SIMULECT Side Effects

6664408-6 | Tachyarrhythmia, Tachycardia
on Mar 29, 2010 Female patient from GERMANY , weighting 144.4 lb, was diagnosed with renal transplant, prophylaxis and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: tachyarrhythmia, tachycardia. Simulect dosage: 20 Mg. During the same period patient was treated with MYFORTIC (1440 Mg) (View Myfortic Review and Myfortic Label ), SANDIMMUNE (200 Mg) (View Sandimmune Review and Sandimmune Label ), NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), DECORTIN (30 Mg, 1xdaily) (View Decortin Review and Decortin Label ), TAMBOCOR (200 Mg/day) (View Tambocor Review and Tambocor Label ). Patient was hospitalized.

6663222-5 | Cardiac Disorder, Cardiac Failure, Complications Of Transplanted Liver, Liver Transplant
Patient was taking Simulect (View Usage). Patient had the following side effects: cardiac disorder, cardiac failure, complications of transplanted liver, liver transplant (What is liver transplant?) on Mar 25, 2010 from GERMANY Additional patient health information: Male patient , weighting 165.3 lb, was diagnosed with liver transplant (What is liver transplant?), immunosuppression, prophylaxis and. Simulect dosage: 20 Mg, Unk. During the same period patient was treated with CERTICAN (1.5 Mg Per Day) (View Certican Review and Certican Label ), COTRIM (960 Mg Per Day) (View Cotrim Review and Cotrim Label ), CELLCEPT (2000 Mg Per Day) (View Cellcept Review and Cellcept Label ). Patient was hospitalized.

6658786-1 | Ascites, Endotracheal Intubation, Enterobacter Sepsis, Enterococcal Infection, Enterococcal Sepsis, Graft Haemorrhage, Graft Loss, Pneumonia, Portal Shunt
Adverse event was reported on Mar 26, 2010 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg/day) was diagnosed with liver transplant (What is liver transplant?) and. Location: GERMANY , weighting 198.4 lb, After Simulect was administered, patient had the following side effects: ascites, endotracheal intubation, enterobacter sepsis, enterococcal infection, enterococcal sepsis, graft haemorrhage, graft loss, pneumonia (What is pneumonia?), portal shunt. During the same period patient was treated with CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), CERTICAN (View Certican Review and Certican Label ). Patient was hospitalized.

6643180-X | Pancytopenia
on Mar 11, 2010 Male patient from GERMANY , weighting 161.4 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: pancytopenia. Simulect dosage: Unk. During the same period patient was treated with MYFORTIC (1080 Mg, Bid) (View Myfortic Review and Myfortic Label ), SANDIMMUNE (125 Mg 2 X 1) (View Sandimmune Review and Sandimmune Label ). Patient was hospitalized.


6609855-3 | Cytomegalovirus Infection, Diabetes Mellitus, Iga Nephropathy, Renal Impairment, Renal Tubular Disorder, Tubulointerstitial Nephritis, Urinary Tract Infection, Viral Haemorrhagic Cystitis
on Feb 19, 2010 Male patient from JAPAN , 60 years of age, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient had the following side effects: cytomegalovirus infection (What is cytomegalovirus infection?), diabetes mellitus, iga nephropathy, renal impairment, renal tubular disorder, tubulointerstitial nephritis, urinary tract infection (What is urinary tract infection?), viral haemorrhagic cystitis. Simulect dosage: . During the same period patient was treated with TACROLIMUS (1.5 Mg Per Day) (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (1.25 Mg Per Day) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), RITUXIMAB (View Rituximab Review and Rituximab Label ).

6599239-9 | Arterial Disorder, Blood Creatinine Increased, Complications Of Transplanted Kidney, Focal Segmental Glomerulosclerosis, Iga Nephropathy, Renal Tubular Necrosis
Patient was taking Simulect (View Usage). After Simulect was administered, patient had the following side effects: arterial disorder, blood creatinine increased, complications of transplanted kidney, focal segmental glomerulosclerosis, iga nephropathy, renal tubular necrosis on Feb 16, 2010 from JAPAN Additional patient health information: Female patient , weighting 127.9 lb, was diagnosed with renal transplant and. Simulect dosage: 20 Mg. During the same period patient was treated with NEORAL (400 Mg Per Day) (View Neoral Review and Neoral Label ), SANDIMMUNE (115 Mg Per Day) (View Sandimmune Review and Sandimmune Label ), PROGRAF (1.8 Mg Per Day) (View Prograf Review and Prograf Label ), SOLU MEDROL (250 Mg Per Day) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (125 Mg Per Day) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (62.5 Mg Per Day) (View Solu-medrol Review and Solu-medrol Label ).

