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Fludara (Fludarabine) - Cytomegalovirus Infection - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Cytomegalovirus Infection (19)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fludara (Fludarabine) where reactions include cytomegalovirus infection. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Fludara side effects in female

Reported by a physician from Japan on 2012-08-23

Patient: female, weighing 49.0 kg (107.8 pounds)

Reactions: Cytomegalovirus Infection, Cytomegalovirus Viraemia, Chronic Graft Versus Host Disease, Chronic Myeloid Leukaemia, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Busulfan
    Dosage: 39 mg, qid
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-08-06
    End date: 2009-08-08

Fludara
    Dosage: 44 mg, qd
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-08-02
    End date: 2009-08-07

Thymoglobulin
    Dosage: 125 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2009-08-08
    End date: 2009-08-11

Other drugs received by patient: Cefozopran Hydrochloride; Cyclosporine; Valproate Sodium; Ursodiol; Methotrexate; Famotidine; Granisetron Hydrochloride; Methotrexate; Methotrexate; Methotrexate; Methylprednisolone Sodium Succinate; Levofloxacin; Cyclosporine; Cyclosporine; Sulfamethoxazole W; Heparin Sodium; Normal Human Immunoglobulin; Heparin; Acyclovir; Hydrocortisone Sodium Succinate; Itraconazole; Micafungin Sodium



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 11 year old female

Reported by a physician from Poland on 2012-08-10

Patient: 11 year old female

Reactions: Cystitis Haemorrhagic, BK Virus Infection, Cytomegalovirus Infection, Haemochromatosis

Drug(s) suspected as cause:
Fludara

Other drugs received by patient: Deferasirox; Neupogen; Deferasirox; Busulfan; Ciprofloxacin; Thymoglobulin; Cyclosporine; 03-OKT



Possible Fludara side effects in 9 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-10

Patient: 9 year old female

Reactions: Sepsis, Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infection, Blastocystis Infection, Haemochromatosis

Drug(s) suspected as cause:
Fludara

Other drugs received by patient: Deferoxamine Mesylate; Methotrexate; Mycophenolate Mofetil; Thymoglobulin; Cyclosporine; Neupogen; Tiotepa; Treosulfan; Deferasirox; Deferasirox



Possible Fludara side effects in 58 year old female

Reported by a physician from Spain on 2012-08-09

Patient: 58 year old female, weighing 61.0 kg (134.2 pounds)

Reactions: Lymphadenopathy, Blood Lactate Dehydrogenase Increased, Neck Mass, Pyrexia, Lymphoproliferative Disorder, Abdominal Pain Upper, Epstein-Barr Virus Infection, Hepatic Cyst, Liver Function Test Abnormal, Cytomegalovirus Infection, Splenomegaly, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: 30 mg/m2, qd (days 7 to 3)
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-03-21
    End date: 2012-03-25

Thymoglobulin
    Dosage: 2.5 mg/kg, qd (day 3 to 1)
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2012-03-25
    End date: 2012-03-27

Other drugs received by patient: Cyclosporine; Methotrexate; Treosulfan



Possible Fludara side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-07-13

Patient: 68 year old female

Reactions: Pneumonia, Fungal Infection, Paraneoplastic Pemphigus, Cytomegalovirus Infection, Neutropenia, Herpes Zoster

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: unk, 1 course
    Indication: Chronic Lymphocytic Leukaemia Recurrent

Cyclophosphamide
    Dosage: unk, 2nd course

Fludara
    Dosage: unk, 1 course
    Indication: Chronic Lymphocytic Leukaemia Recurrent

Fludara
    Dosage: unk, 2 course

Mabcampath
    Dosage: 30 mg, 3x/w
    Indication: Paraneoplastic Pemphigus

Other drugs received by patient: Prednisone; Prednisone; Bendamustine Hydrochloride; Prednisone; Rituximab



Possible Fludara side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-07-09

Patient: 68 year old female

Reactions: Pneumonia, Fungal Infection, Paraneoplastic Pemphigus, Cytomegalovirus Infection, Neutropenia, Herpes Zoster

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: unk, 2nd course

Cyclophosphamide
    Dosage: unk, 1 course
    Indication: Chronic Lymphocytic Leukaemia Recurrent

Fludara
    Dosage: unk, 1 course
    Indication: Chronic Lymphocytic Leukaemia Recurrent

Fludara
    Dosage: unk, 2 course

Mabcampath
    Dosage: 30 mg, 3x/w
    Indication: Paraneoplastic Pemphigus
    Start date: 2009-02-01

Other drugs received by patient: Prednisone; Prednisone; Bendamustine Hydrochloride; Prednisone; Rituximab



Possible Fludara side effects in 8 year old female

Reported by a physician from Japan on 2012-07-03

Patient: 8 year old female

Reactions: Hepatic Function Abnormal, Cytomegalovirus Infection

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 40 mg/kg, unk
    Indication: Bone Marrow Conditioning Regimen

Fludara
    Dosage: 180 mg/m2, unk
    Indication: Bone Marrow Conditioning Regimen

Thymoglobulin
    Dosage: 10 mg/kg, unk
    Indication: Bone Marrow Conditioning Regimen

Other drugs received by patient: Methotrexate; Total Body Radiation; Cyclosporine



