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Simulect (Basiliximab) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Simulect (Basiliximab) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (137)
Death (24)
Life Threatening Events (9)
Disability (4)

Reports by Reaction Type

Kidney Transplant Rejection (22)Blood Creatinine Increased (14)Cytomegalovirus Infection (13)Diarrhoea (12)Pyrexia (11)Pneumonia (10)Complications of Transplanted Kidney (9)Abdominal Pain (8)Thrombotic Microangiopathy (8)Urine Output Decreased (8)Urinary Tract Infection (8)Hypotension (8)

Below are a few examples of reports where side effects / adverse reactions may be related to Simulect (Basiliximab). For a complete list or a specific selection of reports, please use the links above.

Possible Simulect side effects in 27 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24

Patient: 27 year old female

Reactions: Ureteric Anastomosis Complication, Leukoencephalopathy, Neutropenia

Drug(s) suspected as cause:
Simulect

Other drugs received by patient: Tacrolimus; Mycophenolate Mofetil (Cellcept); Medrol



Possible Simulect side effects in male

Reported by a physician from Japan on 2012-08-24

Patient: male, weighing 13.0 kg (28.6 pounds)

Reactions: Post Transplant Lymphoproliferative Disorder, Abdominal Pain, Intestinal Perforation, Kidney Transplant Rejection, Blood Creatine Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Medrol
    Dosage: 20 to 4 mg daily, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-11-24

Mycophenolate Mofetil (Cellcept)
    Dosage: 250 mg, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-11-23
    End date: 2011-05-09

Prograf
    Dosage: 0.6 mg, unk
    Indication: Renal Transplant
    Start date: 2010-11-24

Prograf
    Dosage: 11.6 mg, unk
    Administration route: Oral
    Start date: 2010-12-03

Simulect
    Dosage: 10 mg, unk
    Start date: 2010-11-28
    End date: 2010-11-28

Simulect
    Dosage: 10 mg, unk
    Start date: 2010-11-24
    End date: 2010-11-24



Possible Simulect side effects in male

Reported by a physician from Japan on 2012-08-21

Patient: male

Reactions: Pneumonia Aspiration, Gastrointestinal Hypermotility, Hyperkalaemia, Eye Discharge, Urine Output Decreased, Hypotension, Dyskinesia, Hyponatraemia, Cytomegalovirus Viraemia, Diarrhoea, Bronchitis, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Dosage: 500 mg, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-09-20
    End date: 2010-10-10

Mycophenolate Mofetil (Cellcept)
    Dosage: 250 mg, unk
    Administration route: Oral
    Start date: 2010-11-15
    End date: 2010-11-26

Mycophenolate Mofetil (Cellcept)
    Dosage: 250 mg, unk
    Administration route: Oral
    Start date: 2010-10-12
    End date: 2010-11-09

Mycophenolate Mofetil (Cellcept)
    Dosage: 500 mg, unk
    Administration route: Oral
    Start date: 2010-11-26
    End date: 2011-01-29

Mycophenolate Mofetil (Cellcept)
    Dosage: 500 mg, unk
    Administration route: Oral
    Start date: 2010-11-10
    End date: 2010-11-14

Prednisolone
    Dosage: 17.5 mg, unk
    Start date: 2010-09-18

Prednisolone
    Dosage: 12.5 mg, unk
    Start date: 2010-09-20

Prednisolone
    Dosage: 10 mg, unk
    Indication: Renal Transplant
    Start date: 2010-09-15

Prednisolone
    Dosage: 20 mg, unk
    Start date: 2010-09-16

Prednisolone
    Dosage: 15 mg, unk
    Start date: 2010-09-19

Prednisolone
    Dosage: 10 mg, unk
    Start date: 2010-09-21

Prograf
    Dosage: 0.5 mg, unk
    Indication: Renal Transplant
    Start date: 2010-09-15

Prograf
    Dosage: 2.8 mg, unk
    Administration route: Oral
    Start date: 2010-10-18
    End date: 2010-10-27

