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ACUTE GRAFT VERSUS HOST DISEASE side effect

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Cyclosporine Side Effects Report #5650766-8
Consumer or non-health professional from JAPAN reported CYCLOSPORINE problem on Feb 27, 2008. Male patient, child 11 years of age, was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute graft versus host disease in skin, cytomegalovirus antigen positive, pulmonary oedema, venoocclusive disease, . CYCLOSPORINE dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, MELPHALAN. Patient recovered.

Fludarabine Side Effects Report #5657071-4
FLUDARABINE problem was reported by a Consumer or non-health professional from GERMANY on Feb 27, 2008. Female patient was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, . FLUDARABINE dosage: TOTAL DAILY DOSE: 30 MG/M2. During the same period patient was treated with THIOTEPA. Patient died.

Cyclophosphamide Side Effects Report #5661644-2
Health Professional from JAPAN reported CYCLOPHOSPHAMIDE problem on Mar 10, 2008. Male patient, 17 years of age, was diagnosed with acute biphenotypic leukaemia, prophylaxis and was treated with CYCLOPHOSPHAMIDE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, liver injury, nocardiosis, . CYCLOPHOSPHAMIDE dosage: unknown. During the same period patient was treated with METHOTREXATE, CYTARABINE, CYCLOSPORINE, COLONY STIMULATING FACTOR, TOSUFLOXACIN, FLUCONAZOLE. Patient was hospitalized. Patient recovered.

Cyclosporine Side Effects Report #5662460-8
CYCLOSPORINE problem was reported by a Consumer or non-health professional from JAPAN on Mar 07, 2008. Male patient, 51 years of age, was diagnosed with bone marrow transplant and was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, biopsy lung abnormal, chest x-ray abnormal, chronic graft versus host disease, cough, cryptogenic organising pneumonia, dyskinesia, gait disturbance, infection in an immunocompromised host, . CYCLOSPORINE dosage: unknown. During the same period patient was treated with METHOTREXATE, CELLCEPT, MELPHALAN, ADRENOCORTICOTROPHIC HORMONE, STEROIDS NOS. Patient recovered.


Neoral Side Effects Report #5662694-2
Consumer or non-health professional from JAPAN reported NEORAL problem on Mar 05, 2008. Male patient, 55 years of age, was treated with NEORAL. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, blast cell count increased, cholecystitis infective, cytogenetic abnormality, cytomegalovirus enterocolitis, engraftment syndrome, herpes zoster, leukaemia, marrow hyperplasia, . NEORAL dosage: unknown. During the same period patient was treated with METHOTREXATE, METHYLPREDNISOLONE, FLUDARABINE, CYCLOPHOSPHAMIDE, IRRADIATION. Patient was hospitalized. Patient died.

Busulfan Side Effects Report #5663402-1
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on June 18, 2007. Male patient, child .5 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, anaemia, anorexia, cytomegalovirus viraemia, diarrhoea, gastric haemorrhage, lymphocyte count decreased, malaise, nausea, . BUSULFAN dosage: 1.05 ML; 2.0 ML; 2.4 ML; 0.6 ML. Patient recovered.

Busulfan Side Effects Report #5663404-5
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Feb 22, 2008. Male patient, 46 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute myeloid leukaemia recurrent, anorexia, convulsion, diarrhoea, nausea, staphylococcal sepsis, stomatitis, . BUSULFAN dosage: 27 ML; 36 ML; 9 ML. Patient was hospitalized. Patient died.