Possible Fludara side effects in male

Reported by a physician from Japan on 2012-06-15

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Pneumonia, Anaemia, Febrile Neutropenia, Pyrexia, Liver Disorder, Toxoplasmosis, Cytomegalovirus Infection, Platelet Count Decreased, Neutrophil Count Decreased, Acute Respiratory Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: 50 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-03-08
    End date: 2010-03-13

Thymoglobulin
    Dosage: 150 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-03-12
    End date: 2010-03-13

Other drugs received by patient: Lansoprazole; Sulpiride; Acyclovir; Fluconazole; Busulfan; Tacrolimus; Methotrexate; Sulfamethoxazole W



Possible Fludara side effects in

Reported by a physician from France on 2012-03-16

Patient:

Reactions: Toxoplasmosis, Post Transplant Lymphoproliferative Disorder, Epstein-Barr Virus Infection, Cytomegalovirus Infection, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: 30 mg/m2, unk, for 4 days
    Indication: Bone Marrow Conditioning Regimen

Thymoglobulin
    Dosage: 5 mg/kg, unk, for 4 days
    Indication: Bone Marrow Conditioning Regimen

Other drugs received by patient: PEG G-CSF; Cyclophosphamide; Cyclosporine



Possible Fludara side effects in male

Reported by a physician from Japan on 2012-03-15

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Pneumonia, Anaemia, Febrile Neutropenia, Pyrexia, Liver Disorder, Toxoplasmosis, Cytomegalovirus Infection, Platelet Count Decreased, Neutrophil Count Decreased, Acute Respiratory Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: 50 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-03-08
    End date: 2010-03-13

Thymoglobulin
    Dosage: 150 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-03-12
    End date: 2010-03-13

Other drugs received by patient: Fluconazole; Acyclovir; Busulfan; Methotrexate; Sulfamethoxazole W; Sulpiride; Lansoprazole; Tacrolimus



Possible Fludara side effects in male

Reported by a physician from Japan on 2012-03-09

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Pneumonia, Anaemia, Febrile Neutropenia, Pyrexia, Liver Disorder, Platelet Count Decreased, Cytomegalovirus Infection, Acute Respiratory Failure, Neutrophil Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: 50 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-03-08
    End date: 2010-03-13

Thymoglobulin
    Dosage: 150 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-03-12
    End date: 2010-03-13

Other drugs received by patient: Busulfan; Acyclovir; Methotrexate; Tacrolimus; Sulpiride; Lansoprazole; Sulfamethoxazole W; Fluconazole



Possible Fludara side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-08

Patient: 65 year old male

Reactions: Encephalitis Cytomegalovirus, Cytomegalovirus Infection, Pancytopenia, Chronic Graft Versus Host Disease

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2009-08-01

Thymoglobulin
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2009-08-01

Other drugs received by patient: Rituximab; Thiotepa



Possible Fludara side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-02-09

Patient: female

Reactions: Death, Pneumonia, Cytomegalovirus Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Campath

Fludara

Other drugs received by patient: Trimethoprim; Cyclosporine; Sulphamethoxazole; Anti-Thymocyte Globulin Equine NOS; Fluconazole; Acyclovir; Mycophenolate Mefetil; Busulfan; Corticosteroids



Possible Fludara side effects in 68 year old female

Reported by a physician from Germany on 2012-02-06

Patient: 68 year old female

Reactions: Death, Pneumonia, Cytomegalovirus Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Campath
    Dosage: unk
    Indication: Haematological Malignancy

Fludara
    Dosage: unk
    Indication: Haematological Malignancy

Other drugs received by patient: Anti-Thymocyte Globulin Equine NOS; Sulphamethoxazole; Cyclosporine; Mycophenolate Mofetil; Trimethoprim; Fluconazole; Corticosteroids; Acyclovir; Busulfan



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 34 year old female

Reported by a physician from Japan on 2011-12-06

Patient: 34 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Cytomegalovirus Infection, Pneumonia Staphylococcal, Staphylococcal Sepsis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Fludara
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-05-07
    End date: 2011-05-10

Thymoglobulin
    Dosage: 72 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-05-09
    End date: 2011-05-10

Other drugs received by patient: Fluconazole; Cyclosporine; Sulfamethoprim; Platelets, Concentrated; Cyclophosphamide; Acetaminophen; Voriconazole; Methylprednisolone Sodium Succinate; Chlorpheniramine Maleate; Acyclovir; RED Blood Cells, Concentrated



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:
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

Perifosine 207
    Dosage: unk
    Administration route: Oral
    Indication: Nodal Marginal Zone B-Cell Lymphoma



Possible Fludara side effects in male

Reported by a physician from Japan on 2011-10-17

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Pneumonia, Anaemia, Febrile Neutropenia, Pyrexia, Liver Disorder, Platelet Count Decreased, Cytomegalovirus Infection, Acute Respiratory Failure, Neutrophil Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: 50 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-03-08
    End date: 2010-03-13

Thymoglobulin
    Dosage: 150 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2010-03-12
    End date: 2010-03-13

Other drugs received by patient: Fluconazole; Busulfan; Lansoprazole; Acyclovir; Sulpiride; Tacrolimus; Methotrexate; Sulfamethoxazole W

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