Sandimmune and depressed level of consciousness Patient Reports February 11, 2012

Sandimmune Side Effects Report #5938582-0
Sandimmune side effect was reported by a Health Professional from BRAZIL on Oct 30, 2008. Male patient, weighting 35.27 lb, was diagnosed with transplant, prophylaxis against graft versus host disease and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: amaurosis, blood pressure abnormal, coma, convulsion, depressed level of consciousness, depression , fatigue, graft versus host disease, headache . Sandimmune dosage: 190 MG/DAY. During the same period patient was treated with METHYLPREDNISOLONE, FLUCONAZOLE, ACYCLOVIR, OMEPRAZOLE, ONDANSETRON, AMLODIPINE, URSODIOL. Patient was hospitalized and became disabled. Patient died on 01/22/2008.

Sandimmune Side Effects Report #5822161-X
Sandimmune side effect was reported by a Health Professional from BRAZIL on July 23, 2008. Male patient, weighting 28.66 lb, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: depressed level of consciousness, mechanical ventilation, respiratory failure, visual impairment. Sandimmune dosage: 190 MG, QD. During the same period patient was treated with METHYLPREDNISOLONE, FLUCONAZOLE, ACYCLOVIR, OMEPRAZOLE, ONDANSETRON, AMLODIPINE, URSODIOL. Patient was hospitalized and became disabled. Patient died on 01/22/2008.

Sandimmune Side Effects Report #5825215-7
Sandimmune side effect was reported by a Health Professional from BRAZIL on July 23, 2008. Male patient, weighting 51.59 lb, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: agitation, depressed level of consciousness, irritability, partial seizures, somnolence, vision blurred. Sandimmune dosage: 200 MG, QD. During the same period patient was treated with CEFEPIME, OMEPRAZOLE, LEUCOVORIN CALCIUM, URSODIOL, BROMOPRIDE, AMLODIPINE, ONDANSETRON, ACYCLOVIR. Patient died on 04/30/2008.

Sandimmune Side Effects Report #5825219-4
Sandimmune side effect was reported by a Pharmacist from BRAZIL on July 23, 2008. Male patient, weighting 36.38 lb, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: agitation, confusional state, depressed level of consciousness, disorientation, irritability, respiratory disorder. Sandimmune dosage: 30 MG, Q12H. During the same period patient was treated with ONDANSETRON, ACYCLOVIR, URSODIOL, IMMUNOGLOBULINS, GRANULOKINE, MEROPENEM, CANCIDAS, METRONIDAZOLE. Patient died on 04/26/2008.


Sandimmune Side Effects Report #5916311-4
Sandimmune side effect was reported by a Health Professional from BRAZIL on Oct 08, 2008. Male patient, weighting 28.66 lb, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: depressed level of consciousness, fatigue, mechanical ventilation, respiratory failure, visual impairment. Sandimmune dosage: 190 MG, QD. During the same period patient was treated with METHYLPREDNISOLONE, FLUCONAZOLE, ACYCLOVIR, OMEPRAZOLE, ONDANSETRON, AMLODIPINE, URSODIOL. Patient was hospitalized and became disabled. Patient died on 01/22/2008.

Sandimmune Side Effects Report #5916325-4
Sandimmune side effect was reported by a Health Professional from BRAZIL on Oct 08, 2008. Male patient, weighting 51.59 lb, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: agitation, depressed level of consciousness, irritability, partial seizures, somnolence, vision blurred. Sandimmune dosage: 200 MG, QD. During the same period patient was treated with CEFEPIME, OMEPRAZOLE, LEUCOVORIN CALCIUM, URSODIOL, BROMOPRIDE, AMLODIPINE, ONDANSETRON, ACYCLOVIR. Patient died on 04/30/2008.

Sandimmune Side Effects Report #5916328-X
Sandimmune side effect was reported by a Pharmacist from BRAZIL on Oct 08, 2008. Male patient, weighting 36.38 lb, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: agitation, confusional state, depressed level of consciousness, disorientation, irritability, respiratory disorder. Sandimmune dosage: 30 MG, Q12H. During the same period patient was treated with ONDANSETRON, ACYCLOVIR, URSODIOL, IMMUNOGLOBULINS, GRANULOKINE, MEROPENEM, CANCIDAS, METRONIDAZOLE. Patient died on 04/26/2008.

