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Sandimmune (Cyclosporine) - Reports of Side Effects & Adverse Reactions

 



This is an index of reports of adverse events (side effects, adverse reactions, etc.) related to Sandimmune (Cyclosporine). Click on the relevant link below to view a selection of reports according to the event's seriousness level and/or the nature of the side effect / adverse reaction. Or scroll down to view a sample of recent reports further on this page.

Our database includes reports from Jan 2007 to Dec 2007. The information is not vetted and should not be cosidered as verified clinical evidence.

All cases (158)
     Convulsion (21)Pyrexia (17)Alanine Aminotransferase Increased (15)more >>

Cases resulting in a serious event (157)
     Convulsion (21)Pyrexia (17)Alanine Aminotransferase Increased (15)more >>

Cases resulting in death (54)
     Convulsion (12)Thrombotic Microangiopathy (11)Depressed Level of Consciousness (11)more >>

Cases resulting in life threatening events (7)
     Rash (3)Graft Versus Host Disease (2)Cardiovascular Insufficiency (2)more >>

Cases resulting in hospitalization (71)
     Alanine Aminotransferase Increased (14)Renal Failure (12)Disease Progression (11)more >>

Cases resulting in disability (13)
     Blood Pressure Increased (4)Vomiting (4)Pyrexia (4)more >>

Cases resulting in other serious reactions (89)
     Convulsion (20)Depressed Level of Consciousness (12)Pain in Extremity (10)more >>

Below is a sample of reports where side effects / adverse reactions may be related to Sandimmune (Cyclosporine). For a complete list and/or a specific selection of reports, please use the links in the index above.

Adverse event in 48 year old female receiving Sandimmune (Cyclosporine)

Reported by a physician from Japan on 2007-10-31

Patient: 48 year old female

Adverse reactions / side effects: RED Blood Cell Schistocytes Present, Acute Graft Versus Host Disease, RED Blood Cell Abnormality, Pulmonary Alveolar Haemorrhage, Blood Lactate Dehydrogenase Increased, Thrombotic Microangiopathy, Herpes Zoster, Multi-Organ Failure, Reticulocyte Count Increased, Respiratory Failure, Acute Respiratory Distress Syndrome, Haemolytic Anaemia, Thrombocytopenia

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Sandimmune (Cyclosporine)



Adverse event in 46 year old female receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Japan on 2007-10-29

Patient: 46 year old female

Adverse reactions / side effects: Cytomegalovirus Antigen Positive, Haptoglobin Decreased, RED Blood Cell Abnormality, Proteinuria, Blood Lactate Dehydrogenase Increased, Thrombotic Microangiopathy, Focal Glomerulosclerosis

Adverse event resulted in: disablity

Suspect drug(s):
Cyclophosphamide

Neoral
    Dosage: unk, unk
    Administration route: Oral
    Indication: Allogenic Bone Marrow Transplantation Therapy
    End date: 2007-03-22

Sandimmune
    Dosage: 3 mg/kg/day
    Indication: Allogenic Bone Marrow Transplantation Therapy
    Start date: 2006-12-12

Other drugs received by patient: Methotrexate; Campath; Fludarabine Phosphate



Adverse event in 46 year old female receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Japan on 2007-10-29

Patient: 46 year old female

Adverse reactions / side effects: Cytomegalovirus Antigen Positive, Haptoglobin Decreased, RED Blood Cell Abnormality, Proteinuria, Blood Lactate Dehydrogenase Increased, Thrombotic Microangiopathy, Focal Glomerulosclerosis

Adverse event resulted in: disablity

Suspect drug(s):
Cyclophosphamide

Neoral
    Dosage: unk, unk
    Administration route: Oral
    Indication: Allogenic Bone Marrow Transplantation Therapy
    End date: 2007-03-22

Sandimmune
    Dosage: 3 mg/kg/day
    Indication: Allogenic Bone Marrow Transplantation Therapy
    Start date: 2006-12-12

Other drugs received by patient: Methotrexate; Campath; Fludarabine Phosphate



Adverse event in 48 year old female receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Japan on 2007-10-29

Patient: 48 year old female

Adverse reactions / side effects: Pulmonary Haemorrhage, Respiratory Failure, RED Blood Cell Schistocytes Present, Haemolytic Anaemia, Thrombotic Microangiopathy, Thrombocytopenia, Herpes Zoster

