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Index of reports
> Cases with Hepatic Function Abnormal (12)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fludara (Fludarabine) where reactions include hepatic function abnormal. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Fludara side effects in 11 year old female
Reported by a physician from Japan on 2012-07-03
Patient: 11 year old female
Reactions: Epstein-Barr Virus Infection, Hepatic Function Abnormal, Diarrhoea, Cystitis Haemorrhagic, BK Virus Infection, Lymphoproliferative Disorder
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 10 mg/kg, unk
Indication: Bone Marrow Conditioning Regimen
Fludara
Dosage: 120 mg/m2, unk
Indication: Bone Marrow Conditioning Regimen
Cyclophosphamide
Dosage: 40 mg/kg, unk
Indication: Bone Marrow Conditioning Regimen
Other drugs received by patient: Total Body Irradiation; Methotrexate; Tacrolimus
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:
Thymoglobulin
Dosage: 10 mg/kg, unk
Indication: Bone Marrow Conditioning Regimen
Fludara
Dosage: 180 mg/m2, unk
Indication: Bone Marrow Conditioning Regimen
Cyclophosphamide
Dosage: 40 mg/kg, unk
Indication: Bone Marrow Conditioning Regimen
Other drugs received by patient: Methotrexate; Total Body Radiation; Cyclosporine
Possible Fludara side effects in 20 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-29
Patient: 20 year old female
Reactions: Hepatic Function Abnormal, Blood Creatinine Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Immune Globulin NOS
Dosage: 60 mg, uid/qd
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
Alkeran
Dosage: 100 mg, uid/qd
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
Meropenem
Dosage: 3 g, uid/qd
Indication: Febrile Neutropenia
Start date: 2011-09-24
End date: 2011-10-15
Fludara
Dosage: 20 mg, unknown/d
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
Other drugs received by patient possibly interacting with the suspect drug:
Ambisome
Dosage: 124 mg, unknown/d
Indication: Febrile Neutropenia
Start date: 2011-10-01
End date: 2011-10-15
Other drugs received by patient: Morphine Hydrochloride; Anti-Thymocyte Globulin NOS; Hepagumin; Lasix; Lansoprazole; Methotrexate; Cyclosporine; Baktar; Aciclovin Nichiiko; Gran; Sandimmune; Vancomycin
Possible Fludara side effects in 20 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-21
Patient: 20 year old female
Reactions: Hepatic Function Abnormal, Shock Haemorrhagic
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Anti-Thymocyte Globulin Rabbit NOS
Start date: 2011-09-13
Meropenem
Indication: Febrile Neutropenia
Start date: 2011-09-24
End date: 2011-10-15
Ambisome
Indication: Febrile Neutropenia
Start date: 2011-10-01
End date: 2011-10-15
Fludara
Start date: 2011-09-13
Alkeran
Start date: 2011-09-13
Other drugs received by patient: Sandimmune; Neuart; Concentrated Human Blood Platelet; Gran; Morphine Hydrochloride Hydrate; Lasix; Levofloxacin; Cotrim; Inovan; Ciprofloxacin; Albumin (Human); Aciclovin; Vancomycin Hydrochloride; Concentrated Human RED Blood Cells; Hepagumin; Lansoprazole
Possible Fludara side effects in 20 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-06
Patient: 20 year old female
Reactions: Hepatic Function Abnormal, Blood Creatinine Increased
Adverse event resulted in: death
Drug(s) suspected as cause:
Alkeran
Dosage: 100 mg, uid/qd
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
Immune Globulin NOS
Dosage: 60 mg, uid/qd
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
Meropenem
Dosage: 3 g, uid/qd
Indication: Febrile Neutropenia
Start date: 2011-09-24
End date: 2011-10-15
Fludara
Dosage: 20 mg, unknown/d
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