Busulfan Side Effects Report #5663692-5
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Feb 22, 2008. Male patient, 15 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, anorexia, cystitis haemorrhagic, diarrhoea, hepatitis b, hepatitis post transfusion, nausea, pneumonia, sepsis, . BUSULFAN dosage: 27.48 MGL;QD;IV. During the same period patient was treated with FLUDARABINE, PHENYTOIN, FILGASTRIM, TRACROLIMUS. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5663693-7
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Feb 22, 2008. Male patient, 31 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, adenoviral haemorrhagic cystitis, bacterial infection, bone marrow transplant, complications of transplant surgery, cytomegalovirus antigen positive, renal failure, staphylococcal sepsis, stomatitis, . BUSULFAN dosage: 34.0 ML;QD;IV. During the same period patient was treated with TACROLIMUS HYDRATE, CYCLOPHOSPHAMIDE, PHENYTOIN, FILGRASTIM, METHOTREXATE. Patient was hospitalized. Patient died.


Busulfan Side Effects Report #5663696-2
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Feb 22, 2008. Male patient was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, alanine aminotransferase increased, altered state of consciousness, blood bilirubin increased, gamma-glutamyltransferase increased, hyperglycaemia, pleural effusion, pneumonia, renal failure, . BUSULFAN dosage: 28 ML; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, TACROLIMUS. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5664257-1
Consumer or non-health professional from GERMANY reported FLUDARABINE problem on Feb 27, 2008. Female patient was diagnosed with stem cell transplant and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, . FLUDARABINE dosage: TOTAL DAILY DOSE: 30 MG/M2. During the same period patient was treated with THIOTEPA. Patient died.

Mylotarg Side Effects Report #5664895-6
MYLOTARG problem was reported by a Physician from JAPAN on Mar 07, 2008. Female patient, weighting 112.4 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, bronchopulmonary aspergillosis, eosinophilia, febrile neutropenia, herpes zoster, hypokalaemia, interstitial lung disease, liver disorder, . MYLOTARG dosage: unknown. During the same period patient was treated with MUCOSTA, BAKTAR, ASTOMIN, ALPRAZOLAM, MAXIPIME, ZOLPIDEM TARTRATE, TARGOCID, FUNGUARD. Patient was hospitalized. Patient died on 11/12/2007.

Cyclosporine Side Effects Report #5669339-6
Consumer or non-health professional from JAPAN reported CYCLOSPORINE problem on Mar 07, 2008. Male patient, child 11 years of age, was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, cytomegalovirus antigen positive, pulmonary oedema, venoocclusive disease, . CYCLOSPORINE dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient recovered.

Cyclophosphamide Side Effects Report #5683026-X
CYCLOPHOSPHAMIDE problem was reported by a Health Professional from JAPAN on Mar 19, 2008. Male patient, 17 years of age, was diagnosed with acute biphenotypic leukaemia, prophylaxis and was treated with CYCLOPHOSPHAMIDE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, liver injury, nocardiosis, . CYCLOPHOSPHAMIDE dosage: unknown. During the same period patient was treated with METHOTREXATE, CYTARABINE, CYCLOSPORINE, COLONY STIMULATING FACTOR, TOSUFLOXACIN, FLUCONAZOLE. Patient was hospitalized. Patient recovered.


Cyclosporine Side Effects Report #5618529-7
Consumer or non-health professional from JAPAN reported CYCLOSPORINE problem on Jan 09, 2008. Male patient, child 1 years of age, was diagnosed with stem cell transplant and was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, chronic graft versus host disease, cytomegalovirus infection, hyponatraemia, inappropriate antidiuretic hormone secretion, pancreatitis, sepsis, . CYCLOSPORINE dosage: unknown. During the same period patient was treated with METHOTREXATE, BUSULFAN, CYCLOPHOSPHAMIDE. Patient recovered.

Cyclophosphamide Side Effects Report #5623652-7
CYCLOPHOSPHAMIDE problem was reported by a Consumer or non-health professional from on Feb 06, 2008. Female patient, 28 years of age, was diagnosed with stem cell transplant, prophylaxis against graft versus host disease, chronic graft versus host disease, vaginal stricture and was treated with CYCLOPHOSPHAMIDE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, amenorrhoea, chronic graft versus host disease, dry eye, liver function test abnormal, ovarian failure, stomatitis, vaginal obstruction, vaginal stricture, . CYCLOPHOSPHAMIDE dosage: unknown. During the same period patient was treated with METHOTREXATE, CYCLOSPORINE, BUSULFAN, PREDNISONE, MYCOPHENOLATE MOPHETIL, ESTROGEN. Patient recovered.

