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Neoral (Cyclosporine) - Osteonecrosis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Osteonecrosis ()

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Neoral (Cyclosporine) where reactions include osteonecrosis. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Neoral side effects in female

Reported by a consumer/non-health professional from China on 2012-05-30

Patient: female, weighing 90.0 kg (198.0 pounds)

Reactions: Blood Bilirubin Increased, Osteonecrosis, Pain in Extremity

Drug(s) suspected as cause:
Neoral
    Dosage: 212.5 mg, (100 mg in the morning and 112.5 mg in the evening)

Neoral
    Dosage: unk ukn, unk
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2008-07-22

Medrol
    Dosage: 4 mg, unk
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2008-07-22
    End date: 2009-05-01

Other drugs received by patient: Cellcept; Cellcept



Possible Neoral side effects in male

Reported by a consumer/non-health professional from Denmark on 2012-04-30

Patient: male

Reactions: Complications of Transplanted Kidney, Renal Disorder, Gout, Kidney Fibrosis, Osteopenia, Nephrosclerosis, Blood Calcium Decreased, Vascular Calcification, Osteonecrosis, Renal Impairment, Arthralgia, Blood Uric Acid Increased, Spinal Osteoarthritis, Renal Graft Loss

Drug(s) suspected as cause:
Neoral

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



Possible Neoral side effects in male

Reported by a physician from Japan on 2012-01-20

Patient: male

Reactions: Osteonecrosis, Cytomegalovirus Viraemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Dosage: 750 mg, unk
    Administration route: Oral
    Start date: 2002-10-10

Mycophenolate Mofetil (Cellcept)
    Dosage: 1000 mg, unk
    Administration route: Oral
    Start date: 2003-03-01
    End date: 2005-07-14

Methylprednisolone
    Dosage: 20 mg, unk
    Indication: Lung Transplant Rejection
    Start date: 2002-02-06
    End date: 2002-01-01

Mycophenolate Mofetil (Cellcept)
    Dosage: 1500 mg, unk
    Administration route: Oral
    Start date: 2007-08-10

Mycophenolate Mofetil (Cellcept)
    Dosage: 1250 mg, unk
    Administration route: Oral
    Start date: 2005-07-15
    End date: 2007-08-09

Methylprednisolone
    Dosage: 500 mg, unk
    Start date: 2002-02-01
    End date: 2002-02-01

Neoral
    Dosage: 1300 mg, qd
    Administration route: Oral
    Indication: Lung Transplant Rejection
    Start date: 2002-02-19

Cyclosporine
    Dosage: 12-48 mg
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2002-02-07
    End date: 2002-02-20

Mycophenolate Mofetil (Cellcept)
    Dosage: 500 mg, unk
    Administration route: Oral
    Start date: 2002-05-28
    End date: 2002-10-09

Mycophenolate Mofetil (Cellcept)
    Dosage: 750 mg, qd
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2002-02-07
    End date: 2002-05-27

Prednisone TAB
    Dosage: 3.75 mg, unk
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2002-02-20

Prednisone TAB
    Dosage: 15 mg, qd
    Administration route: Oral
    Start date: 2002-02-28

Neoral
    Dosage: 270 mg, unk
    Administration route: Oral
    Start date: 2003-01-01

Other drugs received by patient: Adrenal Cortex Extract INJ; Adrenal Cortex Extract INJ; Bactrim; Prograf; Adrenal Cortex Extract INJ; Ganciclovir; Ganciclovir; Ganciclovir; Prograf; Sulfamethoxazole; Ganciclovir



Possible Neoral side effects in 76 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-16

Patient: 76 year old male, weighing 64.0 kg (140.8 pounds)

Reactions: Eyelid Oedema, Liver Injury, Intestinal Ulcer, Hypoglycaemia, Blood Albumin Decreased, Hepatic Encephalopathy, Face Oedema, Metabolic Disorder, White Blood Cell Count Increased, Back Pain, Blood Alkaline Phosphatase Increased, Pneumonia, Blood Lactate Dehydrogenase Increased, Anaemia, Pancytopenia, Blood Beta-D-Glucan Increased, Cholelithiasis, Respiratory Rate Decreased, Cachexia, Osteonecrosis, Aspartate Aminotransferase Increased, Depressed Level of Consciousness, Platelet Count Decreased, Leukaemic Infiltration Hepatic, Jaundice, Hepatic Function Abnormal, Haemorrhage, Oedema, Mass, Alanine Aminotransferase Increased, Bone Marrow Leukaemic Cell Infiltration, Chronic Myeloid Leukaemia, Haemosiderosis, Ammonia Increased, Aspergillosis, Bradycardia, Altered State of Consciousness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Neoral
    Dosage: 200 mg, daily (4 mg/kg/day)
    Administration route: Oral
    Indication: Aplasia Pure RED Cell

Meropenem
    Dosage: 2 g, daily
    Indication: Pneumonia

Cytarabine
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Neoplasm

Other drugs received by patient: Livact; Albumin NOS; Hydrea; Amino Acid INJ; Cytotec; Levothyroxine Sodium; Blood and Related Products



Possible Neoral side effects in 76 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-16

Patient: 76 year old male, weighing 64.0 kg (140.8 pounds)

Reactions: Liver Injury, Eyelid Oedema, Intestinal Ulcer, Hypoglycaemia, Blood Albumin Decreased, Face Oedema, Hepatic Encephalopathy, Metabolic Disorder, White Blood Cell Count Increased, Blood Alkaline Phosphatase Increased, Back Pain, Pneumonia, Anaemia, Blood Lactate Dehydrogenase Increased, Pancytopenia, Blood Beta-D-Glucan Increased, Cachexia, Respiratory Rate Decreased, Cholelithiasis, Osteonecrosis, Aspartate Aminotransferase Increased, Depressed Level of Consciousness, Platelet Count Decreased, Leukaemic Infiltration Hepatic, Jaundice, Hepatic Function Abnormal, Haemorrhage, Oedema, Mass, Alanine Aminotransferase Increased, Bone Marrow Leukaemic Cell Infiltration, Chronic Myeloid Leukaemia, Haemosiderosis, Ammonia Increased, Aspergillosis, Bradycardia, Altered State of Consciousness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Neoral
    Dosage: 200 mg, daily (4 mg/kg/day)
    Administration route: Oral
    Indication: Aplasia Pure RED Cell

Starasid
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Neoplasm

Meropenem
    Dosage: 2 g, daily
    Indication: Pneumonia

Other drugs received by patient: Livact; Blood and Related Products; Cytotec; Levothyroxine Sodium; Amino Acid INJ; Hydrea; Albumin NOS

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