortage

    Hearing the term shortage in reference to your baby's formula can sound scary. But that is why it is helpful to know that there are many formula brands for little ones who cannot tolerate regular formula. In this day and age it is easy to contact a doctor and a pediatrician may recommend switching to another brand. With serve allergies a new formula should be confirmed with a doctor before switching to make sure there are no contaminations. Finding the right hypoallergenic formula can be tricky and that's why it is scary to hear that there could be a shortage. Although unlikely, don't panic if you can't find your typical formula, look online or contact your doctor right away to see if they know where to find some. 

    When should the hypoallergenic baby formula be used?

    The American Academy of Pediatrics recommends that hypoallergenic formulas be used in babies with clear medical symptoms that would benefit from a specialty formula.

    Additionally, a hypoallergenic formula may be indicated when there is a strong family history of food or environmental allergies. In fact, a child’s risk of developing a food allergy in the first year increases to approximately 10% if one parent has allergies, and 20% if both parents do.

    It is important to be aware of the common symptoms associated with allergy to cow’s milk so you know when to make changes to help alleviate discomfort.

    Babies with severe allergic reactions to food or milk proteins will show some of the following symptoms:


    You may see many parents and caregivers with a burp cloth hanging from their shoulder. This is because most babies spit-up, also known as reflux. While spitting up is perfectly normal, having more severe symptoms of reflux is not. 

    Symptoms of severe reflux include:

    • Throwing up lots of liquid
    • Choking or gagging
    • Arching away from the bottle or breast
    • Expressing irritability with feedings
    • Poor weight gain

    These signs may be an indication of a milk protein allergy.


    Occasionally spitting up after feeding is to be expected. However, vomiting which is a more forceful projection of stomach fluids, may be a sign that your baby has an allergy or an intolerance. It is important to speak with your healthcare professional to rule out anything more serious. 

    Additionally, it’s also important to know the signs of dehydration to help avoid further medical complications. Symptoms of dehydration may include, few or no tears when crying, fewer than four wet diapers per day, dry lips, unusually fussy, and appearing weak or limp.  


    Diarrhea can signify that your baby has a food allergy or intolerance, and may require a hypoallergenic formula. 

    However, it can be a challenge trying to decipher diarrhea from regular baby poop. Breastfed babies typically have runny stools, while formula-fed infants tend to be a little thicker. 

    Diarrhea on the other hand will be more frequent, watery, and sometimes foul-smelling. Diarrhea can lead to dehydration, so it’s important to know the signs to prevent further medical complications.

    Bloody Stools

    Babies with food intolerances or allergies may have bloody stools caused by the formation of small ulcers within the GI tract. The sight of bloody stools for parents can be quite jarring. 

    However, when the issue is related to an intolerance or allergy, the treatment is simple. If a mother is breastfeeding, she would be placed on a dairy-free diet or the baby can switch to a hypoallergenic formula. 

    It is important to note that approximately 50% of babies who are allergic to cow's milk protein may also be allergic to soy protein. Therefore, if your baby's symptoms don't clear up, it is recommended that a nursing mother avoid both soy and dairy or switch to a soy-free formula.


    Gassiness is a normal part of a developing GI system. Excessive gassiness accompanied by a bloated stomach, clenched fists, and/or a foul odor may be a sign of a milk intolerance or allergy.


    Constipation is another sign that your baby may not be tolerating cow’s milk protein. If your baby’s stool appears as small pellets, or as a hard ball, your baby may be constipated. A hypoallergenic baby formula might help.

    Respiratory Symptoms

    If your baby starts wheezing or has other respiratory symptoms after feedings, they may have a cow’s milk allergy that requires immediate attention. Even if you notice mild respiratory symptoms, it’s important to speak with your health care professional about the possibility of an allergy or intolerance. Mild respiratory symptoms may include sneezing, runny nose, and a persistent cough. 


