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

 
 



Index of reports > Cases with Acute Graft Versus Host Disease (15)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fludara (Fludarabine) where reactions include acute 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 male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-27

Patient: male, weighing 42.0 kg (92.4 pounds)

Reactions: Epstein-Barr Virus Infection, Acute Graft Versus Host Disease, Cytomegalovirus Test Positive, Pyrexia, Chronic Graft Versus Host Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2009-08-20
    End date: 2009-08-23

Thymoglobulin
    Dosage: 86 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2009-08-20
    End date: 2009-08-23

Other drugs received by patient: Tacrolimus; Tacrolimus; Epinastine Hydrochloride; Lactomin; Melphalan Hydrochloride; Sulfamethoprim



Possible Fludara side effects in 28 year old female

Reported by a physician from Japan on 2012-08-27

Patient: 28 year old female

Reactions: Encephalitis Herpes, Acute Graft Versus Host Disease, Encephalomyelitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Fludara

Other drugs received by patient: Melphalan Hydrochloride; Prednisolone; Cyclosporine; Methotrexate; Prednisolone; Tacrolimus



Possible Fludara side effects in 28 year old female

Reported by a physician from Japan on 2012-08-17

Patient: 28 year old female

Reactions: Encephalitis Herpes, Acute Graft Versus Host Disease, Encephalomyelitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Fludara

Other drugs received by patient: Cyclosporine; Methotrexate; Tacrolimus; Prednisolone; Prednisolone; Melphalan Hydrochloride



Possible Fludara side effects in 28 year old female

Reported by a physician from Japan on 2012-08-14

Patient: 28 year old female

Reactions: Encephalitis Herpes, Acute Graft Versus Host Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Fludara



Possible Fludara side effects in female

Reported by a physician from Japan on 2012-08-14

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Acute Graft Versus Host Disease, Pyrexia, Cerebral Toxoplasmosis, Liver Disorder, Acute Graft Versus Host Disease in Skin, Hypomagnesaemia, Brain Oedema, Meningitis Toxoplasmal, Engraft Failure, Decreased Appetite, Haemorrhage Intracranial, Diarrhoea, BK Virus Infection, Skin Infection, Neutropenia, Respiratory Tract Infection, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: 110 mg/day, qid
    Start date: 2011-06-17
    End date: 2011-06-20

Thymoglobulin
    Dosage: 63 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-03-31
    End date: 2011-04-03

Fludara
    Dosage: 36 mg/day, qid
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-03-31
    End date: 2011-04-03

Other drugs received by patient: Omeprazole; Tacrolimus; Cyclophosphamide; Heparin Sodium; Dexamethasone; Melphalan Hydrochloride; Fluconazole; Sulfamethoxazole W; Sodium Bicarbonate; Sodium Bicarbonate; Methotrexate; Total Body Irradiation; Ursodesoxycholic Acid; Sennoside; Mycophenolate Mofetil; Omeprazole; Tacrolimus; Granisetron Hydrochloride; Hydroxyzine Pamoate; Metoclopramide; Leucovorin Calcium; Heparin Sodium; Methylprednisolone Sodium Succinate; Concentrated Glycerin Fructose; Fluconazole; Sulfamethoxazole W; Magnesium Oxide; Omeprazole; Itraconazole; Cord Blood Transplantation; Donor Bone Marrow Infusion; Sulfamethoxazole W; Acyclovir; Granisetron Hydrochloride; Ceftriaxone Sodium; Acyclovir; Acyclovir; Carbazochrome Sodium Sulfonate; Mycophenolate Mofetil; Etizolam; Tacrolimus; Hydrocortisone Sodium Succinate; Granisetron Hydrochloride; Furosemide; Dexamethasone; Hydroxyzine Pamoate; Concentrated Glycerin Fructose; Haptoglobins; Total Body Irradiation; Leucovorin Calcium; Granisetron Hydrochloride; Mesna



Possible Fludara side effects in 10 year old male

Reported by a physician from Japan on 2012-08-14

Patient: 10 year old male

Reactions: Viral Infection, Acute Graft Versus Host Disease, Venoocclusive Liver Disease, Cytomegalovirus Infection

Drug(s) suspected as cause:
Fludara



Possible Fludara side effects in 12 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-14

Patient: 12 year old female

Reactions: Acute Graft Versus Host Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Fludara
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Thymoglobulin
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Therapeutic Radiopharmaceuticals
    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 female

Reported by a physician from Japan on 2012-06-18

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Bronchopulmonary Aspergillosis, Acute Graft Versus Host Disease, Febrile Neutropenia, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: 50 mg, qd, 5 times
    Indication: Acute Myeloid Leukaemia
    Start date: 2010-12-07
    End date: 2010-12-12

Thymoglobulin
    Dosage: 60 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-12-11
    End date: 2010-12-12

