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ACUTE MYELOID LEUKAEMIA RECURRENT side effect

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Cytarabine Side Effects Report #5678119-7
Physician from INDIA reported CYTARABINE problem on Mar 13, 2008. Male patient, 17 years of age, was diagnosed with acute myeloid leukaemia, prophylaxis against graft versus host disease and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, bone marrow failure, febrile neutropenia, fungal infection, graft versus host disease, karyotype analysis abnormal, mutagenic effect, no therapeutic response, stem cell transplant, . CYTARABINE dosage: 100 MG/M2. During the same period patient was treated with IDARUBICIN, BUSULPHAN, CYCLOPHOSPHAMIDE, CYCLOSPORINE, METHOTREXATE. Patient recovered.

Prograf Side Effects Report #5633645-1
PROGRAF problem was reported by a Physician from UNITED STATES on Feb 08, 2008. Male patient, 58 years of age, was diagnosed with stem cell transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, alanine aminotransferase increased, aspartate aminotransferase increased, bacteria blood identified, blood creatinine increased, blood ph increased, blood urea increased, chills, clostridial infection, . PROGRAF dosage: unknown. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient died.

Busulfan Side Effects Report #5523800-3
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Nov 05, 2007. Male patient, child 4 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 myeloid leukaemia recurrent, graft versus host disease, sepsis, stomatitis, . BUSULFAN dosage: 9.63 ML; QD; IV, 12.84 ML; QD; IV, 3.21 ML; QD; IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYTARABINE, CLONAZEPAM, NEUPOGEN, METHOTREXATE. Patient was hospitalized. Patient died on 07/26/2007.

Clolar Side Effects Report #5480410-4
CLOLAR problem was reported by a Pharmacist from UNITED STATES on Oct 04, 2007. Female patient, 47 years of age, weighting 185.2 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with CLOLAR. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, blood culture positive, candidiasis, ejection fraction decreased, febrile neutropenia, hyperbilirubinaemia, nephrotic syndrome, renal failure, respiratory distress, . CLOLAR dosage: 81MG QD X5 DAYS IV. Patient was hospitalized. Patient recovered.


Cytarabine Side Effects Report #5456652-0
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Sept 17, 2007. Male patient, weighting 173.7 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, arthritis bacterial, febrile neutropenia, . CYTARABINE dosage: 4000 MG. Patient was hospitalized. Patient recovered.

Flagyl Side Effects Report #5422253-3
FLAGYL problem was reported by a Consumer or non-health professional from on Aug 14, 2007. Male patient, 17 years of age, was treated with FLAGYL. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, arrhythmia, bronchopulmonary aspergillosis, cardio-respiratory arrest, cerebellar syndrome, coma, convulsion, decerebration, eye movement disorder, . FLAGYL dosage: unknown. During the same period patient was treated with CERUBIDINE, ARACYTINE, NOVANTRONE, AMSIDINE, TAZOCILLINE, AMIKLIN. Patient was hospitalized. Patient died on 06/10/2007.

Prograf Side Effects Report #5403437-7
Physician from JAPAN reported PROGRAF problem on July 19, 2007. Male patient, 49 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 myeloid leukaemia recurrent, csf test abnormal, viith nerve paralysis, . PROGRAF dosage: unknown. Patient died.

Prograf Side Effects Report #5403437-7
PROGRAF problem was reported by a Physician from JAPAN on July 19, 2007. Male patient, 49 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 myeloid leukaemia recurrent, csf test abnormal, viith nerve paralysis, . PROGRAF dosage: unknown. Patient died.

Daunorubicin Side Effects Report #5792885-1
Consumer or non-health professional from UNITED STATES reported DAUNORUBICIN problem on June 09, 2008. Female patient, 68 years of age, was diagnosed with acute myeloid leukaemia and was treated with DAUNORUBICIN. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, myelodysplastic syndrome, . DAUNORUBICIN dosage: 60 MG/M2 QD. During the same period patient was treated with MITOXANTRONE, ETOPOSIDE, CYTARABINE, NEUPOGEN, MELPHALAN. Patient died.


