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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