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Community-reported Simulect side effects:

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Review Simulect Safety Reports submitted to FDA

Total Simulect reports: 56.
Simulect FDA safety alerts: No.
Reported deaths: 18    Reported hospitalizations: 27.
Take Simulect Side Effects Survey, Discuss Simulect with others
FDA Reported Simulect Side Effects: pyrexia, kidney transplant rejection, cytomegalovirus infection, c-reactive protein increased, blood creatinine increased, life support, complications of transplant surgery, angiopathy, mechanical ileus, intubation, cytomegalovirus antigen positive.
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Simulect Side Effects Report #5648474-2
Consumer or non-health professional from JAPAN reported SIMULECT problem on Feb 27, 2008. Female patient, child 1 years of age, was diagnosed with liver and small intestine transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: cholangitis, epstein-barr virus infection, hepatic steatosis, lymphoproliferative disorder, septic shock. SIMULECT dosage: unknown. During the same period patient was treated with PROGRAF. Patient died.

Simulect Side Effects Report #5657978-8
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on Mar 06, 2008. Female patient, weighting 21.83 lb, was diagnosed with liver and small intestine transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: cholangitis, epstein-barr virus infection, hepatic steatosis, intestinal villi atrophy, lymphoproliferative disorder, mucosal exfoliation, septic shock. SIMULECT dosage: unknown. During the same period patient was treated with PROGRAF, STEROIDS NOS. Patient died.

Simulect Side Effects Report #5669588-7
Physician from SWITZERLAND reported SIMULECT problem on Mar 07, 2008. Male patient, 49 years of age, was diagnosed with liver transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, hepatic haematoma, pyrexia, systemic inflammatory response syndrome. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with POLYMYCIN B SULPHATE, NEOMYCIN, DAFALGAN, HEPARIN, NEXIUM, ADALAT. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5688590-2
SIMULECT problem was reported by a Physician from JAPAN on Mar 18, 2008. Male patient, child 9 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: angioplasty, blood aldosterone increased, hypertension, renal artery stenosis, renal vessel disorder, renin increased. SIMULECT dosage: 20 MG/DAY. During the same period patient was treated with CELLCEPT, MEDROL, DIFLUCAN, NEORAL. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5688676-2
Consumer or non-health professional from JAPAN reported SIMULECT problem on Mar 25, 2008. Female patient, child 9 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: calcinosis, cystitis bacterial, mucosal inflammation, pyuria, staphylococcal infection, therapeutic procedure, vesicoureteric reflux. SIMULECT dosage: 20 MG, UNK. During the same period patient was treated with CYCLOSPORINE, CELLCEPT, METHYLPREDNISOLONE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5622919-6
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on Feb 06, 2008. Female patient, child 4 years of age, was diagnosed with organ transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, sepsis. SIMULECT dosage: 10 MG, UNK. During the same period patient was treated with PROGRAF, CELLCEPT, METHYLPREDNISOLONE, RITUXAN, PLASMAPHERESIS. Patient died on 06/28/2007.

Simulect Side Effects Report #5623076-2
Consumer or non-health professional from JAPAN reported SIMULECT problem on Feb 06, 2008. Female patient, child 4 years of age, was diagnosed with organ transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, sepsis. SIMULECT dosage: 10 MG, UNK. During the same period patient was treated with PROGRAF, CELLCEPT, METHYLPREDNISOLONE, RITUXAN, PLASMAPHERESIS. Patient died on 06/28/2007.

Simulect Side Effects Report #5624212-4
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on Feb 06, 2008. Male patient, 56 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, continuous haemodiafiltration, hypersensitivity, hypotension, kidney transplant rejection, respiratory disorder, urine output decreased. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with CELLCEPT, NEORAL, SANDIMMUNE, PROPOFOL, FENTANYL, VECURONIUM BROMIDE, SEVOFLURANE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5624234-3
Consumer or non-health professional from JAPAN reported SIMULECT problem on Feb 06, 2008. Female patient, 53 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, hepatic function abnormal, platelet count decreased, transplant rejection. SIMULECT dosage: unknown. During the same period patient was treated with RITUXAN, MEDROL, PROGRAF, CELLCEPT, BREDININ. Patient recovered.