6591245-3 | Abdominal Pain Upper, Chronic Allograft Nephropathy, Cytomegalovirus Gastritis, Cytomegalovirus Infection, Diarrhoea, Duodenal Ulcer, Gastrointestinal Hypermotility, Kidney Transplant Rejection, Nephritis
Adverse event was reported on Feb 15, 2010 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg, Unk) was diagnosed with renal transplant and. Location: JAPAN , weighting 132.3 lb, Patient experienced the following unwanted or unexpected effects: abdominal pain upper, chronic allograft nephropathy, cytomegalovirus gastritis, cytomegalovirus infection (What is cytomegalovirus infection?), diarrhoea, duodenal ulcer, gastrointestinal hypermotility, kidney transplant rejection, nephritis. During the same period patient was treated with TACROLIMUS (10 Mg, Unk) (View Tacrolimus Review and Tacrolimus Label ), CELLCEPT (2000 Mg, Unk) (View Cellcept Review and Cellcept Label ), MEDROL (16 Mg, Unk) (View Medrol Review and Medrol Label ), SOLU MEDROL (Unk) (View Solu-medrol Review and Solu-medrol Label ). Patient was hospitalized.

6584704-0 | Cytomegalovirus Infection, Duodenal Ulcer Haemorrhage, Haemodialysis, Renal Failure Acute, Renal Tubular Disorder
on Feb 05, 2010 Female patient from JAPAN , 48 years of age, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient had the following side effects: cytomegalovirus infection (What is cytomegalovirus infection?), duodenal ulcer haemorrhage, haemodialysis, renal failure acute, renal tubular disorder. Simulect dosage: 20 Mg. During the same period patient was treated with PROGRAF (View Prograf Review and Prograf Label ), CELLCEPT (View Cellcept Review and Cellcept Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), ADRENOCORTICOTROPHIC HORMONE (View Adrenocorticotrophic Hormone Review and Adrenocorticotrophic Hormone Label ).

6569908-5 | Bradycardia, Catheterisation Cardiac, Coronary Artery Bypass, Endotracheal Intubation, Myocardial Infarction, Non-cardiogenic Pulmonary Oedema, Pyrexia
on Jan 29, 2010 Male patient from UNITED STATES , 41 years of age, was diagnosed with immunosuppression and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: bradycardia, catheterisation cardiac, coronary artery bypass (What is coronary artery bypass?), endotracheal intubation, myocardial infarction, non-cardiogenic pulmonary oedema, pyrexia. Simulect dosage: 20 Mg, Once/single. Patient was hospitalized.

6543977-0 | Cytomegalovirus Infection, Duodenal Ulcer Haemorrhage, Haemodialysis, Renal Failure Acute, Renal Tubular Disorder
Patient was taking Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: cytomegalovirus infection (What is cytomegalovirus infection?), duodenal ulcer haemorrhage, haemodialysis, renal failure acute, renal tubular disorder on Jan 08, 2010 from JAPAN Additional patient health information: Female patient , 47 years of age, was diagnosed with renal transplant and. Simulect dosage: . During the same period patient was treated with ADRENOCORTICOTROPHIC HORMONE (View Adrenocorticotrophic Hormone Review and Adrenocorticotrophic Hormone Label ), PROGRAF (View Prograf Review and Prograf Label ), CELLCEPT (View Cellcept Review and Cellcept Label ).

6525960-4 | Cytomegalovirus Infection, Hypercalcaemia, Nephrolithiasis
Adverse event was reported on Dec 25, 2009 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg) was diagnosed with renal transplant and. Location: JAPAN , 44 years of age, Patient had the following side effects: cytomegalovirus infection (What is cytomegalovirus infection?), hypercalcaemia, nephrolithiasis. During the same period patient was treated with PROGRAF (Unk) (View Prograf Review and Prograf Label ), CELLCEPT (Unk) (View Cellcept Review and Cellcept Label ), METHYLPREDNISOLONE SODIUM SUCCINATE (View Methylprednisolone Sodium Succinate Review and Methylprednisolone Sodium Succinate Label ).

6524040-1 | Cytomegalovirus Infection, Duodenal Ulcer, Renal Failure Acute, Renal Tubular Disorder
on Dec 22, 2009 Female patient from JAPAN , 47 years of age, was diagnosed with renal transplant and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: cytomegalovirus infection (What is cytomegalovirus infection?), duodenal ulcer, renal failure acute, renal tubular disorder. Simulect dosage: . During the same period patient was treated with ADRENOCORTICOTROPHIC HORMONE (View Adrenocorticotrophic Hormone Review and Adrenocorticotrophic Hormone Label ), PROGRAF (View Prograf Review and Prograf Label ), CELLCEPT (View Cellcept Review and Cellcept Label ).

6509956-4 | Chronic Allograft Nephropathy, Cytomegalovirus Infection, Pyelonephritis
on Dec 16, 2009 Male patient from JAPAN , weighting 22.05 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: chronic allograft nephropathy, cytomegalovirus infection (What is cytomegalovirus infection?), pyelonephritis. Simulect dosage: 10 Mg. During the same period patient was treated with BREDININ (80 Mg) (View Bredinin Review and Bredinin Label ), MEDROL (12 Mg) (View Medrol Review and Medrol Label ), PROGRAF (0.5 Mg) (View Prograf Review and Prograf Label ), CELLCEPT (600 Mg) (View Cellcept Review and Cellcept Label ), DENOSINE (100 Mg) (View Denosine Review and Denosine Label ), MODACIN (1200 Mg) (View Modacin Review and Modacin Label ). Patient was hospitalized.

