Xolair Side Effects

Generic Name: omalizumab

Please note - some side effects for Xolair may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Xolair - for the Consumer

Xolair

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xolair:

Bruising, itching, pain, redness, stinging, swelling, or warmth at the injection site; headache; itching and swelling of the skin; leg, arm, or ear pain; sinus inflammation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue or throat); anxiety; calf pain, swelling, or tenderness; chest pain; confusion; cough; dizziness; fainting; fast, weak, or irregular heartbeat; feeling unusually warm; flushing; hoarseness; new or worsening breathing problems or shortness of breath; numbness or tingling; one-sided weakness; speech problems; swelling of a vein; symptoms of sinus or lung infection (congestion, cough, or fever); trouble swallowing; unusual bruising or bleeding; unusual lumps, growths, or moles; unusual swelling of the hands or feet; vision problems; wheezing.

Side Effects by Body System

Hypersensitivity

Anaphylaxis usually occurred within two hours of receiving a omalizumab subcutaneous injection. However, recent reports include patients who had delayed anaphylaxis with onset two to 24 hours or even longer after receiving omalizumab treatment. Anaphylaxis may occur after any dose of omalizumab including the first dose. Health care professionals who administer omalizumab should be prepared to manage life-threatening anaphylaxis and should observe their omalizumab-treated patients for at least two hours after omalizumab is given. Patients under treatment with omalizumab should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following omalizumab treatment, and how to treat it when it occurs.

Hypersensitivity reactions including anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab. Anaphylaxis has occurred as early as after the first dose of omalizumab, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, patients should be closely observed for an appropriate period of time after omalizumab administration, and health care providers administering omalizumab should be prepared to manage anaphylaxis that can be life-threatening. Patients should also be informed of the signs and symptoms of anaphylaxis and instructed to seek immediate medical care should symptoms occur.

Local

Local side effects have included injection site reactions in 45% of patients, including bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation. Severe injection site reactions occurred in 12% of patients (vs 9% with placebo). Most reactions occurred within 1 hour after injection, lasted for 8 days or less, and decreased in frequency with subsequent doses.

Cardiovascular

Cardiovascular side effects have been reported including a study showing a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic, and thrombophlebitic events in patients treated with omalizumab compared to a control group of patients not given the drug.

Dermatologic

Dermatologic side effects have included pruritus (2%) and dermatitis (2%).

Respiratory

Respiratory side effects have included upper respiratory tract infection (20%), sinusitis (16%), and pharyngitis (11%).

Nervous system

Nervous system side effects have included headache (15%) and dizziness (3%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (8%), fracture (2%), leg pain (4%), and arm pain (2%).

Oncologic

Oncologic side effects have included malignancies in 0.5% of patients (n=4127) compared with 0.2% of control patients (n=2236). The types of malignancies in omalizumab-treated patients included breast, skin (nonmelanoma), prostate, melanoma, and parotid.

Other

Other side effects have included viral infections (23%), pain (7%), fatigue (3%), and earache (2%). Three cases of Churg-Strauss syndrome have also been reported.

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