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Index of reports
> Life Threatening Events (40)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fludara (Fludarabine) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 40 Next >>
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 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 2012-08-16
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 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
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 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 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 female
Reported by a physician from Japan on 2012-07-31
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Lymphadenopathy, Pruritus, Disseminated Intravascular Coagulation, Pyrexia, Erythema, Abdominal Discomfort, Graft Versus Host Disease in Skin, Unevaluable Event, Melaena, Epistaxis, Blister, Metabolic Acidosis, Pneumonia, Mouth Haemorrhage, Urine Output Decreased, Pleurisy, General Physical Health Deterioration, Staphylococcal Sepsis, Post Transplant Lymphoproliferative Disorder, Septic Shock, Eye Discharge, Shock Haemorrhagic, Oral Herpes, Electrolyte Depletion, Conjunctival Hyperaemia, Pleural Effusion, Blood Glucose Increased, Renal Failure Acute, Stevens-Johnson Syndrome, White Blood Cell Count Decreased, Vomiting, Excoriation, Ascites, Vulvar Erosion, Diarrhoea, Skin Erosion, Blood Pressure Decreased, Eyelid Erosion
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Allopurinol
Dosage: unk
Indication: Prophylaxis
Start date: 2011-06-23
End date: 2011-06-29
Corticosteroid NOS
Dosage: unk
Indication: Product Used FOR Unknown Indication
Fludara
Dosage: 40 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-02-13
End date: 2011-02-16
Thymoglobulin
Dosage: 115 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-02-11
End date: 2011-02-12
Other drugs received by patient: Cyclophosphamide; Fludarabine Phosphate; Prednisolone; Potassium Chloride; Magnesium Sulfate; Moxifloxacin Hydrochloride; Sulfamethoprim; Magnesium Oxide; Tacrolimus; Acyclovir; Mycophenolate Mofetil; Carbazochrome Sodium Sulfonate; Hydroxyzine Pamoate; Fentanyl Citrate; Rocuronium Bromide; RED Blood Cells, Concentrated; Micafungin Sodium; Granisetron Hydrochloride; Ursodiol; Sodium Bicarbonate; Rebamipide; Aciphex; Hydrocortisone Sodium Succinate; Omeprazole; Midazolam; Levofloxacin; Methylprednisolone Sodium Succinate; Dexchlorpheniramine Maleate; Ramosetron Hydrochloride; Platelets; Acetaminophen; Hydrocortisone Sodium Succinate; Lansoprazole; Valacyclovir Hydrochloride; Propofol; Mesna; Furosemide; Hydroxyzine Pamoate; Dexmedetomidine Hydrochloride
Possible Fludara side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-29
Patient: female, weighing 45.0 kg (99.0 pounds)
Reactions: Cytomegalovirus Test Positive, Haematuria, Thrombotic Microangiopathy, Viral Haemorrhagic Cystitis, Post Transplant Lymphoproliferative Disorder, 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: 2010-06-01
End date: 2010-06-06
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: Risperidone; Cefepime Hydrochloride; Teicoplanin; Grenol; Voriconazole; Roxithromycin; Acyclovir; Imipenem; Zosyn; Furosemide; Phenobarbital TAB; Tacrolimus; Omeprazole; Foscarnet Sodium; Antithrombin III Human; Acyclovir; Lenograstim; Cytarabine; Ursodiol; Fluconazole; Diazepam; Dopamine HCL; Filgrastim; Thrombomodulin Alfa; Melphalan Hydrochloride; Valacyclovir Hydrochloride; Tacrolimus; Meropenem; Famotidine; Lansoprazole; Micafungin Sodium; Amphotericin B; Mycophenolate Mofetil; Miconazole Nitrate; Clobazam; Heparin; Prednisone; Methylprednisolone
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:
Alkeran
Dosage: 100 mg, uid/qd
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
Fludara
Dosage: 20 mg, unknown/d
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
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 female
Reported by a physician from Japan on 2012-06-28