Simulect Side Effects Report #5630420-9
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on Feb 13, 2008. Female patient, 53 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, liver disorder, renal impairment, thrombocytopenia, transplant rejection. SIMULECT dosage: unknown. During the same period patient was treated with RITUXAN, MEDROL, PROGRAF, CELLCEPT, BREDININ. Patient recovered.

Simulect Side Effects Report #5639210-4
Health Professional from JAPAN reported SIMULECT problem on Feb 18, 2008. Female patient, child 4 years of age, was diagnosed with renal and liver transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, sepsis. SIMULECT dosage: 10 MG, UNK. During the same period patient was treated with PROGRAF, CELLCEPT, METHYLPREDNISOLONE, RITUXAN. Patient died on 06/28/2007.

Simulect Side Effects Report #5581317-4
SIMULECT problem was reported by a Physician from TURKEY on Jan 02, 2008. Female patient was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased, hypotension, platelet count decreased, white blood cell count increased. SIMULECT dosage: unknown. During the same period patient was treated with ANESTHETICS NOS. Patient recovered.

Simulect Side Effects Report #5589255-8
Physician from TURKEY reported SIMULECT problem on Jan 10, 2008. Female patient was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased, hypotension, platelet count decreased, white blood cell count increased. SIMULECT dosage: unknown. During the same period patient was treated with ANESTHETICS NOS. Patient recovered.

Simulect Side Effects Report #5592838-2
SIMULECT problem was reported by a Physician from SPAIN on Jan 11, 2008. Male patient, 49 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: anaemia, arteriovenous graft thrombosis, blood amylase increased, cholecystitis infective, neutrophil count increased, pancreatic abscess, pancreatitis haemorrhagic, pancreatitis necrotising, removal of transplanted organ. SIMULECT dosage: 10 MG, UNK. During the same period patient was treated with URBASON, GOBEMICINA, PROGRAF, TOBRADISTIN, CELLCEPT. Patient was hospitalized. Patient died.

Simulect Side Effects Report #5594300-X
Consumer or non-health professional from FRANCE reported SIMULECT problem on Jan 09, 2008. Female patient, 25 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, blood creatinine increased, blood urea increased, c-reactive protein increased, cough, dialysis, endotracheal intubation, folliculitis, hypocapnia. SIMULECT dosage: unknown. During the same period patient was treated with CELLCEPT. Patient was hospitalized. Patient recovered.

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

Simulect Side Effects Report #5506157-3
Consumer or non-health professional from JAPAN reported SIMULECT problem on Oct 29, 2007. Male patient, 56 years of age, was diagnosed with renal transplant, induction of anaesthesia and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, continuous haemodiafiltration, hypersensitivity, hypotension, respiratory disorder. SIMULECT dosage: unknown. During the same period patient was treated with PROPOFOL, FENTANYL, VECURONIUM BROMIDE, SEVOFLURANE, OXYGEN, ANESTHETICS NOS. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5511151-2
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on Nov 07, 2007. Female patient, child 4 years of age, was diagnosed with organ transplant, renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: post procedural complication, sepsis. SIMULECT dosage: unknown. During the same period patient was treated with PROGRAF, CELLCEPT, STEROIDS NOS, RITUXAN. Patient died.

Simulect Side Effects Report #5518962-8
Consumer or non-health professional from JAPAN reported SIMULECT problem on Nov 08, 2007. Male patient, 56 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, continuous haemodiafiltration, hypersensitivity, hypotension, kidney transplant rejection, respiratory disorder, urine output decreased. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with CELLCEPT, NEORAL, SANDIMMUNE, PROPOFOL, FENTANYL, VECURONIUM BROMIDE, SEVOFLURANE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5519038-6
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on Nov 08, 2007. Male patient, 56 years of age, was diagnosed with renal transplant, induction of anaesthesia and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, continuous haemodiafiltration, hypersensitivity, hypotension, respiratory disorder. SIMULECT dosage: unknown. During the same period patient was treated with PROPOFOL, FENTANYL, VECURONIUM BROMIDE, SEVOFLURANE, OXYGEN, ANESTHETICS NOS. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5520264-0
Consumer or non-health professional from JAPAN reported SIMULECT problem on Nov 07, 2007. Female patient, 14 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: convulsion, encephalopathy. SIMULECT dosage: unknown. During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, STEROIDS NOS. Patient recovered.

