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Thymoglobulin (Anti-Thymocyte Globulin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Thymoglobulin (Anti-Thymocyte Globulin) 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 (825)
Death (368)
Life Threatening Events (185)
Disability (19)

Reports by Reaction Type

Pyrexia (140)Febrile Neutropenia (111)Acute Graft Versus Host Disease in Skin (92)Diarrhoea (71)Acute Graft Versus Host Disease (66)Cytomegalovirus Test Positive (64)Sepsis (61)Nausea (57)Pneumonia (56)Chronic Graft Versus Host Disease (45)Neutropenia (45)Cytomegalovirus Infection (44)

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

Possible Thymoglobulin 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 Thymoglobulin side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-24

Patient: male, weighing 73.0 kg (160.6 pounds)

Reactions: Enterococcal Bacteraemia, Lower Respiratory Tract Infection Bacterial, Respiratory Distress, Myopathy, Ascites, Graft Versus Host Disease in Skin, Lower Respiratory Tract Infection Viral, Rash Erythematous, Hypoalbuminaemia, Abdominal Distension, Lung Infiltration, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Thymoglobulin
    Dosage: 2 mg/kg, once
    Start date: 2012-01-04
    End date: 2012-01-04

Thymoglobulin
    Dosage: 0.5 mg/kg, once
    Indication: Prophylaxis Against Graft Versus Host Disease
    Start date: 2012-01-03
    End date: 2012-01-03

Thymoglobulin
    Dosage: 2 mg/kg, once
    Start date: 2012-01-06
    End date: 2012-01-06



Possible Thymoglobulin side effects in 64 year old female

Reported by a physician from Japan on 2012-08-23

Patient: 64 year old female

Reactions: Death

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Thymoglobulin



Possible Thymoglobulin 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 Thymoglobulin side effects in male

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

Patient: male, weighing 57.1 kg (125.6 pounds)

Reactions: Transplant Failure, Blood Creatinine Increased, Hypovolaemia, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Thymoglobulin

Other drugs received by patient: Mycophenolate Mofetil (Cellcept); Prednisolone; Tacrolimus



Possible Thymoglobulin side effects in 7 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-22

Patient: 7 year old female

Reactions: Blood Pressure Increased, Cerebral Vasoconstriction, Vision Blurred, Headache, Cerebral Haemorrhage, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cyclosporine
    Dosage: 60 mg, bid
    Indication: Aplastic Anaemia

Methylprednisolone
    Dosage: 40 mg, qd
    Indication: Aplastic Anaemia

Thymoglobulin
    Dosage: 40 mg, qd
    Indication: Aplastic Anaemia

Other drugs received by patient: Neupogen; Hypnotics and Sedatives



Possible Thymoglobulin side effects in male

Reported by a physician from Japan on 2012-08-21

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Respiratory Disorder, Atrial Fibrillation, Pyrexia, Abdominal Pain Upper, Hypokalaemia, Arrhythmia, Therapeutic Response Decreased, Blood Calcium Decreased, Renal Impairment, Face Oedema, Palpitations, Oedema Peripheral, Aplastic Anaemia, Cytomegalovirus Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Thymoglobulin

Other drugs received by patient: Entecavir; Biapenem; Prednisolone; Dexchlorpheniramine Maleate; Spironolactone; Methylprednisolone Sodium Succinate; Filgrastim; Sulbactam Sodium Cefoperazone Sodium; Arbekacin Sulfate; Teprenone; Biapenem; Cefozopran Hydrochloride; Fluconazole; Rabeprazole Sodium; Deferasirox; Filgrastim; Biapenem; Amino Acids; Entecavir; Filgrastim; Pepsin Treated Human Immunoglobulin; Sulfamethoprim; Deferasirox; Filgrastim; Furosemide; Cefozopran Hydrochloride; Itraconazole



Possible Thymoglobulin 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 Thymoglobulin side effects in male

Reported by a physician from Japan on 2012-08-21

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Cytomegalovirus Test Positive, Acute Graft Versus Host Disease in Skin, Myelodysplastic Syndrome, Acute Myeloid Leukaemia Recurrent

Drug(s) suspected as cause:
Thymoglobulin

Other drugs received by patient: Acyclovir; Acetaminophen; Tacrolimus; Melphalan Hydrochloride; Granisetron Hydrochloride; Granisetron Hydrochloride; Methotrexate; Methylprednisolone Sodium Succinate; Acyclovir; Monoammonium Glycyrrhizinate_glycine_l-Cysteine; Cefazolin Sodium; Tacrolimus; Cytarabine; Cefazolin Sodium; Micafungin Sodium; Fludarabine Phosphate; Levofloxacin; Vancomycin HCL; Fexofenadine HCL; Sulfamethoprim; Valacyclovir Hydrochloride



