Simulect and convulsion Patient Reports February 12, 2012

Simulect Side Effects Report #5279254-8
Simulect side effect was reported by a Physician from JAPAN on Mar 16, 2007. Male patient, child 3 years of age, weighting 26.46 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: brain oedema, cardiac failure, convulsion, depressed level of consciousness, eye disorder, gaze palsy, hypertension, hypertensive encephalopathy. Simulect dosage: 10 MG, ONCE/SINGLE. During the same period patient was treated with SANDIMMUNE, PREDNISOLONE. Patient was hospitalized and became disabled. Patient recovered.

Simulect Side Effects Report #5195507-6
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on Dec 20, 2006. Male patient, 25 years of age, weighting 66.14 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: body temperature increased, chills, convulsion, disease progression, dystonia , eye movement disorder, gaze palsy, heart rate increased, hypertension. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, NEORAL, PREDONINE, CALCIUM CARBONATE, RENAGEL. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5212121-4
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on Jan 09, 2007. Male patient, 25 years of age, weighting 66.14 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: blood pressure increased, body temperature increased, chills, convulsion, depression , disease progression, dyskinesia, dystonia , eye movement disorder. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, NEORAL, PREDONINE, CALCIUM CARBONATE, RENAGEL. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5832740-1
Simulect side effect was reported by a Health Professional from JAPAN on July 29, 2008. Male patient, 25 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: altered state of consciousness, blister, convulsion, encephalitis herpes, herpes zoster, iga nephropathy, malaise, pain . Simulect dosage: 20 MG. During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, PREDNISOLONE. Patient was hospitalized. Patient died.


Simulect Side Effects Report #5853710-3
Simulect side effect was reported by a Health Professional from JAPAN on Aug 19, 2008. Male patient, 25 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: altered state of consciousness, blister, convulsion, encephalitis herpes, herpes zoster, iga nephropathy, malaise, pain . Simulect dosage: 20 MG. During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, PREDNISOLONE. Patient was hospitalized. Patient died.

Simulect Side Effects Report #5857172-1
Simulect side effect was reported by a Health Professional from JAPAN on Aug 19, 2008. Male patient, 25 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: altered state of consciousness, blister, convulsion, encephalitis herpes, herpes zoster, iga nephropathy, malaise, pain . Simulect dosage: 20 MG. During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, PREDNISOLONE. Patient was hospitalized. Patient died.

Simulect Side Effects Report #5857787-0
Simulect side effect was reported by a Health Professional from JAPAN on Aug 19, 2008. Male patient, 25 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: altered state of consciousness, blister, convulsion, encephalitis herpes, herpes zoster, iga nephropathy, malaise, pain . Simulect dosage: 20 MG. During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, PREDNISOLONE. Patient was hospitalized. Patient died.

Simulect Side Effects Report #4568108-8
Simulect side effect was reported by a Consumer or non-health professional from on July 08, 2004. Male patient, 25 years of age, weighting 66.14 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: body temperature increased, chills, convulsion, disease progression, dystonia , gaze palsy, heart rate increased, hypertension, loss of consciousness. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, NEORAL, PREDONINE, CALCIUM CARBONATE, RENAGEL. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #4577184-8
Simulect side effect was reported by a Consumer or non-health professional from on July 08, 2004. Male patient, 25 years of age, weighting 66.14 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: body temperature increased, convulsion, disease progression, dystonia , eye movement disorder, gaze palsy, heart rate increased, hypertension, loss of consciousness. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, NEORAL, PREDONINE, CALCIUM CARBONATE, RENAGEL. Patient was hospitalized. Patient recovered.


Simulect Side Effects Report #5396399-2
Simulect side effect 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 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 #5008814-4
Simulect side effect was reported by a Physician from GERMANY on Oct 27, 2003. Female patient, 15 years of age, weighting 68.34 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cardiac arrest , catheter related infection, cholestasis, convulsion, haematuria, hypotension, hypoventilation, ileus paralytic. Simulect dosage: 10 MG, (DAY 0). During the same period patient was treated with CELLCEPT, NEORAL, URBASON. Patient was hospitalized. Patient died on 11/14/2003.

Simulect Side Effects Report #5520264-0
Simulect side effect was reported by a Consumer or non-health professional from JAPAN 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 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 #5775454-9
Simulect side effect was reported by a Health Professional from JAPAN on June 09, 2008. Female patient, 14 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: convulsion, encephalopathy. Simulect dosage: 20 MG. During the same period patient was treated with TACROLIMUS, CELLCEPT, STEROIDS NOS. Patient recovered.

Simulect Side Effects Report #5751658-6
Simulect side effect was reported by a Physician from JAPAN on May 21, 2008. Female patient, weighting 101.4 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: blood creatinine increased, condition aggravated, convulsion, depressed level of consciousness, haemodialysis, kidney transplant rejection, toxic encephalopathy. Simulect dosage: 20 MG DAILY. During the same period patient was treated with CELLCEPT, PROGRAF, PREDONINE, RITUXAN. Patient recovered.