SIMULECT Side Effects

7014253-7 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Haematoma Evacuation, Hypotension, Intestinal Haematoma, Liver Transplant Rejection, Phlebitis, Portal Vein Flow Decreased
on Sep 22, 2010 Female patient from JAPAN , 51 years of age, was diagnosed with liver transplant (What is liver transplant?) and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, haematoma evacuation, hypotension, intestinal haematoma, liver transplant rejection, phlebitis, portal vein flow decreased. Simulect dosage: 20 Mg, Unk. During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), CORTICOSTEROIDS (View Corticosteroids Review and Corticosteroids Label ).

7012879-8 | Abdominal Discomfort, Blood Creatinine Increased, Cytomegalovirus Infection, Enterococcal Infection, Haemoglobin Decreased, Haemolytic Anaemia, Kidney Transplant Rejection, Melaena, Platelet Count Decreased
Patient was taking Simulect (View Usage). Patient had the following side effects: abdominal discomfort, blood creatinine increased, cytomegalovirus infection (What is cytomegalovirus infection?), enterococcal infection, haemoglobin decreased, haemolytic anaemia, kidney transplant rejection, melaena, platelet count decreased on Sep 15, 2010 from JAPAN Additional patient health information: Female patient , 46 years of age, was diagnosed with renal transplant and. Simulect dosage: 20 Mg. During the same period patient was treated with TACROLIMUS (1.8 Mg) (View Tacrolimus Review and Tacrolimus Label ), METHYLPREDNISOLONE ACETATE (250 Mg) (View Methylprednisolone Acetate Review and Methylprednisolone Acetate Label ), CELLCEPT (1000 Mg) (View Cellcept Review and Cellcept Label ).

7010689-9 | Dehydration, Renal Failure Acute, Renal Haemorrhage, Surgery, Ureteral Catheterisation, Urinary Incontinence
Adverse event was reported on Sep 17, 2010 by a Male patient taking Simulect (View Usage) (Dosage: 20mg) was diagnosed with renal transplant and. Location: GERMANY , weighting 194.0 lb, After Simulect was administered, patient had the following side effects: dehydration, renal failure acute, renal haemorrhage, surgery (What is surgery?), ureteral catheterisation, urinary incontinence (What is urinary incontinence?). During the same period patient was treated with NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), SANDIMMUNE (View Sandimmune Review and Sandimmune Label ), MYFORTIC (View Myfortic Review and Myfortic Label ). Patient was hospitalized.

7002964-9 | Ascites, Endotracheal Intubation, Enterobacter Sepsis, Enterococcal Infection, Enterococcal Sepsis, Graft Haemorrhage, Graft Loss, Pneumonia, Portal Shunt
on Sep 16, 2010 Male patient from GERMANY , weighting 198.4 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: ascites, endotracheal intubation, enterobacter sepsis, enterococcal infection, enterococcal sepsis, graft haemorrhage, graft loss, pneumonia (What is pneumonia?), portal shunt. Simulect dosage: 20 Mg/day. 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.


6999936-7 | Hepatic Failure, Kidney Transplant Rejection, Lung Infection, Renal Graft Loss
on Sep 15, 2010 Male patient from JAPAN , weighting 125.7 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient had the following side effects: hepatic failure, kidney transplant rejection, lung infection, renal graft loss. Simulect dosage: 20 Mg, Once2sdo. During the same period patient was treated with PROGRAF (12 Mg) (View Prograf Review and Prograf Label ), CELLCEPT (1000 Mg) (View Cellcept Review and Cellcept Label ), MEDROL (12 Mg) (View Medrol Review and Medrol Label ).

6992468-1 | Cardio-respiratory Arrest, Gastrointestinal Haemorrhage
Patient was taking Simulect (View Usage). After Simulect was administered, patient had the following side effects: cardio-respiratory arrest, gastrointestinal haemorrhage on Sep 13, 2010 from JAPAN Additional patient health information: Male patient , weighting 202.8 lb, was diagnosed with renal transplant, hypertension and. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with NEORAL (250 To 750 Mg Daily) (View Neoral Review and Neoral Label ), SOLU MEDROL (20 To 500 Mg Daily) (View Solu-medrol Review and Solu-medrol Label ), CELLCEPT (1000 To 1500 Mg Daily) (View Cellcept Review and Cellcept Label ), SANDIMMUNE (270 Mg, Unk) (View Sandimmune Review and Sandimmune Label ), OLMETEC (20 Mg, Unk) (View Olmetec Review and Olmetec Label ), AMLODIPINE BESYLATE (10 Mg, Unk) (View Amlodipine Besylate Review and Amlodipine Besylate Label ). Patient was hospitalized.

