Sandimmune and respiratory failure Patient Reports February 11, 2012

Sandimmune Side Effects Report #5043138-0
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on June 21, 2006. Female patient, 42 years of age, was diagnosed with renal transplant and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: anaplastic large cell lymphoma t- and null-cell types, bone marrow disorder, diffuse large b-cell lymphoma, epstein-barr virus infection, lymphadenopathy, respiratory failure, skin disorder. Sandimmune dosage: 50 MG/D. During the same period patient was treated with PREDNISOLONE, AZATHIOPRINE, CYCLOPHOSPHAMIDE. Patient died.

Sandimmune Side Effects Report #4634252-X
Sandimmune side effect was reported by a Consumer or non-health professional from on Mar 23, 2005. Male patient, 82 years of age, was diagnosed with psoriasis and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: anaplastic large cell lymphoma t- and null-cell types, cerebral haemorrhage, metastases to bone, metastases to pleura, respiratory failure. Sandimmune dosage: unknown. During the same period patient was treated with STEROIDS NOS. Patient was hospitalized. Patient died on 03/09/2002.

Sandimmune Side Effects Report #4663398-5
Sandimmune side effect was reported by a Consumer or non-health professional from on Mar 23, 2005. Male patient, 82 years of age, was diagnosed with psoriasis and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: anaplastic large cell lymphoma t- and null-cell types, cerebral haemorrhage, metastases to bone, metastases to pleura, respiratory failure, subcutaneous nodule. Sandimmune dosage: unknown. During the same period patient was treated with STEROIDS NOS. Patient was hospitalized. Patient died on 03/09/2002.

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 #5825218-2
Sandimmune side effect was reported by a Health Professional from BRAZIL on July 23, 2008. Female patient, weighting 114.2 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 , chest pain , neck pain, respiratory failure, vision blurred. Sandimmune dosage: 75 MG, Q12H. During the same period patient was treated with FLUCONAZOLE, ACYCLOVIR, ONDANSETRON, CEFEPIME, GRANULOKINE, URSODIOL, OMEPRAZOLE. Patient died on 06/27/2008.

Sandimmune Side Effects Report #5825945-7
Sandimmune side effect was reported by a Health Professional from BRAZIL on July 23, 2008. Male patient, weighting 58.20 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: fatigue, hypotension, mechanical ventilation, respiratory failure, somnolence, vision blurred, visual acuity reduced, visual impairment. Sandimmune dosage: 80 MG, UNK. During the same period patient was treated with MEROPENEM, ACYCLOVIR, ONDANSETRON, METYLPREDNISOLON SOLUBILE, CASPOFUNGIN, GRANULOKINE, OMEPRAZOLE. Patient died on 05/31/2008.

Sandimmune Side Effects Report #5825955-X
Sandimmune side effect was reported by a Health Professional from BRAZIL on July 23, 2008. Male patient, weighting 194.4 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: hypoacusis, mechanical ventilation, paraesthesia, respiratory failure, vertigo, vision blurred. Sandimmune dosage: 80 MG, Q12H. During the same period patient was treated with ACYCLOVIR, URSODIOL, AMLODIPINE. Patient died on 06/03/2008.

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 #5916318-7
Sandimmune side effect was reported by a Health Professional from BRAZIL on Oct 08, 2008. Male patient, weighting 194.4 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: hypoacusis, mechanical ventilation, paraesthesia, respiratory failure, vertigo, vision blurred. Sandimmune dosage: 80 MG, Q12H. During the same period patient was treated with ACYCLOVIR, URSODIOL, AMLODIPINE. Patient died on 06/03/2008.


Sandimmune Side Effects Report #5916324-2
Sandimmune side effect was reported by a Health Professional from BRAZIL on Oct 08, 2008. Male patient, weighting 58.20 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: fatigue, hypotension, mechanical ventilation, respiratory failure, somnolence, vision blurred, visual acuity reduced, visual impairment. Sandimmune dosage: 80 MG, UNK. During the same period patient was treated with MEROPENEM, ACYCLOVIR, ONDANSETRON, METYLPREDNISOLON SOLUBILE, CASPOFUNGIN, GRANULOKINE, OMEPRAZOLE. Patient died on 05/31/2008.

Sandimmune Side Effects Report #5940143-4
Sandimmune side effect was reported by a Health Professional from BRAZIL on Oct 30, 2008. Male patient, weighting 57.32 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 , cytomegalovirus infection , fatigue, graft versus host disease, hypotension, mechanical ventilation, respiratory failure, sepsis , somnolence. Sandimmune dosage: 80 MG, UNK. During the same period patient was treated with MEROPENEM, ACYCLOVIR, ONDANSETRON, METYLPREDNISOLON SOLUBILE, CASPOFUNGIN, GRANULOKINE, OMEPRAZOLE. Patient died on 05/31/2008.

Sandimmune Side Effects Report #5850950-4
Sandimmune side effect was reported by a Health Professional from SWITZERLAND on Aug 15, 2008. Female patient was diagnosed with myopathy and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: endotracheal intubation, herpes simplex , pneumocystis jiroveci pneumonia, respiratory failure. Sandimmune dosage: 150 MG / DAY. During the same period patient was treated with METHOTREXATE, PREDNISON. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #6081420-9
Sandimmune side effect was reported by a Health Professional from JAPAN on Feb 13, 2009. Male patient, child 3 years of age, was diagnosed with lymphohistiocytosis, bone marrow transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: cystitis haemorrhagic, engraftment syndrome, interstitial lung disease, mechanical ventilation, respiratory disorder, respiratory failure. Sandimmune dosage: unknown. During the same period patient was treated with DEXAMETHASONE, ETOPOSIDE, BUSULFAN, CYCLOPHOSPHAMIDE. Patient died.

