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 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 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 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 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 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 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 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 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 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 female
Reported by a physician from Japan on 2012-08-13
Patient: female, weighing 45.0 kg (99.0 pounds)
Reactions: Cytomegalovirus Test Positive, Haematuria, Thrombotic Microangiopathy, Post Transplant Lymphoproliferative Disorder, Viral Haemorrhagic Cystitis, Interstitial Lung Disease, Acute Graft Versus Host Disease in Skin, Sepsis
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Fludara
Dosage: 30 mg/m2, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2012-06-03
End date: 2012-06-08
Thymoglobulin
Dosage: 50 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-06-09
End date: 2010-06-10
Other drugs received by patient: Phenobarbital TAB; Clobazam; Teicoplanin; Cytarabine; Lansoprazole; Tacrolimus; Acyclovir; Imipenem; Furosemide; Voriconazole; Roxithromycin; Mycophenolate Mofetil; Foscarnet Sodium; Thrombomodulin Alfa; Acyclovir; Miconazole Nitrate; Cefepime Hydrochloride; Lenograstim; Methylprednisolone; Famotidine; Risperidone; Diazepam; Meropenem; Omeprazole; Prednisone TAB; Filgrastim; Ursodiol; Fluconazole; Valacyclovir Hydrochloride; Micafungin Sodium; Antithrombin III Human; Grenol; Amphotericin B; Zosyn; Melphalan Hydrochloride; Heparin; Tacrolimus; Dopamine HCL
Possible Fludara side effects in 13 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13
Patient: 13 year old female
Reactions: Diarrhoea, Adenovirus Infection
Drug(s) suspected as cause:
Campath
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
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 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
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