Possible Thymoglobulin side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-21

Patient: male, weighing 110.0 kg (242.0 pounds)

Reactions: Transplant Failure, Atelectasis, Blood Bilirubin Increased, White Blood Cell Count Decreased, Dyspnoea, Pyrexia, Venoocclusive Liver Disease, Sepsis, Pleural Effusion, Blood Creatinine Increased, Cardiac Arrest

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

Drug(s) suspected as cause:
Thymoglobulin
    Dosage: 0.5 mg/kg, once
    Indication: Prophylaxis Against Graft Versus Host Disease
    Start date: 2011-08-24
    End date: 2011-08-24

Thymoglobulin
    Dosage: 2 mg/kg, once
    Start date: 2011-08-27
    End date: 2011-08-27

Thymoglobulin
    Dosage: 2 mg/kg, once
    Indication: Immunosuppression
    Start date: 2011-08-25
    End date: 2011-08-25

Other drugs received by patient: Fluconazole; Folic Acid; Acyclovir; Lasix; NPH Insulin; Cyclosporine; Fentanyl Citrate; Humulin N; Ursodiol; Midazolam; Insulin Toronto



Possible Thymoglobulin side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-21

Patient: female, weighing 115.0 kg (253.0 pounds)

Reactions: Bronchopulmonary Aspergillosis, Multi-Organ Failure, Cytomegalovirus Viraemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Thymoglobulin
    Dosage: 2 mg/kg, qd
    Start date: 2011-04-16
    End date: 2011-04-16

Thymoglobulin
    Dosage: 2 mg/kg, qd
    Start date: 2011-04-19
    End date: 2011-04-19

Thymoglobulin
    Dosage: 0.5 mg/kg, qd
    Indication: Prophylaxis Against Graft Versus Host Disease
    Start date: 2011-04-15
    End date: 2011-04-15

Other drugs received by patient: Voriconazole; Cyclosporine; Ganciclovir



Possible Thymoglobulin 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 Thymoglobulin side effects in 13 year old male

Reported by a physician from Japan on 2012-08-20

Patient: 13 year old male, weighing 27.0 kg (59.4 pounds)

Reactions: Haematuria, Blood Creatinine Increased, Graft Loss

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tacrolimus
    Dosage: unk
    Indication: Immunosuppressant Drug Therapy
    Start date: 2011-06-09

Thymoglobulin
    Dosage: 45 mg, qd
    Indication: Kidney Transplant Rejection
    Start date: 2011-11-11
    End date: 2011-11-15

Other drugs received by patient: Hydrocortisone Sodium Succinate; Basiliximab; Prednisolone; Lafutidine; Acetaminophen; Mycophenolate Mofetil; Basiliximab; Rabeprazole Sodium; Sodium Bicarbonate; Prednisolone; Rebamipide; Chlorpheniramine Maleate



Possible Thymoglobulin side effects in female

Reported by a physician from Japan on 2012-08-20

Patient: female, weighing 85.0 kg (187.0 pounds)

Reactions: Drug-Induced Liver Injury, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Thymoglobulin

Other drugs received by patient: Prednisolone; Magnesium Oxide; Methylprednisolone Sodium Succinate; Fluconazole; Acyclovir; Carbazochrome Sodium Sulfonate Hydrate; Nifedipine; Dimemorfan Phosphate; Bifidobacterium; Levofloxacin; NON-Pyrine Cold Preparation; Human RED Blood Cells; Methylprednisolone; Itraconazole; Cyclosporine; Fluconazole; Metoclopramide; Loxoprofen Sodium Succinate; Filgrastim; Sulfamethoprim; Vidarabine; Lansoprazole; Platelets



Possible Thymoglobulin side effects in 48 year old female

Reported by a physician from Japan on 2012-08-20

Patient: 48 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Pneumonia, Oedema, Cytomegalovirus Infection, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Basiliximab
    Dosage: unk
    Indication: Immunosuppressant Drug Therapy
    Start date: 2011-06-09
    End date: 2011-06-09

Basiliximab
    Dosage: unk
    Start date: 2011-06-13
    End date: 2011-06-13

Cyclosporine
    Dosage: unk
    Indication: Immunosuppressant Drug Therapy
    Start date: 2011-06-09

Mycophenolate Mofetil
    Dosage: unk
    Indication: Immunosuppressant Drug Therapy
    Start date: 2011-06-10

Prednisolone
    Dosage: unk
    Indication: Immunosuppressant Drug Therapy
    Start date: 2011-07-16

