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Sandimmune (Cyclosporine) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (20)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Sandimmune (Cyclosporine) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Sandimmune side effects in female

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

Patient: female, weighing 54.0 kg (118.8 pounds)

Reactions: Blood Creatine Phosphokinase Increased, Rhabdomyolysis, Pruritus, Pain, Weight Increased, Myalgia, Acute Respiratory Distress Syndrome, Engraft Failure, Oxygen Saturation Decreased, Blood Urea Increased, Blood Lactate Dehydrogenase Increased, Muscular Weakness, Febrile Neutropenia, Cardiac Failure, Aspartate Aminotransferase Increased, Toxic Skin Eruption

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

Drug(s) suspected as cause:
Sandimmune
    Dosage: 110 mg, unk
    Start date: 2012-03-21
    End date: 2012-03-21

Sandimmune
    Indication: Prophylaxis Against Graft Versus Host Disease
    Start date: 2012-03-12
    End date: 2012-03-20

Other drugs received by patient: Neutrogin; Azactam / SCH /; Acyclovir; Alkeran; Furosemide; Solu-Cortef; M.v.i.-12; Humulin R; Lactec; Fluconazole; Prograf; Prograf; Methotrexate; Neutrogin; Heparin Sodium; Sodium Bicarbonate; Miya-BM; Dobutamine; Methylprednisolone Sodium Succinate; Promac; Clostridium Butyricum; Fludarabine Phosphate; Atarax; Hirudoid; Fulmeta; Acetaminophen; Artificial Tears =; Meropenem; Doripenem Monohydrate; Amino Acids; Epinastine Hydrochloride; Oxycodone Hydrochloride; Omeprazole; Azactam; Alloid; Xylocaine; Celecoxib; Levofloxacin; Furosemide; Dopamine HCL; Acetaminophen; Mucosta; Sodium Bicarbonate; Potassium; Lidomex



Possible Sandimmune side effects in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-07-14

Patient: 61 year old male

Reactions: Bladder Cancer

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Sandimmune
    Indication: Arthritis

Enbrel
    Indication: Arthritis

Sandimmune
    Dosage: 300 mg, per day
    Administration route: Oral
    Indication: Psoriasis
    Start date: 2008-01-01
    End date: 2008-06-01

Methotrexate
    Dosage: 15 mg, qw
    Administration route: Oral
    Indication: Psoriasis
    Start date: 2005-06-01
    End date: 2005-12-01

Enbrel
    Dosage: 50 mg, qw
    Indication: Psoriasis
    Start date: 2010-03-01
    End date: 2012-04-01

Methotrexate
    Indication: Arthritis



Possible Sandimmune side effects in 49 year old male

Reported by a physician from Germany on 2012-06-25

Patient: 49 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Pancreatic Abscess, Tachyarrhythmia, Urinary Retention Postoperative, Cystitis Klebsiella, Pancreas Transplant Rejection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Mycophenolic Acid
    Dosage: 720 mg, bid
    Administration route: Oral
    Indication: Pancreas Transplant
    Start date: 2011-11-15
    End date: 2011-12-18

Sandimmune
    Dosage: 100 mg, bid
    Administration route: Oral
    Start date: 2011-12-19

Other drugs received by patient: Prograf; Anti-Thymocyte Globulin NOS; Prednisolone; Prograf



Possible Sandimmune side effects in 49 year old male

Reported by a physician from Germany on 2012-06-21

Patient: 49 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Pancreatic Abscess, Tachyarrhythmia, Urinary Tract Infection, Urinary Retention, Pancreas Transplant Rejection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Sandimmune
    Dosage: 100 mg, bid
    Administration route: Oral
    Start date: 2011-12-19

Mycophenolic Acid
    Dosage: 720 mg, bid
    Administration route: Oral
    Indication: Pancreas Transplant
    Start date: 2011-11-15
    End date: 2011-12-18

Other drugs received by patient: Prograf; Prograf; Anti-Thymocyte Globulin NOS; Prednisolone



Possible Sandimmune side effects in female

Reported by a physician from Japan on 2012-06-08

Patient: female, weighing 54.0 kg (118.8 pounds)

Reactions: Blood Urea Increased, Blood Creatine Phosphokinase Increased, Rhabdomyolysis, Pruritus, Blood Lactate Dehydrogenase Increased, Pain, Muscular Weakness, Febrile Neutropenia, Weight Increased, Cardiac Failure, Aspartate Aminotransferase Increased, Acute Respiratory Distress Syndrome, Engraft Failure, Toxic Skin Eruption, Oxygen Saturation Decreased