6509929-1 | Cytomegalovirus Infection, Hypercalcaemia, Nephrolithiasis
Patient was taking Simulect (View Usage). Patient had the following side effects: cytomegalovirus infection (What is cytomegalovirus infection?), hypercalcaemia, nephrolithiasis on Dec 11, 2009 from JAPAN Additional patient health information: Male patient , 44 years of age, was diagnosed with renal transplant and. Simulect dosage: . During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), METHYLPREDNISOLONE SODIUM SUCCINATE (View Methylprednisolone Sodium Succinate Review and Methylprednisolone Sodium Succinate Label ).

6498030-1 | Concomitant Disease Progression, Diarrhoea, Kidney Transplant Rejection, Leukopenia
Adverse event was reported on Dec 04, 2009 by a Female patient taking Simulect (View Usage) (Dosage: Unk) was diagnosed with renal transplant and. Location: GERMANY , weighting 370.4 lb, After Simulect was administered, patient had the following side effects: concomitant disease progression, diarrhoea, kidney transplant rejection, leukopenia. During the same period patient was treated with CERTICAN (Unk) (View Certican Review and Certican Label ), MYFORTIC (View Myfortic Review and Myfortic Label ). Patient was hospitalized.

6486837-6 | Pneumonia, Sepsis
on Dec 07, 2009 Male patient from JAPAN , weighting 105.8 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: pneumonia (What is pneumonia?), sepsis (What is sepsis?). Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with NEORAL (300 Mg/day) (View Neoral Review and Neoral Label ), PREDONINE (30 Mg, Qd) (View Predonine Review and Predonine Label ), CELLCEPT (1500 Mg/day) (View Cellcept Review and Cellcept Label ). Patient was hospitalized.

6486830-3 | Pneumonia, Sepsis
on Dec 07, 2009 Male patient from JAPAN , weighting 105.8 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient had the following side effects: pneumonia (What is pneumonia?), sepsis (What is sepsis?). Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with NEORAL (300 Mg/day) (View Neoral Review and Neoral Label ), PREDONINE (30 Mg, Qd) (View Predonine Review and Predonine Label ), CELLCEPT (1500 Mg/day) (View Cellcept Review and Cellcept Label ). Patient was hospitalized.

6475924-4 | Acute Respiratory Distress Syndrome, Dialysis, Mechanical Ventilation, Polyuria, Pulmonary Oedema
Patient was taking Simulect (View Usage). After Simulect was administered, patient had the following side effects: acute respiratory distress syndrome, dialysis (What is dialysis?), mechanical ventilation, polyuria, pulmonary oedema on Nov 26, 2009 from KUWAIT Additional patient health information: Female patient , 48 years of age, was diagnosed with renal transplant and. Simulect dosage: . During the same period patient was treated with MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), STEROIDS (View Steroids Review and Steroids Label ). Patient was hospitalized.

6454409-5 | Cytomegalovirus Infection, Kidney Transplant Rejection, Polyomavirus-associated Nephropathy, Tubulointerstitial Nephritis
Adverse event was reported on Nov 12, 2009 by a Male patient taking Simulect (View Usage) (Dosage: Unk) was diagnosed with renal transplant and. Location: JAPAN , 61 years of age, Patient experienced the following unwanted or unexpected effects: cytomegalovirus infection (What is cytomegalovirus infection?), kidney transplant rejection, polyomavirus-associated nephropathy, tubulointerstitial nephritis. During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ).

6443004-X | Tubulointerstitial Nephritis
on Nov 04, 2009 Male patient from JAPAN , 61 years of age, was treated with Simulect (View Usage). Patient had the following side effects: tubulointerstitial nephritis. Simulect dosage: Unk.

6440636-X | Acute Respiratory Distress Syndrome, Angiopathy, C-reactive Protein Increased, Dialysis, Mechanical Ventilation, Non-cardiogenic Pulmonary Oedema, Pyrexia, Renal Failure, Renal Tubular Necrosis
on Nov 02, 2009 Male patient from IRELAND , child 11 years of age, was diagnosed with renal transplant and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: acute respiratory distress syndrome, angiopathy, c-reactive protein increased, dialysis (What is dialysis?), mechanical ventilation, non-cardiogenic pulmonary oedema, pyrexia, renal failure, renal tubular necrosis. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with CELLCEPT (250 Mg, Bid) (View Cellcept Review and Cellcept Label ), PROGRAF (View Prograf Review and Prograf Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), STEROIDS NOS (View Steroids Nos Review and Steroids Nos Label ), AZATHIOPRINE (View Azathioprine Review and Azathioprine Label ), RANITIDINE (View Ranitidine Review and Ranitidine Label ), ANTIBIOTICS (View Antibiotics Review and Antibiotics Label ). Patient was hospitalized.