Simulect Side Effects Report #5524832-1
SIMULECT problem was reported by a Physician from JAPAN on Nov 19, 2007. Male patient, 56 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, continuous haemodiafiltration, hypersensitivity, hypotension, kidney transplant rejection, respiratory disorder, urine output decreased. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with CELLCEPT, NEORAL, SANDIMMUNE, PROPOFOL, FENTANYL, VECURONIUM BROMIDE, SEVOFLURANE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5524931-4
Consumer or non-health professional from JAPAN reported SIMULECT problem on Nov 16, 2007. Female patient, child 8 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: calcinosis, cystitis bacterial, mucosal inflammation, pyuria, staphylococcal infection, therapeutic procedure, vesicoureteric reflux. SIMULECT dosage: 20 MG, UNK. During the same period patient was treated with CYCLOSPORINE, CELLCEPT, METHYLPREDNISOLONE. Patient recovered.

Simulect Side Effects Report #5526211-X
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on Nov 16, 2007. Female patient, child 8 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: calcinosis, cystitis bacterial, mucosal inflammation, pyuria, staphylococcal infection, therapeutic procedure, vesicoureteric reflux. SIMULECT dosage: 20 MG, UNK. During the same period patient was treated with CYCLOSPORINE, CELLCEPT, METHYLPREDNISOLONE. Patient recovered.

Simulect Side Effects Report #5526467-3
Consumer or non-health professional from JAPAN reported SIMULECT problem on Nov 16, 2007. Female patient, child 4 years of age, was diagnosed with organ transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, sepsis. SIMULECT dosage: unknown. During the same period patient was treated with PROGRAF, CELLCEPT, METHYLPREDNISOLONE, RITUXAN, PLASMAPHERESIS. Patient died on 06/28/2007.

Simulect Side Effects Report #5528659-6
SIMULECT problem was reported by a Physician from JAPAN on Nov 21, 2007. Female patient, 66 years of age, weighting 77.16 lb, was diagnosed with renal transplant, hypertension and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: haemolytic anaemia. SIMULECT dosage: 20 MG, DAY 0. During the same period patient was treated with SANDIMMUNE, CELLCEPT, AMLODIN. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5474094-9
Physician from JAPAN reported SIMULECT problem on Sept 27, 2007. Female patient, child 4 years of age, was diagnosed with organ transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: sepsis. SIMULECT dosage: unknown. During the same period patient was treated with PROGRAF, CELLCEPT, STEROIDS NOS, RITUXAN. Patient died.

Simulect Side Effects Report #5482096-1
SIMULECT problem was reported by a Physician from JAPAN on Oct 02, 2007. Female patient, 66 years of age, weighting 77.16 lb, was diagnosed with renal transplant, hypertension and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: haemolytic anaemia. SIMULECT dosage: 20 MG, DAY 0. During the same period patient was treated with SANDIMMUNE, CELLCEPT, AMLODIPINE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5494189-3
Physician from CANADA reported SIMULECT problem on Oct 15, 2007. Male patient, 59 years of age, weighting 188.7 lb, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: anaemia, asthma, blood creatinine increased, bronchitis, graft dysfunction, renal failure acute, weight decreased. SIMULECT dosage: 40MG PER MONTH. During the same period patient was treated with MYFORTIC, IMURAN, PREDNISONE, ARANESP. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5494603-3
SIMULECT problem was reported by a Physician from GERMANY on Oct 16, 2007. Male patient, 74 years of age, weighting 200.6 lb, was diagnosed with corneal operation, renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: body temperature increased, confusional state, diabetes mellitus inadequate control, gastroenteritis, hyperglycaemia. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5495575-8
Consumer or non-health professional from JAPAN reported SIMULECT problem on Oct 17, 2007. Male patient, 56 years of age, was diagnosed with renal transplant, induction of anaesthesia and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock. SIMULECT dosage: unknown. During the same period patient was treated with PROPOFOL, FENTANYL, VECURONIUM BROMIDE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5452146-7
SIMULECT problem was reported by a Physician from IRELAND on Sept 07, 2007. Male patient, child 12 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: angiopathy, c-reactive protein increased, complications of transplant surgery, dialysis, kidney transplant rejection, mechanical ventilation, pulmonary oedema, pyrexia, thrombotic microangiopathy. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with CELLCEPT, PROGRAF, STEROIDS NOS, ANTIBIOTICS, RANITIDINE, AZATHIOPRINE. Patient recovered.

