Table 5. Reported Adverse Drug Reactions of Omalizumab
System Adverse Reactions
Respiratory Pharyngitis, upper respiratory tract infection, sinusitis, pneumonia, asthma exacerbation
CNS Fatigue, pain, headache, dizziness
Local Injection site reactions (swelling, redness)
Dermatologic Pruritus, dermatitis, urticaria, rash
Musculoskeletal Leg pain, fracture, arm pain, arthralgia
Gastrointestinal Vomiting, gastroenteritis, diarrhea
Otic Earache
Miscellaneous Anaphylaxis, malignancy, eye edema, rhinitis

Adapted from: Lexi-Drugs® online. Omalizumab monograph. Accessed 14 August 2003.
Omalizumab package insert. 1 DNA Way, CA:Genentech Inc.; June 2003.
Food and Drug Administration Center for Biologics Evaluation and Research. Briefing document on safety BLA STN 103976/0 Rockville, MD: The Department of Health & Human Services; 2003.

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