Prograf
    Dosage: 2.4 mg, unk
    Administration route: Oral
    Start date: 2010-11-02
    End date: 2010-11-04

Prograf
    Dosage: 0.3 mg, unk
    Start date: 2010-09-15

Prograf
    Dosage: 0.25 mg, unk
    Start date: 2010-09-22

Prograf
    Dosage: 2.8 mg, unk
    Administration route: Oral
    Start date: 2010-11-05
    End date: 2010-11-08

Prograf
    Dosage: 2.2 mg, unk
    Administration route: Oral
    Start date: 2010-10-28
    End date: 2010-11-01

Prograf
    Dosage: 2 mg, unk
    Administration route: Oral
    Start date: 2010-09-29
    End date: 2010-10-12

Prograf
    Dosage: 2.4 mg, unk
    Administration route: Oral
    Start date: 2010-11-09
    End date: 2010-11-10

Prograf
    Dosage: 3.6 mg, unk
    Administration route: Oral
    Start date: 2010-10-13
    End date: 2010-10-17

Simulect
    Dosage: 10 mg, unk
    Start date: 2010-09-22

Simulect
    Dosage: 10 mg, unk
    Start date: 2010-09-15

Other drugs received by patient: Omeprazole; Prednisolone; Prednisolone; Neoral; Risperdal; Midazolam HCL; Futhan; Cefazolin; Clostridium Butyricum; Clostridium Butyricum; Clostridium Butyricum; Florinef; Aspirin; Prednisolone; Neoral; Neoral; Cefazolin; Depakene; Depakene; Prednisolone; Prednisolone; Prednisolone; Neoral; Neoral; Cefazolin; Clostridium Butyricum; Dantrium; Dantrium; Dantrium; Tannalbin; Fentanyl; Depakene; Lansoprazole; Prednisolone; Dantrium; Midazolam HCL; Rocuronium Bromide; Prednisolone; Lioresal; Levothyroxine Sodium; Levothyroxine Sodium; Precedex; Levothyroxine Sodium; Clostridium Butyricum



Possible Simulect side effects in male

Reported by a physician from Peru on 2012-08-16

Patient: male

Reactions: Complications of Transplanted Kidney, Hypotension, Haematuria, Renal Vein Thrombosis, Kidney Transplant Rejection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simulect

Other drugs received by patient: Mycophenolic Acid; Antihypertensive Drugs; Corticosteroids



Possible Simulect side effects in female

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-16

Patient: female

Reactions: Breast Disorder, Reproductive Tract Disorder

Drug(s) suspected as cause:
Certican
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant

Mycophenolic Acid
    Indication: Renal Transplant

Neoral
    Indication: Renal Transplant

Simulect
    Indication: Renal Transplant



Possible Simulect side effects in male

Reported by a physician from Germany on 2012-08-13

Patient: male, weighing 55.0 kg (121.0 pounds)

Reactions: Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic
    Dosage: 540 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-07-25

Prednisolone
    Dosage: unk
    Indication: Renal Transplant
    Start date: 2012-07-26

Prednisolone
    Dosage: 500 mg, unk
    Indication: Renal Transplant
    Start date: 2012-07-25

Prograf
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-07-24

Simulect
    Dosage: 20 mg, unk
    Indication: Renal Transplant
    Start date: 2012-07-25

Other drugs received by patient: Pantoprazole; Norvasc; Pravastatin; Nebivolol



Possible Simulect side effects in female

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-10

Patient: female

Reactions: Breast Disorder, Reproductive Tract Disorder

Drug(s) suspected as cause:
Certican
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant

Mycophenolic Acid
    Indication: Renal Transplant

Neoral
    Indication: Renal Transplant

Simulect
    Indication: Renal Transplant



Possible Simulect side effects in

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-10

Patient:

Reactions: Mental Disorder

Drug(s) suspected as cause:
Certican

Mycophenolic Acid
    Indication: Renal Transplant

Neoral
    Indication: Renal Transplant

Simulect



Possible Simulect side effects in female

Reported by a physician from Netherlands on 2012-08-03

Patient: female, weighing 46.0 kg (101.2 pounds)

