Xolair (omalizumab) is a monoclonal antibody that targets and neutralizes Immunoglobulin E (IgE), a key player in allergic reactions. Developed by Genentech and Novartis, Xolair received FDA approval in 2003 for treating moderate to severe persistent allergic asthma and later for chronic idiopathic urticaria.

For many individuals managing chronic allergic conditions, Xolair offers relief when other treatments fall short. However, despite its efficacy, many patients experience side effects that can significantly impact their quality of life. These side effects can range from mild discomforts to more severe reactions, leaving patients anxious and uncertain about continuing their treatment.

This comprehensive guide aims to provide detailed information on Xolair’s side effects, practical management tips, and lifestyle adjustments to ensure optimal treatment outcomes.

Key Findings

  • Common side effects of Xolair include injection site reactions, joint pain, fatigue, dizziness, and headaches. These side effects typically reduce over time with continued use.
  • Children treated with Xolair may experience nasopharyngitis, headaches, fever, and upper abdominal pain. These are often related to the body’s immune response to the medication.
  • Serious side effects, although rare, include anaphylaxis, malignancies, eosinophilic conditions, cardiovascular and cerebrovascular events, and serum sickness-like reactions.
  • Side effects that commonly require clinical intervention include viral infections, upper respiratory tract infections, sinusitis, headaches, and pharyngitis.
  • Patient testimonials indicate varied experiences, with some reporting minimal side effects and significant symptom relief, while others experience more severe reactions but still find Xolair beneficial overall.

What is Xolair Used to Treat?

IgE plays a critical role in allergic reactions by binding to allergens and triggering the release of histamines and other inflammatory mediators from mast cells and basophils. Xolair binds to free IgE, preventing it from interacting with these cells and thereby reducing the allergic response. This mechanism helps in controlling symptoms of asthma and hives, improving patients’ quality of life.

Xolair is indicated for the following conditions:

  • Moderate to Severe Persistent Asthma: For adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
  • Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): For adult patients 18 years of age and older with an inadequate response to nasal corticosteroids as add-on maintenance treatment.
  • IgE-mediated Food Allergy: For adults and pediatric patients aged 1 year and older for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods.
  • Chronic Spontaneous Urticaria (CSU): For adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.

What are the Side Effects of Xolair Shots?

A woman wearing a white sports bra is examining her upper arm, which has red, irritated patches and rashes.

While Xolair is generally well-tolerated, some patients may experience side effects. Understanding these side effects helps in early recognition and management.

Common Side Effects of Xolair

Here’s a detailed discussion of the adverse effects experienced by participants during clinical trials for Xolair:

1. For Asthma (Adults and Adolescents 12 Years and Older)

  • Injection Site Reactions: Reactions, such as bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation, are common with subcutaneous injections. This occurred in 45% of patients treated with Xolair. These reactions can be due to:
  • Physical trauma from the needle.
  • An immune response to the foreign substance (omalizumab) was injected.
  • Local irritation caused by the drug formulation.

Most injection site reactions appeared within an hour after injection, lasted less than 8 days, and typically became less frequent with subsequent doses.

  • Arthralgia (Joint Pain): This was the second most common side effect of Xolair in adult and adolescent asthma patients, reported by 8% of those treated. Additionally, pain affecting the entire body was experienced by 7% of the patients. These side effects may result from the body’s inflammatory response to the injection and the presence of an immune-modulating drug. Pain can be a systemic response to the drug’s impact on the immune system and inflammatory pathways. Other specific body pains reported included leg pain (reported by 4% of patients) and arm pain (reported by 2%).
  • Fatigue: Observed in 3% of patients, fatigue is a common side effect of many medications and can result from the body’s response to the immune modulation caused by omalizumab. The immune system’s activation and the body’s efforts to adjust to the drug can lead to increased energy expenditure and fatigue.
  • Dizziness: Similar to fatigue, dizziness was also seen in 3% of patients. Xolair might influence blood pressure in some patients. Fluctuations in blood pressure can lead to dizziness, especially if there is a sudden drop (orthostatic hypotension).

