Prograf and respiratory failure Patient Reports February 10, 2012

Prograf Side Effects Report #6125050-9
Prograf side effect was reported by a Health Professional from UNITED STATES on Mar 10, 2009. Female patient, 51 years of age, was diagnosed with stem cell transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: graft versus host disease in lung, lung infection, respiratory failure, superinfection. Prograf dosage: unknown. Patient was hospitalized. Patient died on 01/16/2009.

Prograf Side Effects Report #5370600-3
Prograf side effect was reported by a Physician from GERMANY on June 12, 2007. Male patient, 47 years of age, was diagnosed with stem cell transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: acute graft versus host disease in skin, areflexia, convulsion, encephalitis herpes, human herpes virus 6 serology positive, respiratory failure, viraemia. Prograf dosage: unknown. Patient recovered.

Prograf Side Effects Report #6075606-7
Prograf side effect was reported by a Physician from JAPAN on Feb 03, 2009. Male patient, 36 years of age, was diagnosed with stem cell transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: chronic graft versus host disease, cytomegalovirus infection , fungal infection , pneumonia aspiration, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with CYCLOSPORINE, PREDNISOLONE. Patient was hospitalized. Patient died.

Prograf Side Effects Report #5613364-8
Prograf side effect was reported by a Physician from JAPAN on Jan 10, 2008. Female patient, 31 years of age, was diagnosed with stem cell transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: bronchopulmonary aspergillosis, cytomegalovirus infection , diabetic ketoacidosis, enterobacter sepsis, febrile neutropenia, respiratory failure. Prograf dosage: 0.02 MG/KG. During the same period patient was treated with METHOTREXATE, METHYLPREDNISOLONE, GANCICLOVIR, TOSUFLOXACIN, FLUCONAZOLE, TRIMETOPRIM, MEROPENEM. Patient died.


Prograf Side Effects Report #4556450-6
Prograf side effect was reported by a Physician from on Jan 06, 2005. Male patient, child 3 years of age, weighting 26.46 lb, was diagnosed with small intestine transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: bacteraemia, brain oedema, brain stem syndrome, escherichia sepsis, graft complication, pneumocystis jiroveci pneumonia, pneumonia aspergillus, respiratory failure, subdural haemorrhage. Prograf dosage: unknown. During the same period patient was treated with METHYLPREDNISOLONE, AZATHIOPRINE. Patient was hospitalized. Patient died on 09/13/1997.

Prograf Side Effects Report #4559461-X
Prograf side effect was reported by a Physician from on Jan 06, 2005. Male patient, child 3 years of age, weighting 26.46 lb, was diagnosed with small intestine transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: brain oedema, brain stem syndrome, cytomegalovirus infection , epstein-barr virus infection, escherichia bacteraemia, pneumocystis jiroveci pneumonia, pneumonia aspergillus, respiratory failure, subdural haemorrhage. Prograf dosage: ORAL; 4 MG, D, ORAL. During the same period patient was treated with METHYLPREDNISOLONE, AZATHIOPRINE. Patient was hospitalized. Patient died on 09/13/1997.

Prograf Side Effects Report #5967987-7
Prograf side effect was reported by a Physician from JAPAN on Nov 18, 2008. Female patient, 82 years of age, weighting 59.52 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: interstitial lung disease, respiratory failure. Prograf dosage: I MG, UID/QD,. During the same period patient was treated with RIMATIL, PREDNISOLONE, GASPORTLET, MUCODYNE, CLINORIL. Patient died on 08/16/2008.

Prograf Side Effects Report #5404734-1
Prograf side effect was reported by a Physician from JAPAN on July 20, 2007. Female patient, 76 years of age, weighting 88.18 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: cardiac failure, condition aggravated, interstitial lung disease, malaise, pleural effusion, pneumonia aspiration, pneumothorax, respiratory failure. Prograf dosage: 1 MG,UID/QD; 1.5 MG, UID/QD; 2 MG, UID/QD. During the same period patient was treated with INDOMETHACIN, PREDNISOLONE, LANSOPRAZOLE, FOSAMAC, BLOPRESS. Patient died on 01/14/2007.

Prograf Side Effects Report #5246211-7
Prograf side effect was reported by a Physician from JAPAN on Feb 08, 2007. Female patient, 73 years of age, weighting 90.39 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: interstitial lung disease, pneumonia , respiratory failure. Prograf dosage: 1 MG, UID/QD, ORAL. During the same period patient was treated with RHEUMATREX, REMICADE, LIPITOR, OLMETEC, CLEANAL, EVISTA, MUCOSTA, TOSUFLOXACIN TOSILATE. Patient died on 10/30/2006.


Prograf Side Effects Report #5255179-9
Prograf side effect was reported by a Physician from JAPAN on Feb 19, 2007. Female patient, 73 years of age, weighting 90.39 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: hyperthermia, interstitial lung disease, pneumonia bacterial, respiratory failure. Prograf dosage: 1 MG, UID/QD, ORAL. During the same period patient was treated with RHEUMATREX, REMICADE, LIPITOR, OLMETEC, CLEANAL, EVISTA, MUCOSTA. Patient died on 10/30/2006.