Busulfex Side Effects Report #5798830-7
BUSULFEX problem was reported by a Health Professional from JAPAN on June 16, 2008. Female patient, 26 years of age, was diagnosed with stem cell transplant and was treated with BUSULFEX. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, . BUSULFEX dosage: 15 ML, INTRAVENOUS; 20 ML, DAILY DOSE; INTRAVENOUS. During the same period patient was treated with CYCLOPHOSPHAMIDE, CLONAZEPAM, LENOGRASTIM, METHOTREXATE, TACROLIMUS. Patient recovered.

Busulfex Side Effects Report #5798835-6
Health Professional from JAPAN reported BUSULFEX problem on June 16, 2008. Male patient, 58 years of age, was diagnosed with stem cell transplant and was treated with BUSULFEX. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, anorexia, enterocolitis, febrile neutropenia, graft versus host disease, malaise, nausea, stomatitis, vomiting, . BUSULFEX dosage: 460 MG INTRAVENOUS. During the same period patient was treated with PHENYTOIN, NEUPOGEN, MITOXANTRONE HYDROCHLORIDE, METHOTREXATE, CYCLOSPORINE, MITOXANTRONE HYDROCHLORIDE. Patient died.

Busulfex Side Effects Report #5729833-6
BUSULFEX problem was reported by a Consumer or non-health professional from JAPAN on Apr 21, 2008. Male patient, 58 years of age, was diagnosed with stem cell transplant and was treated with BUSULFEX. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, anaemia, anorexia, blast cell count increased, blood bilirubin increased, condition aggravated, cytomegalovirus viraemia, graft complication, haematemesis, . BUSULFEX dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, TACROLIMUS, NEUPOGEN, VALPROATE, METHOTREXATE. Patient was hospitalized. Patient died on 05/01/2007.

Busulfex Side Effects Report #5729837-3
Consumer or non-health professional from JAPAN reported BUSULFEX problem on Apr 21, 2008. Male patient, 25 years of age, was diagnosed with stem cell transplant and was treated with BUSULFEX. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, altered state of consciousness, anorexia, bone marrow failure, cardiac arrest, cellulitis, convulsion, diarrhoea, engraft failure, . BUSULFEX dosage: 30 ML INTRAVENOUS. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN, NEUPOGEN, METHOTREXATE, CYCLOSPORINE. Patient was hospitalized and became disabled. Patient died.

Enbrel Side Effects Report #5745854-1
ENBREL problem was reported by a Physician from UNITED STATES on May 16, 2008. Male patient, child 12 years of age, was treated with ENBREL. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, cytomegalovirus infection, respiratory failure, . ENBREL dosage: unknown. During the same period patient was treated with REMICADE, CORTICOSTEROIDS, THYMOGLOBULIN, TACROLIMUS, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient died on 07/12/2005.


Cytarabine Side Effects Report #5692684-5
Consumer or non-health professional from FRANCE reported CYTARABINE problem on Mar 13, 2008. Male patient, child 9 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, cytogenetic abnormality, . CYTARABINE dosage: unknown. During the same period patient was treated with MITOXANTRONE, AMSACRINE, ETOPOSIDE. Patient recovered.

Posaconazole Side Effects Report #5353175-4
POSACONAZOLE problem was reported by a Health Professional from UNITED STATES on June 05, 2007. Female patient, 61 years of age, was diagnosed with fungal infection and was treated with POSACONAZOLE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, cardio-respiratory arrest, dehydration, nausea, pyrexia, vomiting, . POSACONAZOLE dosage: 400 MG;BID;PO. Patient was hospitalized. Patient died on 07/03/2006.

Posaconazole Side Effects Report #5316289-0
Physician from UNITED STATES reported POSACONAZOLE problem on Apr 16, 2007. Female patient, 61 years of age, was diagnosed with fungal infection and was treated with POSACONAZOLE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, dehydration, nausea, pyrexia, vomiting, . POSACONAZOLE dosage: 400 MG; BID; PO. Patient was hospitalized. Patient died on 07/03/2006.

