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Note: This document contains side effect information about omalizumab. Some of the dosage forms listed on this page may not apply to the brand name Xolair.
More frequent side effects include: lower leg pain. See below for a comprehensive list of adverse effects.
Applies to omalizumab: subcutaneous powder for solution
Subcutaneous route (Powder for Solution)
Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported with omalizumab administration. Anaphylaxis may occur at any time from the first dose to more than a year after omalizumab initiation. Closely monitor patients after omalizumab administration and prepare to manage any anaphylactic reactions.
Along with its needed effects, omalizumab (the active ingredient contained in Xolair) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking omalizumab:
Incidence not known
Some side effects of omalizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to omalizumab: subcutaneous powder for injection, subcutaneous solution
The more commonly reported side effects included injection site reactions, headache, and nasopharyngitis.
In clinical trials, any injection site reaction occurred in 45% and 43% of patients given this drug and placebo, respectively; severe reactions occurred in 12% and 9%, respectively.
Very common (10% or more): Any injection site reaction, including pain, swelling, itching, redness, bruising, bleeding, induration, or mass (up to 45%), severe injection site reaction (up to 12%)
Uncommon (0.1% to 1%): Arm swelling
Very common (10% or more): Viral infection (up to 37%)
Uncommon (0.1% to 1%): Moniliasis, parasitic infection
Rare (0.01% to 0.1%): Anti-omalizumab (the active ingredient contained in Xolair) antibody development
Postmarketing reports: Serum sickness, allergic granulomatous angiitis (Churg-Strauss syndrome), lymphadenopathy
In clinical studies, viral infection occurred in 37% and 39% or patients given this drug or placebo, respectively. Increased parasitic infections, compared to placebo, were not statistically significant.
Very common (10% or more): Headache (up to 27%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Syncope, vasovagal syncope, somnolence, paresthesia
Frequency not reported: Migraine, sinus headache
In clinical trials, headache occurred in 37% of patients given either this drug (n=716) or placebo (n=694); headache occurred very commonly in patients 6 to 12 years old.
Very common (10% or more): Back pain (up to 13%)
Common (1% to 10%): Arthralgia, myalgia, sprains, strains, extremity pain, fracture
Postmarketing reports: Joint swelling
In clinical trials with chronic idiopathic urticarial, patients reported nasopharyngitis 9.1%, 6.6%, and 7% in 150 mg, 300 mg, and placebo, respectively; sinusitis (1.1%, 4.9%, 2.1%), cough (1.1%, 2.2%,1.2%), and upper respiratory infection (11.1%, 3.4%, 2.1%) were also reported by patients, respectively.
Common (1% to 10%): Nasopharyngitis, sinusitis, viral upper respiratory infection (URI), URI
Uncommon (0.1% to 1%): Pharyngitis, cough, allergic bronchospasm
Rare (0.01% to 0.1%): Laryngoedema
Frequency not reported: Asthma, oropharyngeal pain
Common (1% to 10%): Dermatitis, pruritus
Uncommon (0.1% to 1%): Skin rashes, flushing, photosensitivity
Postmarketing reports: Alopecia, hair loss
Common (1% to 10%): Fever, earache
Uncommon (0.1% to 1%): Fatigue, post-injection phenomena
In clinical trials, fever occurred very commonly in patients 6 to 12 years old.
In clinical trials, upper abdominal pain was very common in patients 6 to 12 years old. In clinical trials with chronic idiopathic urticarial, patients reported nausea 1.1%, 2.7%, and 2.5% of the time with 150 mg, 300 mg, and placebo, respectively.
Common (1% to 10%): Upper abdominal pain, nausea
Uncommon (0.1% to 1%): Diarrhea, dyspepsia, gastroenteritis
Frequency not reported: Toothache
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Urticaria
Rare (0.01% to 0.1%): Anaphylactic reactions, angioedema
Postmarketing reports: Anaphylactoid reactions
Uncommon (0.1% to 1%): Postural hypotension
Frequency not reported: Peripheral edema, arterial thrombotic events (including transient ischemic attack, myocardial infarction, unstable angina, and cardiovascular death)
Postmarketing reports: Hypotension, chest tightness
Uncommon (0.1% to 1%): Asymptomatic platelet decreases
Postmarketing reports: Idiopathic severe thrombocytopenia, eosinophilic conditions
In clinical trials, 0.6% of patients developed decreased platelet counts below the normal laboratory range; these patients did not have associated bleeding episodes or decreased hemoglobin.
Uncommon (0.1% to 1%): Weight increases
Frequency not reported: Anxiety