Other drugs received by patient possibly interacting with the suspect drug:
Ambisome
Dosage: 124 mg, unknown/d
Indication: Febrile Neutropenia
Start date: 2011-10-01
End date: 2011-10-15
Other drugs received by patient: Anti-Thymocyte Globulin NOS; Cotrim; Hepagumin; Sandimmune; Lansoprazole; Aciclovin Nichiiko; Vancomycin; Lasix; Methotrexate; Gran; Morphine HCL Elixir; Cyclosporine
Possible Fludara side effects in 20 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-31
Patient: 20 year old female
Reactions: Hepatic Function Abnormal
Adverse event resulted in: death
Drug(s) suspected as cause:
Ambisome
Indication: Febrile Neutropenia
Start date: 2011-10-01
End date: 2011-10-15
Fludara
Start date: 2011-09-13
Meropenem
Indication: Febrile Neutropenia
Start date: 2011-09-24
End date: 2011-10-15
Alkeran
Start date: 2011-09-13
Anti-Thymocyte Globulin Rabbit NOS
Start date: 2011-09-13
Other drugs received by patient: Cotrim; Gran; Lansoprazole; Neuart; Morphine Hydrochloride Hydrate; Vancomycin; Ciprofloxacin; Sandimmune; Inovan; Concentrated Human RED Blood Cells; Aciclovin; Concentrated Human Blood Platelet; Hepagumin; Lasix; Levofloxacin; Albumin (Human)
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-05-17
Patient: female, weighing 19.0 kg (41.8 pounds)
Reactions: Hepatic Function Abnormal, Cytomegalovirus Test Positive, Acute Myeloid Leukaemia Recurrent, Serum Ferritin Increased, Staphylococcal Sepsis, Engraftment Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Product Used FOR Unknown Indication
Thymoglobulin
Dosage: 25 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-10-27
End date: 2010-11-05
Other drugs received by patient: Amikacin Sulfate; Methylprednisolone Sodium Succinate; Granisetron HCL; Cyclophosphamide; Polymyxin B Sulfate; Acyclovir; Meropenem; Tacrolimus; Sulfamethoprim; Micafungin Sodium; Ursodiol; Dalteparin Sodium; Methotrexate; Methylprednisolone; Amphotericin B; Acyclovir; Norfloxacin
Possible Fludara side effects in male
Reported by a physician from Japan on 2012-05-15
Patient: male, weighing 11.0 kg (24.2 pounds)
Reactions: Post Transplant Lymphoproliferative Disorder, Hepatic Function Abnormal, Acute Graft Versus Host Disease in Skin, Urticaria, Epstein-Barr Viraemia, Pyrexia, Chronic Graft Versus Host Disease, Oxygen Saturation Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-09-17
End date: 2011-09-20
Thymoglobulin
Dosage: 21 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-09-18
End date: 2011-09-21
Other drugs received by patient: Tacrolimus; Amphotericin B; Tacrolimus; Norfloxacin; RED Blood Cells, Concentrated; Methotrexate; Granisetron HCL; Piperacillin W; Dexamethasone; Immune Cells Human; Methotrexate; Methylprednisolone Sodium Succinate; Acyclovir; Micafungin Sodium; Cefpirome Sulfate; Sulfamethoprim; Methotrexate; Mesna; Immune Cells Human; Methotrexate; Piperacillin W; Tacrolimus; Ursodiol; Cyclophosphamide; Tacrolimus; Clonazepam; Platelets, Concentrated; Methylprednisolone Sodium Succinate; Polymyxin B Sulfate; Methylprednisolone
Possible Fludara side effects in male
Reported by a physician from Japan on 2012-03-20
Patient: male, weighing 53.0 kg (116.6 pounds)
Reactions: Hepatic Function Abnormal, Pain, Chest Wall Mass, Enterococcal Infection, Ewing's Sarcoma, Encephalitis Herpes, Graft Versus Host Disease in Skin, Acute Graft Versus Host Disease in Skin, Bone Marrow Failure, Urinary Retention, Depression, Melaena, Candidiasis, Decreased Appetite, Acute Graft Versus Host Disease in Intestine, Pneumonia, Nausea, Lung Neoplasm, Pseudomonas Infection, Febrile Neutropenia, Hyponatraemia, Lobar Pneumonia, Renal Impairment, Diarrhoea, Insomnia, Graft Versus Host Disease in Intestine, Pancreatitis, Radiation Pneumonitis, Memory Impairment, Infection, Infectious Peritonitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 66 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-02-10