Other side effects experienced by 2% of patients include:

  • Fracture
  • Pruritus (Itching)
  • Dermatitis
  • Earache

The side effects that most commonly required clinical intervention, such as stopping Xolair or needing additional medication to manage the reaction, included injection site reactions, viral infections, upper respiratory tract infections, sinusitis, headaches, and pharyngitis.

However, the frequency of these side effects was not significantly different between the patients who received Xolair and those who did not (the control group). This suggests that these adverse reactions may not be specifically attributed to Xolair, as they were equally common in both groups.

2. For Asthma (Pediatric Patients 6 to <12 Years of Age)

  • Nasopharyngitis: Refers to the inflammation of the nasal passages and pharynx, also known as a cold. This reaction is the most common among children, occurring in 16% of the patients. Xolair can temporarily alter the body’s immune response, making patients more susceptible to viral infections that cause nasopharyngitis. This can also lead to secondary infections such as otitis media, or middle ear infection, which was seen in 4% of Xolair-treated patients.
  • Headache: Nine percent of patients reported headaches. The mechanism by which Xolair might cause headaches is multifaceted. One primary reason is that the body adapts to the changes in immune response dynamics. Another possible explanation is that children with asthma may already be prone to headaches. Asthma can cause hypoxia or fluctuating oxygen levels, which can contribute to headaches. The incidence of headaches in pediatric patients on Xolair could be a combination of the medication’s side effects and the preexisting tendency of these patients to experience headaches due to their underlying conditions.
  • Pyrexia (Fever): In pediatric patients receiving Xolair, pyrexia was observed in 6% of the patients. The body’s defense mechanism may respond to the introduction of a new substance by elevating the body temperature, a natural reaction aimed at fighting perceived threats. This can be particularly evident in children, whose immune systems are more reactive.

Other adverse reactions occurring at a frequency of at least 3% in pediatric patients receiving Xolair, and more frequently than in those receiving placebo, included:

  • Upper Abdominal Pain
  • Pharyngitis Streptococcal
  • Viral Gastroenteritis
  • Arthropod Bite
  • Epistaxis (Nosebleed)

Bronchitis, headache, and urticaria were the side effects that most often necessitated clinical intervention. However, these occurred at similar rates in control patients, indicating that such reactions could be part of children’s general asthma management experience or be due to other factors unrelated to the medication.

3. For Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

The side effects in patients with chronic rhinosinusitis with nasal polyps were similar to those observed in patients with asthma. These include:

  • Headache
  • Injection Site Reactions
  • Arthralgia
  • Upper Abdominal Pain
  • Dizziness

However, unlike in asthma patients, all injection site reactions in this group were of mild to moderate severity and did not lead to any discontinuations.

4. For IgE-Mediated Food Allergy

The Food Allergy (FA) Trial evaluated the safety of Xolair in patients with IgE-mediated allergic reactions, including anaphylaxis triggered by accidental exposure to one or more foods. The trial focused on patients who were allergic to peanuts and at least two other foods.

The adverse reactions in patients with IgE-mediated food allergy included injection site reactions (occurring in 15.5% of patients) and pyrexia (occurring in 6.4% of patients). Importantly, the trial found that there were no discontinuations due to adverse reactions, indicating that the side effects were manageable within the study’s duration and conditions.

5. For Chronic Spontaneous Urticaria (CSU)

The safety of Xolair for treating CSU was evaluated through three placebo-controlled, multiple-dose clinical trials. Pooled data from CSU Trials 1, 2, and 3 revealed similar side effects to those seen in asthma patients. Notably, the incidence rate of these side effects was higher with increased dosages. Specifically:

  • Nausea: Reported by 2.7% of patients on the 300 mg dose and 1.1% on the 150 mg dose.
  • Infections and Infestations: Nasopharyngitis was noted in 9.1% of patients on the 150 mg dose and 6.6% on the 300 mg dose. Sinusitis and upper respiratory tract infections were more frequent in the Xolair groups, particularly at the 300 mg dose.
  • Arthralgia: Reported by 2.9% of patients on both the 150 mg and 300 mg doses, compared to 0.4% on placebo.
  • Headache: Affected 12% of patients on the 150 mg dose and 6.1% on the 300 mg dose, compared to 2.9% on placebo.
  • Cough: Reported by 2.2% of patients on the 300 mg dose and 1.1% on the 150 mg dose.