Gemzar Side Effects Report #5261092-3
GEMZAR problem was reported by a Physician from UNITED STATES on Mar 01, 2007. Female patient, 40 years of age, was diagnosed with malignant neoplasm progression and was treated with GEMZAR. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, . GEMZAR dosage: unknown. During the same period patient was treated with TARCEVA. Patient died on 12/18/2006.

Clofarabine Side Effects Report #5287001-9
Consumer or non-health professional from UNITED KINGDOM reported CLOFARABINE problem on Mar 15, 2007. Female patient, 57 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, bacteria sputum identified, diarrhoea, disseminated intravascular coagulation, hypoxia, lower respiratory tract infection, lung infection, mucosal inflammation, neutropenic sepsis, . CLOFARABINE dosage: 20 MG/M2 QD IV. During the same period patient was treated with CYTARABINE. Patient died on 12/07/2006.


Busulfan Side Effects Report #5663404-5
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN 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.

Cytarabine Side Effects Report #5678113-6
Health Professional from AUSTRALIA reported CYTARABINE problem on Mar 13, 2008. Female patient, 53 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal distension, acute myeloid leukaemia recurrent, ataxia, dysarthria, impaired gastric emptying, nausea, nervous system disorder, neurotoxicity, oral intake reduced, . CYTARABINE dosage: 100 MG/M2 DAILY. During the same period patient was treated with IDARUBICIN. Patient recovered.

Fluoxetine Side Effects Report #5678407-4
FLUOXETINE problem was reported by a Pharmacist from UNITED STATES on Mar 10, 2008. Male patient, 23 years of age, was diagnosed with affective disorder and was treated with FLUOXETINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, acute myeloid leukaemia recurrent, affective disorder, anxiety, attention deficit/hyperactivity disorder, blood culture positive, dyspnoea, . FLUOXETINE dosage: 80 MG; QD; PO. During the same period patient was treated with METHADON, NICOTINE, LORAZEPAM, QUETIAPINE FUMARATE, VORICONAZOLE, CYTARABINE, LINEZOLID. 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.

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.

Neoral Side Effects Report #5487710-2
Consumer or non-health professional from JAPAN reported NEORAL problem 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.

Cyclosporine Side Effects Report #5466581-4
CYCLOSPORINE problem was reported by a Consumer or non-health professional from JAPAN on Sept 19, 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, . CYCLOSPORINE dosage: unknown. During the same period patient was treated with METHOTREXATE, SANDIMMUNE. Patient died.

Exjade Side Effects Report #5400560-8
Physician from UNITED STATES reported EXJADE problem on July 27, 2007. Male patient, 65 years of age, was diagnosed with iron overload, acute myeloid leukaemia and was treated with EXJADE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, acute myeloid leukaemia recurrent, atelectasis, blood albumin decreased, blood alkaline phosphatase increased, blood creatinine increased, blood sodium decreased, bronchoscopy normal, cardiac disorder, . EXJADE dosage: 1750 MG, QD. During the same period patient was treated with RED BLOOD CELLS, PLATELETS, NEUPOGEN, LAMIVUDINE, ACYCLOVIR, METOPROLOL SUCCINATE, NORVASC, DILTIAZEM. Patient was hospitalized. Patient died on 06/10/2007.

Exjade Side Effects Report #5400560-8
EXJADE problem was reported by a Physician from UNITED STATES on July 27, 2007. Male patient, 65 years of age, was diagnosed with iron overload, acute myeloid leukaemia and was treated with EXJADE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, acute myeloid leukaemia recurrent, atelectasis, blood albumin decreased, blood alkaline phosphatase increased, blood creatinine increased, blood sodium decreased, bronchoscopy normal, cardiac disorder, . EXJADE dosage: 1750 MG, QD. During the same period patient was treated with RED BLOOD CELLS, PLATELETS, NEUPOGEN, LAMIVUDINE, ACYCLOVIR, METOPROLOL SUCCINATE, NORVASC, DILTIAZEM. Patient was hospitalized. Patient died on 06/10/2007.