Prograf Side Effects Report #6129504-0
Prograf side effect was reported by a Physician from JAPAN on Mar 13, 2009. Female patient, 72 years of age, weighting 114.6 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: haemodialysis, haemorrhage, nasopharyngitis, proteinuria, pulmonary oedema, renal failure acute, respiratory failure. Prograf dosage: 2 MG, UID/QD, ORAL. During the same period patient was treated with AMLODIN, DIOVAN, BENET, BUFFERINLET, LENDORMIN, PREDNISOLONE, SELBEX, SOL MEDROL. Patient died on 11/22/2008.

Prograf Side Effects Report #5832529-3
Prograf side effect was reported by a Physician from JAPAN on July 16, 2008. Female patient, 71 years of age, weighting 92.59 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: blood pressure decreased, condition aggravated, diffuse alveolar damage, interstitial lung disease, respiratory failure. Prograf dosage: 1 MG, UID/QD, ORAL. During the same period patient was treated with PREDNISOLONE, PARIET, KLARICID, ONEALFA, FOSAMAC, BAKUMONDOUTO, MUCOSOLVAN, MUCODYNE. Patient died on 05/21/2008.

Prograf Side Effects Report #5835112-9
Prograf side effect was reported by a Physician from JAPAN on July 25, 2008. Female patient, 71 years of age, weighting 92.59 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: blood pressure decreased, condition aggravated, diffuse alveolar damage, interstitial lung disease, respiratory failure. Prograf dosage: 1 MG, UID/QD, ORAL. During the same period patient was treated with PREDNISOLONE, PARIET, KLARICID, ONEALFA, FOSAMAC, BAKUMONDOUTO, MUCOSOLVAN, MUCODYNE. Patient died on 05/21/2008.

Prograf Side Effects Report #5921306-0
Prograf side effect was reported by a Physician from JAPAN on Oct 08, 2008. Female patient, 71 years of age, weighting 92.59 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: blood pressure decreased, condition aggravated, diffuse alveolar damage, interstitial lung disease, respiratory failure. Prograf dosage: 1 MG, UID/QD, ORAL. During the same period patient was treated with PREDNISOLONE, PARIET, KLARICID, ONEALFA, FOSAMAC, BAKUMONDOUTO, MUCOSOLVAN, MUCODYNE. Patient died on 05/21/2008.


Prograf Side Effects Report #5536720-5
Prograf side effect was reported by a Physician from JAPAN on Nov 19, 2007. Female patient, 69 years of age, weighting 92.64 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: blood beta-d-glucan increased, condition aggravated, interstitial lung disease, pneumocystis jiroveci pneumonia, respiratory failure, systemic mycosis. Prograf dosage: 2 MG, UID/QD, ORAL. During the same period patient was treated with RHEUMATREX, PREDNISOLONE, GASTER D ORODISPERSABLE CRLET, BAKTAR. Patient died on 10/03/2007.

Prograf Side Effects Report #4778025-6
Prograf side effect was reported by a Physician from JAPAN on Sept 07, 2005. Female patient, 69 years of age, weighting 88.18 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: blood beta-d-glucan increased, cardio-respiratory arrest, hypercapnia, mydriasis, pneumocystis jiroveci pneumonia, pneumonia cytomegaloviral, respiratory failure. Prograf dosage: 1.50 MG, UID/QD, ORAL. During the same period patient was treated with PREDNISOLONE, RHEUMATREX, MOBIC, TAKEPRON, DEPAS, ROHYPNOL, BENET, ALINAMIN F. Patient died on 07/25/2005.

Prograf Side Effects Report #4818346-1
Prograf side effect was reported by a Physician from JAPAN on Oct 18, 2005. Female patient, 69 years of age, weighting 88.18 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, mydriasis, pneumocystis jiroveci pneumonia, pneumonia cytomegaloviral, respiratory failure. Prograf dosage: 1.50 MG, UID/QD, ORAL. During the same period patient was treated with PREDNISOLONE, RHEUMATREX, MOBIC, LANSOPRAZOLE, DEPAS, ROHYPNOL, RISEDRONATE, ALINAMIN F. Patient died on 07/25/2005.

Prograf Side Effects Report #5060073-2
Prograf side effect was reported by a Physician from JAPAN on July 11, 2006. Female patient, 67 years of age, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: interstitial lung disease, red blood cell sedimentation rate increased, respiratory failure. Prograf dosage: 3 MG, ORAL. Patient was hospitalized. Patient died on 01/01/2006.

Prograf Side Effects Report #5085190-2
Prograf side effect was reported by a Physician from JAPAN on July 31, 2006. Female patient, 67 years of age, weighting 123.5 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: condition aggravated, interstitial lung disease, placental insufficiency, respiratory disorder, respiratory failure, uterine disorder. Prograf dosage: 1 MG, UID/QD, ORAL; 3 MG, UID/QD, ORAL. During the same period patient was treated with DETANTOL, CLINORIL, SELBEX, ALFAROL, KOLANTYL, PREDNISOLONE. Patient recovered.


