GILENYA for Off label use: Side Effects & Safety Data
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There are 6 adverse event reports in the FDA FAERS database where GILENYA was used for Off label use.
Most Reported Side Effects for GILENYA
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Fatigue | 208 | 12.4% | 0 | 34 |
| Multiple sclerosis relapse | 161 | 9.6% | 6 | 79 |
| Headache | 154 | 9.2% | 0 | 34 |
| Dizziness | 119 | 7.1% | 1 | 38 |
| Central nervous system lesion | 107 | 6.4% | 4 | 30 |
| Gait disturbance | 93 | 5.6% | 3 | 27 |
| Hypoaesthesia | 90 | 5.4% | 1 | 23 |
| Nausea | 85 | 5.1% | 0 | 24 |
| Fall | 84 | 5.0% | 3 | 28 |
| Vision blurred | 81 | 4.8% | 0 | 13 |
| Muscular weakness | 77 | 4.6% | 2 | 28 |
| Malaise | 75 | 4.5% | 2 | 32 |
| Asthenia | 74 | 4.4% | 3 | 28 |
| Pain | 69 | 4.1% | 2 | 22 |
| Back pain | 65 | 3.9% | 0 | 15 |
Other Indications for GILENYA
Multiple sclerosis (1,114)
Relapsing-remitting multiple sclerosis (256)
Product used for unknown indication (18)
Multiple sclerosis relapse (6)
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)