6440631-0 | Acute Respiratory Distress Syndrome, C-reactive Protein Increased, Mechanical Ventilation, Non-cardiogenic Pulmonary Oedema, Respiratory Failure
Patient was taking Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: acute respiratory distress syndrome, c-reactive protein increased, mechanical ventilation, non-cardiogenic pulmonary oedema, respiratory failure on Nov 02, 2009 from IRELAND Additional patient health information: Male patient , child 6 years of age, was diagnosed with renal transplant and. Simulect dosage: 10 Mg, Once/single. During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), RANITIDINE (View Ranitidine Review and Ranitidine Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), STEROIDS NOS (View Steroids Nos Review and Steroids Nos Label ), GANCICLOVIR (View Ganciclovir Review and Ganciclovir Label ), AMOXICILLIN AND CLAVULANATE POTASSIUM (View Amoxicillin And Clavulanate Potassium Review and Amoxicillin And Clavulanate Potassium Label ), FRUSEMIDE (2 Mg/kg Per Dose) (View Frusemide Review and Frusemide Label ). Patient was hospitalized.

6415336-2 | Acute Graft Versus Host Disease In Skin, Anuria, Bone Marrow Failure, Coagulopathy, Genital Lesion, Hypertension, Hypothermia, Lung Infection, Multi-organ Failure
Adverse event was reported on Oct 23, 2009 by a Male patient taking Simulect (View Usage) (Dosage: 60 Mg, Divided In 3 Doses) was diagnosed with acute graft versus host disease, hypertension, lung infection, convulsion prophylaxis and. Location: SPAIN , 15 years of age, Patient had the following side effects: acute graft versus host disease in skin, anuria, bone marrow failure, coagulopathy, genital lesion, hypertension, hypothermia (What is hypothermia?), lung infection, multi-organ failure. During the same period patient was treated with ADALAT (30 Mg, Qd) (View Adalat Review and Adalat Label ), CEFEPIME (2 G, Bid) (View Cefepime Review and Cefepime Label ), CANCIDAS (50 Mg, Qd) (View Cancidas Review and Cancidas Label ), KEPPRA (1 G, Bid) (View Keppra Review and Keppra Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), CORTICOSTEROIDS (View Corticosteroids Review and Corticosteroids Label ). Patient was hospitalized.

6408343-7 | Blood Creatinine Increased, Diarrhoea, Haemolytic Uraemic Syndrome, Microangiopathy, Thrombosis
on Oct 12, 2009 Male patient from GERMANY , weighting 125.9 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: blood creatinine increased, diarrhoea, haemolytic uraemic syndrome, microangiopathy, thrombosis. Simulect dosage: . During the same period patient was treated with CYCLOSPORINE (125 Mg, Bid) (View Cyclosporine Review and Cyclosporine Label ), MYFORTIC (1080 Mg, Bid) (View Myfortic Review and Myfortic Label ). Patient was hospitalized.

6395183-0 | Asthenia, Bladder Catheterisation, Chest Discomfort, Chronic Allograft Nephropathy, Cytomegalovirus Viraemia, Dialysis, Hydronephrosis, Hyperkalaemia, Kidney Transplant Rejection
on Oct 01, 2009 Female patient from JAPAN , weighting 145.5 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: asthenia, bladder catheterisation, chest discomfort, chronic allograft nephropathy, cytomegalovirus viraemia, dialysis (What is dialysis?), hydronephrosis, hyperkalaemia, kidney transplant rejection. Simulect dosage: 20 Mg, Unk. During the same period patient was treated with NEORAL (280 Mg Daily) (View Neoral Review and Neoral Label ), PREDONINE (50 Mg Daily) (View Predonine Review and Predonine Label ), BREDININ (150 Mg Daily) (View Bredinin Review and Bredinin Label ), SANDIMMUNE (60 Mg, Unk) (View Sandimmune Review and Sandimmune Label ), SOLU MEDROL (625 Mg, Unk) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (250 Mg, Unk) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (125 Mg, Unk) (View Solu-medrol Review and Solu-medrol Label ). Patient was hospitalized.

6389320-1 | Graft Loss, Pneumocystis Jiroveci Pneumonia, Pyrexia, Renal Failure
Patient was taking Simulect (View Usage). Patient had the following side effects: graft loss, pneumocystis jiroveci pneumonia, pyrexia, renal failure on Oct 01, 2009 from JAPAN Additional patient health information: Male patient , weighting 130.1 lb, was diagnosed with renal transplant and. Simulect dosage: 20 Mg. During the same period patient was treated with NEORAL (200 Mg) (View Neoral Review and Neoral Label ), CELLCEPT (1500 Mg) (View Cellcept Review and Cellcept Label ), PREDONINE (50 Mg) (View Predonine Review and Predonine Label ), SANDIMMUNE (60 Mg) (View Sandimmune Review and Sandimmune Label ), SOLU MEDROL (625 G) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (250 G) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (125 G) (View Solu-medrol Review and Solu-medrol Label ).