Prograf Side Effects Report #4846906-0
Prograf side effect was reported by a Consumer or non-health professional from JAPAN on Nov 25, 2005. Female patient, 67 years of age, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: bacterial infection , cerebral infarction, pneumocystis jiroveci pneumonia, respiratory failure. Prograf dosage: 3 MG, UID/QD, ORAL. During the same period patient was treated with PREDNISOLONE, AMARYL, ACTOS, MUCOSOLVAN L, MAGNESIUM OXIDE, LAC B, GASTER D ORODISPERSABLE CRLET, DEPAS. Patient died on 11/18/2005.

Prograf Side Effects Report #4870259-5
Prograf side effect was reported by a Physician from JAPAN on Dec 19, 2005. Female patient, 67 years of age, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: cerebral infarction, hypercoagulation, inflammation, pneumocystis jiroveci pneumonia, respiratory failure. Prograf dosage: 3 MG, UID/QD, ORAL. During the same period patient was treated with PREDNISOLONE, AMARYL, ACTOS, MUCOSOLVAN L, MAGNESIUM OXIDE, LAC B, GASTER OD, DEPAS. Patient died on 11/18/2005.

Prograf Side Effects Report #4914178-4
Prograf side effect was reported by a Physician from JAPAN on Feb 01, 2006. Female patient, 67 years of age, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: cerebral infarction, hypercoagulation, malaise, pneumocystis jiroveci pneumonia, respiratory failure. Prograf dosage: 3 MG, UID/QD, ORAL. During the same period patient was treated with PREDNISOLONE, AMARYL, ACTOS, MUCOSOLVAN L, MAGNESIUM OXIDE, LAC B, GASTER OD, DEPAS. Patient died on 11/18/2005.

Prograf Side Effects Report #4961780-X
Prograf side effect was reported by a Physician from JAPAN on Mar 17, 2006. Female patient, 57 years of age, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: acute pulmonary oedema, blood glucose increased, cardiotoxicity, heart rate increased, nasopharyngitis, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with MEDROL ACETATE. Patient died on 03/05/2006.

Prograf Side Effects Report #5872335-7
Prograf side effect was reported by a Physician from JAPAN on Aug 25, 2008. Female patient, 53 years of age, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: diffuse large b-cell lymphoma, disseminated intravascular coagulation, epstein-barr virus test positive, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient died.


Prograf Side Effects Report #5946024-4
Prograf side effect was reported by a Physician from JAPAN on Oct 30, 2008. Female patient, weighting 59.52 lb, was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: interstitial lung disease, oxygen saturation decreased, respiratory failure. Prograf dosage: 1 MG, UID/QD. During the same period patient was treated with RIMATIL, PREDNISOLONE, GASPORTLET, MUCODYNE, CLINORIL. Patient died on 08/16/2008.

Prograf Side Effects Report #4757742-8
Prograf side effect was reported by a Physician from JAPAN on Aug 19, 2005. Female patient was diagnosed with rheumatoid arthritis  and was treated with Prograf. After drug was administered, patient experienced the following side effects: pneumocystis jiroveci pneumonia, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with PREDNISOLONE, RHEUMATREX, MOBIC, TAKEPRON, DEPAS, ROHYPNOL, BENET, ALINAMIN F. Patient died on 07/25/2005.

Prograf Side Effects Report #6111547-4
Prograf side effect was reported by a Health Professional from SWITZERLAND on Feb 20, 2009. Female patient, 66 years of age, weighting 119.0 lb, was diagnosed with renal transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cardiomegaly, multi-organ failure, pneumocystis jiroveci infection, pulmonary fibrosis , respiratory failure, sepsis . Prograf dosage: 1.5 MG, BID, ORAL. During the same period patient was treated with CELLCEPT, PREDNISONE, ASPIRIN, METO ZEROK, ATACAND, PRAVALOTIN, ACTRAPID, LEVEMIR. Patient was hospitalized. Patient died on 11/25/2008.

Prograf Side Effects Report #6106656-X
Prograf side effect was reported by a Physician from JAPAN on Feb 27, 2009. Female patient, 55 years of age, was diagnosed with renal transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: kidney transplant rejection, pneumocystis jiroveci pneumonia, respiratory failure. Prograf dosage: 6 MG, UID/QD, ORAL. During the same period patient was treated with CELLCEPT, PREDNISOLONE, ORTHOCLONE OKT. Patient died on 05/26/2007.

Prograf Side Effects Report #5448188-8
Prograf side effect was reported by a Physician from JAPAN on Aug 27, 2007. Male patient, 54 years of age, weighting 94.80 lb, was diagnosed with renal transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, pneumocystis jiroveci pneumonia, respiratory failure. Prograf dosage: 20 MG, UID/QD, ORAL. During the same period patient was treated with CELLCEPT, PREDNISOLONE, ROCALTROL, ULGUT, MARZULENE S, ACTONEL, VENOGLOBULIN, PIPERACILLIN. Patient died on 07/01/2007.


