OMALIZUMAB for Chronic spontaneous urticaria: Side Effects & Safety Data
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There are 9,063 adverse event reports in the FDA FAERS database where OMALIZUMAB was used for Chronic spontaneous 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)
Idiopathic urticaria (8,366)
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 Chronic spontaneous urticaria
CYCLOSPORINE (432)
MONTELUKAST (416)
CETIRIZINE (287)
DUPILUMAB (168)
PREDNISONE (146)
BILASTINE (106)
FEXOFENADINE (105)
RUPATADINE (101)
HYDROXYZINE (89)
RANITIDINE (79)