6964122-3 | Multi-organ Failure, Sepsis
Adverse event was reported on Jul 07, 2010 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg, Daily) was diagnosed with liver transplant (What is liver transplant?) and. Location: GERMANY , weighting 185.2 lb, Patient experienced the following unwanted or unexpected effects: multi-organ failure, sepsis (What is sepsis?). During the same period patient was treated with NO TREATMENT RECEIVED NOMED (Unk) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), PROGRAF (Unk) (View Prograf Review and Prograf Label ). Patient was hospitalized.

6946286-0 | Blood Creatinine Increased, Cytomegalovirus Infection, Kidney Transplant Rejection, Urinary Tract Infection
on Aug 19, 2010 Female patient from GERMANY , weighting 176.4 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient had the following side effects: blood creatinine increased, cytomegalovirus infection (What is cytomegalovirus infection?), kidney transplant rejection, urinary tract infection (What is urinary tract infection?). Simulect dosage: 60 Mg, Unk. During the same period patient was treated with CYCLOSPORINE (Unk) (View Cyclosporine Review and Cyclosporine Label ), NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), ISONIAZID (View Isoniazid Review and Isoniazid Label ). Patient was hospitalized.

6946285-9 | Anaphylactic Shock, Antibody Test Abnormal, Blood Creatinine Increased, Bone Marrow Failure, Cytomegalovirus Infection, Kidney Transplant Rejection
on Aug 09, 2010 Male patient from JAPAN , 28 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, antibody test abnormal, blood creatinine increased, bone marrow failure, cytomegalovirus infection (What is cytomegalovirus infection?), kidney transplant rejection. Simulect dosage: 20 Mg. During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), CELLCEPT (View Cellcept Review and Cellcept Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), MIZORIBINE (View Mizoribine Review and Mizoribine Label ), STEROIDS NOS (View Steroids Nos Review and Steroids Nos Label ), PLASMAPHERESIS (View Plasmapheresis Review and Plasmapheresis Label ), RITUXIMAB (View Rituximab Review and Rituximab Label ).

6935172-8 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Haematoma Evacuation, Hypotension, Intestinal Haematoma, Liver Transplant Rejection, Phlebitis, Portal Vein Flow Decreased
Patient was taking Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, haematoma evacuation, hypotension, intestinal haematoma, liver transplant rejection, phlebitis, portal vein flow decreased on Aug 16, 2010 from JAPAN Additional patient health information: Female patient , 51 years of age, was diagnosed with liver transplant (What is liver transplant?) and. Simulect dosage: 20 Mg, Unk. During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), CORTICOSTEROIDS (View Corticosteroids Review and Corticosteroids Label ).

6935053-X | Abdominal Pain, Alanine Aminotransferase Increased, Angiogram, Arterial Catheterisation, Ascites, Aspartate Aminotransferase Increased, Blood Amylase Increased, Blood Lactate Dehydrogenase Increased, Blood Pressure Systolic Decreased
Adverse event was reported on Aug 10, 2010 by a Male patient taking Simulect (View Usage) (Dosage: ) was diagnosed with renal transplant and. Location: JAPAN , 54 years of age, Patient had the following side effects: abdominal pain (What is abdominal pain?), alanine aminotransferase increased, angiogram, arterial catheterisation, ascites, aspartate aminotransferase increased, blood amylase increased, blood lactate dehydrogenase increased, blood pressure systolic decreased. During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), STEROIDS NOS (View Steroids Nos Review and Steroids Nos Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), ANTIHYPERTENSIVES (View Antihypertensives Review and Antihypertensives Label ). Patient was hospitalized.

6935025-5 | Anaphylactic Shock, Antibody Test Abnormal, Blood Creatinine Increased, Bone Marrow Failure, Cytomegalovirus Infection, Kidney Transplant Rejection
on Aug 09, 2010 Male patient from JAPAN , 28 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, antibody test abnormal, blood creatinine increased, bone marrow failure, cytomegalovirus infection (What is cytomegalovirus infection?), kidney transplant rejection. Simulect dosage: 20 Mg. During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), CELL CEPT (View Cell Cept Review and Cell Cept Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), MIZORIBINE (View Mizoribine Review and Mizoribine Label ), STEROIDS NOS (View Steroids Nos Review and Steroids Nos Label ), PLASMAPHERESIS (View Plasmapheresis Review and Plasmapheresis Label ), RITUXIMAB (View Rituximab Review and Rituximab Label ).

