OMALIZUMAB for Idiopathic urticaria: Side Effects & Safety Data
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There are 8,366 adverse event reports in the FDA FAERS database where OMALIZUMAB was used for Idiopathic urticaria.
Most Reported Side Effects for OMALIZUMAB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| No adverse event | 9,736 | 15.3% | 0 | 3 |
| Asthma | 9,354 | 14.7% | 208 | 4,275 |
| Urticaria | 9,231 | 14.5% | 39 | 1,723 |
| Off label use | 9,199 | 14.4% | 100 | 627 |
| Dyspnoea | 8,323 | 13.0% | 133 | 3,674 |
| Drug ineffective | 6,747 | 10.6% | 57 | 1,465 |
| Cough | 5,926 | 9.3% | 86 | 2,751 |
| Pruritus | 5,224 | 8.2% | 32 | 1,202 |
| Fatigue | 5,053 | 7.9% | 94 | 1,826 |
| Malaise | 4,820 | 7.6% | 113 | 2,032 |
| Wheezing | 4,522 | 7.1% | 78 | 2,000 |
| Headache | 4,416 | 6.9% | 47 | 1,505 |
| Pneumonia | 4,251 | 6.7% | 133 | 2,318 |
| Pain | 3,605 | 5.7% | 46 | 1,198 |
| Nasopharyngitis | 3,421 | 5.4% | 48 | 1,472 |
Other Indications for OMALIZUMAB
Asthma (24,041)
Product used for unknown indication (14,050)
Chronic spontaneous urticaria (9,063)
Urticaria (5,500)
Urticaria chronic (1,064)
Food allergy (624)
Angioedema (412)
Hypersensitivity (364)
Rhinitis allergic (305)
Mast cell activation syndrome (257)
Other Drugs Used for Idiopathic urticaria
DUPILUMAB (930)
MONTELUKAST (23)
HUMAN IMMUNOGLOBULIN G (20)
CYCLOSPORINE (19)
HUMAN C1-ESTERASE INHIBITOR (19)
CETIRIZINE (14)
FEXOFENADINE (14)
MEPOLIZUMAB (12)
ADALIMUMAB (11)
LANADELUMAB (11)