RUXOLITINIB for Off label use: Side Effects & Safety Data
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There are 60 adverse event reports in the FDA FAERS database where RUXOLITINIB was used for Off label use.
Most Reported Side Effects for RUXOLITINIB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 12,492 | 18.3% | 1,527 | 1,769 |
| Death | 6,561 | 9.6% | 6,541 | 687 |
| Fatigue | 5,663 | 8.3% | 280 | 1,124 |
| Anaemia | 3,593 | 5.3% | 539 | 1,438 |
| Haemoglobin decreased | 3,297 | 4.8% | 456 | 1,306 |
| Platelet count decreased | 3,028 | 4.4% | 540 | 1,198 |
| Diarrhoea | 2,531 | 3.7% | 193 | 827 |
| Asthenia | 2,529 | 3.7% | 305 | 949 |
| Dizziness | 2,398 | 3.5% | 102 | 587 |
| Pneumonia | 2,343 | 3.4% | 643 | 1,726 |
| Headache | 2,271 | 3.3% | 97 | 541 |
| Product availability issue | 2,142 | 3.1% | 20 | 188 |
| Product dose omission issue | 2,130 | 3.1% | 41 | 281 |
| Dyspnoea | 2,042 | 3.0% | 258 | 886 |
| Splenomegaly | 1,995 | 2.9% | 292 | 686 |
Other Indications for RUXOLITINIB
Myelofibrosis (21,650)
Polycythaemia vera (12,352)
Myeloproliferative neoplasm (2,982)
Product used for unknown indication (2,869)
Graft versus host disease (2,291)
Primary myelofibrosis (2,234)
Essential thrombocythaemia (1,788)
Chronic graft versus host disease (1,679)
Acute lymphocytic leukaemia (1,105)
Vitiligo (1,053)
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)