Additional adverse reactions reported during the 24-week treatment period, occurring in 2% or more of patients receiving Xolair (150 mg or 300 mg), included:

  • Toothache
  • Fungal Infections
  • Urinary Tract Infections
  • Myalgia (Muscle Pain)
  • Pain In Extremity
  • Musculoskeletal Pain
  • Peripheral Edema
  • Fever
  • Migraine
  • Sinus Headache
  • Anxiety
  • Oropharyngeal Pain
  • Asthma
  • Urticaria
  • Alopecia
  • Injection site reactions, including swelling, erythema (redness), pain, bruising, itching, bleeding, and urticaria

Fortunately, none of these reactions resulted in discontinuation or treatment interruption, indicating that they were manageable within the clinical trials.

Serious Side Effects of Xolair

A woman with a painful expression on her face is touching her neck and shoulder area, which appears red and irritated.

Though rare, some side effects of Xolair are serious and require immediate medical attention. These include:

  • Anaphylaxis: Occurred in 0.1% of patients in clinical trials and at least 0.2% based on postmarketing reports. Symptoms included:
  • Bronchospasm
  • Hypotension
  • Syncope
  • Urticaria
  • Angioedema of the throat or tongue
  • Malignancy: Observed in 0.5% of Xolair-treated patients compared to 0.2% of control patients. Types included breast, non-melanoma skin, prostate, melanoma, and parotid cancers. This was often observed, though not exclusively, in individuals who are reducing their dosage or discontinuing an oral steroid medication.

Recent scientific literature found no increased cancer risk associated with Xolair in asthma patients. Additionally, post-marketing surveillance and long-term observational studies reported mild adverse events, like headaches and arthralgia, but no increased tumor incidence. 

  • Eosinophilic Conditions: In rare instances, patients with asthma receiving Xolair therapy may develop severe systemic eosinophilia, occasionally manifesting with vasculitis symptoms similar to Churg-Strauss syndrome, which often requires treatment with systemic corticosteroids.

Eosinophilic conditions are a group of disorders characterized by an elevated number of eosinophils, a type of white blood cell, in the blood or tissues. Eosinophils are part of the immune system and play a role in fighting infections, particularly those caused by parasites. However, in eosinophilic conditions, these cells accumulate in various tissues, leading to inflammation and tissue damage. Here are some common eosinophilic conditions:

  • Eosinophilic Esophagitis (EoE)
  • Eosinophilic Gastroenteritis
  • Hypereosinophilic Syndrome (HES)
  • Eosinophilic Granulomatosis with Polyangiitis (EGPA)
  • Eosinophilic Asthma
  • Drug-Induced Eosinophilia
  • Cardiovascular and Cerebrovascular Events: These side effects are severe medical conditions affecting the heart, blood vessels, and brain. A higher incidence of these events was observed in Xolair-treated patients, including:
  • Myocardial Infarction
  • Pulmonary Hypertension
  • Transient Ischemic Attack
  • Pulmonary Embolism/Venous Thrombosis
  • Unstable Angina
  • Fever, Arthralgia, and Rash: In some patients who used Xolair post-approval, symptoms such as arthritis, rash, fever, and swollen lymph nodes appeared 1 to 5 days after injections. Although tests for type III hypersensitivity (like serum sickness) were negative, these symptoms resemble serum sickness and can recur with additional doses, posing a health risk.

Serum sickness is a type III hypersensitivity reaction where the immune system mistakenly targets proteins in medications or antiserum, forming immune complexes that cause inflammation. If symptoms develop, discontinuing Xolair is recommended.

  • Parasitic (Helminth) Infection: Helminths, including roundworms (nematodes), tapeworms (cestodes), and flukes (trematodes), cause infections when they enter and live in the body’s tissues, often the intestines.