6934918-2 | Abdominal Pain, Alanine Aminotransferase Increased, Angiogram, Arterial Catheterisation, Ascites, Aspartate Aminotransferase Increased, Blood Amylase Increased, Blood Lactate Dehydrogenase Increased, Blood Pressure Systolic Decreased
on Aug 10, 2010 Male patient from JAPAN , 54 years of age, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal pain (What is abdominal pain?), alanine aminotransferase increased, angiogram, arterial catheterisation, ascites, aspartate aminotransferase increased, blood amylase increased, blood lactate dehydrogenase increased, blood pressure systolic decreased. Simulect dosage: . During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), STEROIDS NOS (View Steroids Nos Review and Steroids Nos Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), ANTIHYPERTENSIVES (View Antihypertensives Review and Antihypertensives Label ). Patient was hospitalized.

6923320-5 | Dehydration, Renal Failure Acute, Renal Haemorrhage, Surgery, Ureteral Catheterisation, Urinary Incontinence
Patient was taking Simulect (View Usage). Patient had the following side effects: dehydration, renal failure acute, renal haemorrhage, surgery (What is surgery?), ureteral catheterisation, urinary incontinence (What is urinary incontinence?) on Aug 06, 2010 from GERMANY Additional patient health information: Male patient , weighting 194.0 lb, was diagnosed with renal transplant and. Simulect dosage: 20mg. During the same period patient was treated with NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ). Patient was hospitalized.

6921504-3 | Blood Creatinine Increased, Cytomegalovirus Infection, Kidney Transplant Rejection, Urinary Tract Infection
Adverse event was reported on Aug 04, 2010 by a Female patient taking Simulect (View Usage) (Dosage: 60 Mg, Unk) was diagnosed with renal transplant and. Location: GERMANY , weighting 176.4 lb, After Simulect was administered, patient had the following side effects: blood creatinine increased, cytomegalovirus infection (What is cytomegalovirus infection?), kidney transplant rejection, urinary tract infection (What is urinary tract infection?). During the same period patient was treated with CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), ISONIAZID (View Isoniazid Review and Isoniazid Label ). Patient was hospitalized.

6914830-5 | Blood Creatinine Increased, Chorioretinal Disorder, Cytomegalovirus Infection, Cytomegalovirus Test Positive, Kidney Transplant Rejection, Renal Impairment, Renal Tubular Atrophy
on Jul 28, 2010 Male patient from JAPAN , 25 years of age, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: blood creatinine increased, chorioretinal disorder, cytomegalovirus infection (What is cytomegalovirus infection?), cytomegalovirus test positive, kidney transplant rejection, renal impairment, renal tubular atrophy. Simulect dosage: . During the same period patient was treated with PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), GUSPERIMUS HYDROCHLORIDE (View Gusperimus Hydrochloride Review and Gusperimus Hydrochloride Label ). Patient was hospitalized.

6914071-1 | Venoocclusive Disease
on Aug 04, 2010 Female patient from JAPAN , 51 years of age, was diagnosed with liver transplant (What is liver transplant?) and was treated with Simulect (View Usage). Patient had the following side effects: venoocclusive disease. Simulect dosage: 20 Mg, Unk. During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ).

6914048-6 | Anuria, Blood Creatinine Increased, Blood Pressure Diastolic Decreased, Haemodialysis, Kidney Transplant Rejection, Nephropathy Toxic, Oliguria, Renal Tubular Necrosis, Urine Output Decreased
Patient was taking Simulect (View Usage). After Simulect was administered, patient had the following side effects: anuria, blood creatinine increased, blood pressure diastolic decreased, haemodialysis, kidney transplant rejection, nephropathy toxic, oliguria, renal tubular necrosis, urine output decreased on Jul 29, 2010 from JAPAN Additional patient health information: Female patient , 57 years of age, was diagnosed with renal transplant, transplant rejection and. Simulect dosage: 20 Mg. During the same period patient was treated with PROGRAF (Unk) (View Prograf Review and Prograf Label ), CELLCEPT (View Cellcept Review and Cellcept Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), RITUXIMAB (View Rituximab Review and Rituximab Label ), IMMU G (View Immu-g Review and Immu-g Label ). Patient was hospitalized.

6899611-3 | Anti-erythrocyte Antibody Positive, Anti-platelet Antibody Negative, Blood Bilirubin Increased, Blood Immunoglobulin G Increased, Blood Lactate Dehydrogenase Increased, Coombs Direct Test Positive, Coombs Indirect Test Positive, Haemoglobin Decreased, Haemolytic Anaemia
Adverse event was reported on Jul 21, 2010 by a Female patient taking Simulect (View Usage) (Dosage: ) was diagnosed with renal transplant and. Location: JAPAN , 64 years of age, Patient experienced the following unwanted or unexpected effects: anti-erythrocyte antibody positive, anti-platelet antibody negative, blood bilirubin increased, blood immunoglobulin g increased, blood lactate dehydrogenase increased, coombs direct test positive, coombs indirect test positive, haemoglobin decreased, haemolytic anaemia. During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), MIZORIBINE (View Mizoribine Review and Mizoribine Label ), PREDNISOLONE (60 Mg) (View Prednisolone Review and Prednisolone Label ).