Thymoglobulin
    Dosage: 125 mg, qd
    Indication: Kidney Transplant Rejection
    Start date: 2011-10-20
    End date: 2011-10-24

Other drugs received by patient: Amlodipine Besylate; Acetaminophen; Prednisolone Acetate; Sodium Alginate; Ferrous Citrate; Doxazosin Mesylate; Methylprednisolone; Dexchlorpheniramine Maleate; Rabeprazole Sodium; Aspirin; Hydrocortisone Sodium Succinate



Possible Thymoglobulin side effects in male

Reported by a physician from Japan on 2012-08-20

Patient: male, weighing 72.0 kg (158.4 pounds)

Reactions: Pneumonia, Lung Adenocarcinoma, Cardiac Failure, Oedema Peripheral, Aplastic Anaemia, Neutrophil Count Decreased, Pharyngitis

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

Drug(s) suspected as cause:
Cyclosporine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-12-01
    End date: 2010-03-17

Thymoglobulin
    Dosage: 262.5 mg, qd
    Indication: Aplastic Anaemia
    Start date: 2009-12-09
    End date: 2009-12-13

Other drugs received by patient: Sulfamethoxazole and Trimethoprim; Diazepam; Omeprazole; Polaprezinc; Fluconazole; Deferasirox



Possible Thymoglobulin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: female, weighing 69.7 kg (153.3 pounds)

Reactions: Proteinuria, Antibody Test Positive, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Thymoglobulin

Other drugs received by patient: Vitamin B-12; Miralax; Ventolin HFA; Tylenol-500; Versed; Zofran; Morphine; Bactrim; Lexapro; Pepcid; Synthroid; Benadryl; Prograf; Solu-Medrol; Rituxan; Ulera; Ergocalciferol; Ventolin HFA; Velcade; Sublimaze Preservative Free; Coreg; Plaquenil; Valcyte; Cell Cept; Sublimaze Preservative Free; Topamax; Prednisone TAB; Percocet



Possible Thymoglobulin side effects in female

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

Patient: female, weighing 53.0 kg (116.6 pounds)

Reactions: Hepatic Function Abnormal, Sepsis, Febrile Neutropenia, Cytomegalovirus Viraemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Thymoglobulin

Other drugs received by patient: Levofloxacin; Sulfamethoprim; Meropenem; Metenolone Acetate; Tranexamic Acid; Rabeprazole Sodium; Filgrastim; Cefepime Hydrochloride; Nifedipine; Methylprednisolone Sodium Succinate; Prednisolone; Nifedipine; Indapamide; Platelets; Carbazochrome Sodium Sulfonate; Magnesium Oxide; Telmisartan; RED Blood Cells, Concentrated; Cyclosporine; Fluconazole; Risedronate Sodium



Possible Thymoglobulin side effects in 37 year old male

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

Patient: 37 year old male

Reactions: Graft Versus Host Disease

Adverse event resulted in: death

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

Thymoglobulin
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Other drugs received by patient: Methotrexate; Cyclosporine



Possible Thymoglobulin side effects in male

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

Patient: male, weighing 13.0 kg (28.6 pounds)

Reactions: Acute Graft Versus Host Disease in Skin, Cytomegalovirus Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Thymoglobulin

Other drugs received by patient: Hydroxyzine Pamoate; Dalteparin Sodium; Melphalan Hydrochloride; Polymyxin B Sulfate; Cefozopran Hydrochloride; Granisetron Hydrochloride; Sulpyrine; Methylprednisolone Sodium Succinate; Sulfamethoprim; Cyclophosphamide Monohydrate; Fludara; Alprostadil; Ganciclovir; Mesna; Fluconazole



Possible Thymoglobulin side effects in 1 year old female

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

Patient: 1 year old female

Reactions: Graft Versus Host Disease

Adverse event resulted in: death

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

Cyclophosphamide
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Thymoglobulin
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Other drugs received by patient: Methotrexate; Cyclosporine



Possible Thymoglobulin 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 Thymoglobulin side effects in 4 year old male

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

Patient: 4 year old male

Reactions: Acute Graft Versus Host Disease

Adverse event resulted in: death

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

Cyclophosphamide
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Thymoglobulin
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen

Other drugs received by patient: Methotrexate; Cyclosporine



Possible Thymoglobulin side effects in 66 year old male

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

Patient: 66 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Haemoptysis, Cytomegalovirus Test Positive, Interstitial Lung Disease, Acute Graft Versus Host Disease in Skin, Disseminated Intravascular Coagulation, Pyrexia, Necrotising Oesophagitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Thymoglobulin
    Dosage: 77.5 mg, qd
    Indication: Prophylaxis
    Start date: 2011-06-17
    End date: 2011-06-17

