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Index of reports
> Cases with Graft Versus Host Disease (13)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fludara (Fludarabine) where reactions include graft versus host disease. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Fludara side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-14
Patient: 59 year old male
Reactions: Graft Versus Host Disease
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Melphalan Hydrochloride
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Other drugs received by patient: Cyclosporine
Possible Fludara side effects in 61 year old female
Reported by a physician from Japan on 2012-08-14
Patient: 61 year old female
Reactions: Graft Versus Host Disease
Drug(s) suspected as cause:
Busulfan
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Thymoglobulin
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Other drugs received by patient: Methotrexate; Tacrolimus
Possible Fludara side effects in 57 year old male
Reported by a physician from Japan on 2012-08-14
Patient: 57 year old male
Reactions: Graft Versus Host Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Melphalan Hydrochloride
Dosage: unk
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Other drugs received by patient: Methotrexate; Tacrolimus
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-07-06
Patient: female, weighing 41.0 kg (90.2 pounds)
Reactions: Histiocytosis Haematophagic, Viral Infection, Graft Versus Host Disease, Staphylococcal Infection, Febrile Neutropenia, Engraftment Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 50 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-01-10
End date: 2011-01-10
Fludara
Dosage: 40 mg, qd
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-01-04
End date: 2011-01-09
Methylprednisolone Sodium Succinate
Dosage: unk
Indication: Pyrexia
Other drugs received by patient: Methotrexate; Fluconazole; Cefepime Hydrochloride; Acyclovir; Methotrexate; Methotrexate; Methotrexate; Sulfamethoprim; Busulfan; Filgrastim; Ciprofloxacin; Tacrolimus
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-05-25
Patient: female, weighing 33.0 kg (72.6 pounds)
Reactions: Graft Versus Host Disease, Diarrhoea, Neutropenia, Lymphoproliferative Disorder, Acute Graft Versus Host Disease in Intestine
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 42.5 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-04-25
End date: 2010-04-26
Fludara
Dosage: unk
Indication: Epstein-Barr Virus Infection
Start date: 2010-04-20
End date: 2010-04-24
Other drugs received by patient: Tacrolimus; Vancomycin HCL; Fluconazole; Acyclovir; Omeprazole; Granisetron Hydrochloride; Tacrolimus; Methotrexate; Meropenem; Micafungin Sodium; Bactrim; Acyclovir; Ursodiol; Zopiclone; Heparin Sodium; Melphalan Hydrochloride; Methylpednisolone Sodium Succinate; Lansoprazole
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-05-22
Patient: female, weighing 48.0 kg (105.6 pounds)
Reactions: Encephalitis Cytomegalovirus, Graft Versus Host Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 112.5 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-12-15
End date: 2010-12-18
Fludara
Dosage: 40 mg, qd (6 times)
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-12-13
End date: 2010-12-18
Other drugs received by patient: Methylpednisolone Sodium Succinate; Mixed Amino Acid Carbohydrate Electrolyte Vitamin Combined Drug; Calcium Gluconate; Potassium Chloride; Cefepime Hydrochloride; Voriconazole; Albumin (Human); Cyclophosphamide; Doripenem Hydrate; Granisetron Hydrochloride; Amikacin Sulfate; Cyclosporine; Acyclovir; Normal Human Immunoglobulin
Possible Fludara side effects in male
Reported by a physician from Japan on 2012-04-27
Patient: male, weighing 54.0 kg (118.8 pounds)
Reactions: Systemic Candida, Renal Impairment, Graft Versus Host Disease, Acute Graft Versus Host Disease, Cytomegalovirus Test Positive, Febrile Neutropenia, Staphylococcal Sepsis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: 38 mg, qd, dosing frequency 6 times
Indication: Product Used FOR Unknown Indication
Thymoglobulin
Dosage: 67 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-05-06
End date: 2010-05-07
Other drugs received by patient: Cyclosporine; Cytarabine; Human RED Blood Cells; Fludarabine Phosphate; Acyclovir; Acyclovir; Methylprednisolone Sodium Succinate; Doripenem Hydrate; Methotrexate; Busulfan; Platelets; Melphalan Hydrochloride
