ROMOSOZUMAB for Off label use: Side Effects & Safety Data
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There are 8 adverse event reports in the FDA FAERS database where ROMOSOZUMAB was used for Off label use.
Most Reported Side Effects for ROMOSOZUMAB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Spinal fracture | 36 | 8.3% | 3 | 2 |
| Osteoporotic fracture | 31 | 7.1% | 2 | 1 |
| Pathological fracture | 31 | 7.1% | 2 | 1 |
| Death | 27 | 6.2% | 27 | 3 |
| Fall | 25 | 5.8% | 4 | 9 |
| Off label use | 25 | 5.8% | 0 | 4 |
| Fracture | 23 | 5.3% | 4 | 0 |
| Injection site pain | 22 | 5.1% | 4 | 4 |
| Hip fracture | 19 | 4.4% | 2 | 3 |
| Myalgia | 16 | 3.7% | 0 | 0 |
| Humerus fracture | 15 | 3.5% | 1 | 0 |
| Thoracic vertebral fracture | 15 | 3.5% | 0 | 3 |
| Cardiac failure | 14 | 3.2% | 2 | 5 |
| Headache | 14 | 3.2% | 0 | 0 |
| Radius fracture | 14 | 3.2% | 1 | 1 |
Other Indications for ROMOSOZUMAB
Osteoporosis (228)
Osteoporosis postmenopausal (104)
Product used for unknown indication (66)
Osteoporotic fracture (7)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)