6895559-9 | Renal Failure
on Jul 27, 2010 Female patient from GERMANY , weighting 174.2 lb, was diagnosed with liver transplant (What is liver transplant?) and was treated with Simulect (View Usage). Patient had the following side effects: renal failure. Simulect dosage: 20 Mg. During the same period patient was treated with SANDIMMUNE (150 Mg, Bid) (View Sandimmune Review and Sandimmune Label ), CERTICAN (Unk) (View Certican Review and Certican Label ). Patient was hospitalized.

6877965-1 | Enterococcal Sepsis, Fungal Peritonitis, Gastrointestinal Haemorrhage, Hepatic Function Abnormal, Pancreatitis Haemorrhagic, Pancreatitis Necrotising, Postoperative Ileus, Renal Failure Acute, Transplant Failure
on Jul 23, 2010 Male patient from GERMANY , weighting 165.3 lb, was diagnosed with liver transplant (What is liver transplant?) and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: enterococcal sepsis, fungal peritonitis, gastrointestinal haemorrhage, hepatic function abnormal, pancreatitis haemorrhagic, pancreatitis necrotising, postoperative ileus, renal failure acute, transplant failure. Simulect dosage: 20 Mg, Day 0. During the same period patient was treated with NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), TACROLIMUS (4 Mg) (View Tacrolimus Review and Tacrolimus Label ). Patient was hospitalized.

6870870-6 | Abdominal Discomfort, Blood Creatinine Increased, Cytomegalovirus Infection, Disseminated Intravascular Coagulation, Enterococcal Infection, Haemoglobin Decreased, Haemolytic Anaemia, Kidney Transplant Rejection, Melaena
Patient was taking Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal discomfort, blood creatinine increased, cytomegalovirus infection (What is cytomegalovirus infection?), disseminated intravascular coagulation, enterococcal infection, haemoglobin decreased, haemolytic anaemia, kidney transplant rejection, melaena on Jul 09, 2010 from JAPAN Additional patient health information: Female patient , 46 years of age, was diagnosed with renal transplant and. Simulect dosage: 20 Mg. During the same period patient was treated with TACROLIMUS (1.8 Mg) (View Tacrolimus Review and Tacrolimus Label ), METHYLPREDNISOLONE ACETATE (250 Mg) (View Methylprednisolone Acetate Review and Methylprednisolone Acetate Label ), CELLCEPT (1000 Mg) (View Cellcept Review and Cellcept Label ).

6870869-X | Anti-erythrocyte Antibody Positive, Anti-platelet Antibody Negative, Blood Bilirubin Increased, Blood Immunoglobulin G Increased, Blood Lactate Dehydrogenase Increased, Coombs Direct Test Positive, Coombs Indirect Test Positive, Haemoglobin Decreased, Haemolytic Anaemia
Adverse event was reported on Jul 09, 2010 by a Female patient taking Simulect (View Usage) (Dosage: ) was diagnosed with renal transplant and. Location: JAPAN , 64 years of age, Patient had the following side effects: anti-erythrocyte antibody positive, anti-platelet antibody negative, blood bilirubin increased, blood immunoglobulin g increased, blood lactate dehydrogenase increased, coombs direct test positive, coombs indirect test positive, haemoglobin decreased, haemolytic anaemia. During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), MIZORIBINE (View Mizoribine Review and Mizoribine Label ), PREDNISOLONE (60 Mg) (View Prednisolone Review and Prednisolone Label ).

6863221-4 | Abdominal Pain Lower, Cytomegalovirus Test Positive, Cytomegalovirus Viraemia, Diverticular Perforation, Failure To Anastomose, Intestinal Anastomosis, Malaise, Peritonitis, Pollakiuria
on Jul 09, 2010 Male patient from JAPAN , weighting 99.21 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: abdominal pain lower, cytomegalovirus test positive, cytomegalovirus viraemia, diverticular perforation, failure to anastomose, intestinal anastomosis, malaise, peritonitis, pollakiuria. Simulect dosage: 20 Mg, Once/single. 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 ), PREDONINE (50 Mg Dialy) (View Predonine Review and Predonine 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.

