Table 5 Adverse events with Omalizumab
System | Reaction/AE | Frequency | Other aspects |
|---|---|---|---|
Systemic | Malignancy | 20/4127 patients | 0.5% versus 0.2% control Breast, prostate, melanoma Skin cancer, parotid, etc. |
|  | Anaphylaxis | 1/1000 patients | 0.1%–0.2% 60% within 1–3rd dose <2 hrs 14% after 4th dose, <30 mins |
| Â | Viral infection | 23% | Fever, myalgia, etc. 53% versus 42% control |
| Â | Parasitic infection | 36/68 | Odds risk 1.98 Geohelminths |
| Â | Immunogenicity | <0.1% | Antibody to Omalizumab |
Cutaneous | Injection site reaction | 45% | Warmth, erythema Bruising, burning |
| Â | Skin eruption* | 6% | Dermatitis, urticaria |
Respiratory | Infections* | 20% | Â |
Sinus | Sinusitis* | 15% | Â |
CNS | Headache* | 15% | Â |
Pharynx | Pharyngitis* | 11% | Â |
Platelets | Thrombocytopenia | ? | Post-marketing observation |
Integument | Alopecia | ? | Post-marketing observation |