Index of reports
> Cases with Renal Failure Acute (10)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Sandimmune (Cyclosporine) where reactions include renal failure acute. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Sandimmune side effects in male
Reported by a consumer/non-health professional from France on 2012-06-25
Patient: male
Reactions: Urticaria, Hypertension, Decreased Appetite, Renal Failure Acute
Drug(s) suspected as cause:
Neoral
Indication: Bone Marrow Failure
End date: 2011-12-28
Atgam
Dosage: 2 g, daily
Indication: Bone Marrow Failure
Start date: 2011-12-28
End date: 2011-12-31
Sandimmune
Dosage: 2 df
Start date: 2011-12-28
Other drugs received by patient: Polaramine; Acetaminophen; Valacyclovir Hydrochloride; Solu-Medrol; Bactrim
Possible Sandimmune side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-14
Patient: male, weighing 85.9 kg (189.0 pounds)
Reactions: Nephropathy Toxic, Toxicity To Various Agents, Renal Artery Stenosis, Peripheral Artery Dissection, Prerenal Failure, Renal Graft Loss, Renal Tubular Necrosis, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sandimmune
Dosage: 500 mg daily
Administration route: Oral
Indication: Renal Transplant
Mycophenolic Acid
Dosage: 1440 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2007-10-08
Possible Sandimmune side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-18
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Portal Hypertension, Hyperthermia, Hypoglycaemia, Cholestasis, Hepatic Failure, Lactic Acidosis, Sodium Retention, Cardiomegaly, Hepatomegaly, Hepatorenal Syndrome, Bone Marrow Failure, Hypoxia, Immunosuppressant Drug Level Increased, Thrombocytopenia, Fluid Retention, Renal Failure Acute, Anuria, Dyspnoea, Cytolytic Hepatitis, Hypotension, Arrhythmia, Ascites, Lung Disorder, Diarrhoea, Sepsis, Mitral Valve Incompetence, Venoocclusive Liver Disease, Escherichia Infection, Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Sandimmune
Dosage: 250 mg, daily
Start date: 2012-02-08
End date: 2012-02-17
Methotrexate
Dosage: 20 mg, unk
Start date: 2012-02-12
Sandimmune
Dosage: 100 mg, daily
Start date: 2012-02-17
End date: 2012-02-21
Cyclophosphamide
Dosage: 4980 mg, qd
Start date: 2012-02-03
End date: 2012-02-04
Methotrexate
Dosage: 30 mg, unk
Start date: 2012-02-10
Other drugs received by patient: Irradiation; Mesna; Mesna; Prograf; Irradiation; Irradiation; Mesna
Possible Sandimmune side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-17
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Portal Hypertension, Hyperthermia, Hypoglycaemia, Hepatic Failure, Cholestasis, Sodium Retention, Lactic Acidosis, Cardiomegaly, Hepatomegaly, Hepatorenal Syndrome, Hypoxia, Bone Marrow Failure, Immunosuppressant Drug Level Increased, Thrombocytopenia, Fluid Retention, Anuria, Renal Failure Acute, Dyspnoea, Cytolytic Hepatitis, Hypotension, Ascites, Arrhythmia, Lung Disorder, Diarrhoea, Sepsis, Venoocclusive Liver Disease, Mitral Valve Incompetence, Escherichia Infection, Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Methotrexate
Dosage: 30 mg, unk
Start date: 2012-02-10
Sandimmune
Dosage: 100 mg, daily
Start date: 2012-02-17
End date: 2012-02-21
Sandimmune
Dosage: 250 mg, daily
Start date: 2012-02-08
End date: 2012-02-17
Methotrexate
Dosage: 20 mg, unk
Start date: 2012-02-12
Cyclophosphamide
Dosage: 4980 mg, qd
Start date: 2012-02-03
End date: 2012-02-04
Other drugs received by patient: Mesna; Mesna; Mesna; Irradiation; Irradiation; Irradiation; Prograf
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 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 consumer/non-health professional from Brazil on 2012-03-12
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Blood Pressure Increased, Renal Impairment, Renal Failure Acute
Drug(s) suspected as cause:
Sandimmune
Dosage: 50 mg, qd
Indication: Immunosuppression
Start date: 1996-02-01
End date: 2010-12-01
Certican
Dosage: 1 mg, 1 capsule at morning, 1 at night
Administration route: Oral
Start date: 2010-12-01
Myfortic
Administration route: Oral
Indication: Immunosuppression
Other drugs received by patient: Atenolol; Losartan Potassium
Possible Sandimmune side effects in 56 year old male
Reported by a physician from Switzerland on 2012-03-02
Patient: 56 year old male
Reactions: Diarrhoea, Gout, Acne, Renal Tubular Necrosis, Thrombotic Microangiopathy, Hepatic Enzyme Increased, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Colchicine
Dosage: 1 mg, uid/qd/prn
Administration route: Oral
Indication: Gout
Start date: 2012-01-19
End date: 2012-01-19
Erlotinib Hydrochloride
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2011-10-01
End date: 2012-01-23
Sandimmune
Dosage: 125 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 1994-01-01
Other drugs received by patient: Nitroderm; Torsemide; Enoxaparin Sodium; Calcimagon-D3; Minocin; Azathioprine Sodium; Metoprolol Tartrate and Hydrochlorothiazide; Cardura; Aspirin; Lercanidipine; Prednisone TAB
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
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