FOTEMUSTINE for Autologous bone marrow transplantation therapy: Side Effects & Safety Data
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There are 14 adverse event reports in the FDA FAERS database where FOTEMUSTINE was used for Autologous bone marrow transplantation therapy.
Most Reported Side Effects for FOTEMUSTINE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 66 | 25.0% | 9 | 16 |
| Disease progression | 38 | 14.4% | 8 | 0 |
| Acute myeloid leukaemia | 30 | 11.4% | 4 | 8 |
| Thrombocytopenia | 29 | 11.0% | 6 | 15 |
| Mucosal inflammation | 25 | 9.5% | 5 | 10 |
| Neutropenia | 24 | 9.1% | 6 | 10 |
| Product use in unapproved indication | 23 | 8.7% | 1 | 12 |
| Platelet count decreased | 22 | 8.3% | 1 | 1 |
| Neutrophil count decreased | 20 | 7.6% | 0 | 1 |
| Septic shock | 20 | 7.6% | 3 | 11 |
| White blood cell count decreased | 20 | 7.6% | 1 | 0 |
| Diffuse large b-cell lymphoma | 17 | 6.4% | 0 | 0 |
| Diffuse large b-cell lymphoma recurrent | 17 | 6.4% | 0 | 0 |
| Drug ineffective | 17 | 6.4% | 2 | 3 |
| Vomiting | 17 | 6.4% | 6 | 8 |
Other Indications for FOTEMUSTINE
Diffuse large b-cell lymphoma (77)
Bone marrow conditioning regimen (21)
Non-hodgkin's lymphoma (20)
Glioblastoma (14)
Diffuse large b-cell lymphoma stage iv (12)
Metastatic malignant melanoma (10)
Stem cell transplant (10)
Intraocular melanoma (8)
Product used for unknown indication (8)
Allogenic bone marrow transplantation therapy (6)