BUSULFAN for Off label use: Side Effects & Safety Data
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There are 13 adverse event reports in the FDA FAERS database where BUSULFAN was used for Off label use.
Most Reported Side Effects for BUSULFAN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 1,402 | 12.5% | 329 | 330 |
| Product use in unapproved indication | 1,387 | 12.3% | 250 | 119 |
| Mucosal inflammation | 880 | 7.8% | 156 | 238 |
| Venoocclusive liver disease | 765 | 6.8% | 250 | 190 |
| Febrile neutropenia | 628 | 5.6% | 103 | 218 |
| Cytomegalovirus infection | 620 | 5.5% | 197 | 122 |
| Drug ineffective | 569 | 5.1% | 127 | 163 |
| Graft versus host disease | 507 | 4.5% | 192 | 74 |
| Pyrexia | 502 | 4.5% | 135 | 245 |
| Cytomegalovirus infection reactivation | 481 | 4.3% | 87 | 76 |
| Sepsis | 421 | 3.7% | 290 | 102 |
| Thrombocytopenia | 376 | 3.3% | 55 | 136 |
| Respiratory failure | 360 | 3.2% | 266 | 162 |
| Infection | 357 | 3.2% | 267 | 28 |
| Pneumonia | 341 | 3.0% | 169 | 99 |
Other Indications for BUSULFAN
Bone marrow conditioning regimen (4,669)
Stem cell transplant (1,700)
Allogenic stem cell transplantation (1,624)
Acute myeloid leukaemia (892)
Product used for unknown indication (436)
Prophylaxis against transplant rejection (428)
Chemotherapy (267)
Neuroblastoma (252)
Autologous haematopoietic stem cell transplant (240)
Prophylaxis against graft versus host disease (221)
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)