A one-year clinical trial in Brazil evaluated the risk of geohelminthic infections (roundworms, hookworms, whipworms, and threadworms) in patients receiving XOLAIR (omalizumab). The study found a higher incidence of these infections in XOLAIR-treated patients, suggesting that healthcare providers should be vigilant, especially in high-risk regions. Although the findings were not statistically significant, providers should monitor and prevent infections in susceptible populations.

These adverse effects highlight the importance of monitoring and managing patients receiving Xolair, ensuring that both the benefits and potential risks are carefully considered.

Tips for Managing Xolair Injection Side Effects

A woman lying on a gray couch suffering from a headache or fever wears a white cloth over her forehead.

Managing side effects effectively can enhance the overall treatment experience. Here are general strategies for coping with Xolair’s side effects.

Managing Injection Site Reactions

1. Pre-Injection Tips

  • Inform your healthcare provider about any past injection site reactions. They might adjust your injection technique or site rotation schedule.
  • Choose injection sites with ample subcutaneous tissue, such as the abdomen, upper thighs, or back of the upper arms.
  • Avoid areas with scars, bruises, or skin conditions.

Additionally, ensure you are well-hydrated and have eaten a balanced meal before your injection.

2. During Injection

  • Try to stay calm and relaxed during the injection. Tension can make the injection more painful.
  • Ensure the injection is administered correctly by a healthcare professional, or if self-administering, ensure you follow the training provided.
  • Let the Xolair solution reach room temperature before injection to reduce discomfort.

3. Post-Injection Care

  • Apply a cold compress to the injection site immediately after the injection to reduce swelling and pain.
  • Keep track of your injection sites and rotate them to avoid repeated trauma to the same area.
  • Gently massaging the injection site after administering can help distribute the medication and reduce discomfort.

You may also take over-the-counter pain relievers like ibuprofen or acetaminophen to help manage pain and inflammation, but consult your healthcare provider before taking any medication.

4. Managing Reactions

  • Use topical antihistamines or corticosteroids to manage itching or redness at the injection site.
  • Applying over-the-counter hydrocortisone cream can help reduce itching and inflammation.
  • Aloe vera gel can provide a cooling effect and soothe irritated skin.

Keep a journal of your injection experiences, noting any reactions and their severity. Share this information with your healthcare provider to adjust your treatment plan if necessary. Contact your healthcare provider if you notice any signs of infection, such as increased redness, swelling, warmth, or pus.

Dealing with Headaches

1. General Tips

  • Drink plenty of water throughout the day to prevent dehydration.
  • Ensure you get adequate and consistent sleep.
  • Avoid skipping meals and maintain a balanced diet to keep your blood sugar levels stable.
  • Reduce the intake of caffeine and alcohol, as they can sometimes trigger or worsen headaches.

2. Medication Management

Use over-the-counter pain relievers such as ibuprofen or acetaminophen to manage headache pain, but consult your healthcare provider before taking any medication. If possible, take your headache medication at the onset of symptoms to prevent them from worsening.

3. Home Remedies

  • Apply a cold or warm compress to your forehead or the back of your neck to relieve headache pain.
  • Lie down in a dark, quiet room to help alleviate headache symptoms.

Track your headaches, noting their frequency, duration, intensity, and potential triggers, and share this information with your healthcare provider for better management. Seek medical attention if your headaches are severe, persistent, or accompanied by other concerning symptoms such as vision changes, confusion, or neck stiffness.

Managing Fatigue

Managing fatigue while undergoing Xolair treatment can be challenging. Here are some strategies that might help:

  1. Regular Exercise: Engage in light to moderate exercise, such as walking or yoga. Exercise can help improve energy levels and reduce fatigue.
  2. Healthy Diet: Eat a balanced diet rich in fruits, vegetables, lean proteins, and whole grains. Avoid excessive sugar and processed foods, which can lead to energy crashes.
  3. Adequate Sleep: Ensure you get enough restful sleep each night. Maintain a regular sleep schedule and create a relaxing bedtime routine.
  4. Hydration: Stay well-hydrated by drinking plenty of water throughout the day. Dehydration can contribute to fatigue.
  5. Stress Management: Practice stress-reducing techniques such as meditation, deep breathing exercises, or mindfulness. High stress levels can exacerbate fatigue.
  6. Pacing Activities: Break tasks into smaller, manageable parts and take frequent breaks to avoid overexertion. Prioritize activities and focus on the most important ones first.
  7. Supplements: Talk to your doctor about vitamins or supplements that might help improve energy levels, such as vitamin D, B vitamins, or iron.
  8. Stay Organized: Keep a daily planner to track activities and appointments. Being organized can help reduce stress and conserve energy.

If fatigue persists or worsens, it is essential to consult with your healthcare provider to rule out other potential causes and adjust your treatment plan as necessary.

Relieving Joint Pain

1. General Tips

  • Drink plenty of water to keep your joints lubricated and maintain overall health.
  • Wear supportive shoes that provide adequate cushioning and arch support to reduce stress on joints, especially if the pain is in your knees, hips, or back.
  • Engage in low-impact exercises such as walking to keep joints flexible and strengthen the muscles around them.
  • Maintain a healthy weight to reduce stress on weight-bearing joints.
  • Eat a diet rich in anti-inflammatory foods, including fruits, vegetables, whole grains, and omega-3 fatty acids found in fish and flaxseeds. Avoid processed foods and sugars that can contribute to inflammation.
  • Practices such as yoga, tai chi, and meditation can help manage pain and improve overall well-being.

2. Home Remedies

  • Apply a warm towel, heating pad, or cold pack to the affected joints. Heat can help relax muscles and improve circulation, while cold can reduce swelling and numb sharp pain.
  • Rest the affected joints and elevate them to reduce swelling. Avoid activities that exacerbate the pain.

You may also consider combining medications, supplements, professional treatments, and medical interventions to manage joint pain. Additionally, review your current medications with your healthcare provider to ensure they aren’t contributing to joint pain. Regular check-ups are essential to monitor and adjust your treatment plan as needed.

Patient Experiences and Testimonials

A child, surrounded by three smiling healthcare professionals, standing in a hospital hallway with arms raised in joy.

Dealing with medication side effects can be challenging, especially with treatments like Xolair. 

To provide real-life insights, here are some patient accounts discussing their experiences and concerns about Xolair’s side effects.

From Reddit Discussions

A Reddit user expressed intense anxiety about starting Xolair due to fears of severe side effects such as hair loss, cancer, vision changes, slurred speech, joint pain, weight changes, and anaphylaxis. Despite these worries, they were considering the treatment due to the ineffectiveness of antihistamines for their severe allergic reactions and facial flushing.

I’m getting xolair tomorrow and am panicking so much about having side effects , reassure me??
byu/Sea-starr inMCAS

Here’s a summary of some user experiences shared on Reddit:

Sonotathrowawayforme shared that after a six-month course of Xolair, they experienced a slight increase in allergy symptoms, a mild fever, and sluggishness for a few days post-injection. However, they reported significant improvements in their condition after 1-2 months without any serious side effects.

HuskyTalesOfMischief reported being on Xolair for three years, initially at 300mg every 30 days, later adjusted to every two weeks. Their side effects included minor injection site pain and fatigue a few hours post-injection. Importantly, they noted a significant reduction in the need for emergency services since starting Xolair.

Littlemoth99 provided a reassuring perspective, stating that after 2½ years on Xolair, they managed to gain weight and control their hives better. They emphasized the importance of trusting their doctor’s judgment, who likely prescribed Xolair believing its benefits outweighed the risks.

Mysterious-Art8838 highlighted that, despite their sensitivity to side effects from various medications, Xolair ranked lowest in terms of adverse effects. They recommended the treatment, noting it took about six months to notice significant benefits.

Insights from Patients on Xolair for Urticaria

The Canadian Skin Patient Alliance gathered a detailed summary of patient input regarding the use of Xolair for treating chronic idiopathic urticaria (CIU), which reflects a wide range of patient experiences. Here’s a compelling look at their experiences:

Impact of CIU on Patients

Patients reported that CIU significantly impacts their lives, causing severe itching, hives, and swelling. These symptoms lead to high levels of anxiety and depression, largely due to the unpredictability of flare-ups. The condition also disrupts sleep and daily activities, affecting social interactions and employment.

