IBRUTINIB for Off label use: Side Effects & Safety Data
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There are 5 adverse event reports in the FDA FAERS database where IBRUTINIB was used for Off label use.
Most Reported Side Effects for IBRUTINIB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 8,007 | 10.7% | 7,998 | 836 |
| Off label use | 5,446 | 7.3% | 866 | 1,760 |
| Fatigue | 4,479 | 6.0% | 203 | 1,352 |
| Diarrhoea | 3,903 | 5.2% | 331 | 1,322 |
| Atrial fibrillation | 3,671 | 4.9% | 407 | 1,633 |
| Pneumonia | 3,015 | 4.0% | 679 | 2,279 |
| Incorrect dose administered | 2,752 | 3.7% | 250 | 887 |
| Contusion | 2,712 | 3.6% | 102 | 770 |
| Fall | 2,375 | 3.2% | 243 | 1,444 |
| Asthenia | 2,200 | 2.9% | 191 | 1,104 |
| Nausea | 2,142 | 2.9% | 146 | 764 |
| Arthralgia | 2,095 | 2.8% | 99 | 503 |
| Rash | 2,029 | 2.7% | 93 | 487 |
| Haemorrhage | 1,907 | 2.5% | 183 | 461 |
| Disease progression | 1,813 | 2.4% | 676 | 584 |
Other Indications for IBRUTINIB
Chronic lymphocytic leukaemia (37,003)
Product used for unknown indication (15,132)
Mantle cell lymphoma (6,306)
Waldenstrom's macroglobulinaemia (5,044)
B-cell small lymphocytic lymphoma (1,882)
Non-hodgkin's lymphoma (1,581)
Diffuse large b-cell lymphoma (1,382)
Lymphocytic leukaemia (1,308)
B-cell lymphoma (933)
Lymphoma (896)
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)