Reactions: Upper Respiratory Tract Infection, Urosepsis, Pyelonephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycophenolic Acid
    Dosage: 360 mg, bid
    Indication: Renal Transplant
    Start date: 2011-06-05
    End date: 2012-07-28

Prednisone
    Dosage: 10 mg, unk
    Start date: 2011-04-10

Prednisone
    Dosage: unk
    Start date: 2011-06-05
    End date: 2012-07-28

Prograf
    Dosage: 4 mg, bid
    Indication: Renal Transplant
    Start date: 2011-06-05
    End date: 2012-07-28

Simulect
    Dosage: 5 mg, bid
    Indication: Renal Transplant
    Start date: 2011-04-10

Other drugs received by patient: Cotrim; Cotrim; Selokeen; Nexium; Calcium Carbonate; Zantac; Amlodipine; Lisinopril; Metoprolol Tartrate; Alfacalcidol



Possible Simulect side effects in 36 year old male

Reported by a physician from India on 2012-07-26

Patient: 36 year old male

Reactions: Complications of Transplanted Kidney, Blood Lactate Dehydrogenase Increased, Kidney Transplant Rejection, Blood Creatinine Increased, Thrombocytopenia

Drug(s) suspected as cause:
Neoral

Simulect
    Dosage: 20 mg, unk
    Indication: Renal Transplant



Possible Simulect side effects in male

Reported by a physician from France on 2012-07-25

Patient: male, weighing 76.0 kg (167.2 pounds)

Reactions: Vomiting, Bacteraemia, Pseudomonas Infection, Pyrexia, Hypertension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycophenolic Acid
    Dosage: 2160 mg/day
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2009-12-31

Neoral
    Dosage: 375 mg/day
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2009-12-31

Simulect
    Dosage: unk
    Indication: Renal Transplant
    Start date: 2009-12-31



Possible Simulect side effects in 8 year old female

Reported by a health professional (non-physician/pharmacist) from China on 2012-07-24

Patient: 8 year old female

Reactions: Acute Graft Versus Host Disease in Skin, Chronic Graft Versus Host Disease, Epilepsy

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Dosage: 5 mg/kg, from day 4 to day 1 before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 1.5 mg/kg, per day for 7 day
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 5 mg/kg, per day
    Administration route: Oral

Cyclosporine
    Dosage: 2.5 mg/kg, for 18 hour 1-day before transplantation

Methotrexate
    Dosage: 10 mg/m2, on day 3, 6 and 11

Methotrexate
    Dosage: 15 mg/m2, one day before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Mycophenolate Mofetil
    Dosage: 0.25-0.5 g, per day; from day 7 of transplantation to day 100
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, two hour before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, at day 4 after transplantation

Other drugs received by patient: Cytarabine; Cyclophosphamide



Possible Simulect side effects in 8 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-07-24

Patient: 8 year old male

Reactions: Chronic Graft Versus Host Disease in Skin, Acute Lymphocytic Leukaemia Recurrent, Graft Versus Host Disease in Lung, Chronic Graft Versus Host Disease, Herpes Zoster, Acute Graft Versus Host Disease in Intestine

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Dosage: 5 mg/kg, from day 4 to day 1 before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 1.5 mg/kg, per day for 7 day
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 5 mg/kg, per day
    Administration route: Oral

Cyclosporine
    Dosage: 2.5 mg/kg, for 18 hour 1-day before transplantation

Methotrexate
    Dosage: 15 mg/m2, one day before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Methotrexate
    Dosage: 10 mg/m2, on day 3, 6 and 11

Mycophenolate Mofetil
    Dosage: 0.25-0.5 g, per day; from day 7 of transplantation to day 100
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, two hour before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, at day 4 after transplantation

Other drugs received by patient: Cyclophosphamide; Cytarabine



Possible Simulect side effects in 8 year old female

Reported by a health professional (non-physician/pharmacist) from China on 2012-07-24

