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Home > Drugs > Selective immunosuppressants > Omalizumab > Omalizumab Side Effects
Selective immunosuppressants

Omalizumab Side Effects

Summary

More frequently reported 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]

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