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Fludara (Fludarabine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fludara (Fludarabine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (261)
Death (137)
Life Threatening Events (40)
Disability (5)

Reports by Reaction Type

Pyrexia (29)Neutropenia (25)Febrile Neutropenia (23)Sepsis (22)Diarrhoea (20)Pneumonia (19)Cytomegalovirus Infection (19)Acute Graft Versus Host Disease in Skin (18)Acute Graft Versus Host Disease (15)Graft Versus Host Disease (13)Progressive Multifocal Leukoencephalopathy (13)Hepatic Function Abnormal (12)

Below are a few examples of reports where side effects / adverse reactions may be related to Fludara (Fludarabine). For a complete list or a specific selection of reports, please use the links above.

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 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 male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male, weighing 79.0 kg (173.8 pounds)

Reactions: Phlebitis, Hydronephrosis, Adenovirus Infection, Cystitis Haemorrhagic, Human Polyomavirus Infection, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath
    Dosage: 30 mg/m2, on first 3 days of each cycle (total 6 cycles)
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Cyclophosphamide
    Dosage: 500 mg/m2, on first 3 days of each cycle (total 6 cycles)
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Fludara
    Dosage: 80 mg/m2, on first 3 days of each cycle (total 6 cycles)
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Other drugs received by patient: Folic Acid; Bactrim; Vfend; Valganciclovir



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 60 year old female

Reported by a physician from United Kingdom on 2012-08-23

Patient: 60 year old female

Reactions: Night Sweats, Endophthalmitis, Fungal Endocarditis, Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath-1
    Indication: Chronic Lymphocytic Leukaemia

Cyclophosphamide
    Indication: Chronic Lymphocytic Leukaemia

Fludara
    Indication: Chronic Lymphocytic Leukaemia

Mycophenolate Mefetil
    Indication: Graft Versus Host Disease



Possible Fludara side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: male

Reactions: Phlebitis, Lymphocyte Percentage Decreased, Hydronephrosis, Arterial Thrombosis Limb, Urinary Tract Infection, Cystitis Noninfective, Human Polyomavirus Infection, Prothrombin Time Prolonged, Urethritis, Blood Fibrinogen Increased, Genitourinary Tract Infection, Renal Impairment, Adenovirus Infection, Prostatomegaly, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath
    Dosage: 30 mg/m2, first 3 days of each cycle (6 cycles)
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Cyclophosphamide
    Dosage: 500 mg/m2, first 3 days of each cycle (6 cycles)
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Fludara
    Dosage: 80 mg/m2, first 3 days of each cycle (6 cycles)
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Other drugs received by patient: Bactrim; Valganciclovir; Vfend; Folic Acid



Possible Fludara side effects in male

Reported by a consumer/non-health professional from France on 2012-08-23

Patient: male, weighing 79.0 kg (173.8 pounds)

Reactions: Abdominal Pain Lower, Bronchopulmonary Aspergillosis, Prostatitis, Cystitis Haemorrhagic, Human Polyomavirus Infection, Pyrexia, Dysuria, Adenovirus Infection, Pollakiuria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath
    Dosage: 30 mg/m2, 3 times per 1 cycle
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Cyclophosphamide
    Dosage: 500 mg/m2, unk
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Fludara
    Dosage: 80 mg/m2, unk
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Other drugs received by patient: Valganciclovir; Bactrim; Folic Acid; Vfend



Possible Fludara side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient: 60 year old female

Reactions: Endophthalmitis, Bronchopulmonary Aspergillosis, Cerebral Artery Embolism, Fungal Endocarditis, Pancytopenia, Infection in AN Immunocompromised Host

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath
    Indication: Chronic Lymphocytic Leukaemia

Cyclophosphamide
    Indication: Chronic Lymphocytic Leukaemia

Fludara
    Indication: Chronic Lymphocytic Leukaemia

Mycophenolate Mofetil
    Indication: Graft Versus Host Disease



Possible Fludara side effects in 45 year old female

Reported by a physician from United States on 2012-08-21

Patient: 45 year old female

Reactions: Epstein-Barr Virus Infection, Splenic Infection Fungal, Mycosis Fungoides Refractory, Granuloma, Pneumonia Cytomegaloviral

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Campath
    Dosage: unk
    Indication: Mycosis Fungoides
    Start date: 2006-06-01

Cisplatin
    Dosage: unk
    Indication: Mycosis Fungoides

Cyclophosphamide
    Dosage: unk
    Indication: Mycosis Fungoides
    Start date: 2006-01-01

Daunorubicin HCL
    Dosage: unk
    Indication: Mycosis Fungoides
    Start date: 2006-01-01