Other drugs received by patient: Lansoprazole; Platelets; Sulfamethoprim; Tacrolimus; Methotrexate; Sulfamethoprim; Acyclovir; Levofloxacin; Itraconazole; Busulfan; RED Blood Cells, Concentrated



Possible Fludara side effects in

Reported by a physician from Japan on 2012-06-13

Patient:

Reactions: Cytomegalovirus Test Positive, Pneumonia Bacterial, Acute Graft Versus Host Disease, Cystitis Haemorrhagic, Device Related Infection

Drug(s) suspected as cause:
Fludara

Other drugs received by patient: Tacrolimus; Busulfan; Mycophenolate Mofetil



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 16 year old male

Reported by a physician from Japan on 2012-03-29

Patient: 16 year old male, weighing 51.0 kg (112.2 pounds)

Reactions: Acute Graft Versus Host Disease, Cytomegalovirus Viraemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Thymoglobulin
    Dosage: 125 mg, qd
    Indication: Acute Graft Versus Host Disease
    Start date: 2011-07-05
    End date: 2011-07-05

Fludara
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-06-01
    End date: 2011-06-06

Other drugs received by patient: Prednisolone; Micafungin Sodium; Famotidine; Fentanyl Citrate; Tacrolimus; Meropenem; Tacrolimus; Albumin (Human); Freeze Dried Sulfonated Human; Voriconazole; Cefozopran Hydrochloride; Methylprednisolone Sodium Succinate; Filgrastim; Freeze Dried Sulfonated Human; Vancomycin Hydrochloride



Possible Fludara side effects in female

Reported by a physician from Japan on 2011-12-30

Patient: female, weighing 49.0 kg (107.8 pounds)

Reactions: Pneumonia Bacterial, Acute Graft Versus Host Disease, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Thymoglobulin
    Dosage: 50 mg, qd
    Start date: 2010-07-26
    End date: 2010-07-26

Thymoglobulin
    Dosage: 52.5 mg, qd
    Indication: Acute Graft Versus Host Disease
    Start date: 2010-07-20
    End date: 2010-07-20

Fludara
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-05-01

Other drugs received by patient: Itraconazole; Tacrolimus; Melphalan Hydrochloride; Cytarabine; Mycophenolate Mofetil; Corticosteroids; Bactrim; Total Body Irradiation



Possible Fludara side effects in 58 year old male

Reported by a physician from Japan on 2011-12-09

Patient: 58 year old male, weighing 64.0 kg (140.8 pounds)

Reactions: Acute Graft Versus Host Disease, Cytomegalovirus Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-11-30
    End date: 2010-12-05

Thymoglobulin
    Dosage: 80 mg, unk
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-01-12
    End date: 2011-01-15

Thymoglobulin
    Indication: Acute Graft Versus Host Disease

Other drugs received by patient: Plasma; Platelets; Busulfan; Methylprednisolone Sodium Succinate; Acetaminophen; RED Blood Cells, Concentrated; Chlorpheniramine Maleate; Filgrastim



Possible Fludara side effects in male

Reported by a physician from Japan on 2011-11-17

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Acute Graft Versus Host Disease, Pseudomonal Sepsis, Septic Shock

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Thymoglobulin
    Dosage: 175 mg, qd
    Indication: Acute Graft Versus Host Disease
    Start date: 2010-09-14
    End date: 2010-09-16

Fludara
    Dosage: 45 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-07-28

Other drugs received by patient: Mycophenolate Mofetil; Neupogen; Fentanyl Citrate; Corticosteroids; Tacrolimus; Fluconazole; Micafungin Sodium; RED Blood Cells, Concentrated; Morphine HCL Elixir; Micafungin Sodium; Melphalan Hydrochloride; Platelets; Fresh Frozen Plasma



Possible Fludara side effects in male

Reported by a physician from Japan on 2011-10-06

Patient: male, weighing 59.0 kg (129.8 pounds)

Reactions: Jaundice, Hyperbilirubinaemia, Acute Graft Versus Host Disease, Hyperkalaemia, Hypernatraemia, Pyrexia, Disorientation, Thrombotic Microangiopathy, C-Reactive Protein Increased, Abdominal Distension, Oxygen Saturation Decreased, Renal Disorder, Rash, Diarrhoea, Hypoalbuminaemia, Lung Infiltration, Pulmonary Mycosis

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Alkeran
    Dosage: 50mgm2 per day
    Indication: Stem Cell Transplant
    Start date: 2007-06-08
    End date: 2007-06-09

Fludara
    Dosage: 30mgm2 per day
    Indication: Stem Cell Transplant
    Start date: 2007-06-07
    End date: 2007-06-10

Other drugs received by patient: Ciprofloxacin HCL; Magnesium Oxide; Gaslon N; Serotone; Zovirax; Depas; Urso 250; Gran; Tacrolimus

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