Prograf Side Effects Report #5187562-4
Prograf side effect was reported by a Physician from UNITED STATES on Dec 06, 2006. Female patient, 52 years of age, weighting 166.4 lb, was diagnosed with renal transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: acinetobacter infection, pneumocystis jiroveci pneumonia, pneumonia bacterial, respiratory failure, sepsis . Prograf dosage: unknown. During the same period patient was treated with PREDNISONE, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient died on 11/25/2006.

Prograf Side Effects Report #5506353-5
Prograf side effect was reported by a Physician from UNITED STATES on Oct 22, 2007. Female patient, 52 years of age, weighting 166.4 lb, was diagnosed with renal transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: acinetobacter infection, pneumocystis jiroveci pneumonia, respiratory failure, sepsis . Prograf dosage: unknown. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient died on 11/25/2006.

Prograf Side Effects Report #5878684-0
Prograf side effect was reported by a Physician from UNITED STATES on Aug 26, 2008. Female patient, 50 years of age, was diagnosed with renal transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood lactate dehydrogenase increased, infection in an immunocompromised host, multi-organ failure, pulmonary alveolar haemorrhage, respiratory failure, strongyloidiasis, urinary tract infection . Prograf dosage: unknown. During the same period patient was treated with PREDNISOLONE ACETATE, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient died.

Prograf Side Effects Report #4750335-8
Prograf side effect was reported by a Physician from JAPAN on Aug 10, 2005. Male patient, 50 years of age, weighting 137.1 lb, was diagnosed with renal transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: bacterial infection , candidiasis, disseminated intravascular coagulation, fungal infection , pneumocystis jiroveci pneumonia, respiratory failure, septic shock, staphylococcal infection , viral infection . Prograf dosage: 9.00 MG, BID, ORAL : 6.00 MG, UID/QD, IV DRIP : 9.00 MG, BID, ORAL : 8.00 MG, BID, ORAL : BID, ORAL. During the same period patient was treated with CELLCEPT, PREDNISOLONE. Patient died on 07/02/2002.

Prograf Side Effects Report #4777911-0
Prograf side effect was reported by a Physician from JAPAN on Sept 08, 2005. Male patient, 50 years of age, weighting 137.1 lb, was diagnosed with renal transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: candida pneumonia, disease recurrence, disseminated intravascular coagulation, immunosuppression, pneumocystis jiroveci pneumonia, pneumonia staphylococcal, respiratory failure, septic shock. Prograf dosage: unknown. During the same period patient was treated with CELLCEPT, PREDNISOLONE. Patient died on 07/02/2002.


Prograf Side Effects Report #5371071-3
Prograf side effect was reported by a Physician from GERMANY on June 11, 2007. Female patient, 43 years of age, was diagnosed with renal transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: bronchospasm, graft dysfunction, haemodynamic instability, hypersensitivity, platelet adhesiveness abnormal, respiratory failure. Prograf dosage: unknown. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5616237-X
Prograf side effect was reported by a Health Professional from COLOMBIA on Jan 24, 2008. Male patient, child 12 years of age, was diagnosed with renal transplant and was treated with Prograf. After drug was administered, patient experienced the following side effects: pneumonia , respiratory failure, septic shock, transplant rejection, white blood cell count decreased. Prograf dosage: unknown. Patient was hospitalized. Patient died on 12/20/2007.

Prograf Side Effects Report #4696268-7
Prograf side effect was reported by a Physician from on June 08, 2005. Male patient, 68 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: diarrhoea, graft versus host disease, multi-organ failure, neutropenia, rash maculo-papular, renal failure acute, respiratory failure. Prograf dosage: unknown. Patient died.

Prograf Side Effects Report #4870403-X
Prograf side effect was reported by a Consumer or non-health professional from UNITED STATES on Dec 20, 2005. Female patient, 64 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: pneumonia , rectal haemorrhage, respiratory failure, sepsis , urosepsis, wound infection. Prograf dosage: 0.50 MG, BID, ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, SIMULECT, SEPTRA, MYCELEX, ASPIRIN, NORVASC, CLONIDINE. Patient was hospitalized. Patient died.

Prograf Side Effects Report #5069087-X
Prograf side effect was reported by a Physician from UNITED STATES on July 19, 2006. Female patient, 63 years of age, weighting 129.0 lb, was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: cardiac failure, enterococcal infection, multi-organ failure, pseudomonas infection, renal failure acute, respiratory failure, staphylococcal infection , thrombotic microangiopathy. Prograf dosage: 1 MG, BID, ORAL. Patient was hospitalized. Patient died on 06/27/2006.