Fludarabine Side Effects Report #5640856-8
Health Professional from POLAND reported FLUDARABINE problem on Feb 20, 2008. Female patient, child 11 years of age, was diagnosed with bone marrow conditioning regimen and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, neurotoxicity, . FLUDARABINE dosage: unknown. During the same period patient was treated with TREOSULFAN. Patient died.

Fludarabine Side Effects Report #5579066-1
FLUDARABINE PHOSPHATE problem was reported by a Health Professional from UNITED STATES on Dec 07, 2007. Male patient, child 9 years of age, was diagnosed with bone marrow conditioning regimen and was treated with FLUDARABINE PHOSPHATE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute graft versus host disease in skin, viral haemorrhagic cystitis, . FLUDARABINE PHOSPHATE dosage: unknown. During the same period patient was treated with NEUPOGEN, ACYCLOVIR. Patient recovered.

Busulfan Side Effects Report #5585735-X
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Dec 21, 2007. Female patient, 32 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute graft versus host disease in intestine, brain abscess, cytomegalovirus viraemia, diarrhoea, haemodynamic instability, no therapeutic response, stomatitis, . BUSULFAN dosage: 19.2 ML; XL; IV, 25.6 ML; X1; IV, 6.4 ML; X1; IV. During the same period patient was treated with MELPHALAN, FLUDARABINE PHOSPHATE, VALPROATE, ATGAM, IMMUNOGLOBULIN. Patient died on 08/20/2007.


Busulfan Side Effects Report #5585755-5
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Male patient, 56 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, adenoviral haemorrhagic cystitis, anorexia, cytomegalovirus viraemia, diarrhoea, enterococcal infection, hepatic function abnormal, malaise, nausea, . BUSULFAN dosage: 36 ML; QD; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5585758-0
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Dec 21, 2007. Male patient, 64 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute myeloid leukaemia recurrent, anorexia, atrial tachycardia, atrioventricular block, bone marrow transplant, cytomegalovirus antigen positive, dysgeusia, hepatic function abnormal, . BUSULFAN dosage: unknown. During the same period patient was treated with PHENYTOIN, NARTOGRASTIM, METHOTREXATE, TACROLIMUS, CYLOCIDE, NOVANTRONE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5585760-9
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Male patient, 24 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, anorexia, bone marrow transplant rejection, cytomegalovirus infection, febrile neutropenia, liver disorder, nausea, pancytopenia, stomatitis, . BUSULFAN dosage: 8.13 ML; ; IV. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5586026-3
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Dec 21, 2007. Male patient, child 8 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, anorexia, blister, diabetes mellitus, diarrhoea, febrile neutropenia, haematochezia, hepatic function abnormal, malaise, . BUSULFAN dosage: 12 ML; IV, 16 ML; IV, 4 ML; IV. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5586027-5
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Female patient, 52 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, cytomegalovirus viraemia, diarrhoea, hepatic function abnormal, malaise, nausea, stomatitis, vomiting, . BUSULFAN dosage: 25.2 ML; X1; IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, PHENYTOIN. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5586040-8
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Dec 21, 2007. Female patient, 64 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute respiratory distress syndrome, bone marrow transplant, candidiasis, convulsion, disseminated intravascular coagulation, neutropenia, pancreatitis acute, . BUSULFAN dosage: 10 ML; IV, 20 ML; IV. Patient died.