Simulect Side Effects Report #5461107-3
Physician from CANADA reported SIMULECT problem on Sept 13, 2007. Male patient, 59 years of age, weighting 188.7 lb, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: anaemia, asthma, blood creatinine increased, bronchitis, graft dysfunction, renal failure acute, weight decreased. SIMULECT dosage: 40MG PER MONTH. During the same period patient was treated with MYFORTIC, IMURAN, PREDNISONE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5472335-5
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on Sept 20, 2007. Male patient, 55 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: anaemia, cytomegalovirus antigen positive, duodenal ulcer haemorrhage, faeces discoloured, gastrectomy, pylorectomy. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with NEORAL, CELLCEPT, MEDROL, RITUXAN. Patient was hospitalized. Patient recovered.

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

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

Simulect Side Effects Report #5385007-2
Consumer or non-health professional from JAPAN reported SIMULECT problem on July 03, 2007. Female patient, 32 years of age, was diagnosed with renal and pancreas transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, renal impairment. SIMULECT dosage: 40 MG/D. During the same period patient was treated with PROGRAF, CYCLOPHOSPHAMIDE, CELLCEPT, PREDNISOLONE, ANTICOAGULANTS, ANTIBIOTICS, ANTIFUNGALS. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5387314-6
SIMULECT problem was reported by a Physician from JAPAN on July 13, 2007. Female patient, child 4 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: post procedural complication. SIMULECT dosage: unknown. During the same period patient was treated with PROGRAF, CELLCEPT, STEROIDS NOS. Patient died.

Simulect Side Effects Report #5389834-7
Consumer or non-health professional from JAPAN reported SIMULECT problem on July 11, 2007. Male patient, 39 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus antigen positive, infection, lymphorrhoea, subcutaneous abscess. SIMULECT dosage: 20 MG, UNK. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE, CELLCEPT, BREDININ. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5393666-3
SIMULECT problem was reported by a Physician from JAPAN on July 19, 2007. Male patient, 23 years of age, weighting 114.6 lb, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: candidiasis, epstein-barr virus infection, histiocytosis haematophagic, incisional drainage, intestinal haemorrhage, kidney transplant rejection, malaise, melaena, pyrexia. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, MEDROL, PREDONINE. Patient died on 12/26/2003.

Simulect Side Effects Report #5396398-0
Consumer or non-health professional from JAPAN reported SIMULECT problem on July 19, 2007. Male patient, 23 years of age, weighting 114.6 lb, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: candidiasis, epstein-barr virus infection, histiocytosis haematophagic, incisional drainage, intestinal haemorrhage, kidney transplant rejection, malaise, melaena, pyrexia. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, MEDROL, PREDONINE. Patient died on 12/26/2003.

Simulect Side Effects Report #5396399-2
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on July 19, 2007. Female patient, 15 years of age, weighting 116.8 lb, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: back pain, blister, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, blood potassium increased, blood sodium decreased, cardiac arrest, convulsion, depressed level of consciousness. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, MEDROL. Patient died on 11/23/2003.

Simulect Side Effects Report #5396751-5
Physician from IRELAND reported SIMULECT problem on July 20, 2007. Male patient, child 12 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: angiopathy, c-reactive protein increased, complications of transplant surgery, life support, pulmonary oedema, pyrexia, thrombotic microangiopathy. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with CELLCEPT, PROGRAF, STEROIDS NOS, ANTIBIOTICS, RANITIDINE, AZATHIOPRINE. Patient recovered.

Simulect Side Effects Report #5396771-0
SIMULECT problem was reported by a Physician from IRELAND on July 20, 2007. Male patient, child 12 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: angiopathy, c-reactive protein increased, complications of transplant surgery, life support, pulmonary oedema, pyrexia, thrombotic microangiopathy. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with CELLCEPT, PROGRAF, STEROIDS NOS, ANTIBIOTICS, RANITIDINE, AZATHIOPRINE. Patient recovered.