Patient: 8 year old female

Reactions: Acute Graft Versus Host Disease in Skin, Chronic Graft Versus Host Disease, Epilepsy

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Dosage: 5 mg/kg, from day 4 to day 1 before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 1.5 mg/kg, per day for 7 day
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 2.5 mg/kg, for 18 hour 1-day before transplantation

Cyclosporine
    Dosage: 5 mg/kg, per day
    Administration route: Oral

Methotrexate
    Dosage: 10 mg/m2, on day 3, 6 and 11

Methotrexate
    Dosage: 15 mg/m2, one day before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Mycophenolate Mofetil
    Dosage: 0.25-0.5 g, per day; from day 7 of transplantation to day 100
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, at day 4 after transplantation

Simulect
    Dosage: 20 mg, two hour before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Other drugs received by patient: Cyclophosphamide; Cytarabine



Possible Simulect side effects in 6 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-07-23

Patient: 6 year old male

Reactions: Acute Lymphocytic Leukaemia Recurrent

Adverse event resulted in: death

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Dosage: 5 mg/kg, from day 4 to day 1 before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 1.5 mg/kg, per day for 7 day
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 2.5 mg/kg, for 18 hour 1-day before transplantation

Cyclosporine
    Dosage: 5 mg/kg, per day
    Administration route: Oral

Methotrexate
    Dosage: 10 mg/m2, on day 3, 6 and 11

Methotrexate
    Dosage: 15 mg/m2, one day before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Mycophenolate Mofetil
    Dosage: 0.25-0.5 g, per day; from day 7 of transplantation to day 100
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, two hour before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, at day 4 after transplantation

Other drugs received by patient: Cyclophosphamide; Cytarabine



Possible Simulect side effects in 6 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-07-22

Patient: 6 year old male

Reactions: Acute Lymphocytic Leukaemia Recurrent

Adverse event resulted in: death

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Dosage: 5 mg/kg, from day 4 to day 1 before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 5 mg/kg, per day
    Administration route: Oral

Cyclosporine
    Dosage: 1.5 mg/kg, per day for 7 day
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 2.5 mg/kg, for 18 hour 1-day before transplantation

Methotrexate
    Dosage: 10 mg/m2, on day 3, 6 and 11

Methotrexate
    Dosage: 15 mg/m2, one day before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Mycophenolate Mofetil
    Dosage: 0.25-0.5 g, per day; from day 7 of transplantation to day 100
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, two hour before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, at day 4 after transplantation

Other drugs received by patient: Cytarabine; Cyclophosphamide



Possible Simulect side effects in 2 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-07-20

Patient: 2 year old male

Reactions: Acute Graft Versus Host Disease in Skin, Acute Myeloid Leukaemia Recurrent

Adverse event resulted in: death

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Dosage: 5 mg/kg, from day 4 to day 1 before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 5 mg/kg, per day
    Administration route: Oral

Cyclosporine
    Dosage: 2.5 mg/kg, for 18 hour 1-day before transplantation

Cyclosporine
    Dosage: 1.5 mg/kg, per day for 7 day
    Indication: Prophylaxis Against Graft Versus Host Disease

Methotrexate
    Dosage: 15 mg/m2, one day before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Methotrexate
    Dosage: 10 mg/m2, on day 3, 6 and 11

Mycophenolate Mofetil
    Dosage: 0.25-0.5 g, per day; from day 7 of transplantation to day 100
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, at day 4 after transplantation

Simulect
    Dosage: 20 mg, two hour before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Other drugs received by patient: Busulfan; Cyclophosphamide; Cytarabine



Possible Simulect side effects in 2 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-07-20

Patient: 2 year old male

Reactions: Acute Graft Versus Host Disease in Skin, Acute Myeloid Leukaemia Recurrent

Adverse event resulted in: death

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Dosage: 5 mg/kg, from day 4 to day 1 before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 1.5 mg/kg, per day for 7 day
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: 2.5 mg/kg, for 18 hour 1-day before transplantation