Previous Treatments

Before trying Xolair, patients typically used treatments such as antihistamines, corticosteroids, and immunosuppressants. However, these treatments often had limited effectiveness and were associated with undesirable side effects.

Experience with Xolair

Most patients found Xolair to be highly effective in reducing symptoms and the frequency of flare-ups. The reported side effects were generally mild, including headaches and fatigue, with some minor injection site reactions. Patients appreciated the subcutaneous injection format, although regular visits for injections were seen as a minor inconvenience.

Overall, patients using Xolair were highly satisfied. Many described it as life-changing, noting significant improvements in physical symptoms and emotional well-being. Patients strongly endorsed Xolair, emphasizing its effectiveness and manageable side effects.

Patient Recommendations

Patients recommended increasing accessibility to Xolair and raising awareness among healthcare providers about its benefits. They highlighted the importance of this treatment option for those who have not found relief with traditional therapies.

These discussions underline the diverse experiences with Xolair. For many, Xolair has proven to be a beneficial treatment despite initial fears, while others have chosen alternative paths due to specific health concerns.

Wrap Up

Understanding and managing the side effects of Xolair is vital for effective treatment. By following the tips provided and maintaining open communication with healthcare providers, patients can manage side effects and enjoy the benefits of Xolair.

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Frequently Asked Questions

Can I stop Xolair if I feel better?

No, you should not stop taking Xolair without consulting your healthcare provider. Stopping treatment abruptly can lead to a return of symptoms. Your doctor will guide you on the best course of action based on your condition.

How long do Xolair side effects last?

The duration of Xolair’s side effects can vary. Common side effects like redness, swelling, or pain at the injection site usually last from a few hours to a few days. More serious side effects, such as allergic reactions, might require medical intervention, and their duration can vary based on the severity and the treatment provided.

How long does Xolair stay in your system?

Xolair has an approximate half-life of 26 days, meaning it can take several months to completely clear from your body. Generally, it may take around 130 days (about four to five half-lives) for the drug to be eliminated.

What happens if you stop taking Xolair?

Discontinuing Xolair may cause your symptoms to return or worsen. It is important to consult your healthcare provider before stopping the medication to discuss potential risks and alternative treatment options 

Is there an alternative to Xolair?

Yes, there are alternatives to Xolair, such as other monoclonal antibodies, including:

The choice of alternative depends on the specific condition being treated and patient-specific factors.

What are the long-term side effects of Xolair?

Long-term side effects of Xolair may include an increased risk of cardiovascular and cerebrovascular events and a potential increased risk of malignancies. These side effects are relatively rare but require monitoring by a healthcare professional.

Can Xolair cause weight gain?

Weight gain is not commonly reported as a side effect of Xolair. While some patients may experience weight changes, it is not typically associated with the medication itself. Any significant weight changes should be discussed with a healthcare provider.

Can Xolair cause anxiety and depression?

No, anxiety and depression are not a commonly reported side effect of Xolair, in fact, Xolair treatment may help reduce anxiety in some patients. A study involving 20 patients evaluated the benefits of omalizumab (Xolair) on anxiety and depression in individuals with severe asthma. Participants received omalizumab for an average of 17.6 months (ranging from 2 to 40 months). The results demonstrated a significant reduction in anxiety levels when comparing scores before and after treatment. Initially, 12 patients had moderate to severe depression before starting omalizumab, but this number decreased to 3 patients after the treatment.

Can Xolair cause hair loss?

Yes, alopecia (hair loss) was reported as a side effect during the 24-week treatment period, occurring in 2% or more of patients receiving Xolair for chronic spontaneous urticaria (CSU).

Are there any dietary restrictions while on Xolair?

There are no specific dietary restrictions, but maintaining a balanced diet and avoiding known allergens can help support overall health and potentially reduce side effects.


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