Simulect Side Effects Report #5401134-5
Consumer or non-health professional from JAPAN reported SIMULECT problem on July 23, 2007. Male patient, 39 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: abscess drainage, cytomegalovirus antigen positive, infection, kidney transplant rejection, lymphorrhoea, pyrexia, subcutaneous abscess, wound infection staphylococcal. SIMULECT dosage: 20 MG, UNK. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE, CELLCEPT, BREDININ. Patient was hospitalized. Patient recovered.

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

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

Simulect Side Effects Report #5385007-2
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on July 03, 2007. Female patient, 32 years of age, was diagnosed with renal and pancreas transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, renal impairment. SIMULECT dosage: 40 MG/D. During the same period patient was treated with PROGRAF, CYCLOPHOSPHAMIDE, CELLCEPT, PREDNISOLONE, ANTICOAGULANTS, ANTIBIOTICS, ANTIFUNGALS. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5387314-6
Physician from JAPAN reported SIMULECT problem on July 13, 2007. Female patient, child 4 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: post procedural complication. SIMULECT dosage: unknown. During the same period patient was treated with PROGRAF, CELLCEPT, STEROIDS NOS. Patient died.

Simulect Side Effects Report #5389834-7
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on July 11, 2007. Male patient, 39 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus antigen positive, infection, lymphorrhoea, subcutaneous abscess. SIMULECT dosage: 20 MG, UNK. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE, CELLCEPT, BREDININ. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5393666-3
Physician from JAPAN reported SIMULECT problem on July 19, 2007. Male patient, 23 years of age, weighting 114.6 lb, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: candidiasis, epstein-barr virus infection, histiocytosis haematophagic, incisional drainage, intestinal haemorrhage, kidney transplant rejection, malaise, melaena, pyrexia. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, MEDROL, PREDONINE. Patient died on 12/26/2003.

Simulect Side Effects Report #5396398-0
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on July 19, 2007. Male patient, 23 years of age, weighting 114.6 lb, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: candidiasis, epstein-barr virus infection, histiocytosis haematophagic, incisional drainage, intestinal haemorrhage, kidney transplant rejection, malaise, melaena, pyrexia. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, MEDROL, PREDONINE. Patient died on 12/26/2003.

Simulect Side Effects Report #5396399-2
Consumer or non-health professional from JAPAN reported SIMULECT problem on July 19, 2007. Female patient, 15 years of age, weighting 116.8 lb, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: back pain, blister, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, blood potassium increased, blood sodium decreased, cardiac arrest, convulsion, depressed level of consciousness. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, MEDROL. Patient died on 11/23/2003.

Simulect Side Effects Report #5396751-5
SIMULECT problem was reported by a Physician from IRELAND on July 20, 2007. Male patient, child 12 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: angiopathy, c-reactive protein increased, complications of transplant surgery, life support, pulmonary oedema, pyrexia, thrombotic microangiopathy. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with CELLCEPT, PROGRAF, STEROIDS NOS, ANTIBIOTICS, RANITIDINE, AZATHIOPRINE. Patient recovered.

Simulect Side Effects Report #5396771-0
Physician from IRELAND reported SIMULECT problem on July 20, 2007. Male patient, child 12 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: angiopathy, c-reactive protein increased, complications of transplant surgery, life support, pulmonary oedema, pyrexia, thrombotic microangiopathy. SIMULECT dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with CELLCEPT, PROGRAF, STEROIDS NOS, ANTIBIOTICS, RANITIDINE, AZATHIOPRINE. Patient recovered.

Simulect Side Effects Report #5401134-5
SIMULECT problem was reported by a Consumer or non-health professional from JAPAN on July 23, 2007. Male patient, 39 years of age, was diagnosed with renal transplant and was treated with SIMULECT. After drug was administered, patient experienced the following problems/side effects: abscess drainage, cytomegalovirus antigen positive, infection, kidney transplant rejection, lymphorrhoea, pyrexia, subcutaneous abscess, wound infection staphylococcal. SIMULECT dosage: 20 MG, UNK. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE, CELLCEPT, BREDININ. Patient was hospitalized. Patient recovered.