6857607-1 | Anuria, Blood Creatinine Increased, Blood Pressure Diastolic Decreased, Haemodialysis, Kidney Transplant Rejection, Nephropathy Toxic, Oliguria, Renal Tubular Necrosis, Urine Output Decreased
on Jul 08, 2010 Female patient from JAPAN , 57 years of age, was diagnosed with renal transplant, transplant rejection and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: anuria, blood creatinine increased, blood pressure diastolic decreased, haemodialysis, kidney transplant rejection, nephropathy toxic, oliguria, renal tubular necrosis, urine output decreased. Simulect dosage: Unk. During the same period patient was treated with TACROLIMUS (Unk) (View Tacrolimus Review and Tacrolimus Label ), CELLCEPT (View Cellcept Review and Cellcept Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), RITUXIMAB (View Rituximab Review and Rituximab Label ), IMMU G (View Immu-g Review and Immu-g Label ).

6840461-1 | Acute Respiratory Distress Syndrome, Chest X-ray Abnormal, Oxygen Supplementation, Pyrexia
Patient was taking Simulect (View Usage). Patient had the following side effects: acute respiratory distress syndrome, chest x-ray abnormal, oxygen supplementation, pyrexia on Jul 09, 2010 from FRANCE Additional patient health information: Female patient , weighting 27.56 lb, was diagnosed with liver transplant (What is liver transplant?) and. Simulect dosage: 10 Mg, Qd. During the same period patient was treated with PROGRAF (View Prograf Review and Prograf Label ).

6832192-9 | Enterococcal Sepsis, Fungal Peritonitis, Gastrointestinal Haemorrhage, Ileus, Pancreatitis Haemorrhagic, Pancreatitis Necrotising, Renal Failure Acute, Transplant Failure
Adverse event was reported on Jul 08, 2010 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg, Day 0) was diagnosed with liver transplant (What is liver transplant?) and. Location: GERMANY , weighting 165.3 lb, After Simulect was administered, patient had the following side effects: enterococcal sepsis, fungal peritonitis, gastrointestinal haemorrhage, ileus, pancreatitis haemorrhagic, pancreatitis necrotising, renal failure acute, transplant failure. During the same period patient was treated with NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), TACROLIMUS (4 Mg) (View Tacrolimus Review and Tacrolimus Label ).

6832184-X | Cytomegalovirus Infection, Disseminated Intravascular Coagulation, Enterococcus Test Positive, Haemolytic Anaemia, Kidney Transplant Rejection, Pseudomonas Test Positive, Staphylococcus Test Positive
on Jun 30, 2010 Female patient from JAPAN , 46 years of age, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: cytomegalovirus infection (What is cytomegalovirus infection?), disseminated intravascular coagulation, enterococcus test positive, haemolytic anaemia, kidney transplant rejection, pseudomonas test positive, staphylococcus test positive. Simulect dosage: 20 Mg. During the same period patient was treated with TACROLIMUS (1.8 Mg) (View Tacrolimus Review and Tacrolimus Label ), METHYLPREDNISOLONE ACETATE (250 Mg) (View Methylprednisolone Acetate Review and Methylprednisolone Acetate Label ), CELLCEPT (1000 Mg) (View Cellcept Review and Cellcept Label ).

6832180-2 | Haemolytic Anaemia, Idiopathic Thrombocytopenic Purpura
on Jun 30, 2010 Female patient from JAPAN , 64 years of age, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient had the following side effects: haemolytic anaemia, idiopathic thrombocytopenic purpura. Simulect dosage: . During the same period patient was treated with TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), MIZORIBINE (View Mizoribine Review and Mizoribine Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ).

6831563-4 | Cytomegalovirus Test Positive, Cytomegalovirus Viraemia, Diverticular Perforation, Peritonitis, Surgery
Patient was taking Simulect (View Usage). After Simulect was administered, patient had the following side effects: cytomegalovirus test positive, cytomegalovirus viraemia, diverticular perforation, peritonitis, surgery (What is surgery?) on Jun 30, 2010 from JAPAN Additional patient health information: Male patient , weighting 99.21 lb, was diagnosed with renal transplant and. Simulect dosage: 20 Mg, Once/single. 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 ), PREDONINE (50 Mg Dialy) (View Predonine Review and Predonine 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.

6814082-0 | Multi-organ Failure, Sepsis
Adverse event was reported on Jun 29, 2010 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg, Daily) was diagnosed with liver transplant (What is liver transplant?) and. Location: GERMANY , weighting 185.2 lb, Patient experienced the following unwanted or unexpected effects: multi-organ failure, sepsis (What is sepsis?). During the same period patient was treated with NO TREATMENT RECEIVED NOMED (Unk) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), PROGRAF (Unk) (View Prograf Review and Prograf Label ). Patient was hospitalized.