Dexamethasone
    Dosage: unk
    Indication: Mycosis Fungoides

Etoposide
    Dosage: unk
    Indication: Mycosis Fungoides

Fludara
    Dosage: 2 cycles
    Indication: Mycosis Fungoides

Ifosfamide
    Dosage: unk
    Indication: Mycosis Fungoides

Prednisone
    Dosage: unk
    Indication: Mycosis Fungoides
    Start date: 2006-01-01

Vincristine
    Dosage: unk
    Indication: Mycosis Fungoides
    Start date: 2006-01-01



Possible Fludara side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female, weighing 25.0 kg (55.0 pounds)

Reactions: Ischaemia, Pulmonary Alveolar Haemorrhage, Pericardial Effusion, Renal Failure, Cardiac Failure, Respiratory Failure, Sepsis, Pleural Effusion, Hypertension, Fusarium Infection

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

Drug(s) suspected as cause:
Clolar
    Dosage: 70 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-10
    End date: 2012-01-11

Fludara
    Dosage: 140 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-11
    End date: 2012-06-15

Mozobil
    Dosage: 6 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-16
    End date: 2012-06-18

Thymoglobulin
    Dosage: 254 mg, qd
    Start date: 2012-06-16
    End date: 2012-06-19

Thymoglobulin
    Dosage: 229.9 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-15
    End date: 2012-01-18

Other drugs received by patient: Meropenem; Fentanyl Citrate; Cytarabine; Thiotepa; Melphalan Hydrochloride; Dilaudid; Busulfan



Possible Fludara side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female, weighing 25.0 kg (55.0 pounds)

Reactions: Ischaemia, Pulmonary Alveolar Haemorrhage, Pericardial Effusion, Renal Failure, Respiratory Failure, Cardiac Failure, Sepsis, Pleural Effusion, Fusarium Infection, Hypertension

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

Drug(s) suspected as cause:
Clolar
    Dosage: 70 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-10
    End date: 2012-01-11

Fludara
    Dosage: 140 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-11
    End date: 2012-06-15

Mozobil
    Dosage: 6 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-16
    End date: 2012-06-18

Thymoglobulin
    Dosage: 229.9 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-15
    End date: 2012-01-18

Thymoglobulin
    Dosage: 254 mg, qd
    Start date: 2012-06-16
    End date: 2012-06-19

Other drugs received by patient: Busulfan; Thiotepa; Dilaudid; Meropenem; Cytarabine; Melphalan Hydrochloride; Fentanyl Citrate



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 male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: male

Reactions: Hydronephrosis, Urinary Tract Infection, Cystitis Noninfective, Urethritis, Human Polyomavirus Infection, Renal Impairment, Adenovirus Infection, Prostatomegaly, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath
    Dosage: 30 mg/m2, unk
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Cyclophosphamide
    Dosage: 500 mg/m2, unk
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Fludara
    Dosage: 80 mg/m2, unk
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Other drugs received by patient: Bactrim; Vfend; Valganciclovir; Folic Acid



Possible Fludara side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: male, weighing 79.0 kg (173.8 pounds)

Reactions: Cystitis Haemorrhagic, Adenovirus Infection, Human Polyomavirus Infection, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath
    Dosage: 30 mg/m2, 3 times per 1 cycle
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Cyclophosphamide
    Dosage: 500 mg/m2, unk
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Fludara
    Dosage: 80 mg/m2, unk
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Other drugs received by patient: Vfend; Bactrim; Valganciclovir; Folic Acid



Possible Fludara side effects in female

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

Patient: female, weighing 13.0 kg (28.6 pounds)

Reactions: Vomiting, Pneumonia, Cytomegalovirus Test Positive, Escherichia Urinary Tract Infection, Pyrexia, Staphylococcal Sepsis, Epstein-Barr Virus Infection, Pulmonary Haemorrhage, Bacterial Infection, Acute Respiratory Distress Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Fludara
    Dosage: 15 mg/m2, qd (4 days); injection
    Indication: Aplastic Anaemia
    Start date: 2011-04-15
    End date: 2011-04-18

Thymoglobulin
    Indication: Aplastic Anaemia

Thymoglobulin
    Dosage: 33 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-04-15
    End date: 2011-04-18

Other drugs received by patient: Fluconazole; Acyclovir; Sulfamethoprim; Cyclophosphamide; Platelets; Hydroxyzine Pamoate; Human RED Blood Cells; Cyclosporine; Methylprednisolone Sodium Succinate



Possible Fludara side effects in male

Reported by a consumer/non-health professional from France on 2012-08-17

Patient: male, weighing 79.0 kg (173.8 pounds)

Reactions: Abdominal Pain Lower, Prostatitis, Adenovirus Infection, Dysuria, Cystitis Haemorrhagic, Pollakiuria, Human Polyomavirus Infection, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath
    Dosage: 30 mg/m2, 3 times per 1 cycle
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Cyclophosphamide
    Dosage: 500 mg/m2, unk
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Fludara
    Dosage: 80 mg/m2, unk
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2008-07-15
    End date: 2008-12-03

