FINGOLIMOD for Off label use: Side Effects & Safety Data
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There are 6 adverse event reports in the FDA FAERS database where FINGOLIMOD was used for Off label use.
Most Reported Side Effects for FINGOLIMOD
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Fatigue | 8,901 | 12.6% | 34 | 921 |
| Multiple sclerosis relapse | 6,728 | 9.5% | 52 | 1,787 |
| Headache | 5,993 | 8.5% | 30 | 754 |
| Dizziness | 4,317 | 6.1% | 13 | 627 |
| White blood cell count decreased | 3,597 | 5.1% | 14 | 311 |
| Lymphocyte count decreased | 3,232 | 4.6% | 31 | 499 |
| Hypoaesthesia | 3,180 | 4.5% | 14 | 684 |
| Gait disturbance | 3,007 | 4.2% | 24 | 754 |
| Fall | 2,715 | 3.8% | 19 | 727 |
| Memory impairment | 2,623 | 3.7% | 8 | 310 |
| Malaise | 2,605 | 3.7% | 22 | 543 |
| Drug ineffective | 2,571 | 3.6% | 17 | 282 |
| Nausea | 2,446 | 3.5% | 18 | 431 |
| Central nervous system lesion | 2,416 | 3.4% | 22 | 437 |
| Pain | 2,370 | 3.3% | 17 | 484 |
Other Indications for FINGOLIMOD
Multiple sclerosis (43,123)
Product used for unknown indication (16,965)
Relapsing-remitting multiple sclerosis (8,814)
Relapsing multiple sclerosis (851)
Multiple sclerosis relapse (355)
Secondary progressive multiple sclerosis (351)
Foetal exposure during pregnancy (319)
Primary progressive multiple sclerosis (66)
Multiple sclerosis relapse prophylaxis (53)
Progressive multiple sclerosis (20)
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)