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Sandimmune (Cyclosporine)



Adverse event in 57 year old male receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Japan on 2007-10-25

Patient: 57 year old male

Adverse reactions / side effects: Hepatic Function Abnormal, Acute Graft Versus Host Disease, Renal Abscess, Rash, Lung Abscess, Aspergillosis, Sinus Tachycardia, Myocarditis Mycotic, Cardiac Hypertrophy, Blood Pressure Decreased

Adverse event resulted in: death

Suspect drug(s):
Sandimmune (Cyclosporine)

Other drugs received by patient: Endoxan; Methotrexate; Prograf; Thiotepa; Cyclophosphamide; Irradiation; Cellcept; Steroids NOS



Adverse event in 1 year old male receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Japan on 2007-10-17

Patient: 1 year old male, weighing 8.5 kg (18.7 pounds)

Adverse reactions / side effects: Stem Cell Transplant, Immunosuppressant Drug Level Decreased, Acute Graft Versus Host Disease, Acute Myeloid Leukaemia Recurrent

Adverse event resulted in: death

Suspect drug(s):
Neoral
    Dosage: unk, unk
    Administration route: Oral
    Indication: Bone Marrow Transplant
    End date: 2003-08-14

Sandimmune
    Dosage: 1.5 mg/kg
    Indication: Bone Marrow Transplant

Other drugs received by patient: Methotrexate; Endoxan



Adverse event in 43 year old male receiving Sandimmune (Cyclosporine)

Reported by a physician from Germany on 2007-10-15

Patient: 43 year old male, weighing 84.0 kg (184.8 pounds)

Adverse reactions / side effects: Mean Cell Haemoglobin Concentration Decreased, Blood Triglycerides Increased, Blood Cholesterol Increased, Condition Aggravated, Mean Cell Volume Increased, Blood Creatinine Increased, Hypertriglyceridaemia

Suspect drug(s):
Sandimmune (Cyclosporine)

Other drugs received by patient: Fumaderm



Adverse event in 7 year old female receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Greece on 2007-10-15

Patient: 7 year old female

Adverse reactions / side effects: White Blood Cell Count Decreased, Parvovirus Infection, Blood Urea Increased, Histiocytosis Haematophagic, Parvovirus B19 Serology Positive, Prothrombin Time Prolonged, Haemoglobin Decreased, Activated Partial Thromboplastin Time Prolonged, Haematocrit Decreased, Fibrin D Dimer Increased, Immunosuppression

Adverse event resulted in: death

Suspect drug(s):
Azathioprine

Corticosteroids

Cyclophosphamide

Enbrel

Kineret
    Indication: Vasculitis
    Start date: 2007-04-14

Methotrexate

Methylprednisolone

Prezolon

Sandimmune
    Indication: Vasculitis



Adverse event in 7 year old female receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Greece on 2007-10-15

Patient: 7 year old female

Adverse reactions / side effects: White Blood Cell Count Decreased, Parvovirus Infection, Blood Urea Increased, Histiocytosis Haematophagic, Parvovirus B19 Serology Positive, Prothrombin Time Prolonged, Haemoglobin Decreased, Activated Partial Thromboplastin Time Prolonged, Haematocrit Decreased, Fibrin D Dimer Increased, Immunosuppression

Adverse event resulted in: death

Suspect drug(s):
Azathioprine

Corticosteroids

Cyclophosphamide

Enbrel

Kineret
    Indication: Vasculitis
    Start date: 2007-04-14

Methotrexate

Methylprednisolone

Prezolon

Sandimmune
    Indication: Vasculitis



Adverse event in 66 year old female receiving Sandimmune (Cyclosporine)

Reported by a physician from Japan on 2007-10-11

Patient: 66 year old female, weighing 35.0 kg (77.0 pounds)

Adverse reactions / side effects: Haemolytic Anaemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Cellcept
    Dosage: 1000 mg/daily
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-02-01

Sandimmune
    Dosage: 60 mg/daily
    Indication: Renal Transplant
    Start date: 2007-01-31

Simulect
    Dosage: 20 mg, day 0
    Indication: Renal Transplant
    Start date: 2007-01-31
    End date: 2007-01-31

Simulect
    Dosage: 20 mg, day 4
    Start date: 2007-02-04
    End date: 2007-02-04

