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Index of reports
> Cases with Acute Graft Versus Host Disease (15)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fludara (Fludarabine) where reactions include acute graft versus host disease. The selected reports were submitted to the FDA during the sample period of about a year.
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 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 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 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
Thymoglobulin
Dosage: 63 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-03-31
End date: 2011-04-03
Fludara
Dosage: 36 mg/day, qid
Indication: Product Used FOR Unknown Indication
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 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 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
Thymoglobulin
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Therapeutic Radiopharmaceuticals
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 female
Reported by a physician from Japan on 2012-06-18
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Bronchopulmonary Aspergillosis, Acute Graft Versus Host Disease, Febrile Neutropenia, Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: 50 mg, qd, 5 times
Indication: Acute Myeloid Leukaemia
Start date: 2010-12-07
End date: 2010-12-12
Thymoglobulin
Dosage: 60 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-12-11
End date: 2010-12-12
Other drugs received by patient: Lansoprazole; Platelets; Sulfamethoprim; Tacrolimus; Methotrexate; Sulfamethoprim; Acyclovir; Levofloxacin; Itraconazole; Busulfan; RED Blood Cells, Concentrated
Possible Fludara side effects in
Reported by a physician from Japan on 2012-06-13
Patient:
Reactions: Cytomegalovirus Test Positive, Pneumonia Bacterial, Acute Graft Versus Host Disease, Cystitis Haemorrhagic, Device Related Infection
Drug(s) suspected as cause:
Fludara
Other drugs received by patient: Tacrolimus; Busulfan; Mycophenolate Mofetil
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 16 year old male
Reported by a physician from Japan on 2012-03-29
Patient: 16 year old male, weighing 51.0 kg (112.2 pounds)
Reactions: Acute Graft Versus Host Disease, Cytomegalovirus Viraemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 125 mg, qd
Indication: Acute Graft Versus Host Disease
Start date: 2011-07-05
End date: 2011-07-05
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-06-01
End date: 2011-06-06
Other drugs received by patient: Prednisolone; Micafungin Sodium; Famotidine; Fentanyl Citrate; Tacrolimus; Meropenem; Tacrolimus; Albumin (Human); Freeze Dried Sulfonated Human; Voriconazole; Cefozopran Hydrochloride; Methylprednisolone Sodium Succinate; Filgrastim; Freeze Dried Sulfonated Human; Vancomycin Hydrochloride
Possible Fludara side effects in female
Reported by a physician from Japan on 2011-12-30
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Pneumonia Bacterial, Acute Graft Versus Host Disease, Herpes Zoster
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 50 mg, qd
Start date: 2010-07-26
End date: 2010-07-26
Thymoglobulin
Dosage: 52.5 mg, qd
Indication: Acute Graft Versus Host Disease
Start date: 2010-07-20
End date: 2010-07-20
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-05-01
Other drugs received by patient: Itraconazole; Tacrolimus; Melphalan Hydrochloride; Cytarabine; Mycophenolate Mofetil; Corticosteroids; Bactrim; Total Body Irradiation
Possible Fludara side effects in 58 year old male
Reported by a physician from Japan on 2011-12-09
Patient: 58 year old male, weighing 64.0 kg (140.8 pounds)
Reactions: Acute Graft Versus Host Disease, Cytomegalovirus Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-11-30
End date: 2010-12-05
Thymoglobulin
Dosage: 80 mg, unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2011-01-12
End date: 2011-01-15
Thymoglobulin
Indication: Acute Graft Versus Host Disease
Other drugs received by patient: Plasma; Platelets; Busulfan; Methylprednisolone Sodium Succinate; Acetaminophen; RED Blood Cells, Concentrated; Chlorpheniramine Maleate; Filgrastim
Possible Fludara side effects in male
Reported by a physician from Japan on 2011-11-17
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Acute Graft Versus Host Disease, Pseudomonal Sepsis, Septic Shock
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Thymoglobulin
Dosage: 175 mg, qd
Indication: Acute Graft Versus Host Disease
Start date: 2010-09-14
End date: 2010-09-16
Fludara
Dosage: 45 mg, qd
Indication: Bone Marrow Conditioning Regimen
Start date: 2010-07-28
Other drugs received by patient: Mycophenolate Mofetil; Neupogen; Fentanyl Citrate; Corticosteroids; Tacrolimus; Fluconazole; Micafungin Sodium; RED Blood Cells, Concentrated; Morphine HCL Elixir; Micafungin Sodium; Melphalan Hydrochloride; Platelets; Fresh Frozen Plasma
Possible Fludara side effects in male
Reported by a physician from Japan on 2011-10-06
Patient: male, weighing 59.0 kg (129.8 pounds)
Reactions: Jaundice, Hyperbilirubinaemia, Acute Graft Versus Host Disease, Hyperkalaemia, Hypernatraemia, Pyrexia, Disorientation, Thrombotic Microangiopathy, C-Reactive Protein Increased, Abdominal Distension, Oxygen Saturation Decreased, Renal Disorder, Rash, Diarrhoea, Hypoalbuminaemia, Lung Infiltration, Pulmonary Mycosis
Adverse event resulted in: death, life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Alkeran
Dosage: 50mgm2 per day
Indication: Stem Cell Transplant
Start date: 2007-06-08
End date: 2007-06-09
Fludara
Dosage: 30mgm2 per day
Indication: Stem Cell Transplant
Start date: 2007-06-07
End date: 2007-06-10
Other drugs received by patient: Ciprofloxacin HCL; Magnesium Oxide; Gaslon N; Serotone; Zovirax; Depas; Urso 250; Gran; Tacrolimus
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