Patient: female, weighing 38.0 kg (83.6 pounds)
Reactions: Pneumocystis Jiroveci Pneumonia, Cytomegalovirus Test Positive, Anaemia, Acute Graft Versus Host Disease in Skin, Platelet Count Decreased, Pneumonia Cytomegaloviral
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: 25 mg/m2, qd, five times
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-06-08
End date: 2011-06-11
Thymoglobulin
Dosage: 100 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-06-06
End date: 2011-06-07
Other drugs received by patient: Cyclophosphamide; Itraconazole; Cyclosporine; Amphotericin B; Cyclosporine; Cyclosporine
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:
Alkeran
Start date: 2011-09-13
Ambisome
Indication: Febrile Neutropenia
Start date: 2011-10-01
End date: 2011-10-15
Anti-Thymocyte Globulin Rabbit NOS
Start date: 2011-09-13
Fludara
Start date: 2011-09-13
Meropenem
Indication: Febrile Neutropenia
Start date: 2011-09-24
End date: 2011-10-15
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 male
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-18
Patient: male
Reactions: Bradypnoea, Hypotension, Atrial Fibrillation, Device Occlusion, Loss of Consciousness, Death, Ventricular Tachycardia, Coronary Artery Occlusion, Pneumothorax, Pleural Effusion, Haemolytic Anaemia, Cardiac Arrest
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: unk
Start date: 2012-03-19
Cyclophosphamide
Dosage: 450 mg, qd
Indication: Waldenstrom's Macroglobulinaemia
Start date: 2012-02-10
End date: 2012-02-12
Fludara
Dosage: 40 mg, qd
Indication: Waldenstrom's Macroglobulinaemia
Start date: 2012-02-10
End date: 2012-02-12
Mabthera
Dosage: 650 mg, unk
Indication: Waldenstrom's Macroglobulinaemia
Start date: 2012-02-13
End date: 2012-02-13
Mabthera
Dosage: unk
Start date: 2012-03-22
Other drugs received by patient: Vastarel; Acetaminophen; Mirtazapine; Pravastatin; Lorazepam; Zantac; Sotalol HCL; Potassium Chloride
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-06-08
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Pruritus, Disseminated Intravascular Coagulation, Pyrexia, Oral Herpes, Abdominal Discomfort, Graft Versus Host Disease in Skin, Renal Failure Acute, Blood Glucose Increased, Stevens-Johnson Syndrome, Epistaxis, White Blood Cell Count Decreased, Vomiting, Pneumonia, Pleurisy, Staphylococcal Sepsis, Post Transplant Lymphoproliferative Disorder, Diarrhoea
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Fludara
Dosage: 40 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-02-13
End date: 2011-02-16
Thymoglobulin
Dosage: 115 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-02-11
End date: 2011-02-12
Other drugs received by patient: Rebamipide; Furosemide; Allopurinol; Omeprazole; Dexmedetomidine Hydrochloride; Platelets; Mesna; Acetaminophen; Hydrocortisone Sodium Succinate; Sodium Bicarbonate; Micafungin Sodium; Cyclophosphamide; Hydroxyzine Pamoate; Dexchlorpheniramine Maleate; Valacyclovir Hydrochloride; RED Blood Cells, Concentrated; Levofloxacin; Aciphex; Fludarabine Phosphate; Hydrocortisone Sodium Succinate; Moxifloxacin Hydrochloride; Carbazochrome Sodium Sulfonate; Sulfamethoprim; Fentanyl Citrate; Granisetron Hydrochloride; Ursodiol; Acyclovir; Mycophenolate Mofetil; Magnesium Sulfate; Lansoprazole; Ramosetron Hydrochloride; Rocuronium Bromide; Methylprednisolone Sodium Succinate; Prednisolone; Hydroxyzine Pamoate; Potassium Chloride; Magnesium Oxide; Tacrolimus; Propofol; Midazolam
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-06-07
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Anxiety, Febrile Neutropenia, Hypertension, Cytomegalovirus Gastritis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Fludara
Dosage: 25 mg, qd
Indication: Bone Marrow Conditioning Regimen
Thymoglobulin
Dosage: 125 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2009-11-12
End date: 2009-11-12