6338096-2 | Abdominal Pain Upper, Cytomegalovirus Hepatitis, Hepatic Function Abnormal, Pancytopenia, Pneumocystis Jiroveci Pneumonia, Productive Cough, Respiratory Distress
Adverse event was reported on Aug 27, 2009 by a Female patient taking Simulect (View Usage) (Dosage: 20 Mg, Once/single) was diagnosed with renal transplant, pneumocystis jiroveci pneumonia and. Location: JAPAN , weighting 103.6 lb, After Simulect was administered, patient had the following side effects: abdominal pain upper, cytomegalovirus hepatitis, hepatic function abnormal, pancytopenia, pneumocystis jiroveci pneumonia, productive cough, respiratory distress. During the same period patient was treated with NEORAL (200 Mg/day) (View Neoral Review and Neoral Label ), CELLCEPT (1500 Mg/day) (View Cellcept Review and Cellcept Label ), PREDONINE (50 Mg/day) (View Predonine Review and Predonine Label ), BAKTAR (View Baktar Review and Baktar Label ), SANDIMMUNE (48 Mg) (View Sandimmune Review and Sandimmune Label ), SOLU MEDROL (625 Mg) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (250 Mg) (View Solu-medrol Review and Solu-medrol Label ). Patient was hospitalized.

6335656-X | Acute Graft Versus Host Disease In Skin, Anuria, Bone Marrow Failure, Coagulopathy, Genital Lesion, Hypertension, Hypothermia, Lung Infection, Multi-organ Failure
on Aug 28, 2009 Male patient from SPAIN , 15 years of age, was diagnosed with acute graft versus host disease, hypertension, lung infection, convulsion prophylaxis and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: acute graft versus host disease in skin, anuria, bone marrow failure, coagulopathy, genital lesion, hypertension, hypothermia (What is hypothermia?), lung infection, multi-organ failure. Simulect dosage: 60 Mg, Divided In 3 Doses. During the same period patient was treated with ADALAT (30 Mg, Qd) (View Adalat Review and Adalat Label ), CEFEPIME (2 G, Bid) (View Cefepime Review and Cefepime Label ), CANCIDAS (50 Mg, Qd) (View Cancidas Review and Cancidas Label ), KEPRA (1 G, Bid) (View Kepra Review and Kepra Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), CORTICOSTEROIDS (View Corticosteroids Review and Corticosteroids Label ). Patient was hospitalized.

6334774-X | Graft Loss, Pneumocystis Jiroveci Pneumonia, Pyrexia, Renal Failure
on Aug 27, 2009 Male patient from JAPAN , weighting 130.1 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient had the following side effects: graft loss, pneumocystis jiroveci pneumonia, pyrexia, renal failure. Simulect dosage: 20 Mg. During the same period patient was treated with NEORAL (200 Mg) (View Neoral Review and Neoral Label ), CELLCEPT (1500 Mg) (View Cellcept Review and Cellcept Label ), PREDONINE (50 Mg) (View Predonine Review and Predonine Label ), SANDIMMUNE (60 Mg) (View Sandimmune Review and Sandimmune Label ), SOLU MEDROL (625 G) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (250 G) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (125 G) (View Solu-medrol Review and Solu-medrol Label ).

6327529-3 | Biopsy Kidney Abnormal, Bk Virus Infection, Blood Creatinine Increased, Jc Virus Infection, Renal Tubular Atrophy, Urine Analysis Abnormal
Patient was taking Simulect (View Usage). After Simulect was administered, patient had the following side effects: biopsy kidney abnormal, bk virus infection, blood creatinine increased, jc virus infection, renal tubular atrophy, urine analysis abnormal on Aug 18, 2009 from JAPAN Additional patient health information: Male patient , 32 years of age, was diagnosed with renal transplant and. Simulect dosage: 20 Mg/day. During the same period patient was treated with NEORAL (275 Mg/day) (View Neoral Review and Neoral Label ).

6326128-7 | C-reactive Protein Increased, Ileus, Intestinal Obstruction
Adverse event was reported on Aug 18, 2009 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg, Once/single) was diagnosed with renal transplant and. Location: JAPAN , weighting 132.3 lb, Patient experienced the following unwanted or unexpected effects: c-reactive protein increased, ileus, intestinal obstruction. During the same period patient was treated with SANDIMMUNE (140 Mg) (View Sandimmune Review and Sandimmune Label ), NEORAL (350 Mg) (View Neoral Review and Neoral Label ), SOLU MEDROL (500 Mg) (View Solu-medrol Review and Solu-medrol Label ), CELLCEPT (2000 Mg) (View Cellcept Review and Cellcept Label ). Patient was hospitalized.

6312332-0 | Arterial Disorder, Blood Creatinine Increased, Complications Of Transplanted Kidney, Focal Segmental Glomerulosclerosis, Renal Tubular Necrosis
on Aug 07, 2009 Female patient from JAPAN , weighting 127.9 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient had the following side effects: arterial disorder, blood creatinine increased, complications of transplanted kidney, focal segmental glomerulosclerosis, renal tubular necrosis. Simulect dosage: 20 Mg. During the same period patient was treated with NEORAL (400 Mg Per Day) (View Neoral Review and Neoral Label ), SANDIMMUNE (115 Mg Per Day) (View Sandimmune Review and Sandimmune Label ), PROGRAF (1.8 Mg Per Day) (View Prograf Review and Prograf Label ), SOLU MEDROL (250 Mg Per Day) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (125 Mg Per Day) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (62.5 Mg Per Day) (View Solu-medrol Review and Solu-medrol Label ).