Cyclosporine
    Dosage: 5 mg/kg, per day
    Administration route: Oral

Methotrexate
    Dosage: 10 mg/m2, on day 3, 6 and 11

Methotrexate
    Dosage: 15 mg/m2, one day before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Mycophenolate Mofetil
    Dosage: 0.25-0.5 g, per day; from day 7 of transplantation to day 100
    Indication: Prophylaxis Against Graft Versus Host Disease

Simulect
    Dosage: 20 mg, at day 4 after transplantation

Simulect
    Dosage: 20 mg, two hour before transplantation
    Indication: Prophylaxis Against Graft Versus Host Disease

Other drugs received by patient: Cyclophosphamide; Cytarabine; Busulfan



Possible Simulect side effects in male

Reported by a lawyer from Germany on 2012-07-18

Patient: male

Reactions: Multi-Organ Failure, Skin Discolouration, Skin Ulcer, Oedema Peripheral, Oedema, Testicular Swelling, Rash Generalised, Drug Intolerance, General Physical Health Deterioration, Chronic Graft Versus Host Disease, Rash, Penile Swelling, Nasal Mucosal Disorder, Oral Disorder, Skin Erosion, Blood Disorder, Gait Disturbance, Multi-Organ Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Sandimmune
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Bone Marrow Transplant
    Start date: 2010-03-01

Simulect
    Dosage: 20 mg, unk
    Start date: 2010-11-19

Simulect
    Dosage: 20 mg, unk
    Start date: 2010-11-11

Simulect
    Dosage: 20 mg, unk
    Start date: 2010-11-04

Simulect
    Dosage: once every week, total for 4 times
    Indication: Bone Marrow Transplant
    Start date: 2010-10-15
    End date: 2010-11-19

Other drugs received by patient: Corticosteroids; Corticosteroids; Cellcept



Possible Simulect side effects in male

Reported by a physician from Peru on 2012-07-17

Patient: male

Reactions: Complications of Transplanted Kidney, Hypotension, Haematuria, Renal Vein Thrombosis, Kidney Transplant Rejection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simulect



Possible Simulect side effects in 59 year old male

Reported by a health professional (non-physician/pharmacist) from Chile on 2012-07-13

Patient: 59 year old male

Reactions: Aspiration Bronchial, Pneumonia, Liver Transplant Rejection

Adverse event resulted in: death

Drug(s) suspected as cause:
Simulect

Other drugs received by patient: Tacrolimus; Sirolimus; Steroids; Mycophenolate Mofetil



Possible Simulect side effects in female

Reported by a physician from United States on 2012-07-12

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Hydronephrosis, Pain in Extremity, Oedema Peripheral, Perinephric Collection, Lymphocele

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Start date: 2011-01-27

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-01-26
    End date: 2011-01-27

Corticosteroids
    Administration route: Oral
    Indication: Renal Transplant

Simulect
    Indication: Renal Transplant

Tacrolimus
    Administration route: Oral



Possible Simulect side effects in female

Reported by a physician from United States on 2012-07-12

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Hydronephrosis, Pain in Extremity, Oedema Peripheral, Perinephric Collection, Lymphocele

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Certican
    Dosage: 1.5 mg, bid
    Administration route: Oral
    Start date: 2011-01-27

Certican
    Dosage: 0.75 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-01-26
    End date: 2011-01-27

Corticosteroids
    Administration route: Oral
    Indication: Renal Transplant

Simulect
    Indication: Renal Transplant

Tacrolimus
    Administration route: Oral



Possible Simulect side effects in 36 year old male

Reported by a consumer/non-health professional from India on 2012-07-11

Patient: 36 year old male

Reactions: Complications of Transplanted Kidney, Blood Lactate Dehydrogenase Increased, Kidney Transplant Rejection, Thrombocytopenia, Blood Creatinine Increased

Drug(s) suspected as cause:
Neoral

Simulect
    Dosage: 20 mg, unk
    Indication: Renal Transplant



Possible Simulect side effects in female

Reported by a physician from Argentina on 2012-07-10

Patient: female, weighing 63.0 kg (138.6 pounds)