6786093-5 | Biliary Anastomosis Complication, Biliary Tract Dilation Procedure, Graft Loss, Hepatic Congestion, Hepatic Enzyme Increased, Hepatic Failure, Hepatic Infiltration Eosinophilic, Hepatic Necrosis, Liver Transplant
on Jun 15, 2010 Male patient from GERMANY , weighting 162.0 lb, was diagnosed with liver transplant (What is liver transplant?) and was treated with Simulect (View Usage). Patient had the following side effects: biliary anastomosis complication, biliary tract dilation procedure, graft loss, hepatic congestion, hepatic enzyme increased, hepatic failure, hepatic infiltration eosinophilic, hepatic necrosis, liver transplant (What is liver transplant?). Simulect dosage: 20 Mg, Day 0. During the same period patient was treated with SANDIMMUNE (Unk) (View Sandimmune Review and Sandimmune Label ), NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ). Patient was hospitalized.

6785023-X | Renal Failure
on Jun 15, 2010 Female patient from GERMANY , weighting 174.2 lb, was diagnosed with liver transplant (What is liver transplant?) and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side effects: renal failure. Simulect dosage: 20 Mg. During the same period patient was treated with SANDIMMUNE (150 Mg, Bid) (View Sandimmune Review and Sandimmune Label ), CERTICAN (Unk) (View Certican Review and Certican Label ). Patient was hospitalized.

6766589-2 | Cerebral Infarction
Patient was taking Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: cerebral infarction on May 31, 2010 from JAPAN Additional patient health information: Female patient , weighting 121.3 lb, was diagnosed with renal transplant and. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with NEORAL (440 Mg/day) (View Neoral Review and Neoral Label ), PREDNISOLONE (30 Mg/day) (View Prednisolone Review and Prednisolone Label ), BREDININ (450 Mg) (View Bredinin Review and Bredinin Label ). Patient was hospitalized.

6762237-6 | Blood Creatinine Increased, Blood Pressure Increased, Renal Failure, Renal Graft Loss, Venous Thrombosis
Adverse event was reported on May 31, 2010 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg, Once/single) was diagnosed with renal transplant and. Location: JAPAN , weighting 147.7 lb, Patient had the following side effects: blood creatinine increased, blood pressure increased, renal failure, renal graft loss, venous thrombosis. During the same period patient was treated with PREDNISOLONE (30 Mg) (View Prednisolone Review and Prednisolone Label ), CELLCEPT (500 Mg) (View Cellcept Review and Cellcept Label ), TACROLIMUS (20 Mg) (View Tacrolimus Review and Tacrolimus Label ).

6761317-9 | Anal Sphincter Atony, Bronchospasm, Cerebral Haematoma, Craniotomy, Csf Pressure Abnormal, 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). After Simulect was administered, patient had the following side effects: anal sphincter atony, bronchospasm, cerebral haematoma, craniotomy, csf pressure abnormal, 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.

6759102-7 | Blood Beta-d-glucan Increased, Cerebral Infarction, Depressed Level Of Consciousness, Mechanical Ventilation, Pneumocystis Jiroveci Pneumonia, Pyrexia, Respiratory Failure
on Jun 04, 2010 Male patient from JAPAN , weighting 154.3 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: blood beta-d-glucan increased, cerebral infarction, depressed level of consciousness, mechanical ventilation, pneumocystis jiroveci pneumonia, pyrexia, respiratory failure. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with NEORAL (150 Mg Daily) (View Neoral Review and Neoral Label ), SOLU MEDROL (500 Mg Daily) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (500 Mg Daily) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (1000 Mg Daily) (View Solu-medrol Review and Solu-medrol Label ), CELLCEPT (1000 Mg Daily) (View Cellcept Review and Cellcept Label ).

6751331-1 | Enterococcal Sepsis, Fungal Peritonitis, Gastrointestinal Haemorrhage, Pancreatitis Haemorrhagic, Pancreatitis Necrotising, Renal Failure Acute
Patient was taking Simulect (View Usage). Patient had the following side effects: enterococcal sepsis, fungal peritonitis, gastrointestinal haemorrhage, pancreatitis haemorrhagic, pancreatitis necrotising, renal failure acute on May 28, 2010 from GERMANY Additional patient health information: Male patient , weighting 165.3 lb, was diagnosed with liver transplant (What is liver transplant?) and. Simulect dosage: 20 Mg, Day 0. During the same period patient was treated with NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ).

6747693-1 | Enterococcal Sepsis, Fungal Peritonitis, Pancreatitis Haemorrhagic, Pancreatitis Necrotising, Renal Failure Acute
Adverse event was reported on May 19, 2010 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg, Day 0) was diagnosed with liver transplant (What is liver transplant?) and. Location: GERMANY , weighting 165.3 lb, After Simulect was administered, patient had the following side effects: enterococcal sepsis, fungal peritonitis, pancreatitis haemorrhagic, pancreatitis necrotising, renal failure acute. During the same period patient was treated with NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ).

