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Fludara (Fludarabine) - Graft Versus Host Disease - Suspected Cause - Side Effect Reports

 
 



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 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 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 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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