FLUDARABINE for Stem cell transplant: Side Effects & Safety Data
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There are 1,601 adverse event reports in the FDA FAERS database where FLUDARABINE was used for Stem cell transplant.
Most Reported Side Effects for FLUDARABINE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 3,018 | 12.8% | 814 | 673 |
| Febrile neutropenia | 2,055 | 8.7% | 337 | 1,096 |
| Drug ineffective | 1,630 | 6.9% | 489 | 532 |
| Pyrexia | 1,606 | 6.8% | 361 | 963 |
| Product use in unapproved indication | 1,530 | 6.5% | 382 | 198 |
| Cytokine release syndrome | 1,458 | 6.2% | 238 | 940 |
| Neutropenia | 1,175 | 5.0% | 349 | 486 |
| Cytomegalovirus infection | 1,132 | 4.8% | 300 | 226 |
| Mucosal inflammation | 1,036 | 4.4% | 223 | 243 |
| Sepsis | 981 | 4.2% | 618 | 403 |
| Thrombocytopenia | 975 | 4.1% | 199 | 399 |
| Cytomegalovirus infection reactivation | 917 | 3.9% | 182 | 184 |
| Pneumonia | 867 | 3.7% | 371 | 436 |
| Pancytopenia | 836 | 3.5% | 238 | 335 |
| Infection | 834 | 3.5% | 507 | 200 |
Other Indications for FLUDARABINE
Bone marrow conditioning regimen (6,080)
Chronic lymphocytic leukaemia (2,777)
Allogenic stem cell transplantation (2,008)
Acute myeloid leukaemia (1,927)
Product used for unknown indication (1,336)
Acute lymphocytic leukaemia (554)
B-cell lymphoma (526)
Prophylaxis against transplant rejection (524)
Immunosuppressant drug therapy (519)
Diffuse large b-cell lymphoma (495)
Other Drugs Used for Stem cell transplant
BUSULFAN (1,700)
CYCLOPHOSPHAMIDE (1,262)
CYCLOSPORINE (1,251)
MYCOPHENOLATE MOFETIL (938)
THIOTEPA (799)
MELPHALAN (738)
TACROLIMUS (600)
METHOTREXATE (481)
LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN (442)
ALEMTUZUMAB (235)