6724584-3 | Bk Virus Infection, Chronic Allograft Nephropathy, Hydronephrosis, Hyperkalaemia, Kidney Transplant Rejection, Nephrostomy, Pancytopenia, Pyrexia, Rectal Haemorrhage
on Apr 26, 2010 Male patient from JAPAN , 48 years of age, was diagnosed with renal transplant, immunosuppression, kidney transplant rejection and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: bk virus infection, chronic allograft nephropathy, hydronephrosis, hyperkalaemia, kidney transplant rejection, nephrostomy, pancytopenia, pyrexia, rectal haemorrhage. Simulect dosage: 20 Mg. During the same period patient was treated with NEORAL (Unk) (View Neoral Review and Neoral Label ), MYCOPHENOLATE MOFETIL (2000 Mg/day) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), METHYLPREDNISOLONE 4MG TAB (250 Mg) (View Methylprednisolone 4mg Tab Review and Methylprednisolone 4mg Tab Label ). Patient was hospitalized and became disabled.

6723437-4 | C-reactive Protein Increased, Diarrhoea, Gastrointestinal Infection, Hepatic Haematoma, Pyrexia
on May 06, 2010 Male patient from GERMANY , weighting 173.9 lb, was diagnosed with liver transplant (What is liver transplant?) and was treated with Simulect (View Usage). Patient had the following side effects: c-reactive protein increased, diarrhoea, gastrointestinal infection, hepatic haematoma, pyrexia. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with CERTICAN (No Treatment) (View Certican Review and Certican Label ), PROGRAF (4 Mg, Bid) (View Prograf Review and Prograf Label ). Patient was hospitalized.

6722661-4 | Asthenia, Cholestasis, Confusional State, Cytolytic Hepatitis, Respiratory Failure, Tremor
Patient was taking Simulect (View Usage). After Simulect was administered, patient had the following side effects: asthenia, cholestasis, confusional state, cytolytic hepatitis, respiratory failure, tremor on Apr 19, 2010 from FRANCE Additional patient health information: Male patient , 55 years of age, was diagnosed with liver transplant (What is liver transplant?) and. Simulect dosage: . During the same period patient was treated with CORTICOSTEROIDS (View Corticosteroids Review and Corticosteroids Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), RITUXIMAB (375 Mg/m2, Unk) (View Rituximab Review and Rituximab Label ). Patient was hospitalized.

6722658-4 | Acute Respiratory Distress Syndrome, Bronchopneumonia, Cholestasis, Continuous Haemodiafiltration, Cytolytic Hepatitis, Haemodynamic Instability, Intra-abdominal Haemorrhage, Multi-organ Failure, Renal Failure Acute
Adverse event was reported on Apr 19, 2010 by a Female patient taking Simulect (View Usage) (Dosage: 20 Mg, Once/single) was diagnosed with liver transplant (What is liver transplant?) and. Location: FRANCE , 29 years of age, Patient experienced the following unwanted or unexpected effects: acute respiratory distress syndrome, bronchopneumonia, cholestasis, continuous haemodiafiltration, cytolytic hepatitis, haemodynamic instability, intra-abdominal haemorrhage, multi-organ failure, renal failure acute. 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 ), CORTICOSTEROIDS (View Corticosteroids Review and Corticosteroids Label ), ANTI THYMOCYTE GLOBULIN RABBIT NOS (View Anti-thymocyte Globulin Rabbit Nos Review and Anti-thymocyte Globulin Rabbit Nos Label ), METHYLPREDNISOLONE 4MG TAB (View Methylprednisolone 4mg Tab Review and Methylprednisolone 4mg Tab Label ), PIPERACILLIN W/TAZOBACTAM (View Piperacillin W/tazobactam Review and Piperacillin W/tazobactam Label ), GANCICLOVIR (5 Mg/kg/day) (View Ganciclovir Review and Ganciclovir Label ). Patient was hospitalized.

6706528-3 | Cytomegalovirus Infection, Kidney Transplant Rejection, Nephropathy
on Apr 28, 2010 Female patient from JAPAN , weighting 127.9 lb, was diagnosed with renal transplant, prophylaxis against gastrointestinal ulcer, diabetes prophylaxis and was treated with Simulect (View Usage). Patient had the following side effects: cytomegalovirus infection (What is cytomegalovirus infection?), kidney transplant rejection, nephropathy. Simulect dosage: 20 Mg/day. 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 ), SOLU MEDROL (500 Mg, Unk) (View Solu-medrol Review and Solu-medrol Label ), PARIET (Unk) (View Pariet Review and Pariet Label ), BASEN (Unk) (View Basen Review and Basen Label ). Patient was hospitalized.

