Sandimmune and agitation Patient Reports February 12, 2012

Sandimmune Side Effects Report #4971648-0
Sandimmune side effect was reported by a Pharmacist from GERMANY on Apr 07, 2006. Male patient was diagnosed with rheumatoid arthritis  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: abdominal pain upper, agitation, cerebrovascular accident, decreased appetite, fall , hemiparesis, nervousness. Sandimmune dosage: 100 MG/DAY. During the same period patient was treated with FORTECORTIN. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5397400-2
Sandimmune side effect was reported by a Physician from SWITZERLAND on July 20, 2007. Female patient, 85 years of age, was diagnosed with renal transplant, depression  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: agitation, akinesia, anxiety , c-reactive protein increased, clonus, confusional state, disorientation. Sandimmune dosage: 125 MG/D. During the same period patient was treated with CIPRALEX, CEFUROXIME AXETIL, IMUREK, PERFALGAN, VANCOMYCIN, ROCEPHIN, MEMANTINE. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5876979-8
Sandimmune side effect was reported by a Health Professional from SWITZERLAND on Aug 29, 2008. Female patient, 85 years of age, was diagnosed with renal transplant, depression  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: agitation, akinesia, anxiety , c-reactive protein increased, clonus, confusional state, delirium, disorientation. Sandimmune dosage: 125 MG/D. During the same period patient was treated with CIPRALEX, CEFUROXIME AXETIL, IMUREK, PERFALGAN, VANCOMYCIN, ROCEPHIN, MEMANTINE. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5369982-8
Sandimmune side effect was reported by a Physician from FRANCE on June 22, 2007. Male patient, 13 years of age, weighting 92.59 lb, was diagnosed with renal transplant, anaesthesia and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: agitation, allergy test positive, anaphylactic shock, anuria, arteriovenous fistula thrombosis, central venous pressure decreased, chills, circulatory collapse, depressed level of consciousness. Sandimmune dosage: 75 MG PER DAY. During the same period patient was treated with SIMULECT, SUFENTA, NIMBEX, CLAFORAN, HYPNOVEL, AZATHIOPRINE. Patient was hospitalized. Patient recovered.


Sandimmune Side Effects Report #5703759-6
Sandimmune side effect was reported by a Consumer or non-health professional from FRANCE on Apr 08, 2008. Male patient, 13 years of age, weighting 92.59 lb, was diagnosed with renal transplant, anaesthesia and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: agitation, allergy test positive, anaphylactic shock, anuria, arteriovenous fistula thrombosis, central venous pressure decreased, chills, circulatory collapse, depressed level of consciousness. Sandimmune dosage: 75 MG PER DAY. During the same period patient was treated with SIMULECT, SUFENTA, NIMBEX, CLAFORAN, HYPNOVEL, IMUREL. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5723431-6
Sandimmune side effect was reported by a Consumer or non-health professional from FRANCE on Apr 24, 2008. Male patient, 13 years of age, weighting 92.59 lb, was diagnosed with renal transplant, anaesthesia and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: agitation, allergy test positive, anaphylactic shock, anuria, arteriovenous fistula thrombosis, central venous pressure decreased, chills, circulatory collapse, depressed level of consciousness. Sandimmune dosage: 75 MG PER DAY. During the same period patient was treated with SIMULECT, SUFENTA, NIMBEX, CLAFORAN, HYPNOVEL, IMUREL. Patient was hospitalized. Patient recovered.

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 #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 #5940996-X
Sandimmune side effect was reported by a Health Professional from BRAZIL on Oct 30, 2008. Male patient, weighting 194.4 lb, was diagnosed with prophylaxis against graft versus host disease, bone marrow transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: agitation, anxiety , coma, graft versus host disease, hypoacusis, inflammation, mechanical ventilation, neurotoxicity, nuclear magnetic resonance imaging abnormal. Sandimmune dosage: 80 MG, Q12H. During the same period patient was treated with VFEND, ACYCLOVIR, URSODIOL, AMLODIPINE, ZOLBEN, ZYLORIC, AMIKACIN. Patient died on 06/03/2008.

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 #6047973-1
Sandimmune side effect was reported by a Physician from FRANCE on Jan 14, 2009. Male patient, 73 years of age, was diagnosed with bone marrow failure, atrial fibrillation , sarcoidosis and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: abdominal pain , agitation, confusional state, delirium, delusion, mesenteric vein thrombosis, nausea , psychotic disorder . Sandimmune dosage: 100 MG/DAY. During the same period patient was treated with CORDARONE, NOXAFIL, HALDOL, ANTILYMPHOCYTE SERUM, CORTICOSTEROIDS, RITUXIMAB. Patient was hospitalized. Patient recovered.