End date: 2010-02-11
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-02-04
End date: 2010-02-08
Other drugs received by patient: Carboplatin; Hydrocortisone Sodium Succinate; Imipem; Ceftriaxone; Itraconazol A; Pirarubicin Hydrochloride; Platelets, Concentrated; Platelets, Concentrated; Vincristine Sulfate; Micafungin Sodium; Prednisolone Acetate; Ethyl Icosapentate; Platelets, Concentrated; Platelets, Concentrated; Ifosfamide; Etoposide; Famotidine; Methylprednisolone Sodium Succinate; Vancomycin Hydrochloride; Ursodiol; Sulfamethoprim; Platelets, Concentrated; Platelets, Concentrated; Pirarubicin Hydrochloride; Pirarubicin Hydrochloride; Glycyrrhizin Glycine Cyteine Combined; Tacrolimus; Filgrastim; Polymyxin B Sulfate; Prednisolone; Platelets, Concentrated; Ifosfamide; Carboplatin; Vincristine Sulfate; Cyclophosphamide Monohydrate; Micafungin Sodium; Methotrexate; Ceftriaxone; Zovirax; Prednisolone; Ifosfamide; Etoposide; Carboplatin; Cyclophosphamide Monohydrate; Glutathione; Hydrocortisone Sodium Succinate; Dalteparin Sodium; Hydroxyzine Hydrochloride; Tacrolimus; Prednisolone; Itraconazol A; Granisetron HCL; Piperacillin Sodium; Melphalan Hydrochloride; Methotrexate; Fluconal
Possible Fludara side effects in male
Reported by a physician from Japan on 2012-03-20
Patient: male, weighing 53.0 kg (116.6 pounds)
Reactions: Hepatic Function Abnormal, Chest Wall Mass, Enterococcal Infection, Pain, Ewing's Sarcoma, Encephalitis Herpes, Graft Versus Host Disease in Skin, Acute Graft Versus Host Disease in Skin, Bone Marrow Failure, Depression, Urinary Retention, Melaena, Candidiasis, Acute Graft Versus Host Disease in Intestine, Decreased Appetite, Pneumonia, Nausea, Pseudomonas Infection, Lung Neoplasm, Febrile Neutropenia, Hyponatraemia, Lobar Pneumonia, Renal Impairment, Diarrhoea, Insomnia, Pancreatitis, Graft Versus Host Disease in Intestine, Memory Impairment, Radiation Pneumonitis, Infection, Infectious Peritonitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 66 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-02-10
End date: 2010-02-11
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-02-04
End date: 2010-02-08
Other drugs received by patient: Etoposide; Cyclophosphamide Monohydrate; Hydrocortisone Sodium Succinate; Ceftriaxone; Ursodiol; Prednisolone; Prednisolone; Ifosfamide; Granisetron HCL; Hydrocortisone Sodium Succinate; Micafungin Sodium; Methotrexate; Methotrexate; Platelets, Concentrated; Etoposide; Melphalan Hydrochloride; Prednisolone Acetate; Vancomycin Hydrochloride; Polymyxin B Sulfate; Itraconazol A; Itraconazol A; Platelets, Concentrated; Platelets, Concentrated; Platelets, Concentrated; Ifosfamide; Dalteparin Sodium; Tacrolimus; Tacrolimus; Zovirax; Ethyl Icosapentate; Pirarubicin Hydrochloride; Carboplatin; Glycyrrhizin Glycine Cyteine Combined; Methylprednisolone Sodium Succinate; Filgrastim; Fluconal; Prednisolone; Platelets, Concentrated; Pirarubicin Hydrochloride; Vincristine Sulfate; Famotidine; Piperacillin Sodium; Sulfamethoprim; Ifosfamide; Pirarubicin Hydrochloride; Carboplatin; Imipem; Ceftriaxone; Carboplatin; Vincristine Sulfate; Cyclophosphamide Monohydrate; Glutathione; Micafungin Sodium; Hydroxyzine Hydrochloride; Platelets, Concentrated; Platelets, Concentrated
Possible Fludara side effects in male
Reported by a physician from Japan on 2011-12-08
Patient: male, weighing 53.0 kg (116.6 pounds)