Busulfan Side Effects Report #5586043-3
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Male patient, 60 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, anorexia, aplasia pure red cell, blood creatinine increased, cytomegalovirus antigen positive, hyperkalaemia, nausea, stomatitis, . BUSULFAN dosage: 29.08 ML; X1; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5607486-5
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Jan 11, 2008. Male patient was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, anorexia, cellulitis, diarrhoea, escherichia sepsis, ileus, malaise, nausea, pneumonia, . BUSULFAN dosage: 27 ML; X1; IV, 6 ML; X1; IV, 9 ML; X1, IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5613381-8
PROGRAF problem was reported by a Physician from JAPAN on Jan 10, 2008. Male patient, 32 years of age, was diagnosed with bone marrow transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, diabetic hyperglycaemic coma, platelet count decreased, pyrexia, white blood cell count decreased, . PROGRAF dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient was hospitalized. Patient recovered.

Methotrexate Side Effects Report #5535257-7
Health Professional from PORTUGAL reported METHOTREXATE problem on Dec 03, 2007. Male patient, 53 years of age, was treated with METHOTREXATE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, adenomatous polyposis coli, diplopia, embolism venous, meningioma, nephrotic syndrome, renal tubular necrosis, . METHOTREXATE dosage: unknown. During the same period patient was treated with CARBOPLATIN, ETOPOSIDE, ENALAPRIL, SULFAMETHOXAZOLE AND TRIMETHOPRIM, CYTARABINE, IDARUBICIN, FLUDARABINE PHOSPHATE, BUSULFAN. Patient recovered.

Cyclophosphamide Side Effects Report #5536995-2
CYCLOPHOSPHAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 30, 2007. Male patient, child 2 years of age, was diagnosed with bone marrow conditioning regimen, prophylaxis against graft versus host disease, acute graft versus host disease and was treated with CYCLOPHOSPHAMIDE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, alopecia, cardiac failure, . CYCLOPHOSPHAMIDE dosage: unknown. During the same period patient was treated with FLUDARA, MABLIN, PROGRAF, MEROPEN, PREDONINE, ZOVIRAX, METHOTREXATE, RIVOTRIL. Patient died on 07/07/2006.

Fludara Side Effects Report #5542456-7
Physician from JAPAN reported FLUDARA problem on Dec 06, 2007. Female patient, 40 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with FLUDARA. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, convulsion, histiocytosis haematophagic, liver disorder, sepsis, thrombotic microangiopathy, . FLUDARA dosage: unknown. During the same period patient was treated with MELPHALAN, TACROLIMUS. Patient died on 11/14/2006.

Methotrexate Side Effects Report #5549891-1
METHOTREXATE problem was reported by a Health Professional from PORTUGAL on Dec 10, 2007. Male patient, 53 years of age, was treated with METHOTREXATE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, cytomegalovirus infection, diplopia, embolism venous, meningioma, nephrotic syndrome, renal tubular necrosis, . METHOTREXATE dosage: unknown. During the same period patient was treated with CARBOPLATIN, ETOPOSIDE, ENALAPRIL, SULFAMETHOXAZOLE AND TRIMETHOPRIM, CYTARABINE, IDARUBICIN, FLUDARABINE, BUSULFAN. Patient recovered.

Cyclosporine Side Effects Report #5557404-3
Physician from PORTUGAL reported CYCLOSPORINE problem on Nov 27, 2007. Male patient, 53 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute graft versus host disease in liver, acute graft versus host disease in skin, anaemia, autoimmune disorder, cholestasis, cytomegalovirus infection, diplopia, dry eye, . CYCLOSPORINE dosage: 50 MG, Q12H,. During the same period patient was treated with METHOTREXATE, PREDNISOLONE, FLUDARABINE PHOSPHATE, BUSULFAN, ENALAPRIL MALEATE, BISOPROLOL FUMARATE, SULFAMETHOXAZOLE W, ACYCLOVIR. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5564485-X
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Dec 03, 2007. Male patient, 25 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, anorexia, bone marrow failure, bone marrow transplant, cystitis haemorrhagic, cytomegalovirus infection, diarrhoea, malaise, nausea, . BUSULFAN dosage: 16 ML; QD;IV, 32 ML; QD; IV. Patient recovered.