6706429-0 | Tachyarrhythmia, Tachycardia
on Apr 26, 2010 Female patient from GERMANY , weighting 144.4 lb, was diagnosed with renal transplant, prophylaxis and was treated with Simulect (View Usage). After Simulect was administered, patient had the following side 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.

6706421-6 | Bk Virus Infection, Chronic Allograft Nephropathy, Hydronephrosis, Hyperkalaemia, Kidney Transplant Rejection, Nephrostomy, Pancytopenia, Pyrexia, Rectal Haemorrhage
Patient was taking Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: bk virus infection, chronic allograft nephropathy, hydronephrosis, hyperkalaemia, kidney transplant rejection, nephrostomy, pancytopenia, pyrexia, rectal haemorrhage on Apr 23, 2010 from JAPAN Additional patient health information: Male patient , 48 years of age, was diagnosed with renal transplant, immunosuppression, kidney transplant rejection and. Simulect dosage: 20 Mg. During the same period patient was treated with NEORAL (Unk) (View Neoral Review and Neoral Label ), MYCOPHENOLATE MOFETIL (2000 Mg/day) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), METHYLPREDNISOLONE (250 Mg) (View Methylprednisolone Review and Methylprednisolone Label ). Patient was hospitalized and became disabled.

6700655-2 | Bk Virus Infection, Chronic Allograft Nephropathy, Hydronephrosis, Hyperkalaemia, Kidney Transplant Rejection, Nephrostomy, Pancytopenia, Pyrexia, Rectal Haemorrhage
Adverse event was reported on Apr 19, 2010 by a Male patient taking Simulect (View Usage) (Dosage: 20 Mg) was diagnosed with renal transplant, immunosuppression, kidney transplant rejection and. Location: JAPAN , 48 years of age, Patient had the following side effects: bk virus infection, chronic allograft nephropathy, hydronephrosis, hyperkalaemia, kidney transplant rejection, nephrostomy, pancytopenia, pyrexia, rectal haemorrhage. During the same period patient was treated with CYCLOSPORINE (Unk) (View Cyclosporine Review and Cyclosporine Label ), MYCOPHENOLATE MOFETIL (2000 Mg/day) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), METHYLPREDNISOLONE (250 Mg) (View Methylprednisolone Review and Methylprednisolone Label ).

6671708-2 | Delayed Engraftment, Kidney Fibrosis, Nephrocalcinosis, Parathyroid Gland Enlargement, Parathyroidectomy, Renal Tubular Atrophy
on Mar 29, 2010 Male patient from JAPAN , child 8 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: delayed engraftment, kidney fibrosis, nephrocalcinosis, parathyroid gland enlargement, parathyroidectomy, renal tubular atrophy. Simulect dosage: Unk. During the same period patient was treated with TACROLIMUS (Unk) (View Tacrolimus Review and Tacrolimus Label ), METHYLPREDNISOLONE (Unk) (View Methylprednisolone Review and Methylprednisolone Label ), MYCOPHENOLATE MOFETIL (Unk) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ).

6667987-8 | Arterial Disorder, Blood Creatinine Increased, Complications Of Transplanted Kidney, Focal Segmental Glomerulosclerosis, Iga Nephropathy, Renal Tubular Necrosis
on Mar 25, 2010 Female patient from JAPAN , weighting 127.9 lb, was diagnosed with renal transplant and was treated with Simulect (View Usage). Patient experienced the following unwanted or unexpected effects: arterial disorder, blood creatinine increased, complications of transplanted kidney, focal segmental glomerulosclerosis, iga nephropathy, renal tubular necrosis. Simulect dosage: 20 Mg, Once/single. 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 ).

6664417-7 | Blood Beta-d-glucan Increased, Cerebral Infarction, Depressed Level Of Consciousness, Mechanical Ventilation, Pneumocystis Jiroveci Pneumonia, Pyrexia, Respiratory Failure
Patient was taking Simulect (View Usage). Patient had the following side effects: blood beta-d-glucan increased, cerebral infarction, depressed level of consciousness, mechanical ventilation, pneumocystis jiroveci pneumonia, pyrexia, respiratory failure on Mar 29, 2010 from JAPAN Additional patient health information: Male patient , weighting 154.3 lb, was diagnosed with renal transplant and. Simulect dosage: 20 Mg, Once/single. During the same period patient was treated with NEORAL (150 Mg Daily) (View Neoral Review and Neoral Label ), SOLU MEDROL (500 Mg Daily) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (500 Mg Daily) (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (1000 Mg Daily) (View Solu-medrol Review and Solu-medrol Label ), CELLCEPT (1000 Mg Daily) (View Cellcept Review and Cellcept Label ).