Other drugs received by patient: Tacrolimus; Tosufloxacin Tosilate; Valproate Sodium; Methylprednisolone Sodium Succinate; Busulfan; Haptoglobins; Sulfamethoxazole W; Cimetidine; Methotrexate; Itraconazole; Acyclovir
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-05-25
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Post Transplant Lymphoproliferative Disorder, Insomnia, Acute Graft Versus Host Disease in Skin, Febrile Neutropenia, Neutrophil Count Decreased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: 36 mg, qd
Indication: Epstein-Barr Virus Infection
Start date: 2010-11-18
End date: 2010-11-22
Thymoglobulin
Dosage: 62.5 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-11-23
End date: 2010-11-24
Other drugs received by patient: Melphalan Hydrochloride; Tacrolimus; Micafungin Sodium; Lansoprazole; Omeprazole; Acyclovir; Ursodiol; Fluconazole; Methotrexate; Levofloxacin; Azasetron Hydrochloride; Acyclovir; Sulfamethoprim; Methylpednisolone Sodium Succinate
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-05-25
Patient: female, weighing 33.0 kg (72.6 pounds)
Reactions: Graft Versus Host Disease, Diarrhoea, Neutropenia, Lymphoproliferative Disorder, Acute Graft Versus Host Disease in Intestine
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Epstein-Barr Virus Infection
Start date: 2010-04-20
End date: 2010-04-24
Thymoglobulin
Dosage: 42.5 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-04-25
End date: 2010-04-26
Other drugs received by patient: Tacrolimus; Vancomycin HCL; Fluconazole; Acyclovir; Omeprazole; Granisetron Hydrochloride; Tacrolimus; Methotrexate; Meropenem; Micafungin Sodium; Bactrim; Acyclovir; Ursodiol; Zopiclone; Heparin Sodium; Melphalan Hydrochloride; Methylpednisolone Sodium Succinate; Lansoprazole
Possible Fludara side effects in male
Reported by a physician from Japan on 2012-04-27
Patient: male, weighing 54.0 kg (118.8 pounds)
Reactions: Systemic Candida, Renal Impairment, Graft Versus Host Disease, Acute Graft Versus Host Disease, Cytomegalovirus Test Positive, Febrile Neutropenia, Staphylococcal Sepsis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: 38 mg, qd, dosing frequency 6 times
Indication: Product Used FOR Unknown Indication
Thymoglobulin
Dosage: 67 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-05-06
End date: 2010-05-07
Other drugs received by patient: Cyclosporine; Cytarabine; Human RED Blood Cells; Fludarabine Phosphate; Acyclovir; Acyclovir; Methylprednisolone Sodium Succinate; Doripenem Hydrate; Methotrexate; Busulfan; Platelets; Melphalan Hydrochloride
Possible Fludara side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-26
Patient:
Reactions: Hodgkin's Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Fludara
Other drugs received by patient: Cyclophosphamide; Rituximab
Possible Fludara side effects in male
Reported by a physician from Japan on 2012-04-18
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Pseudomonal Sepsis, Neutropenia
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Busulfan
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2010-11-10
End date: 2010-11-14
Fludara
Dosage: 30 mg/m2, qd
Indication: Acute Myeloid Leukaemia
Start date: 2010-11-10
End date: 2010-11-14
Thymoglobulin
Dosage: 82.5 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-11-15
End date: 2010-11-15
Other drugs received by patient: Carbocisteine; Mosapride Citrate; Methylprednisolone Sodium Succinate; Estazolam; Ambroxol Hydrochloride; Lansoprazole; Ambroxol Hydrochloride; Dimemorfan Phosphate; Dimemorfan Phosphate; Aluminium Hydroxide W; Carbocisteine; Mosapride Citrate; Deferasirox; Lansoprazole; Estazolam; Aluminium Hydroxide W; Tacrolimus
Possible Fludara side effects in 10 year old female
Reported by a physician from Japan on 2012-03-21
Patient: 10 year old female, weighing 34.0 kg (74.8 pounds)
Reactions: Pulmonary Hypertension, Post Transplant Lymphoproliferative Disorder, Cardiac Failure, Acute Graft Versus Host Disease in Skin
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-03-18
End date: 2011-03-21