Solu-Medrol
    Dosage: 500 mg/daily
    Indication: Renal Transplant
    Start date: 2007-01-31

Other drugs received by patient: Amlodipine



Adverse event in 60 year old male receiving Sandimmune (Cyclosporine)

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2007-10-08

Patient: 60 year old male

Adverse reactions / side effects: Hyperkalaemia, Skin Lesion, Kaposi's Sarcoma, Azotaemia, Lymphoedema

Adverse event resulted in: death

Suspect drug(s):
Ciclosporin
    Dosage: unk, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 1991-05-18

Neoral
    Indication: Renal Transplant

Sandimmune
    Dosage: 250 mg, qd
    Indication: Renal Transplant

Other drugs received by patient: Azathioprine; Prednisolone; Amlodipine Besylate; CO-Codamol; Gaviscon Liquid ^boehringer Ingelheim^; Isoniazid; Lactulose; Omeprazole; Pyridoxine Hydrochloride



Adverse event in 12 year old male receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Japan on 2007-10-08

Patient: 12 year old male

Adverse reactions / side effects: Stomatitis, Acute Graft Versus Host Disease in Skin, Rash, Drug Level Decreased

Suspect drug(s):
Methotrexate

Sandimmune
    Dosage: 200 mg/day
    Indication: Stem Cell Transplant
    Start date: 2006-05-01
    End date: 2006-07-01

Other drugs received by patient: Fludarabine Phosphate; Melphalan



Adverse event in male receiving Sandimmune (Cyclosporine)

Reported by a consumer/non-health professional from Italy on 2007-10-05

Patient: male

Adverse reactions / side effects: Dermatitis, Pyrexia, Lipase Increased

Suspect drug(s):
Sandimmune (Cyclosporine)



Adverse event in receiving Sandimmune (Cyclosporine)

Reported by a consumer/non-health professional from Sweden on 2007-10-04

Patient:

Adverse reactions / side effects: Intentional Overdose, Suicide Attempt

Suspect drug(s):
Sandimmune (Cyclosporine)



Adverse event in 4 year old female receiving Sandimmune (Cyclosporine)

Reported by a physician from Germany on 2007-10-02

Patient: 4 year old female

Adverse reactions / side effects: Drug Toxicity, Renal Failure, Acute Hepatic Failure, Drug Interaction, Hepatic Failure, Accidental Overdose

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Sandimmune
    Indication: Colitis
    Start date: 2007-08-01

Voriconazole



Adverse event in 4 year old female receiving Sandimmune (Cyclosporine)

Reported by a physician from Germany on 2007-10-02

Patient: 4 year old female

Adverse reactions / side effects: Drug Toxicity, Renal Failure, Acute Hepatic Failure, Drug Interaction, Hepatic Failure, Accidental Overdose

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Sandimmune
    Indication: Colitis
    Start date: 2007-08-01

Voriconazole



Adverse event in 1 year old male receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Japan on 2007-10-02

Patient: 1 year old male, weighing 8.5 kg (18.7 pounds)

Adverse reactions / side effects: Stem Cell Transplant, Immunosuppressant Drug Level Decreased, Acute Graft Versus Host Disease, Acute Myeloid Leukaemia Recurrent

Adverse event resulted in: death

Suspect drug(s):
Cyclosporine
    Administration route: Oral
    Indication: Bone Marrow Transplant

Sandimmune
    Dosage: 1.5 mg/kg
    Indication: Bone Marrow Transplant

Other drugs received by patient: Methotrexate



Adverse event in male receiving Sandimmune (Cyclosporine)

Reported by a pharmacist from Germany on 2007-10-02

Patient: male

Adverse reactions / side effects: White Blood Cell Count Decreased, Cachexia, Immunosuppressant Drug Level Decreased, Renal Impairment, RED Blood Cell Count Decreased, Dialysis, Blood Albumin Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
Sandimmune (Cyclosporine)

Other drugs received by patient: Drug Therapy NOS



Adverse event in 54 year old male receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Japan on 2007-07-27

Patient: 54 year old male

Adverse reactions / side effects: Multi-Organ Failure, Hepatitis C, Hepatitis C RNA Positive, RED Blood Cell Schistocytes Present, Blood Lactate Dehydrogenase Increased, Thrombotic Microangiopathy