Busulfan Side Effects Report #5570101-3
Health Professional from JAPAN reported BUSULFAN problem on Dec 03, 2007. Male patient, 58 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute graft versus host disease in skin, anorexia, ascites, bk virus infection, blister, blood bilirubin increased, cystitis haemorrhagic, diarrhoea, . BUSULFAN dosage: 31.72 ML;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient died on 09/11/2007.

Busulfan Side Effects Report #5573171-1
BUSULFAN problem was reported by a Health Professional from JAPAN on Dec 06, 2007. Male patient, 53 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, anorexia, gamma-glutamyltransferase increased, malaise, pneumonia, venoocclusive liver disease, . BUSULFAN dosage: 40 MG; QID; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN, FILGRASTIM, METHOTREXATE, CYCLOSPORINE. Patient was hospitalized and became disabled. Patient recovered.

Busulfan Side Effects Report #5506440-1
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Oct 23, 2007. Male patient, 63 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, blood lactate dehydrogenase increased, diarrhoea, febrile neutropenia, haemodialysis, haemorrhagic cerebral infarction, intestinal functional disorder, liver disorder, . BUSULFAN dosage: unknown. Patient was hospitalized and became disabled. Patient died.

Cyclophosphamide Side Effects Report #5517637-9
CYCLOPHOSPHAMIDE problem was reported by a Consumer or non-health professional from on Nov 08, 2007. Male patient, child 9 years of age, was diagnosed with bone marrow conditioning regimen, prophylaxis against graft versus host disease, acute graft versus host disease, antifungal prophylaxis and was treated with CYCLOPHOSPHAMIDE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, chronic graft versus host disease, haemolysis, haemolytic uraemic syndrome, hypertension, rash maculo-papular, renal failure, sepsis, . CYCLOPHOSPHAMIDE dosage: unknown. During the same period patient was treated with METHOTREXATE, PREDNISONE, CYCLOSPORINE, IMMUNE GLOBULIN INTRAVENOUS, NEUPOGEN, CASPOFUNGIN, PLATELETS. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5523822-2
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Nov 05, 2007. Female patient, 14 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, cytomegalovirus hepatitis, klebsiella sepsis, venoocclusive liver disease, . BUSULFAN dosage: 21.6 ML; QD; IV, 30.8 ML; QD; IV, 7.2 ML;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, MELPHALAN, PHENYTOIN, LENOGRASTIM, METHOTREXATE, TACROLIMUS. Patient died on 08/21/2007.

Cyclosporine Side Effects Report #5474025-1
CYCLOSPORINE problem was reported by a Consumer or non-health professional from JAPAN on Sept 27, 2007. Male patient, child 1 years of age, weighting 18.74 lb, was diagnosed with bone marrow transplant and was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute myeloid leukaemia recurrent, stem cell transplant, . CYCLOSPORINE dosage: unknown. During the same period patient was treated with METHOTREXATE, SANDIMMUNE. Patient died.

Ciclosporin Side Effects Report #5485171-0
Consumer or non-health professional from JAPAN reported CICLOSPORIN problem on Oct 10, 2007. Male patient, 57 years of age, was diagnosed with stem cell transplant and was treated with CICLOSPORIN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, aspergillosis, hepatic function abnormal, myocarditis mycotic, . CICLOSPORIN dosage: unknown. During the same period patient was treated with ENDOXAN, METHOTREXATE, PROGRAF. Patient died.

Neoral Side Effects Report #5487710-2
NEORAL problem was reported by a Consumer or non-health professional from JAPAN on Oct 11, 2007. Male patient, child 1 years of age, weighting 18.74 lb, was diagnosed with bone marrow transplant and was treated with NEORAL. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute myeloid leukaemia recurrent, stem cell transplant, . NEORAL dosage: unknown. During the same period patient was treated with METHOTREXATE, SANDIMMUNE, ENDOXAN. Patient died.