Sandimmune Side Effects Report #5940145-8
Sandimmune side effect was reported by a Health Professional from BRAZIL on Oct 30, 2008. Male patient, weighting 51.59 lb, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: abdominal pain , agitation, amaurosis, aphasia , ataxia , coma, depressed level of consciousness, echolalia, graft versus host disease. Sandimmune dosage: 200 MG/DAY. During the same period patient was treated with CEFEPIME, OMEPRAZOLE, LEUCOVORIN CALCIUM, URSODIOL, BROMOPRIDE, AMLODIPINE, ONDANSETRON, ACYCLOVIR. Patient was hospitalized. Patient died on 04/30/2008.

Sandimmune Side Effects Report #5941003-5
Sandimmune side effect was reported by a Pharmacist from BRAZIL on Oct 30, 2008. Male patient, weighting 36.38 lb, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: abdominal pain , agitation, altered state of consciousness, arrhythmia , confusional state, depressed level of consciousness, disorientation, hallucination, visual, headache . Sandimmune dosage: 30 MG, BID. During the same period patient was treated with ZOVIRAX, ONDANSETRON HYDROCHLORIDE, URSACOL, IMMUNE GLOBULIN NOS, GRANULOKINE, MEROPENEM, CANCIDAS. Patient died on 04/26/2008.


Sandimmune Side Effects Report #5883489-0
Sandimmune side effect was reported by a Health Professional from JAPAN on Sept 04, 2008. Female patient was diagnosed with colitis ulcerative and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: depressed level of consciousness, toxic encephalopathy. Sandimmune dosage: ABOUT 200 MG/DAY. During the same period patient was treated with PENTASA, SALAZOPYRIN, PREDNISOLONE. Patient recovered.

Sandimmune Side Effects Report #5958534-4
Sandimmune side effect was reported by a Health Professional from JAPAN on Nov 13, 2008. Male patient, 44 years of age, was diagnosed with bone marrow transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: convulsion, depressed level of consciousness, encephalitis herpes, encephalopathy, engraftment syndrome, graft versus host disease, human herpesvirus 6 infection, hypoxia. Sandimmune dosage: 250 MG/DAY. During the same period patient was treated with METHOTREXATE, CYCLOPHOSPHAMIDE. Patient died.

Sandimmune Side Effects Report #5958535-6
Sandimmune side effect was reported by a Health Professional from JAPAN on Nov 13, 2008. Male patient, 44 years of age, was diagnosed with bone marrow transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: convulsion, depressed level of consciousness, encephalitis herpes, encephalopathy, engraftment syndrome, graft versus host disease, human herpesvirus 6 infection, hypoxia. Sandimmune dosage: 250 MG/DAY. During the same period patient was treated with METHOTREXATE, CYCLOPHOSPHAMIDE. Patient died.

Sandimmune Side Effects Report #4544544-0
Sandimmune side effect was reported by a Physician from on Dec 09, 2004. Male patient, 39 years of age, weighting 163.1 lb, was diagnosed with bone marrow transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: cellulitis , convulsion, depressed level of consciousness, dyspnoea, electroencephalogram abnormal, local swelling, mydriasis, nervous system disorder, pupillary reflex impaired. Sandimmune dosage: unknown. During the same period patient was treated with BUSULFAN, ENDOXAN, FRAGMIN, ZOVIRAX, CARBENIN, VANCOMYCIN, HABEKACIN, MEROPEN. Patient died on 11/25/2004.

Sandimmune Side Effects Report #5379781-9
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on July 04, 2007. Female patient, child 9 years of age, was treated with Sandimmune. After drug was administered, patient experienced the following side effects: acute graft versus host disease, convulsion, depressed level of consciousness, interstitial lung disease, neurological symptom, pain in extremity, renal impairment. Sandimmune dosage: unknown. During the same period patient was treated with PREDNISOLONE, BUSULFAN, MELPHALAN, VANCOMYCIN. Patient died on 06/22/2005.


