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Table 5 Adverse events with Omalizumab

From: Severe asthma and the omalizumab option

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
  Viral infection 23% Fever, myalgia, etc. 53% versus 42% control
  Parasitic infection 36/68 Odds risk 1.98 Geohelminths
  Immunogenicity <0.1% Antibody to Omalizumab
Cutaneous Injection site reaction 45% Warmth, erythema Bruising, burning
  Skin eruption* 6% Dermatitis, urticaria
Respiratory Infections* 20%  
Sinus Sinusitis* 15%  
CNS Headache* 15%  
Pharynx Pharyngitis* 11%  
Platelets Thrombocytopenia ? Post-marketing observation
Integument Alopecia ? Post-marketing observation
  1. * Reactions occurring at the same rate as placebo/controls