Endoxan Side Effects Report #5489858-5
Consumer or non-health professional from UNITED STATES reported ENDOXAN problem on Oct 12, 2007. Male patient, child 2 years of age, was diagnosed with bone marrow conditioning regimen, prophylaxis against graft versus host disease and was treated with ENDOXAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, alopecia, cardiac failure, . ENDOXAN dosage: unknown. During the same period patient was treated with FLUDARA, MABLIN, PROGRAF, MEROPEN, PREDONINE, ZOVIRAX, METHOTREXATE, RIVOTRIL. Patient died on 07/07/2006.

Norvir Side Effects Report #5494423-X
NORVIR problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 22, 2007. Male patient, weighting 211.0 lb, was diagnosed with hiv test positive and was treated with NORVIR. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, lipodystrophy acquired, osteopenia, . NORVIR dosage: unknown. During the same period patient was treated with FORTOVASE GSK, TRIZIVIR, FOSAMAX D, SINGULAIR, ZYRTEC, RITALIN LA, NORDITROPIN, LUNESTA. Patient recovered.

Busulfan Side Effects Report #5496979-X
Health Professional from JAPAN reported BUSULFAN problem on Oct 09, 2007. Male patient, child .8 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, bone marrow transplant, cholecystitis, diarrhoea, hypoalbuminaemia, oral intake reduced, platelet count decreased, sepsis, . BUSULFAN dosage: 0.45 ML; X1; IV, 5.08 ML; X1; IV. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5497620-2
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Oct 09, 2007. Female patient, 34 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, bone marrow transplant, diarrhoea, enteritis, enterococcal sepsis, gamma-glutamyltransferase increased, . BUSULFAN dosage: 26.8 MG;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN, NEUPOGEN, METHOTREXATE, TACROLIMUS. Patient recovered.

Busulfan Side Effects Report #5497678-0
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Oct 09, 2007. Female patient, 55 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, anorexia, arthritis bacterial, cardiac failure, cytomegalovirus viraemia, diarrhoea, febrile neutropenia, hyponatraemia, . BUSULFAN dosage: 10.6 ML;X1;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5497956-5
SANDIMMUNE problem was reported by a Consumer or non-health professional from JAPAN on Oct 17, 2007. Male patient, 57 years of age, was diagnosed with stem cell transplant and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, aspergillosis, blood pressure decreased, cardiac hypertrophy, hepatic function abnormal, lung abscess, myocarditis mycotic, rash, renal abscess, . SANDIMMUNE dosage: 3 MG/KG/DAY. During the same period patient was treated with ENDOXAN, METHOTREXATE, PROGRAF, THIOTEPA, CYCLOPHOSPHAMIDE, IRRADIATION, CELLCEPT, STEROIDS NOS. Patient died.

Sandimmune Side Effects Report #5502768-X
Physician from JAPAN reported SANDIMMUNE problem on Oct 29, 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 problems/side effects: acute graft versus host disease, acute respiratory distress syndrome, blood lactate dehydrogenase increased, haemolytic anaemia, herpes zoster, multi-organ failure, pulmonary alveolar haemorrhage, red blood cell abnormality, red blood cell schistocytes present, . SANDIMMUNE dosage: 100 MG/DAY. Patient was hospitalized. Patient died on 01/01/1999.

Busulfan Side Effects Report #5447577-5
BUSULFAN problem was reported by a Health Professional from JAPAN on Aug 22, 2007. Male patient, 55 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, anorexia, cytomegalovirus infection, diarrhoea, malaise, nausea, sepsis, stomatitis, . BUSULFAN dosage: 32.8 ML;. During the same period patient was treated with METHOTREXATE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5466146-4
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Sept 10, 2007. Female patient, 56 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, diarrhoea, haemodialysis, pneumonia, renal failure acute, sepsis, stomatitis, . BUSULFAN dosage: 26.4 ML; QD; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, NEUPOGEN, VALPROATE, METHOTREXATE, TACROLIMUS, CYCLOSPORINE. Patient died on 06/15/2007.