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-03-19
Patient: female, weighing 33.0 kg (72.6 pounds)
Reactions: Diarrhoea, Graft Versus Host Disease, Neutropenia, Lymphoproliferative Disorder, Acute Graft Versus Host Disease in Intestine
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 42.5 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-04-25
End date: 2010-04-26
Fludara
Dosage: unk
Indication: Epstein-Barr Virus Infection
Start date: 2010-04-20
End date: 2010-04-24
Other drugs received by patient: Methylprednisolone Sodium Succinate; Meropenem; Vancomycin HCL; Ursodiol; Bactrim; Heparin Sodium; Tacrolimus; Fluconazole; Zopiclone; Micafungin Sodium; Tacrolimus; Acyclovir; Lansoprazole; Granisetron HCL; Melphalan Hydrochloride; Methotrexate; Acyclovir; Omeprazole
Possible Fludara side effects in
Reported by a physician from United States on 2012-01-27
Patient:
Reactions: Confusional State, Bronchopulmonary Aspergillosis, Graft Versus Host Disease, Amnesia, Tremor, Convulsion, Posterior Reversible Encephalopathy Syndrome, Peripheral T-Cell Lymphoma Unspecified, Haemorrhagic Stroke
Adverse event resulted in: death
Drug(s) suspected as cause:
Fludara
Dosage: 24 mg/m2, qd (5 days)
Indication: Bone Marrow Conditioning Regimen
Campath
Dosage: 20 mg, qd (5 days)
Indication: Bone Marrow Conditioning Regimen
Other drugs received by patient: Mycophenolate Mofetil; Tacrolimus; Melphalan Hydrochloride
Possible Fludara side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-01-17
Patient:
Reactions: Pneumocystis Jiroveci Pneumonia, Graft Versus Host Disease, Chronic Graft Versus Host Disease
Drug(s) suspected as cause:
Melphalan
Dosage: 100 mg/m2, unk
Indication: Multiple Myeloma
Start date: 2008-06-01
Fludara
Dosage: 125 mg/m2, unk
Indication: Multiple Myeloma
Start date: 2008-06-01
Melphalan
Indication: Stem Cell Transplant
Fludara
Indication: Stem Cell Transplant
Other drugs received by patient: Tacrolimus; Methotrexate
Possible Fludara side effects in male
Reported by a physician from Japan on 2011-12-19
Patient: male, weighing 56.0 kg (123.2 pounds)
Reactions: Cytomegalovirus Test Positive, Graft Versus Host Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-01-09
End date: 2010-01-13
Thymoglobulin
Dosage: 50 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-01-11
End date: 2010-01-13
Other drugs received by patient: Carbenin; Ganciclovir; Isepamicin Sulfate; Acyclovir; Mycophenolate Mofetil; Methylprednisolone Sodium Succinate; Dexchlorpheniramine Maleate; Cefazolin Sodium; Hydrocortisone Sodium Succinate; Tacrolimus; Amphotericin B
Possible Fludara side effects in 61 year old male
Reported by a physician from Japan on 2011-11-17
Patient: 61 year old male, weighing 64.0 kg (140.8 pounds)
Reactions: Enterococcal Sepsis, Interstitial Lung Disease, Graft Versus Host Disease, Respiratory Failure, Cytomegalovirus Gastritis, Abscess Bacterial
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: 125 mg/m2, unk
Indication: Bone Marrow Conditioning Regimen
Thymoglobulin
Dosage: 80 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2009-11-05
End date: 2009-11-06
Other drugs received by patient: Bactrim; Voriconazole; Melphalan Hydrochloride; Methotrexate; Voriconazole; Methylprednisolone Sodium Succinate; Acetaminophen; Acyclovir; Fluconazole; Amphotericin B; Radiology; Chlorpheniramine Maleate; Tacrolimus
Possible Fludara side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-15
Patient: 61 year old female
Reactions: Hyperbilirubinaemia, Graft Versus Host Disease, Cystitis Haemorrhagic, Pancytopenia, Myelodysplastic Syndrome, Pyrexia, Multi-Organ Failure, BK Virus Infection, Cytomegalovirus Infection, Pleural Effusion, Thrombocytopenia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Perifosine 207
Dosage: unk
Administration route: Oral
Indication: Nodal Marginal Zone B-Cell Lymphoma
Cyclophosphamide
Dosage: 1 course in preparation for stem cell transplant
Indication: Nodal Marginal Zone B-Cell Lymphoma
Cyclophosphamide
Indication: Bone Marrow Conditioning Regimen
Fludara
Dosage: 2 cycles (after relapse)
Indication: Bone Marrow Conditioning Regimen
Fludara
Dosage: 2 cycles (initial diagnosis)
Indication: Nodal Marginal Zone B-Cell Lymphoma
Fludara
Dosage: 1 course in preparation for stem cell transplant
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