Prograf Side Effects Report #5442448-2
Prograf side effect was reported by a Physician from UNITED STATES on Aug 29, 2007. Female patient, 59 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, anaemia, crohn's disease , metapneumovirus infection, pneumonia viral, procedural hypotension, respiratory failure, septic shock, upper respiratory tract infection. Prograf dosage: unknown. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5424810-7
Prograf side effect was reported by a Physician from UNITED STATES on July 13, 2007. Male patient, 54 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: candidiasis, clostridium difficile colitis, cytomegalovirus hepatitis, cytomegalovirus viraemia, kidney transplant rejection, pneumonia , respiratory failure. Prograf dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, CIPROFLOXACIN, CEFEPIME, PIPERACILLIN W, SULFAMETHOXAZOLE AND TRIMETHOPRIM, FLUCONAZOLE, LAMIVUDINE. Patient was hospitalized. Patient died.

Prograf Side Effects Report #5023891-2
Prograf side effect was reported by a Physician from UNITED STATES on May 26, 2006. Female patient, 40 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: choriomeningitis lymphocytic, hepatic necrosis, laboratory test abnormal, leukopenia, lung infiltration, petechiae, respiratory failure, skin haemorrhage, skin inflammation. Prograf dosage: unknown. Patient was hospitalized. Patient died.

Prograf Side Effects Report #4709347-2
Prograf side effect was reported by a Consumer or non-health professional from ARGENTINA on June 24, 2005. Female patient, 33 years of age, weighting 110.2 lb, was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: aphasia , asthenia, bradycardia, dysarthria, leukoencephalopathy, quadriplegia, respiratory failure. Prograf dosage: 2.00 MG, BID, ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #4743434-8
Prograf side effect was reported by a Physician from ARGENTINA on July 29, 2005. Female patient, 33 years of age, weighting 110.2 lb, was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: aphasia , bradycardia, dysarthria, leukoencephalopathy, quadriplegia, respiratory failure, speech disorder. Prograf dosage: 2.00 MG, BID, ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #4951435-X
Prograf side effect was reported by a Pharmacist from UNITED STATES on Mar 10, 2006. Male patient, 20 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: adenovirus infection, cardiac failure, depressed level of consciousness, hepatic failure, multi-organ failure, pancytopenia, respiratory failure, thrombotic thrombocytopenic purpura. Prograf dosage: 3MG, BID; ORAL. During the same period patient was treated with RANITIDINE, PENTAMIDINE, ITRACONZOLE, VALGANCICLOVIR. Patient died.

Prograf Side Effects Report #4626657-8
Prograf side effect was reported by a Physician from on Mar 21, 2005. Female patient was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: agitation, coma, convulsion, delirium, encephalitis , rabies , respiratory failure. Prograf dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE. Patient died on 06/01/2004.

Prograf Side Effects Report #4626658-X
Prograf side effect was reported by a Physician from on Mar 21, 2005. Female patient was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: agitation, coma, convulsion, delirium, encephalitis , respiratory failure. Prograf dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE. Patient died on 06/01/2004.

Prograf Side Effects Report #4626659-1
Prograf side effect was reported by a Physician from on Mar 21, 2005. Female patient was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: agitation, coma, convulsion, delirium, encephalitis , nervous system disorder, rabies , respiratory failure. Prograf dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE. Patient died on 06/01/2004.

Prograf Side Effects Report #4830398-1
Prograf side effect was reported by a Physician from UNITED STATES on Nov 02, 2005. Female patient was diagnosed with prophylaxis against transplant rejection and was treated with Prograf. After drug was administered, patient experienced the following side effects: adenovirus infection, blood creatinine increased, respiratory failure, sepsis . Prograf dosage: 0.40 MG/KG, ORAL. During the same period patient was treated with PREDNISONE, URSODIOL, LANSOPRAZOLE, GANCICLOVIR, NYSTATIN. Patient died.


Prograf Side Effects Report #4852943-2
Prograf side effect was reported by a Physician from JAPAN on Dec 01, 2005. Female patient, 81 years of age, weighting 81.57 lb, was diagnosed with myasthenia gravis and was treated with Prograf. After drug was administered, patient experienced the following side effects: cryptococcosis, cytomegalovirus infection , infection in an immunocompromised host, intestinal obstruction, meningitis cryptococcal, pneumocystis jiroveci pneumonia, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with PREDNISOLONE, AMISALIN, TAGAMET, PRAVASTATIN, BONALON, GLIMICRON. Patient died on 11/16/2005.

Prograf Side Effects Report #4885996-6
Prograf side effect was reported by a Physician from JAPAN on Jan 06, 2006. Female patient, 81 years of age, weighting 81.57 lb, was diagnosed with myasthenia gravis and was treated with Prograf. After drug was administered, patient experienced the following side effects: cryptococcosis, cytomegalovirus infection , intestinal obstruction, meningitis cryptococcal, pneumocystis jiroveci pneumonia, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with PREDNISOLONE, AMISALIN, TAGAMET, MEVALOTIN, BONALON. Patient died on 11/16/2005.