Other drugs received by patient: Valganciclovir; Vfend; Folic Acid; Bactrim



Possible Fludara side effects in female

Reported by a physician from United States on 2012-08-16

Patient: female, weighing 25.2 kg (55.4 pounds)

Reactions: Ischaemia, Pulmonary Alveolar Haemorrhage, Pericardial Effusion, Renal Failure, Cardiac Failure, Respiratory Failure, Sepsis, Pleural Effusion, Fusarium Infection, Hypertension

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

Drug(s) suspected as cause:
Clolar
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-10
    End date: 2012-01-11

Fludara
    Dosage: 140 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-11
    End date: 2012-06-15

Mozobil
    Dosage: 6 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-16
    End date: 2012-06-18

Thymoglobulin
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-15
    End date: 2012-01-18

Thymoglobulin
    Dosage: unk
    Start date: 2012-06-16
    End date: 2012-06-19

Other drugs received by patient: Melphalan Hydrochloride; Busulfan; Fentanyl; Thiotepa; Cytarabine; Dilaudid; Meropenem



Possible Fludara side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-15

Patient: 60 year old female

Reactions: Endophthalmitis, Night Sweats, Fungal Endocarditis, Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alemtuzumab

Cyclophosphamide

Fludara

Mycophenolate Mofetil
    Indication: Graft Versus Host Disease



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 40 year old female

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

Patient: 40 year old female

Reactions: Dyspnoea, Renal Failure, Tumour Lysis Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fludara



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 male

Reported by a pharmacist from Canada on 2012-08-14

Patient: male

Reactions: Troponin Increased

Drug(s) suspected as cause:
Fludara
    Dosage: 60 mg, for 3 days
    Administration route: Oral
    Start date: 2012-07-28
    End date: 2012-07-30

Fludara
    Dosage: 60 mg, for 3 days
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-01
    End date: 2012-06-01



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 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

Fludara
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Thymoglobulin
    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 2012-08-14

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

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

Thymoglobulin
    Dosage: 63 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    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 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

Melphalan Hydrochloride
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Therapeutic Radiopharmaceuticals
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Thymoglobulin
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Other drugs received by patient: Cyclosporine



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:
Fludara
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Melphalan Hydrochloride
    Dosage: unk

Other drugs received by patient: Methotrexate; Tacrolimus



Possible Fludara side effects in female

Reported by a physician from United States on 2012-08-13

Patient: female, weighing 25.2 kg (55.4 pounds)

Reactions: Ischaemia, Pulmonary Alveolar Haemorrhage, Pericardial Effusion, Renal Failure, Respiratory Failure, Cardiac Failure, Sepsis, Pleural Effusion, Fusarium Infection, Hypertension

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

Drug(s) suspected as cause:
Clolar
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-10
    End date: 2012-01-11

Fludara
    Dosage: 140 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-11
    End date: 2012-06-15

Mozobil
    Dosage: 6 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-16
    End date: 2012-06-18

Thymoglobulin
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-15
    End date: 2012-01-18

Thymoglobulin
    Dosage: unk
    Start date: 2012-06-16
    End date: 2012-06-19

Other drugs received by patient: Meropenem; Melphalan Hydrochloride; Cytarabine; Busulfan; Dilaudid; Fentanyl; Thiotepa



Possible Fludara side effects in 11 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: 11 year old male

Reactions: Pneumonia Viral, Adenovirus Infection

Adverse event resulted in: death

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

Melphalan Hydrochloride
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen



Possible Fludara side effects in female

Reported by a physician from Japan on 2012-08-13

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Stomatitis, Supraventricular Tachycardia, Shock Haemorrhagic, Disseminated Intravascular Coagulation, Endotoxaemia, Febrile Neutropenia, Pyrexia, Hypokalaemia, Venoocclusive Disease, Hypoalbuminaemia, Oedema, Neutropenia, Engraft Failure, Antithrombin III Decreased, Renal Failure Acute

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

Drug(s) suspected as cause:
Fludara
    Dosage: 20 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-09-13
    End date: 2011-09-17

Thymoglobulin
    Dosage: 60 mg, qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-09-18
    End date: 2011-09-19

Other drugs received by patient: Azasetron Hydrochloride; Antibiotics-Resistant Lactic Acid Bacteriae; Dexchlorpheniramine Maleate; Rebamipide; Aprepitant; Itraconazole; Lansoprazole; Allopurinol; Acyclovir; Methylprednisolone Sodium Succinate; Polymyxin B Sulfate; Sulfamethoprim; Acetaminophen; Clostridium Butyricum; Acetaminophen; Lansoprazole; Cyclosporine; Dalteparin Sodium; Itraconazole; Melphalan Hydrochloride; Methotrexate

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