Thymoglobulin
Dosage: 85 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-03-18
End date: 2011-03-21
Other drugs received by patient: Deferasirox; Acyclovir; Filgrastim; Cyclophosphamide; Tacrolimus; RED Blood Cells, Concentrated; Methotrexate; Methylprednisolone Sodium Succinate; Acetaminophen; Micafungin Sodium; Methotrexate; Sulfamethoprim; Ceftazidime; Ceftazidime; Platelets
Possible Fludara side effects in 60 year old female
Reported by a physician from Japan on 2012-03-21
Patient: 60 year old female, weighing 32.0 kg (70.4 pounds)
Reactions: Stenotrophomonas Sepsis, Engraft Failure
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-11-08
End date: 2011-11-13
Thymoglobulin
Dosage: 42.5 mg, qd
Indication: Acute Graft Versus Host Disease
Start date: 2011-11-24
End date: 2011-11-24
Other drugs received by patient: Micafungin Sodium; Vancomycin Hydrochloride; Cytarabine; Foscarnet Sodium; Mycophenolate Mofetil; Meropenem; Tacrolimus; Filgrastim; Ciprofloxacin; Melphalan Hydrochloride
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-03-19
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Diarrhoea, Febrile Neutropenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2010-07-01
End date: 2010-07-05
Thymoglobulin
Dosage: 62.5 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-07-06
End date: 2010-07-07
Other drugs received by patient: Fentanyl; Micafungin Sodium; Ursodiol; Atenolol; Diltiazem HCL; Omeprazole; Melphalan Hydrochloride; Acyclovir; Acyclovir; Methotrexate; Fentanyl; Losartan Potassium; Granisetron HCL; Methylprednisolone Sodium Succinate; Fluconazole; Cefepime Hydrochloride; Tacrolimus
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-03-19
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Post Transplant Lymphoproliferative Disorder, Acute Graft Versus Host Disease in Skin, Insomnia, Febrile Neutropenia, Neutrophil Count Decreased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: 36 mg, qd
Indication: Epstein-Barr Virus Infection
Start date: 2010-11-18
End date: 2010-11-22
Thymoglobulin
Dosage: 62.5 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-11-23
End date: 2010-11-24
Other drugs received by patient: Acyclovir; Lansoprazole; Levofloxacin; Sulfamethoprim; Azasetron Hydrochloride; Methylprednisolone Sodium Succinate; Methotrexate; Fluconazole; Melphalan Hydrochloride; Omeprazole; Tacrolimus; Micafungin Sodium; Ursodiol; Acyclovir
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-03-19
Patient: female, weighing 33.0 kg (72.6 pounds)
Reactions: Diarrhoea, Graft Versus Host Disease, Neutropenia, Lymphoproliferative Disorder, Acute Graft Versus Host Disease in Intestine
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Epstein-Barr Virus Infection
Start date: 2010-04-20
End date: 2010-04-24
Thymoglobulin
Dosage: 42.5 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-04-25
End date: 2010-04-26
Other drugs received by patient: Methylprednisolone Sodium Succinate; Meropenem; Vancomycin HCL; Ursodiol; Bactrim; Heparin Sodium; Tacrolimus; Fluconazole; Zopiclone; Micafungin Sodium; Tacrolimus; Acyclovir; Lansoprazole; Granisetron HCL; Melphalan Hydrochloride; Methotrexate; Acyclovir; Omeprazole
Possible Fludara side effects in female
Reported by a consumer/non-health professional from France on 2012-03-07
Patient: female, weighing 61.0 kg (134.2 pounds)
Reactions: Chronic Lymphocytic Leukaemia, Herpes Zoster
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Campath
Dosage: 30 mg, 3x per cycle, day 1-3
Indication: Chronic Lymphocytic Leukaemia
Start date: 2008-08-19
End date: 2009-01-09
Cyclophosphamide
Dosage: 390 mg (250mg/m2), 3x per cycle, day 1-3
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2008-08-19
End date: 2009-01-09
Fludara
Dosage: 62 mg (40mg/m2), 3x per cycle, day 1-3
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2008-08-19
End date: 2009-01-09
Other drugs received by patient: Antiinflammatory
Possible Fludara side effects in female