Reactions: Hepatic Function Abnormal, Chest Wall Mass, Pain, Enterococcal Infection, Ewing's Sarcoma, Encephalitis Herpes, Graft Versus Host Disease in Skin, Acute Graft Versus Host Disease in Skin, Bone Marrow Failure, Urinary Retention, Depression, Melaena, Decreased Appetite, Acute Graft Versus Host Disease in Intestine, Candidiasis, Pneumonia, Nausea, Pseudomonas Infection, Lung Neoplasm, Febrile Neutropenia, Hyponatraemia, Lobar Pneumonia, Renal Impairment, Diarrhoea, Insomnia, Graft Versus Host Disease in Intestine, Pancreatitis, Radiation Pneumonitis, Memory Impairment, Infection, Infectious Peritonitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-02-04
End date: 2010-02-08
Thymoglobulin
Dosage: 66 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-02-10
End date: 2010-02-11
Other drugs received by patient: Etoposide; Carboplatin; Carboplatin; Melphalan Hydrochloride; Hydroxyzine Hydrochloride; Tacrolimus; Ceftriaxone; Vancomycin HCL; Fluconal; Prednisolone; Platelets, Concentrated; Platelets, Concentrated; Pirarubicin Hydrochloride; Vincristine Sulfate; Cyclophosphamide Monohydrate; Hydrocortisone Sodium Succinate; Ceftriaxone; Polymyxin B Sulfate; Ifosfamide; Ifosfamide; Ifosfamide; Glycyrrhizin Glycine Cyteine Combined; Glutathione; Dalteparin Sodium; Piperacillin Sodium; Prednisolone Acetate; Imipem; Methotrexate; Platelets, Concentrated; Famotidine; Filgrastim; Platelets, Concentrated; Platelets, Concentrated; Vincristine Sulfate; Granisetron HCL; Micafungin Sodium; Ethyl Icosapentate; Prednisolone; Itraconazol A; Platelets, Concentrated; Etoposide; Pirarubicin Hydrochloride; Pirarubicin Hydrochloride; Micafungin Sodium; Methylprednisolone Sodium Succinate; Tacrolimus; Methotrexate; Sulfamethoprim; Platelets, Concentrated; Carboplatin; Cyclophosphamide Monohydrate; Hydrocortisone Sodium Succinate; Zovirax; Ursodiol
Possible Fludara side effects in male
Reported by a physician from Japan on 2011-10-03
Patient: male, weighing 53.0 kg (116.6 pounds)
Reactions: Hepatic Function Abnormal, Chest Wall Mass, Pain, Enterococcal Infection, Encephalitis Herpes, Acute Graft Versus Host Disease in Skin, Bone Marrow Failure, Depression, Urinary Retention, Melaena, Decreased Appetite, Acute Graft Versus Host Disease in Intestine, Candidiasis, Pneumonia, Nausea, Pseudomonas Infection, Lung Neoplasm, Hyponatraemia, Febrile Neutropenia, Lobar Pneumonia, Renal Impairment, Diarrhoea, Insomnia, Pancreatitis, Memory Impairment, Radiation Pneumonitis, Infection, Infectious Peritonitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 66 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-02-10
End date: 2010-02-11
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-02-04
End date: 2010-02-08
Other drugs received by patient: Glutathione; Granisetron Hydrochloride; Hydrocortisone Sodium Succinate; Dalteparin Sodium; Piperacillin Sodium; Platelets, Concentrated; Platelets, Concentrated; Ifosfamide; Pirarubicin Hydrochloride; Melphalan Hydrochloride; Tacrolimus; Methotrexate; Zovirax; Ethyl Icosapentate; Carboplatin; Prednisolone; Itraconazol A; Platelets, Concentrated; Platelets, Concentrated; Etoposide; Pirarubicin Hydrochloride; Carboplatin; Cyclophosphamide Monohydrate; Glycyrrhizin Glycine Cyteine Combined; Prednisolone Acetate; Filgrastim; Imipem; Prednisolone; Platelets, Concentrated; Platelets, Concentrated; Ifosfamide; Micafungin Sodium; Methylprednisolone Sodium Succinate; Hydroxyzine Hydrochloride; Tacrolimus; Methotrexate; Ceftriaxone; Vancomycin Hychloride; Carboplatin; Ceftriaxone; Polymyxin B Sulfate; Fluconal; Sulfamethoprim; Ifosfamide; Vincristine Sulfate; Vincristine Sulfate; Cyclophosphamide Monohydrate; Famotidine; Hydrocortisone Sodium Succinate; Ursodiol; Platelets, Concentrated; Etoposide; Pirarubicin Hydrochloride; Micafungin Sodium
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