Simulect and cytomegalovirus infection Patient Reports February 12, 2012

Simulect Side Effects Report #5133558-8
Simulect side effect was reported by a Physician from JAPAN on Apr 11, 2006. Male patient, 44 years of age, weighting 183.0 lb, was diagnosed with renal transplant, hypertension, kidney transplant rejection and was treated with Simulect. After drug was administered, patient experienced the following side effects: blood creatinine increased, cytomegalovirus infection , decreased appetite, kidney transplant rejection, pyrexia. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PREDONINE, ADALAT, NORVASC. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #4980235-X
Simulect side effect was reported by a Physician from JAPAN on Apr 11, 2006. Male patient, 44 years of age, weighting 183.0 lb, was diagnosed with renal transplant, hypertension, kidney transplant rejection and was treated with Simulect. After drug was administered, patient experienced the following side effects: blood creatinine increased, cytomegalovirus infection , decreased appetite, kidney transplant rejection, pyrexia. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PREDONINE, ADALAT, NORVASC. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #4828759-X
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on Nov 02, 2005. Female patient, 43 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , epstein-barr virus infection, kidney transplant rejection, nephritis interstitial. Simulect dosage: unknown. During the same period patient was treated with TACROLIMUS, CELLCEPT, METHYLPREDNISOLONE. Patient recovered.

Simulect Side Effects Report #4835126-1
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on Nov 02, 2005. Female patient, 43 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , epstein-barr virus infection, haematuria, haemodialysis, hydronephrosis, infectious mononucleosis , kidney enlargement, kidney transplant rejection, nephritis interstitial. Simulect dosage: unknown. During the same period patient was treated with TACROLIMUS, CELLCEPT, METHYLPREDNISOLONE. Patient was hospitalized. Patient recovered.


Simulect Side Effects Report #5284276-7
Simulect side effect was reported by a Physician from JAPAN on Mar 22, 2007. Male patient, 40 years of age, weighting 127.9 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , urinary retention, urinary tract obstruction, urine output decreased. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with NEORAL, MIZORIBINE, PREDNISOLONE, SANDIMMUNE, PREDONINE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5078998-0
Simulect side effect was reported by a Physician from JAPAN on Apr 25, 2006. Female patient, 40 years of age, weighting 143.3 lb, was diagnosed with renal transplant, pneumonia , cholelithiasis, hypertension and was treated with Simulect. After drug was administered, patient experienced the following side effects: cholecystitis acute, cytomegalovirus infection , hepatitis c antibody positive, kidney transplant rejection, liver function test abnormal, suture related complication. Simulect dosage: 20 MG, DAY 0. During the same period patient was treated with CYCLOSPORINE, CELLCEPT, PREDNISOLONE, BACTRIM, BLOPRESS, BREDININ. Patient recovered.

Simulect Side Effects Report #5083266-7
Simulect side effect was reported by a Physician from JAPAN on Aug 09, 2006. Female patient, 31 years of age, weighting 132.3 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: anaemia, complement fixation abnormal, cytomegalovirus infection , duodenal ulcer haemorrhage, pyrexia, shock. Simulect dosage: unknown. During the same period patient was treated with CELLCEPT, PREDONINE, SANDIMMUNE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5096215-2
Simulect side effect was reported by a Physician from JAPAN on Aug 09, 2006. Female patient, 31 years of age, weighting 132.3 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: anaemia, complement fixation abnormal, cytomegalovirus antigen positive, cytomegalovirus infection , diarrhoea, dizziness , duodenal ulcer haemorrhage, haemoglobin decreased, malaise. Simulect dosage: unknown. During the same period patient was treated with CELLCEPT, PREDONINE, SANDIMMUNE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #4566448-X
Simulect side effect was reported by a Consumer or non-health professional from on Sept 07, 2004. Male patient, 28 years of age, weighting 132.3 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , dyspnoea, henoch-schonlein purpura, interstitial lung disease. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with TACROLIMUS, MIZORIBINE. Patient was hospitalized. Patient recovered.