Thymoglobulin
    Dosage: 72.5 mg, qd
    Indication: Acute Graft Versus Host Disease
    Start date: 2011-07-05
    End date: 2011-07-05

Other drugs received by patient: Busulfan; Micafungin Sodium; Fosfomycin Calcium; Fludarabine Phosphate; Cefepime Hydrochloride; Methylprednisolone Sodium Succinate; Tacrolimus; Acyclovir; Micafungin Sodium; Mycophenolate Mofetil; Doripenem Hydrate; Doripenem Hydrate; Lenograstim



Possible Thymoglobulin side effects in 40 year old female

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

Patient: 40 year old female, weighing 40.0 kg (88.0 pounds)

Reactions: Haemoptysis, Engraft Failure, Necrotising Oesophagitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Thymoglobulin
    Dosage: 100 mg, qd (over 12 hours)
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-09-08
    End date: 2011-09-09

Thymoglobulin
    Indication: Prophylaxis Against Graft Versus Host Disease

Other drugs received by patient: Methylprednisolone Sodium Succinate; Mycophenolate Mofetil; Tacrolimus; Cefepime Hydrochloride; Meropenem; Acyclovir; Fludarabine Phosphate; Foscarnet Sodium; Micafungin Sodium; Filgrastim; Vancomycin HCL; Busulfan



Possible Thymoglobulin side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-16

Patient: female

Reactions: Hepatic Pain, Hyperthermia, Bicytopenia, Weight Increased, Renal Failure, Hepatomegaly, Respiratory Failure, Staphylococcal Infection, Oliguria, Thrombocytopenia, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 3900 mg, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-03

Methotrexate
    Dosage: 17.6 mg, unk
    Start date: 2012-06-13

Methotrexate
    Dosage: 26.5 unk, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-08

Methotrexate
    Dosage: 17.6 mg, unk
    Start date: 2012-06-10

Thymoglobulin
    Dosage: 0.5 mg/kg, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-04

Thymoglobulin
    Dosage: 2.5 mg/kg, unk
    Start date: 2012-06-06

Thymoglobulin
    Dosage: 2 mg/kg, unk
    Start date: 2012-06-05



Possible Thymoglobulin side effects in male

Reported by a physician from Japan on 2012-08-16

Patient: male, weighing 8.0 kg (17.6 pounds)

Reactions: Venoocclusive Liver Disease, Mucous Membrane Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Thymoglobulin

Other drugs received by patient: Cyclosporine; Dexamethasone; Itraconazole; Acyclovir; Dalteparin Sodium; Tobramycin; Enalapril Maleate; Tacrolimus; Prednisolone; Melphalan Hydrochloride; Alprostadil; Lactomin; Micafungin Sodium; Methylprednisolone Sodium Succinate; Methotrexate; Furosemide; Meropenem; Fludarabine Phosphate; Granisetron Hydrochloride; Lenograstim; Famotidine; Transfusion; Procardia; Ursodiol; Hydroxyzine Hydrochloride; Freeze-Dried Sulfonated Human



Possible Thymoglobulin 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 Thymoglobulin side effects in male

Reported by a physician from Japan on 2012-08-16

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Cytomegalovirus Test Positive, Acute Graft Versus Host Disease in Skin, Myelodysplastic Syndrome, Acute Myeloid Leukaemia Recurrent

Drug(s) suspected as cause:
Thymoglobulin

Other drugs received by patient: Sulfamethoprim; Methotrexate; Cytarabine; Acyclovir; Valacyclovir Hydrochloride; Acyclovir; Monoammonium Glycyrrhizinate_glycine_l-Cysteine; Acetaminophen; Melphalan Hydrochloride; Granisetron Hydrochloride; Fexofenadine HCL; Micafungin Sodium; Fludarabine Phosphate; Vancomycin Hydrochloride; Cefazolin Sodium; Tacrolimus; Methylprednisolone Sodium Succinate; Levofloxacin; Granisetron Hydrochloride; Cefazolin Sodium; Tacrolimus



Possible Thymoglobulin side effects in female

Reported by a physician from Japan on 2012-08-15

Patient: female, weighing 37.0 kg (81.4 pounds)

Reactions: Multi-Organ Failure, Disseminated Intravascular Coagulation, Bacterial Infection, Meningitis, Thrombotic Microangiopathy

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Thymoglobulin

Other drugs received by patient: Ganciclovir; Carbenin; Tacrolimus; Fludara; Methotrexate; Acyclovir; Cefazolin Sodium; Micafungin Sodium; Filgrastim; Cyclophosphamide; Lenograstim; Methylprednisolone Sodium Succinate

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