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.