Reactions: Cellulitis

Drug(s) suspected as cause:
Prograf
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-06-27

Simulect
    Dosage: 20 mg, unk
    Indication: Renal Transplant
    Start date: 2012-06-27
    End date: 2012-06-29

Simulect
    Dosage: 20 mg, unk
    Start date: 2012-07-02

Other drugs received by patient: Methylprednisolone; Omeprazole; Insulin; Losartan Potassium; Myfortic; Carvedilol; Amlodipine; Levothyroxine Sodium



Possible Simulect side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-09

Patient: male, weighing 64.0 kg (140.8 pounds)

Reactions: Hepatitis B Antibody Positive, Epstein-Barr Virus Infection, Post Transplant Lymphoproliferative Disorder, Primary Mediastinal Large B-Cell Lymphoma, Cytomegalovirus Test Positive, Blood Uric Acid Increased, Cytomegalovirus Infection, Pyrexia, Hepatic Neoplasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: 1500 mg/day
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-05-17

Neoral
    Dosage: 500 mg/day
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-05-13
    End date: 2007-05-23

Simulect
    Dosage: 20 mg, once/single
    Start date: 2007-05-20
    End date: 2007-05-20

Simulect
    Dosage: 20 mg, once/single
    Indication: Renal Transplant
    Start date: 2007-05-16
    End date: 2007-05-16

Other drugs received by patient: Sandimmune; Cinalong; Diovan; Solu-Medrol; Zyloric ^fresenius^; Prednisolone; Prednisolone; Allopurinol



Possible Simulect side effects in female

Reported by a physician from Argentina on 2012-07-05

Patient: female, weighing 63.0 kg (138.6 pounds)

Reactions: Cellulitis

Drug(s) suspected as cause:
Prograf
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-06-27

Simulect
    Dosage: 20 mg, unk
    Indication: Renal Transplant
    Start date: 2012-06-27
    End date: 2012-06-29

Simulect
    Dosage: 20 mg, unk
    Start date: 2012-07-02

Other drugs received by patient: Myfortic; Methylprednisolone; Carvedilol; Omeprazole; Losartan Potassium; Levothyroxine Sodium; Amlodipine; Insulin



Possible Simulect side effects in male

Reported by a physician from Germany on 2012-06-27

Patient: male

Reactions: Megacolon, Large Intestine Perforation, Intestinal Ischaemia, Renal Vessel Disorder, Concomitant Disease Progression, Peritonitis, Renal Failure, Sepsis, Intestinal Gangrene, Septic Shock

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cyclosporine
    Dosage: 400 mg, unk
    Indication: Renal Transplant
    Start date: 2011-12-11

Mycophenolic Acid
    Dosage: 2880 mg, unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-12-11

NO Treatment Received
    Dosage: no treatment
    Indication: Renal Transplant

Prednisone TAB
    Dosage: 80 mg, unk
    Indication: Renal Transplant
    Start date: 2011-12-11

Simulect
    Dosage: 20 mg, unk
    Indication: Renal Transplant
    Start date: 2011-12-11
    End date: 2011-12-11

Other drugs received by patient: Hydrocortisone Acetate



Possible Simulect side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-07

Patient: 60 year old male

Reactions: Hydronephrosis, Ureteric Obstruction, Urine Output Decreased, Blood Creatinine Increased, Candidiasis

Drug(s) suspected as cause:
Simulect

Other drugs received by patient: Methylprednisolone; Tacrolimus; Mycophenolate Mofetil



Possible Simulect side effects in male

Reported by a physician from Germany on 2012-06-03

Patient: male

Reactions: Bone Pain, Hepatic Neoplasm Malignant Recurrent, Metastases To Bone

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
NO Treatment Received
    Dosage: unk
    Indication: Liver Transplant

Prograf
    Dosage: unk
    Administration route: Oral
    Indication: Liver Transplant

Simulect
    Dosage: 20 mg / day
    Indication: Liver Transplant
    Start date: 2007-06-20
    End date: 2007-06-20

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