Sandimmune Side Effects Report #6081580-X
Sandimmune side effect was reported by a Health Professional from JAPAN on Feb 13, 2009. Male patient, child 3 years of age, was diagnosed with lymphohistiocytosis, bone marrow transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: cystitis haemorrhagic, engraftment syndrome, interstitial lung disease, mechanical ventilation, respiratory disorder, respiratory failure. Sandimmune dosage: unknown. During the same period patient was treated with DEXAMETHASONE, ETOPOSIDE, BUSULFAN, CYCLOPHOSPHAMIDE. Patient died.


Sandimmune Side Effects Report #4674605-7
Sandimmune side effect was reported by a Physician from on Dec 16, 2004. Male patient, 58 years of age, weighting 235.9 lb, was diagnosed with lung transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: disease progression, dyspnoea, obliterative bronchiolitis, pneumonia , respiratory failure. Sandimmune dosage: 250 MG / DAY. During the same period patient was treated with IMUREL, PREDNISOLONE. Patient was hospitalized. Patient died on 05/05/2005.

Sandimmune Side Effects Report #4700992-7
Sandimmune side effect was reported by a Physician from on Dec 16, 2004. Male patient, 58 years of age, weighting 235.9 lb, was diagnosed with lung transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: disease progression, dyspnoea, obliterative bronchiolitis, pneumonia , respiratory failure. Sandimmune dosage: 250 MG / DAY. During the same period patient was treated with IMUREL, PREDNISOLONE. Patient was hospitalized. Patient died on 05/05/2005.

Sandimmune Side Effects Report #4826463-5
Sandimmune side effect was reported by a Physician from DENMARK on Dec 16, 2004. Male patient, 58 years of age, weighting 235.9 lb, was diagnosed with lung transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: blood creatinine increased, disease progression, dyspnoea, hypoglycaemia, obliterative bronchiolitis, pneumonia , respiratory failure, transplant rejection. Sandimmune dosage: 250 MG / DAY. During the same period patient was treated with IMUREL, PREDNISOLONE. Patient was hospitalized. Patient died on 05/04/2005.

Sandimmune Side Effects Report #5276732-2
Sandimmune side effect was reported by a Physician from GERMANY on Mar 19, 2007. Female patient, 61 years of age, weighting 176.4 lb, was diagnosed with liver transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: leukoencephalopathy, life support, pupillary reflex impaired, respiratory failure, somnolence. Sandimmune dosage: 200 MG, BID. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5058243-2
Sandimmune side effect was reported by a Physician from GERMANY on July 04, 2006. Female patient, 61 years of age, weighting 176.4 lb, was diagnosed with liver transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: life support, neurological symptom, pupillary reflex impaired, respiratory failure. Sandimmune dosage: 200 MG, BID. Patient was hospitalized. Patient died on 07/14/2006.


Sandimmune Side Effects Report #5065610-X
Sandimmune side effect was reported by a Physician from GERMANY on July 04, 2006. Female patient, 61 years of age, weighting 176.4 lb, was diagnosed with liver transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: leukoencephalopathy, life support, pupillary reflex impaired, respiratory failure, somnolence. Sandimmune dosage: 200 MG, BID. Patient was hospitalized. Patient died.

Sandimmune Side Effects Report #5366475-9
Sandimmune side effect was reported by a Physician from GERMANY on June 19, 2007. Male patient, 32 years of age, was diagnosed with liver transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: cardiovascular insufficiency, catheter placement, laparotomy, lung disorder, post procedural haemorrhage, renal failure, respiratory failure, tracheostomy. Sandimmune dosage: 100 - 200 MG/DAY. During the same period patient was treated with NEORAL. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5375852-1
Sandimmune side effect was reported by a Physician from GERMANY on June 19, 2007. Male patient, 32 years of age, was diagnosed with liver transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: cardiovascular insufficiency, catheter placement, laparotomy, lung disorder, post procedural haemorrhage, renal failure, respiratory failure, tracheostomy. Sandimmune dosage: 100 - 200 MG/DAY. During the same period patient was treated with NEORAL. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5052523-2
Sandimmune side effect was reported by a Physician from JAPAN on July 04, 2006. Male patient, 16 years of age, was diagnosed with colitis ulcerative and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, chest pain , life support, pulmonary infarction, respiratory failure, sepsis . Sandimmune dosage: 180 MG/D. Patient died on 07/04/2006.

Sandimmune Side Effects Report #5123106-0
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on Sept 27, 2006. Female patient, 68 years of age, weighting 99.21 lb, was diagnosed with bone marrow transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: graft versus host disease, idiopathic pneumonia syndrome, pneumonia herpes viral, respiratory failure. Sandimmune dosage: unknown. During the same period patient was treated with NEORAL. Patient died on 12/30/2005.


Sandimmune Side Effects Report #5500989-3
Sandimmune side effect was reported by a Consumer or non-health professional from JAPAN on Oct 23, 2007. Female patient, 48 years of age, was diagnosed with bone marrow transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: haemolytic anaemia, herpes zoster, pulmonary haemorrhage, red blood cell schistocytes present, respiratory failure, thrombocytopenia, thrombotic microangiopathy. Sandimmune dosage: 100 MG/DAY. Patient was hospitalized. Patient died on 01/01/1999.

Sandimmune Side Effects Report #4923570-3
Sandimmune side effect was reported by a Physician from JAPAN on Dec 27, 2005. Male patient, 26 years of age, was diagnosed with bone marrow transplant  and was treated with Sandimmune. After drug was administered, patient experienced the following side effects: graft complication, pneumonia , respiratory failure. Sandimmune dosage: 3 MG/KG/DAY. Patient died on 12/27/2005.