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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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