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Omalizumab Side Effects

In Summary

More frequently reported side effects include: leg pain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to omalizumab: subcutaneous powder for solution

As well as its needed effects, omalizumab may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking omalizumab, check with your doctor or nurse immediately:

Rare:
  • Cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or skin rash
  • malignant tumor
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness

Severity: Minor

Some omalizumab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Bleeding
  • blistering
  • body aches or pain
  • burning
  • chills
  • cold or flu-like symptoms
  • coldness
  • congestion
  • discoloration of the skin
  • dryness or soreness of the throat
  • feeling of pressure
  • fever
  • headache
  • hoarseness
  • itching
  • leg pain
  • lumps
  • muscle or joint pain
  • numbness
  • pain
  • pain or tenderness around the eyes and cheekbones
  • redness
  • runny nose
  • scarring
  • sore throat
  • soreness
  • stinging
  • stuffy or runny nose
  • swelling
  • tender, swollen glands in the neck
  • tenderness
  • tingling
  • ulceration
  • voice changes
  • warmth
Less common:
  • Arm pain
  • blistering, crusting, irritation, itching, or reddening of the skin
  • body produces substance that can bind to drug making it less effective or cause side effects
  • cracked, dry, or scaly skin
  • earache
  • itching skin

For Healthcare Professionals

Applies to omalizumab: subcutaneous powder for injection

General

The more commonly reported side effects included injection site reactions, headache, and nasopharyngitis.[Ref]

Local

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]

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]

Immunologic

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]

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]

Nervous system

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]

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]

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

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]

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]

Dermatologic

Common (1% to 10%): Dermatitis, pruritus
Uncommon (0.1% to 1%): Skin rashes, flushing, photosensitivity
Postmarketing reports: Alopecia, hair loss[Ref]

Other

Common (1% to 10%): Fever, earache
Uncommon (0.1% to 1%): Fatigue, post-injection phenomena[Ref]

In clinical trials, fever occurred very commonly in patients 6 to 12 years old.[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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Xolair (omalizumab)." Genentech, South San Francisco, CA.

It is possible that some side effects of omalizumab may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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