6297385-0 | Abscess Drainage, Blood Urea Increased, Concomitant Disease Aggravated, Hepatic Cirrhosis, Pelvic Abscess
on Jul 30, 2009 Male patient from JAPAN , weighting 116.8 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: abscess drainage, blood urea increased, concomitant disease aggravated, hepatic cirrhosis, pelvic abscess. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with PROGRAF (2.5 Mg) (View Prograf Review and Prograf Label ), CELLCEPT (1 G/day) (View Cellcept Review and Cellcept Label ), MEDROL (40 Mg/day) (View Medrol Review and Medrol Label ), SOLU MEDROL (500 Mg) (View Solu-medrol Review and Solu-medrol Label ). Patient was hospitalized.

6294845-3 | Cytomegalovirus Antigen Positive, Cytomegalovirus Viraemia, Diverticular Perforation, Peritonitis, Surgery
Patient was taking Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: cytomegalovirus antigen positive, cytomegalovirus viraemia, diverticular perforation, peritonitis, surgery (What is surgery?) on Jul 24, 2009 from JAPAN Additional patient health information: Male patient , weighting 99.21 lb, was diagnosed with renal transplant and. Simulect dosage: 20 Mg Daily. During the same period patient was treated with PROGRAF (1.44 Mg Daily) (View Prograf Review and Prograf Label ), CELLCEPT (1000 Mg Daily) (View Cellcept Review and Cellcept Label ), PREDNISOLONE (50 Mg Dialy) (View Prednisolone Review and Prednisolone Label ), SOLU MEDROL (625 Mg) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (250 Mg) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (125 Mg) (View Solu-medrol Review and Solu-medrol Label ). Patient was hospitalized.

6267550-7 | Abscess Drainage, Arthritis Bacterial, Cerebral Infarction, Depressed Level Of Consciousness, Disseminated Intravascular Coagulation
Adverse event was reported on Jul 10, 2009 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg Daily) was diagnosed with renal transplant and. Location: JAPAN , weighting 94.80 lb, Patient had the following side effects: abscess drainage, arthritis bacterial, cerebral infarction, depressed level of consciousness, disseminated intravascular coagulation. During the same period patient was treated with SANDIMMUNE (Unk) (View Sandimmune Review and Sandimmune Label ), NEORAL (Unk) (View Neoral Review and Neoral Label ), PREDNISOLONE (Unk) (View Prednisolone Review and Prednisolone Label ), CELLCEPT (2000 Mg Daily) (View Cellcept Review and Cellcept Label ).

6257551-7 | Anaphylactic Shock
on Jun 25, 2009 Female patient from FRANCE , 17 years of age, was diagnosed with renal transplant and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: anaphylactic shock. Simulect dosage: 150 Mg, Unk. During the same period patient was treated with NEORAL (150 Mg, Unk) (View Neoral Review and Neoral Label ), CELLCEPT (150 Mg, Unk) (View Cellcept Review and Cellcept Label ).

6257368-3 | Acidosis, Blood Lactic Acid Increased, Cardiac Arrest, Hyperglycaemia, Shock
on Jul 01, 2009 Male patient from GERMANY , weighting 176.4 lb, was diagnosed with liver transplant (What is liver transplant?) and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: acidosis, blood lactic acid increased, cardiac arrest (What is cardiac arrest?), hyperglycaemia, shock. Simulect dosage: 20 Mg, Unk.

6257363-4 | Abdominal Pain, Anaemia, Disseminated Intravascular Coagulation, Gastrointestinal Necrosis, Renal Graft Loss, Urine Output Decreased
Patient was taking Simulect (View Usage). Patient had the following side effects: abdominal pain (What is abdominal pain?), anaemia, disseminated intravascular coagulation, gastrointestinal necrosis, renal graft loss, urine output decreased on Jul 02, 2009 from JAPAN Additional patient health information: Male patient , weighting 90.39 lb, was diagnosed with renal transplant and. Simulect dosage: 20 Mg. During the same period patient was treated with PROGRAF (Unk) (View Prograf Review and Prograf Label ), CELLCEPT (1500 Mg/day) (View Cellcept Review and Cellcept Label ), PREDNISOLONE (60 Mg/day) (View Prednisolone Review and Prednisolone Label ), FRESH FROZEN PLASMA (10 Iu, Unk) (View Fresh Frozen Plasma Review and Fresh Frozen Plasma Label ).

6250034-X | Hepatitis B, Pancytopenia
Adverse event was reported on Jun 19, 2009 by a Female patient taking Simulect (View Usage) (Dosage: 20 Mg/day) was diagnosed with renal transplant and. Location: JAPAN , 34 years of age, After Simulect was administered, patient had the following side effects: hepatitis b (What is hepatitis b?), pancytopenia. During the same period patient was treated with TACROLIMUS (8 Mg/day) (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (2000 Mg/day) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ). Patient was hospitalized.