Prograf Side Effects Report #4642361-4
Prograf side effect was reported by a Physician from on Apr 07, 2005. Female patient, 51 years of age, was diagnosed with myasthenia gravis and was treated with Prograf. After drug was administered, patient experienced the following side effects: atelectasis, headache , malaise, meningitis listeria, musculoskeletal stiffness, pyrexia, respiratory failure. Prograf dosage: 6.00 MG, /D. During the same period patient was treated with PREDNISONE, PYRIDOSTIGMINE. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5409827-0
Prograf side effect was reported by a Physician from JAPAN on July 25, 2007. Female patient, 41 years of age, was diagnosed with myasthenia gravis and was treated with Prograf. After drug was administered, patient experienced the following side effects: graft versus host disease, malignant neoplasm progression, metastasis, respiratory failure, thymoma, thymoma malignant recurrent. Prograf dosage: 3 MG, UID/QD, ORAL. During the same period patient was treated with MYTELASE, PREDNISOLONE, ATROPINE SULPHATE, GASTERLET, SELBEX, BIOFERMIN. Patient died on 12/29/2005.

Prograf Side Effects Report #5419995-2
Prograf side effect was reported by a Physician from JAPAN on Aug 02, 2007. Female patient, 41 years of age, was diagnosed with myasthenia gravis and was treated with Prograf. After drug was administered, patient experienced the following side effects: graft versus host disease, malignant neoplasm progression, metastases to abdominal cavity, metastasis, respiratory failure, thymoma malignant recurrent. Prograf dosage: 3 MG, UID/QD, ORAL. During the same period patient was treated with MYTELASE, PREDNISOLONE, ATROPINE SULPHATE, GASTERLET, SELBEX, BIOFERMIN. Patient died on 12/29/2005.

Prograf Side Effects Report #5465192-4
Prograf side effect was reported by a Physician from UNITED STATES on Sept 07, 2007. Female patient, 61 years of age, was diagnosed with lung transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: blood ph decreased, hypercapnia, respiratory failure. Prograf dosage: unknown. Patient was hospitalized. Patient died on 10/26/2005.

Prograf Side Effects Report #5482018-3
Prograf side effect was reported by a Health Professional from UNITED STATES on Sept 27, 2007. Female patient, 61 years of age, was diagnosed with lung transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: confusional state, lethargy, respiratory failure. Prograf dosage: 2.5 MG, BID, ORAL; 3.5 MG, BID, ORAL; 3 MG, BID, ORAL; 3.5 MG, BID, ORAL; 4 MG, BID, ORAL; 5 MG, BID. Patient was hospitalized. Patient died on 10/26/2005.

Prograf Side Effects Report #4928486-4
Prograf side effect was reported by a Physician from SPAIN on Feb 13, 2006. Female patient was diagnosed with lung transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: disease recurrence, gastroenteritis , jaundice , liver disorder, lung transplant rejection, pulmonary tuberculosis, respiratory failure, skin reaction. Prograf dosage: unknown. During the same period patient was treated with AZATHIOPRINE, PREDNISONE. Patient died.

Prograf Side Effects Report #5866978-4
Prograf side effect was reported by a Consumer or non-health professional from JAPAN on Aug 18, 2008. Male patient, 49 years of age, weighting 125.7 lb, was diagnosed with liver transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: brain oedema, cardiac arrest , continuous haemodiafiltration, hepatic function abnormal, liver injury, renal disorder, respiratory arrest, respiratory failure, sputum retention. Prograf dosage: 5 MG, BID, ORAL. During the same period patient was treated with FLUCONAZOLE, PANIPENEM, CLINDAMYCIN, ACYCLOVIR, POTASSIUM CANRENOATE, MYCOPHENOLIC ACID, METHYLPREDNISOLONE SUCCINATE. Patient died on 06/11/2002.

Prograf Side Effects Report #5573711-2
Prograf side effect was reported by a Physician from UNITED STATES on Dec 04, 2007. Female patient, 20 years of age, was diagnosed with liver transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: brain hypoxia, hepatitis c , pregnancy , premature labour, respiratory failure. Prograf dosage: unknown. Patient died.


Prograf Side Effects Report #5827693-6
Prograf side effect was reported by a Physician from UNITED KINGDOM on July 10, 2008. Male patient, 15 years of age, was diagnosed with liver transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: autoimmune hepatitis, bronchopulmonary aspergillosis, haemoptysis, hydropneumothorax, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with PREDNISONE, MYCOPHENOLATE MOFETIL. Patient died.

Prograf Side Effects Report #4750273-0
Prograf side effect was reported by a Physician from UNITED KINGDOM on Aug 08, 2005. Male patient, 15 years of age, was diagnosed with liver transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: aspergillosis, autoimmune hepatitis, cholangitis, haemoptysis, hydropneumothorax, lung disorder, pseudomonas infection, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with PREDNISONE, MYCOPHENOLATE MOFETIL, ANTIBIOTICS. Patient died.

Prograf Side Effects Report #5383422-4
Prograf side effect was reported by a Physician from JAPAN on June 28, 2007. Female patient was diagnosed with liver transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: failure to thrive, respiratory failure. Prograf dosage: unknown. Patient died on 11/12/2004.