Sandimmune Side Effects Report #5379885-0
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on July 04, 2007. Female patient, child 9 years of age, was treated with Sandimmune. After drug was administered, patient experienced the following side effects: acute graft versus host disease, convulsion, depressed level of consciousness, interstitial lung disease, neurological symptom, pain in extremity, renal impairment. Sandimmune dosage: unknown. During the same period patient was treated with PREDNISOLONE, BUSULFAN, MELPHALAN, VANCOMYCIN. Patient died on 06/22/2005.

Sandimmune Side Effects Report #5621809-2
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on Feb 08, 2008. Male patient, 53 years of age, was treated with Sandimmune. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia, convulsion, delirium, depressed level of consciousness, reversible posterior leukoencephalopathy syndrome, visual disturbance. Sandimmune dosage: unknown. Patient died.

Sandimmune Side Effects Report #5621811-0
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on Feb 08, 2008. Male patient, 53 years of age, was treated with Sandimmune. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia, convulsion, delirium, depressed level of consciousness, reversible posterior leukoencephalopathy syndrome, visual disturbance. Sandimmune dosage: unknown. Patient died.

Sandimmune Side Effects Report #6019591-2
Sandimmune side effect was reported by a Health Professional from JAPAN on Dec 19, 2008. Female patient, 32 years of age, was treated with Sandimmune. After drug was administered, patient experienced the following side effects: blood pressure increased, cytokine storm, depressed level of consciousness, grand mal convulsion, hypertension, pneumonia , reversible posterior leukoencephalopathy syndrome, subarachnoid haemorrhage. Sandimmune dosage: 150-200 MG/DAY. During the same period patient was treated with CYLOCIDE, ENDOXAN. Patient was hospitalized. Patient died on 11/30/2008.

Sandimmune Side Effects Report #5379717-0
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on July 04, 2007. Male patient, 15 years of age, was treated with Sandimmune. After drug was administered, patient experienced the following side effects: adenovirus infection, convulsion, depressed level of consciousness, graft versus host disease, neurological symptom, pain in extremity, renal failure acute. Sandimmune dosage: unknown. During the same period patient was treated with PREDNISOLONE, BUSULFAN, CIDOFOVIR. Patient died on 06/01/2005.


Sandimmune Side Effects Report #5379889-8
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on July 04, 2007. Male patient, 15 years of age, was treated with Sandimmune. After drug was administered, patient experienced the following side effects: adenovirus infection, convulsion, depressed level of consciousness, graft versus host disease, neurological symptom, pain in extremity, renal failure acute. Sandimmune dosage: unknown. During the same period patient was treated with PREDNISOLONE, BUSULFAN, CIDOFOVIR. Patient died on 06/01/2005.

Sandimmune Side Effects Report #5379698-X
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on July 04, 2007. Male patient, child 10 years of age, was treated with Sandimmune. After drug was administered, patient experienced the following side effects: acute graft versus host disease in intestine, chronic graft versus host disease, convulsion, depressed level of consciousness, haemorrhage intracranial, neurological symptom, pain in extremity, thrombotic microangiopathy. Sandimmune dosage: unknown. During the same period patient was treated with METHOTREXATE, BUSULFAN, TACROLIMUS. Patient died.

Sandimmune Side Effects Report #5379891-6
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on July 04, 2007. Male patient, child 10 years of age, was treated with Sandimmune. After drug was administered, patient experienced the following side effects: acute graft versus host disease in intestine, chronic graft versus host disease, convulsion, depressed level of consciousness, haemorrhage intracranial, neurological symptom, pain in extremity, thrombotic microangiopathy. Sandimmune dosage: unknown. During the same period patient was treated with METHOTREXATE, BUSULFAN, TACROLIMUS. Patient died.

Sandimmune Side Effects Report #5800264-3
Sandimmune side effect was reported by a Pharmacist from BRAZIL on June 24, 2008. Female patient was treated with Sandimmune. After drug was administered, patient experienced the following side effects: depressed level of consciousness, disorientation. Sandimmune dosage: unknown. Patient recovered.

Sandimmune Side Effects Report #5812040-6
Sandimmune side effect was reported by a Pharmacist from BRAZIL on July 07, 2008. Female patient was treated with Sandimmune. After drug was administered, patient experienced the following side effects: depressed level of consciousness, disorientation. Sandimmune dosage: 220 MG PER DAY. Patient recovered.