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Sandimmune (Cyclosporine)

Other drugs received by patient: Fresh Frozen Plasma



Adverse event in 54 year old male receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Japan on 2007-07-27

Patient: 54 year old male

Adverse reactions / side effects: Multi-Organ Failure, Hepatitis C, Hepatitis C RNA Positive, RED Blood Cell Schistocytes Present, Blood Lactate Dehydrogenase Increased, Thrombotic Microangiopathy

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Sandimmune (Cyclosporine)

Other drugs received by patient: Fresh Frozen Plasma



Adverse event in 85 year old female receiving Sandimmune (Cyclosporine)

Reported by a physician from Switzerland on 2007-07-26

Patient: 85 year old female

Adverse reactions / side effects: Agitation, Confusional State, Personality Change, Drug Interaction, Disorientation, Pyrexia, Serotonin Syndrome, Fall, Muscle Rigidity, C-Reactive Protein Increased, Clonus, Urinary Tract Infection, Hyperreflexia, General Physical Health Deterioration, Akinesia, Antidepressant Drug Level Increased, Anxiety, Heart Rate Increased, Extrapyramidal Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Cefuroxime Axetil
    Start date: 2007-03-09
    End date: 2007-03-19

Cipralex
    Dosage: 10 mg/d
    Indication: Depression
    Start date: 2006-10-01
    End date: 2007-03-26

Cipralex
    Dosage: 15 mg
    Start date: 2007-04-05
    End date: 2007-04-06

Sandimmune
    Dosage: 125 mg/d
    Indication: Renal Transplant
    Start date: 1995-01-01

Other drugs received by patient: Imurek; Perfalgan; Vancomycin HCL; Rocephin; Memantine HCL; Haldol; Lorazepam; Rocaltrol; Calcium Chloride; Seroquel



Adverse event in 55 year old female receiving Sandimmune (Cyclosporine)

Reported by a health professional (non-physician/pharmacist) from Croatia (Local Name: Hrvatska) on 2007-07-26

Patient: 55 year old female

Adverse reactions / side effects: Neurotoxicity, Grand MAL Convulsion, Confusional State, Blood Amylase Increased, Insomnia, Dizziness, Memory Impairment, Nervousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Cellcept

Decortin

Lamivudine
    Indication: Drug USE FOR Unknown Indication

Lamivudine
    Dosage: 150mg given intermittently during the last six months before hospitalisation

Sandimmune
    Dosage: 2.5mg/kg/day

Sandimmune
    Dosage: slightly tapered

Other drugs received by patient: Nifedipine; Atenolol



Adverse event in female receiving Sandimmune (Cyclosporine)

Reported by a physician from Spain on 2007-07-24

Patient: female

Adverse reactions / side effects: Anaphylactic Reaction, Rash, Erythema, Hypertension

Suspect drug(s):
Sandimmune (Cyclosporine)



Adverse event in 57 year old female receiving Sandimmune (Cyclosporine)

Reported by a physician from Croatia (Local Name: Hrvatska) on 2007-07-19

Patient: 57 year old female, weighing 75.5 kg (166.1 pounds)

Adverse reactions / side effects: Blood Creatine Phosphokinase Increased, Rhabdomyolysis, Diabetes Mellitus, Cytomegalovirus Infection, Muscular Weakness

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Lescol XL
    Dosage: 80 mg, qd
    Administration route: Oral
    End date: 2007-04-12

Sandimmune
    Dosage: 150 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-02-17

Other drugs received by patient: Cellcept; Decortin; Nitrofurantoin; Lacidipine; Furosemide; Controloc; Cortef



Adverse event in 11 year old male receiving Sandimmune (Cyclosporine)

Reported by a individual with unspecified qualification from Japan on 2007-07-18

Patient: 11 year old male, weighing 27.0 kg (59.4 pounds)

Adverse reactions / side effects: Neutrophilia, Leukocytosis

Suspect drug(s):
Neoral
    Indication: Renal Transplant

Neoral
    Dosage: 350 mg/d
    Administration route: Oral
    Start date: 2000-08-22

Sandimmune
    Dosage: unk, unk
    Indication: Renal Transplant
    End date: 2000-08-21

Other drugs received by patient: Solu-Medrol; Mizoribine; Valproate Sodium; Amlodipine; Kalimate; Medrol

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