6248286-5 | Anal Sphincter Atony, Bronchospasm, Cerebral Haematoma, Circulatory Collapse, Craniotomy, Hypercapnia, Hypertensive Crisis, Indifference, Neurological Symptom
on Jun 15, 2009 Female patient from MEXICO , 39 years of age, was diagnosed with renal transplant, immunosuppression and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: anal sphincter atony, bronchospasm, cerebral haematoma, circulatory collapse, craniotomy, hypercapnia, hypertensive crisis, indifference, neurological symptom. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with SOLU MEDROL (1 G) (View Solu-medrol Review and Solu-medrol Label ), CELLCEPT (1 G) (View Cellcept Review and Cellcept Label ), PROGRAF (View Prograf Review and Prograf Label ). Patient was hospitalized.

6243302-9 | Arrhythmia, Cardiac Arrest, Kidney Transplant Rejection
on Jun 18, 2009 Male patient from JAPAN , weighting 154.3 lb, was diagnosed with renal transplant, gastric ulcer, hypotension, hypothyroidism and was treated with Simulect (View Usage). Patient had the following side effects: arrhythmia (What is arrhythmia?), cardiac arrest (What is cardiac arrest?), kidney transplant rejection. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with NEORAL (250 Mg) (View Neoral Review and Neoral Label ), CELLCEPT (2000 Mg) (View Cellcept Review and Cellcept Label ), MEDROL (20 Mg) (View Medrol Review and Medrol Label ), TAKEPRON (30 Mg) (View Takepron Review and Takepron Label ), TANADOPA (2250 Mg) (View Tanadopa Review and Tanadopa Label ), ETILEFRINE HYDROCHLORIDE (6 Df) (View Etilefrine Hydrochloride Review and Etilefrine Hydrochloride Label ), THYRADIN S (75 Mg) (View Thyradin S Review and Thyradin S Label ).

6233213-7 | Acute Myocardial Infarction, Complications Of Transplanted Kidney, Fluid Overload, Hypoxia, Pulmonary Oedema, Respiratory Disorder
Patient was taking Simulect (View Usage). After Simulect was administered, patient had the following side effects: acute myocardial infarction, complications of transplanted kidney, fluid overload, hypoxia, pulmonary oedema, respiratory disorder on Jun 12, 2009 from UNITED STATES Additional patient health information: Male patient , weighting 172.0 lb, was diagnosed with renal transplant and. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), CELLCEPT (View Cellcept Review and Cellcept Label ), DILTIAZEM (View Diltiazem Review and Diltiazem Label ), BACTRIM (View Bactrim Review and Bactrim Label ), MYCELEX (View Mycelex Review and Mycelex Label ), METOPROLOL SUCCINATE (View Metoprolol Succinate Review and Metoprolol Succinate Label ), ZANTAC (View Zantac Review and Zantac Label ). Patient was hospitalized.

6230873-1 | Cytomegalovirus Infection, Kidney Transplant Rejection, Nephropathy
Adverse event was reported on Jun 04, 2009 by a Female patient taking Simulect (View Usage) (Dosage: 20 Mg/day) was diagnosed with renal transplant, prophylaxis against gastrointestinal ulcer, hyperglycaemia and. Location: JAPAN , weighting 127.9 lb, Patient experienced the following unwanted or unexpected effects: cytomegalovirus infection (What is cytomegalovirus infection?), kidney transplant rejection, nephropathy. During the same period patient was treated with BREDININ (500 Mg/day) (View Bredinin Review and Bredinin Label ), PROGRAF (8 Mg/day) (View Prograf Review and Prograf Label ), PREDNISOLONE (60 Mg/day) (View Prednisolone Review and Prednisolone Label ), CELLCEPT (1500 Mg, Unk) (View Cellcept Review and Cellcept Label ), PARIET (Unk) (View Pariet Review and Pariet Label ), BASEN (Unk) (View Basen Review and Basen Label ). Patient was hospitalized.

6228668-8 | Hyperamylasaemia
on Jun 04, 2009 Female patient from JAPAN , weighting 92.59 lb, was diagnosed with renal transplant, prophylaxis against gastrointestinal ulcer, hypertension and was treated with Simulect (View Usage). Patient had the following side effects: hyperamylasaemia. Simulect dosage: 20 Mg, Unk. During the same period patient was treated with NEORAL (300 Mg, Qd) (View Neoral Review and Neoral Label ), CELLCEPT (1500 Mg, Unk) (View Cellcept Review and Cellcept Label ), PREDNISOLONE (60 Mg,) (View Prednisolone Review and Prednisolone Label ), PARIET (1 Dose Daily) (View Pariet Review and Pariet Label ), MAINTATE (2.5 Mg, Unk) (View Maintate Review and Maintate Label ).

