Note: This document contains side effect information about omalizumab. Some dosage forms listed on this page may not apply to the brand name Xolair.
Summary
More frequent side effects include: lower leg pain. Continue reading for a comprehensive list of adverse effects.
Applies to omalizumab: parenteral powder for sub-q injection.
Warning
- Anaphylaxis (e.g., bronchospasm, hypotension, syncope, urticaria, angioedema of throat or tongue) reported.1
- Anaphylaxis can occur after the first or second dose of omalizumab, but may occur after >1 year of therapy.1 Monitor patient for an appropriate period of time following administration.1 (See Medical Personnel and Facilities and also see Sensitivity Reactions under Cautions.)
- Administer omalizumab in a setting prepared to manage potentially life-threatening anaphylaxis; clinicians administering the drug should be familiar with management of anaphylaxis.1
- Inform patient of the signs and symptoms of anaphylaxis and instruct patient to obtain immediate medical care should symptoms develop.1
Side effects include:
Patients with asthma: Arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, earache.
Patients with chronic idiopathic urticaria: Headache, nasopharyngitis, sinusitis, arthralgia, nausea, cough, upper respiratory tract infection (sometimes viral).
For Healthcare Professionals
Applies to omalizumab: subcutaneous powder for injection, subcutaneous solution.
General
The more commonly reported side effects included injection site reactions, headache, and nasopharyngitis.[Ref]
Local
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[Ref]
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.[Ref]
Immunologic
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.[Ref]
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 antibody development
Postmarketing reports: Serum sickness, allergic granulomatous angiitis (Churg-Strauss syndrome), lymphadenopathy[Ref]
Nervous system
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.[Ref]
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[Ref]
Musculoskeletal
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[Ref]
Respiratory
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[Ref]
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.[Ref]
Dermatologic
Common (1% to 10%): Dermatitis, pruritus
Uncommon (0.1% to 1%): Skin rashes, flushing, photosensitivity
Postmarketing reports: Alopecia, hair loss[Ref]
Other
In clinical trials, fever occurred very commonly in patients 6 to 12 years old.[Ref]
Common (1% to 10%): Fever, earache
Uncommon (0.1% to 1%): Fatigue, post-injection phenomena[Ref]
Gastrointestinal
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.[Ref]
Common (1% to 10%): Upper abdominal pain, nausea
Uncommon (0.1% to 1%): Diarrhea, dyspepsia, gastroenteritis
Frequency not reported: Toothache[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Urticaria
Rare (0.01% to 0.1%): Anaphylactic reactions, angioedema
Postmarketing reports: Anaphylactoid reactions[Ref]
Cardiovascular
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[Ref]
Hematologic
Uncommon (0.1% to 1%): Asymptomatic platelet decreases
Postmarketing reports: Idiopathic severe thrombocytopenia, eosinophilic conditions[Ref]
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.[Ref]
Metabolic
Uncommon (0.1% to 1%): Weight increases[Ref]
Psychiatric
Frequency not reported: Anxiety[Ref]
