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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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