Simulect Side Effects Report #4575038-4
Simulect side effect was reported by a Consumer or non-health professional from on Sept 07, 2004. Male patient, 28 years of age, weighting 132.3 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , dyspnoea, interstitial lung disease. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with TACROLIMUS, MIZORIBINE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #4634306-8
Simulect side effect was reported by a Consumer or non-health professional from on Sept 07, 2004. Male patient, 28 years of age, weighting 132.3 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , dyspnoea, interstitial lung disease, liver disorder, transaminases increased, weight increased. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with TACROLIMUS, MIZORIBINE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #4682113-2
Simulect side effect was reported by a Health Professional from on Sept 07, 2004. Male patient, 28 years of age, weighting 132.3 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , dyspnoea, henoch-schonlein purpura, interstitial lung disease, liver disorder, po2 decreased, renal disorder, transaminases increased, weight increased. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with TACROLIMUS, MIZORIBINE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #4689794-8
Simulect side effect was reported by a Health Professional from on Sept 07, 2004. Male patient, 28 years of age, weighting 132.3 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: anoxia, cardiac failure congestive, cytomegalovirus infection , dehydration, dyspnoea, henoch-schonlein purpura, hepatic congestion, interstitial lung disease, liver function test abnormal. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with TACROLIMUS, MIZORIBINE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5190359-2
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on Nov 29, 2006. Male patient, child 11 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , laparotomy, mechanical ileus. Simulect dosage: unknown. During the same period patient was treated with TACROLIMUS, ENDOXAN, PREDNISOLONE, MYCOPHENOLATE MOFETIL. Patient recovered.


Simulect Side Effects Report #5376850-4
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on June 27, 2007. Male patient, child 11 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , laparotomy, mechanical ileus. Simulect dosage: unknown. During the same period patient was treated with TACROLIMUS, CYCLOPHOSPHAMIDE, PREDNISOLONE, MYCOPHENOLATE MOFETIL. Patient recovered.

Simulect Side Effects Report #5378896-9
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on July 03, 2007. Male patient, child 11 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: abdominal pain , cytomegalovirus infection , laparotomy, mechanical ileus, vomiting. Simulect dosage: unknown. During the same period patient was treated with TACROLIMUS, CYCLOPHOSPHAMIDE, PREDNISOLONE, MYCOPHENOLATE MOFETIL. Patient recovered.

Simulect Side Effects Report #5566157-4
Simulect side effect was reported by a Pharmacist from JAPAN on Dec 12, 2007. Female patient was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, cytomegalovirus infection , hepatic function abnormal. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with SANDIMMUNE, PANSPORIN, GANCICLOVIR. Patient recovered.

Simulect Side Effects Report #5780232-0
Simulect side effect was reported by a Physician from JAPAN on June 11, 2008. Female patient was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , hyperlipidaemia, low density lipoprotein increased. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with NEORAL, CELLCEPT, SANDIMMUNE, PREDONINE, ASPIRIN. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5967626-5
Simulect side effect was reported by a Physician from JAPAN on Nov 14, 2008. Female patient was diagnosed with renal transplant, thrombosis prophylaxis and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , hypercholesterolaemia, low density lipoprotein increased. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with NEORAL, CELLCEPT, SANDIMMUNE, PREDONINE, ASPIRIN. Patient was hospitalized. Patient recovered.


Simulect Side Effects Report #6126703-9
Simulect side effect was reported by a Physician from JAPAN on Mar 17, 2009. Female patient, weighting 46.30 lb, was diagnosed with renal transplant, infection  and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , multi-organ failure, sepsis . Simulect dosage: 10 MG. During the same period patient was treated with PROGRAF, CELLCEPT, VICCILLIN, CEFOTAXIME, MEROPEN. Patient died on 06/27/2007.

Simulect Side Effects Report #6130266-1
Simulect side effect was reported by a Physician from JAPAN on Mar 17, 2009. Female patient was diagnosed with renal transplant, hypertension and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , gastritis haemorrhagic, hypertension. Simulect dosage: 20 MG/DAY. During the same period patient was treated with SANDIMMUNE, NEORAL, MEDROL, CELLCEPT, NORVASC, SEPAMIT. Patient recovered.

Simulect Side Effects Report #6133385-9
Simulect side effect was reported by a Physician from JAPAN on Mar 17, 2009. Male patient, weighting 22.05 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: chronic allograft nephropathy, cytomegalovirus infection , pyelonephritis. Simulect dosage: 10 MG. During the same period patient was treated with BREDININ, MEDROL, PROGRAF, CELLCEPT, DENOSINE, MODACIN. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5167895-8
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on Nov 29, 2006. Male patient, child 11 years of age, was diagnosed with focal glomerulosclerosis and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , mechanical ileus. Simulect dosage: unknown. During the same period patient was treated with TACROLIMUS, CYCLOPHOSPHAMIDE, PREDNISOLONE, MYCOPHENOLATE MOFETIL. Patient recovered.

Simulect Side Effects Report #5187942-7
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on Nov 29, 2006. Male patient, child 11 years of age, was diagnosed with focal glomerulosclerosis and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , laparotomy, mechanical ileus. Simulect dosage: unknown. During the same period patient was treated with TACROLIMUS, CYCLOPHOSPHAMIDE, PREDNISOLONE, MYCOPHENOLATE MOFETIL. Patient recovered.