What you need to know

A food allergy is a health condition where your body’s immune system overreacts when you eat certain foods. Food allergies are either immunoglobulin E (IgE)–mediated or non–IgE-mediated:

IgE-mediated

  • Caused by IgE antibodies, which trigger your body to quickly release chemicals such as histamine
  • Usually occurs in minutes to up to 2 hours after eating a food allergen
  • Symptoms may present as:
    • An itchy sensation inside the mouth, throat, or ears
    • A raised itchy red rash (urticaria, or “hives”)
    • Swelling of the face, around the eyes, lips, tongue, and roof of the mouth (angioedema)

Other symptoms may also be seen. Always consult your doctor.

Non–IgE-mediated

  • Not caused by IgE antibodies
  • Usually occurs up to several hours after eating a food allergen
  • Gastrointestinal symptoms such as vomiting, diarrhea, and abdominal pain are common

How does IgE cause food allergies?

IgE is the most common cause of food allergy. The abnormal immune response of a food allergy begins when someone eats a food and their immune system makes a type of antibody, called IgE, against an allergen in the food.

When a person with IgE antibodies eats the same food allergen again, the allergen binds to the IgE antibodies, which causes certain immune cells to release chemicals such as histamine from mast cells. These chemicals cause different symptoms of the food allergy reaction. In severe cases, a reaction may occur if the allergen is inhaled or touched even without eating.

It’s more than nuts

More than 160 foods cause IgE-mediated food allergies. Here are the most common food allergens in the United States:

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When do food allergies usually develop?

Food allergies can develop at any time in children and adults but often begin in the first 2 years of life.

How common are food allergies?

The prevalence of food allergy in children (aged 0 to 17 years) has been increasing in the United States.

FOR CHILDREN

4.6% of children

(about 3.4 million) have a physician-diagnosed food allergy.*
Of these children, 
about 38% are allergic to multiple foods.

FOR ADULTS

5.1% of adults

(about 13.6 million) have a food allergy.*

Over half of adults develop the condition during childhood.

FOR CHILDREN

51% of children

with 2 or more food allergies have been
treated at an emergency department.

FOR CHILDREN

1 in 3 children

with food allergies also have asthma.
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FOR CHILDREN AND ADULTS

In an online survey study, 36% of people with a single food allergy and 53% of people with multiple food allergies had asthma.

People who have both asthma and food allergy have more severe allergic reactions to food.

*Based on estimates for 2024.

Know the symptoms of food allergies

Food allergy symptoms can vary greatly and look different in each person. Symptoms of an IgE-allergic reaction may involve the skin, stomach, heart, and lungs. They can surface in one or more of the following ways (some of these can also be with non–IgE-mediated):

  • Vomiting and/or stomach cramps
  • Hives
  • Shortness of breath
  • Wheezing
  • Repetitive cough
  • Tight, hoarse throat; trouble swallowing
  • Swelling of the tongue, affecting the ability to talk or breathe
  • Weak pulse
  • Pale or blue coloring of skin
  • Dizziness or feeling faint
  • Shock or circulatory collapse
  • Anaphylaxis, a severe, life-threatening allergic reaction

Food allergies or food intolerance?

It’s important to know the difference
Food intolerance is often confused with food allergy. Here are the important differences between the two that you should know about:

Food allergies

Food allergy is a condition in which eating certain foods leads to an abnormal immune response. Food allergies are either immunoglobulin E (lgE)-mediated or non–IgE-mediated reactions.

Unlike food intolerance, food allergies can be associated with anaphylaxis, which is a serious reaction that includes difficulty breathing and can be potentially life-threatening—requiring immediate medical attention.

Food intolerance

Food intolerance doesn’t involve the immune system. For example, an intolerance to lactose–a sugar found in many milk products–can lead to bloating or stomach pain.

Food intolerance is not associated with severe reactions such as anaphylaxis.

You’ve got a whole support network on your side

From diagnosis to treatment, everyone’s food allergy experience is unique. The Support For You program is designed with YOU in mind. Access free 1-on-1 sessions and learn about programs that may help you save on XOLAIR.

IMPORTANT SAFETY INFORMATION & INDICATION

What is XOLAIR?

XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat:

  • moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age.

  • food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking XOLAIR you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age.

XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. XOLAIR should also not be used to treat sudden breathing problems.

What is the most important information I should know about XOLAIR?

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

  • wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
  • flushing, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:

  • have a latex allergy or any other allergies (such as seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex.
  • have sudden breathing problems (bronchospasm)
  • have ever had a severe allergic reaction called anaphylaxis
  • have or have had a parasitic infection
  • have or have had cancer
  • are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I receive and use XOLAIR?

  • When starting treatment, XOLAIR should be given by your healthcare provider in a healthcare setting.
  • If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training on the right way to prepare and inject XOLAIR.
  • Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider.
  • The XOLAIR autoinjector (all doses) is intended for use only in adults and adolescents aged 12 years and older. For children 12 years of age and older, XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision. For children 1 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver.
  • See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.
  • XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
  • In people with asthma and food allergy, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency.
  • Do not decrease or stop taking any of your asthma or food allergy medicine or allergen immunotherapy, unless your healthcare providers tell you to.
  • You may not see improvement in your symptoms right away after XOLAIR treatment. If your symptoms do not improve or get worse, call your healthcare provider.
  • If you inject more XOLAIR than prescribed, call your healthcare provider right away.

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

  • Cancer. Cases of cancer were observed in some people who received XOLAIR.
  • Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs.
  • Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
  • Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
  • Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.

The most common side effects of XOLAIR:

  • In adults and children 12 years of age and older with asthma: joint pain especially in your arms and legs, dizziness, feeling tired, itching, skin rash, bone fractures, and pain or discomfort of your ears.
  • In children 6 to less than 12 years of age with asthma: swelling of the inside of your nose, throat, or sinuses, headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds.
  • In people with food allergy: injection site reactions and fever.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information and Instructions for Use.