Prograf Side Effects Report #5494844-5
Prograf side effect was reported by a Physician from JAPAN on Oct 05, 2007. Female patient, 71 years of age, was diagnosed with interstitial lung disease and was treated with Prograf. After drug was administered, patient experienced the following side effects: condition aggravated, interstitial lung disease, no therapeutic response, respiratory failure. Prograf dosage: 0.5 MG, /D, IV NOS; 0.75 MG, /D, IV NOS. During the same period patient was treated with FUNGUARD, MILLISROL, CIPROFLAXACIN, DALACIN, DOXAZOSIN MESYLATE, BAKTAR, ISONIAZID. Patient died on 10/03/2007.

Prograf Side Effects Report #6137555-5
Prograf side effect was reported by a Health Professional from BELGIUM on Jan 14, 2009. Female patient, 22 years of age, was diagnosed with immunosuppression, pneumonia legionella and was treated with Prograf. After drug was administered, patient experienced the following side effects: pneumonia , respiratory failure. Prograf dosage: MG, ORAL/D ; D/IV. During the same period patient was treated with CLARITHROMYCIN, METHYLPREDNISOLONE, MEROPENEM, GANCICLOVIR, AZATHIOPRINE, PIRITRAMIDE, MIDAZOLAM. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #4708751-6
Prograf side effect was reported by a Physician from FRANCE on June 20, 2005. Female patient, 42 years of age, was diagnosed with heart transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: anaemia, blood disorder, eosinophilia, herpes virus infection, kaposi's sarcoma , pharyngolaryngeal pain, respiratory failure, splenomegaly. Prograf dosage: unknown. Patient was hospitalized. Patient died.

Prograf Side Effects Report #5120014-6
Prograf side effect was reported by a Physician from JAPAN on Sept 19, 2006. Female patient, 78 years of age, weighting 132.3 lb, was diagnosed with dermatomyositis and was treated with Prograf. After drug was administered, patient experienced the following side effects: anaemia, pyrexia, renal impairment, respiratory failure, thrombotic thrombocytopenic purpura, vascular purpura. Prograf dosage: 3 MG, UID/QD, ORAL. During the same period patient was treated with NEORAL, BAKTAR, PREDNISOLONE. Patient died on 12/10/2005.

Prograf Side Effects Report #4877535-0
Prograf side effect was reported by a Physician from JAPAN on Dec 26, 2005. Female patient, 78 years of age, weighting 132.3 lb, was diagnosed with dermatomyositis and was treated with Prograf. After drug was administered, patient experienced the following side effects: haematocrit decreased, haemoglobin decreased, renal function test abnormal, respiratory failure, thrombotic thrombocytopenic purpura. Prograf dosage: 3 MG, UID/QD, ORAL. During the same period patient was treated with NEORAL, BAKTAR, PREDNISOLONE. Patient died on 12/10/2005.

Prograf Side Effects Report #6029355-1
Prograf side effect was reported by a Physician from JAPAN on Dec 24, 2008. Female patient, child 9 years of age, weighting 31.97 lb, was diagnosed with bone marrow transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: convulsion, pain , pancreatic necrosis, pericardial effusion, pneumothorax, pulmonary congestion, respiratory failure. Prograf dosage: 0.38 MG, CONTINUOUS, IV NOS. During the same period patient was treated with ALEVIATIN, CLAFORAN, FUNGUARD, FOSCAVIR, NORAVID. Patient died on 08/25/2008.

Prograf Side Effects Report #4994139-X
Prograf side effect was reported by a Physician from JAPAN on Apr 26, 2006. Male patient, 43 years of age, was diagnosed with bone marrow transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: encephalopathy, graft versus host disease, pneumonia cytomegaloviral, respiratory failure. Prograf dosage: 2 MG, UID/QD, IV NOS; SEE IMAGE. During the same period patient was treated with METHOTREXATE, CYCLOPHOSPHAMIDE, NEUPOGEN, TIENAM, DECADRON. Patient died on 10/09/2005.


Prograf Side Effects Report #5030520-0
Prograf side effect was reported by a Physician from JAPAN on June 05, 2006. Male patient, 43 years of age, was diagnosed with bone marrow transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: depressed level of consciousness, graft versus host disease, pneumonia cytomegaloviral, respiratory failure, toxic induced encephalopathy. Prograf dosage: 2 MG, CONTINUOUS, IV DRIP; SEE IMAGE. During the same period patient was treated with METHOTREXATE, ENDOXAN, NEUPOGEN, TIENAM, DECADRON. Patient died on 10/09/2005.

