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
|