Reported by a physician from Japan on 2012-02-21
Patient: female, weighing 47.0 kg (103.4 pounds)
Reactions: Pseudomonal Sepsis, Acute Graft Versus Host Disease in Skin, Acute Myeloid Leukaemia
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Fludara
Dosage: 45 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2009-09-15
End date: 2009-09-20
Fludara
Dosage: unk mg, qd
Indication: Acute Myeloid Leukaemia
Start date: 2010-05-25
End date: 2010-05-27
Thymoglobulin
Dosage: 50 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2009-09-21
End date: 2009-09-23
Thymoglobulin
Dosage: 50 mg, unk
Indication: Acute Graft Versus Host Disease
Start date: 2010-05-27
Thymoglobulin
Dosage: 50 mg, unk
Start date: 2010-05-30
End date: 2010-06-01
Other drugs received by patient: Cytarabine; Melphalan Hydrochloride; Cyclosporine; Voriconazole; Itraconazole; Vancomycin Hydrochloride; Gabexate Mesilate; Doripenem Hydrate; Acyclovir; Cefepime Hydrochloride; Meropenem; Piperacillin W; Cytarabine Ocfosfate; Doripenem Hydrate; Prednisolone; Linezolid; Amphotericin B; Meropenem; Naproxen; Mycophenolate Mofetil; Methylprednisolone; Tacrolimus; Vancomycin Hydrochloride; Ganciclovir; Naproxen; Cytarabine; Busulfan; Ceftazidime
Possible Fludara side effects in female
Reported by a consumer/non-health professional from France on 2012-02-10
Patient: female, weighing 61.0 kg (134.2 pounds)
Reactions: Chronic Lymphocytic Leukaemia, Herpes Zoster
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Campath
Dosage: 30 mg, 3x per cycle, day 1-3
Indication: Chronic Lymphocytic Leukaemia
Start date: 2008-08-19
End date: 2009-01-09
Cyclophosphamide
Dosage: 390 mg (250mg/m2), 3x per cycle, day 1-3
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2008-08-19
End date: 2009-01-09
Fludara
Dosage: 62 mg (40mg/m2), 3x per cycle, day 1-3
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2008-08-19
End date: 2009-01-09
Other drugs received by patient: Diclofenac Sodium
Possible Fludara side effects in male
Reported by a physician from Japan on 2012-02-06
Patient: male, weighing 44.0 kg (96.8 pounds)
Reactions: Pruritus, Intraventricular Haemorrhage, Cystitis Viral, Disseminated Intravascular Coagulation, Cytomegalovirus Viraemia, Headache, Chronic Graft Versus Host Disease, Staphylococcal Sepsis, Staphylococcal Infection, Diarrhoea, Acute Graft Versus Host Disease in Skin, Insomnia, Aspergillosis, Neutropenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Fludara
Dosage: 40 mg, qdx4
Indication: Bone Marrow Conditioning Regimen
Start date: 2009-08-15
End date: 2009-08-18
Thymoglobulin
Dosage: 100 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2009-08-15
End date: 2009-08-16
Other drugs received by patient: Methylprednisolone Sodium Succinate; Rebamipide; Metoclopramide; Ganciclovir; Tacrolimus; Valaciclovir; Alprostadil; Prednisolone; Filgrastim (Genetical Recombination); Micafungin; Cyclophosphamide; Ganciclovir; Morphine; Haptoglobins; Glycyrrhizin Glycine Cysteine Combined Drug; Cytarabine; Methotrexate; Heparin; Furosemide; Methylprednisolone Sodium Succinate; Ramosetron Hydrochloride; Pirenzepine Dihydrochloride; Mesna; Sulfamethoxazole W
Possible Fludara side effects in 56 year old male
Reported by a physician from Netherlands on 2011-12-22
Patient: 56 year old male
Reactions: Idiopathic Thrombocytopenic Purpura
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Campath
Start date: 2010-09-07
End date: 2010-09-09
Campath
Start date: 2010-10-04
End date: 2010-10-04
Cyclophosphamide
Administration route: Oral
Start date: 2010-10-04
End date: 2010-10-06
Cyclophosphamide
Administration route: Oral
Start date: 2010-09-08
End date: 2010-09-10
Fludara
Administration route: Oral
Start date: 2010-09-08
End date: 2010-09-10
Fludara
Administration route: Oral
Start date: 2010-10-04
End date: 2010-10-06
Other drugs received by patient: Valaciclovir; Lactulose; Sulfamethoxazole and Trimethoprim; Fluconazole
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