Prograf Side Effects Report #4840055-3
Prograf side effect was reported by a Physician from JAPAN on Nov 15, 2005. Female patient, 31 years of age, was diagnosed with bone marrow transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: lung transplant , obliterative bronchiolitis, pneumatosis intestinalis, pneumomediastinum, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with STEROID, BASILIXIMAB, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #4849597-8
Prograf side effect was reported by a Physician from JAPAN on Nov 25, 2005. Female patient, 31 years of age, was diagnosed with bone marrow transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: lung transplant , obliterative bronchiolitis, pneumatosis intestinalis, pneumomediastinum, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with STEROID, SIMULECT, CELLCEPT. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5678222-1
Prograf side effect was reported by a Physician from JAPAN on Mar 03, 2008. Male patient, child 10 years of age, was diagnosed with bone marrow transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: abdominal pain , blood lactate dehydrogenase increased, epstein-barr virus infection, histiocytosis haematophagic, pyrexia, respiratory failure, serum ferritin increased. Prograf dosage: unknown. During the same period patient was treated with PREDNISOLONE, TRANILAST, MYCOPHENOLATE MOFETIL, THALIDOMIDE, OCTREOTIDE ACETATE, INFLIXIMAB, ETOPOSIDE. Patient died.

Prograf Side Effects Report #5728760-8
Prograf side effect was reported by a Physician from JAPAN on Apr 23, 2008. Male patient, child 10 years of age, was diagnosed with bone marrow transplant  and was treated with Prograf. After drug was administered, patient experienced the following side effects: blood lactate dehydrogenase increased, histiocytosis haematophagic, infection , pancreatitis, pyrexia, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with PREDNISOLONE, MYCOPHENOLATE MOFETIL. Patient died.

Prograf Side Effects Report #5802236-1
Prograf side effect was reported by a Physician from JAPAN on June 26, 2008. Female patient, 71 years of age, was treated with Prograf. After drug was administered, patient experienced the following side effects: lung disorder, respiratory failure. Prograf dosage: ORAL; 3 MG, UID/QD, ORAL; 1 MG, ORAL. During the same period patient was treated with PARIET, ALFAROL, BAKUMONDOUTO, ASPARA, OZEX. Patient died on 04/11/2008.

Prograf Side Effects Report #5844808-4
Prograf side effect was reported by a Physician from JAPAN on July 31, 2008. Female patient, 71 years of age, was treated with Prograf. After drug was administered, patient experienced the following side effects: lung disorder, pneumonia , respiratory failure. Prograf dosage: ORAL; 3 MG, UID/QD, ORAL; 1 MG, /D, ORAL. During the same period patient was treated with RABEPRAZOLE, ALFAROL, BAKUMONDOUTO, ASPARA, CODEINE PHOSHATEMULATION, OZEX. Patient was hospitalized. Patient died on 04/11/2008.

Prograf Side Effects Report #5663771-2
Prograf side effect was reported by a Physician from UNITED STATES on Feb 27, 2008. Female patient, 63 years of age, was treated with Prograf. After drug was administered, patient experienced the following side effects: respiratory failure. Prograf dosage: unknown. Patient was hospitalized. Patient died on 01/20/2008.

Prograf Side Effects Report #5487328-1
Prograf side effect was reported by a Physician from JAPAN on Oct 03, 2007. Male patient, 60 years of age, was treated with Prograf. After drug was administered, patient experienced the following side effects: bone marrow failure, hypovolaemic shock, platelet count decreased, pleural effusion, pulmonary alveolar haemorrhage, pulmonary congestion, respiratory failure. Prograf dosage: 0.03 MG/KG, IV NOS. Patient died.

Prograf Side Effects Report #5751430-7
Prograf side effect was reported by a Health Professional from UNITED STATES on May 16, 2008. Male patient, 40 years of age, was treated with Prograf. After drug was administered, patient experienced the following side effects: cardiac failure, respiratory failure. Prograf dosage: 0.5 MG. Patient died on 04/09/2008.


Prograf Side Effects Report #5947367-0
Prograf side effect was reported by a Health Professional from UNITED STATES on Oct 23, 2008. Male patient, 40 years of age, was treated with Prograf. After drug was administered, patient experienced the following side effects: cardiac failure, disease progression, respiratory failure. Prograf dosage: 0.5 MG,. Patient died on 04/09/2008.

Prograf Side Effects Report #5525659-7
Prograf side effect was reported by a Physician from UNITED STATES on Nov 12, 2007. Female patient, 16 years of age, was treated with Prograf. After drug was administered, patient experienced the following side effects: graft versus host disease, herpes sepsis, herpes simplex , oral herpes, pancytopenia, pneumonia herpes viral, respiratory failure. Prograf dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient died.

Prograf Side Effects Report #5986744-9
Prograf side effect was reported by a Physician from JAPAN on Nov 21, 2008. Female patient, weighting 9.92 lb, was treated with Prograf. After drug was administered, patient experienced the following side effects: leukaemia, neutrophil count increased, respiratory failure, respiratory syncytial virus infection . Prograf dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient died on 03/09/2008.

Prograf Side Effects Report #5994894-6
Prograf side effect was reported by a Physician from JAPAN on Dec 04, 2008. Female patient, weighting 9.92 lb, was treated with Prograf. After drug was administered, patient experienced the following side effects: blood pressure decreased, cardiac arrest , condition aggravated, engraftment syndrome, respiratory failure, respiratory syncytial virus infection . Prograf dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient died on 03/09/2008.