6207435-5 | Anuria, Dialysis, Hydronephrosis, Nephropathy Toxic, Nephrostomy, Renal Tubular Disorder, Ureteric Stenosis, Urine Output Decreased
on May 22, 2009 Female patient from JAPAN , weighting 147.7 lb, was diagnosed with renal transplant, prophylaxis and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: anuria, dialysis (What is dialysis?), hydronephrosis, nephropathy toxic, nephrostomy, renal tubular disorder, ureteric stenosis, urine output decreased. Simulect dosage: 20 Mg Daily. During the same period patient was treated with NEORAL (550 Mg/day, Then Tapered) (View Neoral Review and Neoral Label ), CELLCEPT (1500 Mg/day) (View Cellcept Review and Cellcept Label ), PROGRAF (10 Mg/day, Then Tapered) (View Prograf Review and Prograf Label ), PREDNISOLONE (50 Mg/day, Then Tapered) (View Prednisolone Review and Prednisolone Label ), CALONAL (4 Df In Total) (View Calonal Review and Calonal Label ), PARIET (1 Df, Unk) (View Pariet Review and Pariet Label ). Patient was hospitalized and became disabled.

6196971-6 | Anal Sphincter Atony, Bronchospasm, Cerebral Haematoma, Craniotomy, Hypercapnia, Hypertensive Crisis, Neurological Symptom, Oliguria, Renal Haematoma
Patient was taking Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: anal sphincter atony, bronchospasm, cerebral haematoma, craniotomy, hypercapnia, hypertensive crisis, neurological symptom, oliguria, renal haematoma on May 13, 2009 from MEXICO Additional patient health information: Female patient , 39 years of age, was diagnosed with renal transplant and. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with SOLU MEDROL (1 G/day) (View Solu-medrol Review and Solu-medrol Label ), CELLCEPT (1 G/day) (View Cellcept Review and Cellcept Label ). Patient was hospitalized.

6190471-5 | Blood Creatinine Increased, Cytomegalovirus Antigen Positive, Cytomegalovirus Infection, Diarrhoea, Gastroenteritis Staphylococcal, Histiocytosis Haematophagic, Immunodeficiency, Kidney Transplant Rejection, Pyrexia
Adverse event was reported on May 07, 2009 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg/day) was diagnosed with renal transplant and. Location: JAPAN , weighting 152.1 lb, Patient had the following side effects: blood creatinine increased, cytomegalovirus antigen positive, cytomegalovirus infection (What is cytomegalovirus infection?), diarrhoea, gastroenteritis staphylococcal, histiocytosis haematophagic, immunodeficiency, kidney transplant rejection, pyrexia. During the same period patient was treated with NEORAL (400 Mg/day) (View Neoral Review and Neoral Label ), MEDROL (40 Mg/day) (View Medrol Review and Medrol Label ), CELLCEPT (1000mg/day) (View Cellcept Review and Cellcept Label ), SANDIMMUNE (140 Mg) (View Sandimmune Review and Sandimmune Label ). Patient was hospitalized.

6171112-X | Cytomegalovirus Infection, Multi-organ Failure, Sepsis
on Apr 22, 2009 Female patient from JAPAN , weighting 46.30 lb, was diagnosed with renal transplant, infection (What is infection?) and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: cytomegalovirus infection (What is cytomegalovirus infection?), multi-organ failure, sepsis (What is sepsis?). Simulect dosage: 10 Mg. During the same period patient was treated with PROGRAF (0.4 To 0.8 Mg Daily) (View Prograf Review and Prograf Label ), SOL MELCORT (10 To 20 Mg Daily) (View Sol-melcort Review and Sol-melcort Label ), CELLCEPT (340 Mg Daily) (View Cellcept Review and Cellcept Label ), VICCILLIN (1500 Mg) (View Viccillin Review and Viccillin Label ), CEFOTAXIME SODIUM (1500 Mg) (View Cefotaxime Sodium Review and Cefotaxime Sodium Label ), MEROPEN (1500 Mg) (View Meropen Review and Meropen Label ).

6169418-3 | Anaemia, Aplasia Pure Red Cell, Viral Infection
on Jan 08, 2009 Female patient from CANADA , weighting 98.55 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: anaemia, aplasia pure red cell, viral infection (What is viral infection?). Simulect dosage: 20mg. During the same period patient was treated with MYCOPHENOLATE MOFETIL (1000 Mg, Bid) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ), EPREX (View Eprex Review and Eprex Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ), ATACAND (View Atacand Review and Atacand Label ), SEPTRA (View Septra Review and Septra Label ), VALCYTE (View Valcyte Review and Valcyte Label ).

6168923-3 | Abdominal Operation, Anaemia, Colectomy, Haemostasis, Hepatic Function Abnormal, Intestinal Ulcer, Large Intestine Perforation, Lower Gastrointestinal Haemorrhage
Patient was taking Simulect (View Usage). Patient had the following side effects: abdominal operation, anaemia, colectomy, haemostasis, hepatic function abnormal, intestinal ulcer, large intestine perforation, lower gastrointestinal haemorrhage on Apr 22, 2009 from JAPAN Additional patient health information: Female patient , 39 years of age, was diagnosed with renal transplant and. Simulect dosage: . During the same period patient was treated with METHYLPREDNISOLONE 4MG TAB (View Methylprednisolone 4mg Tab Review and Methylprednisolone 4mg Tab Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), AZATHIOPRINE (View Azathioprine Review and Azathioprine Label ).