    Anaphylaxis is an extremely serious allergic reaction that comes on quickly, affects the whole body, and is potentially life-threatening. Signs of anaphylaxis include breathing difficulties, fainting, and swelling around the face. Thankfully, this type of allergic reaction is not common in infants, however, if you suspect your child is experiencing anaphylaxis, immediately seek medical attention.

    Extreme Fussiness

    Extreme fussiness, also known as colic, is fussiness and extensive crying, even when basic needs have been met. The baby is not hungry, tired, or does not require a diaper change. 

    According to research, colic can affect up to 20% of infants. The formal definition of colic is crying for more than 3 hours per day, for more than three days per week, and for more than three weeks. Colic can be a result of extreme abdominal pain caused by a milk protein allergy or intolerance, which a change in diet or formula may help.

    Itchy Rash

    Babies can develop rashes for a variety of reasons. Sometimes rashes may be due to the milk protein they are eating if they have an allergy. If your baby develops hives after eating, it may be caused by a food allergy.

    A food allergy or intolerance may also present as eczema. Eczema is characterized by red bumps on your baby's face, scalp, hands or feet that may itch or feel like dry, scaly skin.

    Inadequate weight gain

    The majority of babies double their birth weight by 6 months and triple it by 12 months.

    Slow weight gain, also known as Failure to Thrive (FTT), is a symptom of a cow’s milk allergy. Oftentimes food allergy reactions can create problems digesting and absorbing nutrients due to issues like vomiting or diarrhea which can lead to impaired growth.

    Can a baby be allergic to hypoallergenic formula?

    Since there are a variety of formulas marketed as “hypoallergenic”, there are some babies that still may be allergic to it. It is possible for a baby with allergies to certain types of food to react to partially hydrolyzed, or extensively hydrolyzed formulas. This is because the protein in these formulas, albeit small, is still intact.

    Amino acid-based formulas on the other hand don’t contain actual allergen proteins, they only contain amino acids which can’t cause a reaction. Amino acid-based formulas have been subjected to extensive clinical testing and meet the standard for complete hypoallergenicity.

    Can hypoallergenic formula cause gas?

    Gas is generally caused when a baby swallows too much air while feeding. However, the type of formula you choose, may contribute to gas production, or can help alleviate it. 

    For example, an intolerance to dairy, and/or soy can cause gas along with other uncomfortable GI symptoms. A lactose-free and/or soy-free formula may be beneficial for babies with this type of sensitivity.

    Can hypoallergenic formula help reflux?

    Acid reflux happens when stomach contents and acid flow back up into the throat and esophagus. A typical, healthy infant with mild acid reflux may spit up after feedings, but is gaining weight and generally isn’t upset.

    Frequent spitting up and/or vomiting may be a sign that your baby cannot tolerate their formula. Hypoallergenic formulas are gentler on a baby’s system and can be effective in reducing reflux. They are often recommended for babies with allergies to select food.

    Regardless of the cause of your baby’s reflux, there are some steps you can take to help alleviate symptoms:

    • Burp your baby after every 1-2 oz. of formula
    • Offer smaller, more frequent feedings
    • Keep your baby in an upright position for 30 minutes after each feeding
    • Avoid vigorous movement and active play after a feeding

    Can hypoallergenic formula cause diarrhea?

    It can be a challenge trying to distinguish regular baby poop from diarrhea as baby stool often appears soft and runny. Signs of diarrhea may include extremely liquid bowel movements, an increase in the frequency of stools, and the stool may be accompanied by an unusually foul smell.

    Additionally, the color, consistency, and frequency of bowel movements can differ for your baby from day to day.

    If you have made the switch to a hypoallergenic formula and your baby is experiencing diarrhea, this is normal for a period of time. Your baby’s body is digesting and absorbing the hypoallergenic formula differently than a previous standard formula. It can take up to 2 weeks for your baby to adjust to a new formula.

    Alternatives to hypoallergenic formula 


    According to the American Academy of Pediatrics, breast milk provides the optimal nutrition for your baby. On occasion, a food protein (allergen) can pass through the breast milk and trigger a reaction. However, babies with allergies to certain food can also benefit from breastfeeding if the lactating mother removes the foods that trigger the baby’s symptoms from their diet. 