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

Drug(s) suspected as cause:
Sandimmune

Other drugs received by patient: Azactam; Neutrogin; Solu-Cortef; Potassium; Hirudoid; Lidomex; Prograf; Dopamine HCL; Fulmeta; Acetaminophen; Fluconazole; Meropenem; Methylprednisolone Sodium Succinate; Levofloxacin; Neutrogin; Sodium Bicarbonate; Amino Acids; Acetaminophen; Omeprazole; Prograf; Fludarabine Phosphate; Alkeran; Furosemide; Doripenem Monohydrate; M.v.i.-12; Lactec; Celecoxib; Artificial Tears =; Mucosta; Acyclovir; Atarax; Alloid; Xylocaine; Sodium Bicarbonate; Azactam / SCH /; Dobutamine HCL; Clostridium Butyricum; Methotrexate; Furosemide; Heparin Sodium; Miya-BM; Humulin R; Promacta; Epinastine Hydrochloride; Oxinorm



Possible Sandimmune side effects in male

Reported by a physician from Japan on 2012-03-30

Patient: male

Reactions: Rhabdomyolysis, Blood Lactate Dehydrogenase Increased, Aspartate Aminotransferase Increased, Toxic Skin Eruption

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sandimmune

Other drugs received by patient: Levofloxacin; Mucosta; Omeprazole; Clostridium Butyricum; Meropenem; Zyvox; Fluconazole; Acyclovir; Azactam



Possible Sandimmune side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-27

Patient: female, weighing 2.5 kg (5.5 pounds)

Reactions: White Blood Cell Count Decreased, Urine Output Decreased, Nephrotic Syndrome, Haemoglobin Decreased, Haematocrit Decreased, RED Blood Cell Count Decreased, Platelet Count Decreased, Immunosuppressant Drug Level Increased, Renal Failure Acute

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sandimmune

Other drugs received by patient: Famotidine; Cefazolin; Solu-Medrol; Lasix



Possible Sandimmune side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-27

Patient: female, weighing 2.5 kg (5.5 pounds)

Reactions: White Blood Cell Count Decreased, Urine Output Decreased, Nephrotic Syndrome, Haemoglobin Decreased, Haematocrit Decreased, RED Blood Cell Count Decreased, Platelet Count Decreased, Immunosuppressant Drug Level Increased, Renal Failure Acute

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sandimmune

Other drugs received by patient: Cefazolin; Famotidine; Lasix; Solu-Medrol



Possible Sandimmune side effects in male

Reported by a physician from Germany on 2012-03-07

Patient: male

Reactions: Epstein-Barr Virus Infection, C-Reactive Protein Increased, B-Cell Lymphoma, Bacterial Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Everolimus
    Dosage: unk
    Administration route: Oral
    Indication: Heart Transplant

Mycophenolate Mofetil
    Indication: Heart Transplant

Sandimmune
    Indication: Heart Transplant



Possible Sandimmune side effects in male

Reported by a physician from Netherlands on 2012-03-01

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Pneumonia, Respiratory Failure

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Sandimmune
    Dosage: 130 mg, unk
    Indication: Stem Cell Transplant
    Start date: 2012-02-13

Mycophenolic Acid
    Dosage: 1080 mg, unk
    Administration route: Oral
    Indication: Stem Cell Transplant
    Start date: 2012-02-16



Possible Sandimmune side effects in male

Reported by a physician from Netherlands on 2012-02-28

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Pneumonia, Respiratory Failure

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Mycophenolic Acid
    Dosage: 1080 mg, unk
    Administration route: Oral
    Indication: Stem Cell Transplant
    Start date: 2012-02-16

Sandimmune
    Dosage: 130 mg, unk
    Indication: Stem Cell Transplant
    Start date: 2012-02-13



Possible Sandimmune side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-02-09

Patient: 54 year old female

Reactions: Circulatory Collapse, Petit MAL Epilepsy, Asphyxia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Chlorhexidine (Rinse)

Sandimmune
    Dosage: 50 mg, 1 in 1 d, oral
    Administration route: Oral
    Indication: Dermatitis Atopic
    Start date: 2010-06-01
    End date: 2011-07-01



Possible Sandimmune side effects in female

Reported by a physician from Netherlands on 2012-02-06

Patient: female

Reactions: Hepatorenal Syndrome, Venoocclusive Liver Disease, Coma, Thrombotic Thrombocytopenic Purpura, Renal Failure Acute

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

Drug(s) suspected as cause:
Sandimmune
    Dosage: 200 mg, unk
    Indication: Stem Cell Transplant
    Start date: 2011-11-07
    End date: 2011-11-11

Sandimmune
    Dosage: 500 mg, unk
    Start date: 2011-11-15
    End date: 2011-11-17

Sandimmune
    Dosage: 300 mg, unk
    Start date: 2011-11-11
    End date: 2011-11-15

Sandimmune
    Dosage: 450 mg, unk
    Start date: 2011-11-17
    End date: 2011-11-20