    Soy-based Formula

    Soy formulas contain soy protein rather than cow’s milk protein. These are sometimes recommended for babies who are unable to digest lactose, the main carbohydrate found in cow's milk formula. 

    However, up to 50% of children with a cow's milk protein allergy can also have a soy protein intolerance. These babies will require a true hypoallergenic formula such as an extensively hydrolyzed or amino-acid based formula.

    Soy-based formulas contain high levels of plant-based estrogen-like compounds. Studies show that infants who consume soy-based formulas have differences in reproductive system tissues and cells, raising questions about the long term effects of these differences.

    Goat milk-based formula

    Occasionally, a baby that has an intolerance to standard formula made with cow milk, may have an easier time tolerating a formula based on goat milk. A goat milk-based formula contains smaller fat molecules than a regular formula made with cow’s milk.

    However, it is important to note that formula made from goat’s milk is not considered a suitable alternative for babies with a cow’s milk protein allergy. The majority of children that react to cow’s milk protein will also react to goat’s milk protein. Goat milk-based formula is difficult to come by in the US and may have to be purchased in Europe.

    Rice Milk

    Some formulas can be made from hydrolyzed rice protein, as a plant-based alternative to cow’s milk protein formulas. Rice is one of the few kinds of foods that is not likely to cause allergies.

    Studies show that hydrolyzed rice protein formulas can be used for babies with cow’s milk protein allergies without compromising normal growth patterns. However, more research is needed on the safety and long-term growth trends with the use of hydrolyzed rice protein formulas.

    Hydrolyzed rice-protein formula is not widely available in the United States but can be found in some countries in North Africa, the Middle East, and South America.

    Choosing a Hypoallergenic Baby Formula

    Hypoallergenic baby formulas are intended to safely feed a baby with allergies while supporting their optimal growth and development.  Almost all children with cow’s milk protein allergy will require a hypoallergenic formula in the absence of breastmilk. It is important to notify your health care practitioner of the first sign of food allergy symptoms to prevent discomfort and suboptimal growth.

    In summary, the protein in cow’s milk causes babies with a cow’s milk protein allergy to experience unpleasant symptoms. A standard baby formula is made with cow’s milk protein which contains large protein molecules that a baby with an allergy will react to. 

    Some babies can tolerate partially hydrolyzed formulas because their protein chains are slightly smaller. Although, babies with a true cow’s milk protein allergy will not be able to tolerate this type of formula.

    Extensively hydrolyzed formula contains very small protein particles, and most babies with a cow’s milk allergy can tolerate these formulas. Babies with a severe milk protein allergy may not be able to tolerate extensively hydrolyzed formulas and may require an amino-acid-based formula.

    Amino acid-based formulas are broken down into the building blocks of protein, amino acids. Amino acid-based formulas will not cause a reaction in babies with a cow’s milk allergy because they are non-allergic.

    It’s important to recognize that not every baby will respond well to every hypoallergenic formula. You may have to try more than one before you find a brand that works for your baby. The best hypoallergenic formula may be found through trial and error. If your baby needs hypoallergenic formula talk to your baby's doctor before switching and make sure not to use homemade formula as it does not include all the necessary nutrients your little ones need. 

    While navigating the world of allergies can be challenging, there is promising news ahead. According to the latest researchapproximately 50% of affected children develop tolerance by the age of 1 year. More than 75% are tolerant by the age of 3 years, and over 90% at 6 years old.

    Else Nutrition has created an innovative formula option for those who are looking for another alternative. Made from almonds, tapioca, and buckwheat, Else toddler formula does not contain soy or dairy, common allergens that lead parents to search for different ingredients. Else’s baby formula, with similar ingredients, is currently in development as well. 


    The content and advice provided in this article is for informational purposes only and is not a substitute for medical diagnosis, treatment, advice for specific medical conditions. Always consult a pediatrician to understand the individual needs of your child.

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