Mycophenolic Acid
    Dosage: unk
    Indication: Stem Cell Transplant
    Start date: 2011-11-10

Other drugs received by patient: Mycophenolate Mofetil (Cellcept); Prednisone; Voriconazole; Zolpidem; Voriconazole; Lorazepam; Haloperidol



Possible Sandimmune side effects in female

Reported by a physician from Netherlands on 2012-01-26

Patient: female

Reactions: Hepatorenal Syndrome, Renal Failure Acute

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

Drug(s) suspected as cause:
Sandimmune
    Dosage: 450 mg, unk
    Start date: 2011-11-17
    End date: 2011-11-20

Mycophenolic Acid
    Dosage: unk
    Indication: Haematological Malignancy
    Start date: 2011-11-10

Sandimmune
    Dosage: 500 mg, unk
    Start date: 2011-11-15
    End date: 2011-11-17

Sandimmune
    Dosage: 300 mg, unk
    Start date: 2011-11-11
    End date: 2011-11-15

Sandimmune
    Dosage: 200 mg, unk
    Indication: Haematological Malignancy
    Start date: 2011-11-07
    End date: 2011-11-11

Other drugs received by patient: Prednisone TAB; Voriconazole; Zolpidem; Lorazepam; Voriconazole; Haloperidol



Possible Sandimmune side effects in 54 year old female

Reported by a physician from Germany on 2012-01-24

Patient: 54 year old female

Reactions: Circulatory Collapse, Petit MAL Epilepsy, Asphyxia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Sandimmune
    Dosage: 50 mg every day
    Administration route: Oral
    Indication: Dermatitis Atopic
    Start date: 2010-06-01

Chlorhexidine Gluconate
    Indication: Tooth Abscess



Possible Sandimmune side effects in 23 year old male

Reported by a physician from Japan on 2012-01-17

Patient: 23 year old male

Reactions: Pericardial Effusion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sandimmune
    Indication: Prophylaxis Against Graft Versus Host Disease

Sandimmune
    Dosage: unk ukn, unk
    Indication: Bone Marrow Transplant
    Start date: 2011-11-15
    End date: 2011-12-22



Possible Sandimmune side effects in 15 year old male

Reported by a physician from Germany on 2011-12-26

Patient: 15 year old male, weighing 62.0 kg (136.4 pounds)

Reactions: Weight Increased, Gastrointestinal Pain, C-Reactive Protein Increased, Pain in Extremity, Oliguria, Headache, Pyrexia, Hypertension, White Blood Cell Count Increased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sandimmune

Other drugs received by patient: Furosemide; Prednisolone



Possible Sandimmune side effects in 13 year old male

Reported by a physician from Germany on 2011-11-23

Patient: 13 year old male

Reactions: Pancreatitis Acute, Malaise, Oedematous Pancreatitis, Uveitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Sandimmune
    Dosage: 3 mg per kg body weight per day, unk
    Administration route: Oral
    End date: 2011-10-01

Sandimmune
    Dosage: 2.5 mg per kg body weight, unk
    Administration route: Oral
    Indication: Uveitis
    Start date: 2011-09-01



Possible Sandimmune side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-18

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Systemic Candida, Jaundice, Hepatic Function Abnormal, Histiocytosis Haematophagic, Neutrophil Count Increased, Cytomegalovirus Test Positive, Hepatic Failure, Thrombotic Microangiopathy, Ascites, Weight Increased, Venoocclusive Liver Disease, Pleural Effusion, Bilirubin Conjugated Increased

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 3900 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-11
    End date: 2010-07-12

Busulfex
    Dosage: 208 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-07
    End date: 2010-07-10

Neoral
    Dosage: unk ukn, unk

Sandimmune
    Dosage: 150 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-13
    End date: 2010-07-29

Other drugs received by patient: Thrombomodulin Alfa; Recomodulin; Funguard; Methotrexate; Vfend; Solu-Medrol



Possible Sandimmune side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-18

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Jaundice, Systemic Candida, Hepatic Function Abnormal, Histiocytosis Haematophagic, Neutrophil Count Increased, Cytomegalovirus Test Positive, Hepatic Failure, Thrombotic Microangiopathy, Ascites, Weight Increased, Venoocclusive Liver Disease, Pleural Effusion, Bilirubin Conjugated Increased

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Neoral
    Dosage: unk ukn, unk

Busulfex
    Dosage: 208 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-07
    End date: 2010-07-10

Cyclophosphamide
    Dosage: 3900 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-11
    End date: 2010-07-12

Sandimmune
    Dosage: 150 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-13
    End date: 2010-07-29

Other drugs received by patient: Recomodulin; Vfend; Methotrexate; Thrombomodulin Alfa; Solu-Medrol; Funguard

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