Clolar Side Effects Report #5776285-6
Health Professional from UNITED STATES reported CLOLAR problem on June 06, 2008. Female patient, 60 years of age, weighting 193.1 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOLAR. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease in skin, acute myeloid leukaemia recurrent, deep vein thrombosis, haemosiderosis, hepatocellular injury, hyperglycaemia, hypermagnesaemia, liver injury, no therapeutic response, . CLOLAR dosage: 53 MG, QDX5, INTRAVENOUS. During the same period patient was treated with BUSULFAN. Patient was hospitalized. Patient recovered.

Busulfex Side Effects Report #5744160-9
BUSULFEX problem was reported by a Consumer or non-health professional from JAPAN on May 08, 2008. Female patient, 55 years of age, was diagnosed with stem cell transplant and was treated with BUSULFEX. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, acute myeloid leukaemia recurrent, anorexia, bone marrow transplant rejection, cytomegalovirus infection, disseminated intravascular coagulation, encephalitis viral, gamma-glutamyltransferase increased, . BUSULFEX dosage: 18 ML, INTRAVENOUS; 24 ML, INTRAVENOUS; 6 ML, INTRAVENOUS. During the same period patient was treated with CYCLOPHOSPHAMIDE, PHENYTOIN, NARTOGRASTIN, NEUPOGEN, LENOGRASTIM, METHOTREXATE. Patient was hospitalized. Patient died.

Etoposide Side Effects Report #5263002-1
Physician from UNITED STATES reported ETOPOSIDE problem on Feb 27, 2007. Female patient, 40 years of age, was diagnosed with pancreatic carcinoma and was treated with ETOPOSIDE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, acute myeloid leukaemia recurrent, . ETOPOSIDE dosage: 140 MG, OTHER. During the same period patient was treated with GEMCITABINE. Patient was hospitalized and became disabled. Patient died on 12/18/2006.

Etoposide Side Effects Report #5263005-7
ETOPOSIDE problem was reported by a Physician from UNITED STATES on Mar 08, 2007. Female patient, 40 years of age, was diagnosed with pancreatic carcinoma and was treated with ETOPOSIDE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, acute myeloid leukaemia recurrent, . ETOPOSIDE dosage: 140 MG, OTHER. During the same period patient was treated with GEMCITABINE. Patient was hospitalized and became disabled. Patient died on 12/18/2006.

Decitabine Side Effects Report #5663732-3
Physician from UNITED STATES reported DECITABINE problem on Feb 25, 2008. Female patient, 65 years of age, was diagnosed with acute myeloid leukaemia, pneumonia fungal and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: abdominal hernia, abdominal pain, acute myeloid leukaemia recurrent, diabetes mellitus inadequate control, disease progression, febrile neutropenia, fluid overload, haematocrit decreased, . DECITABINE dosage: 20 MG/M2, IN 1 DAY, INTRAVENOUS. Patient was hospitalized. Patient recovered.

Cerezyme Side Effects Report #5625442-8
CEREZYME problem was reported by a Physician from UNITED STATES on Feb 05, 2008. Male patient, 60 years of age, weighting 205.0 lb, was diagnosed with gaucher's disease and was treated with CEREZYME. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, acute myeloid leukaemia (in remission), acute myeloid leukaemia recurrent, . CEREZYME dosage: unknown. During the same period patient was treated with FOSAMAX. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5472216-7
Consumer or non-health professional from UNITED STATES reported PROGRAF problem on Sept 10, 2007. Female patient, 46 years of age, was diagnosed with off label use and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: abscess limb, acute myeloid leukaemia, acute myeloid leukaemia recurrent, anorexia, atrial fibrillation, atrial flutter, blood potassium decreased, catheter site erythema, cellulitis, . PROGRAF dosage: 0.5 MG, BID; ORAL. During the same period patient was treated with CELLCEPT, DACLIZUMAB, ACYCLOVIR, PROTONIX, VFEND, PROVERA, PROCRIT, ALLEGRA. Patient was hospitalized. Patient died on 06/01/2007.

Prograf Side Effects Report #5704606-9
PROGRAF problem was reported by a Physician from JAPAN on Mar 24, 2008. Male patient, 17 years of age, was diagnosed with stem cell transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease in liver, acute graft versus host disease in skin, acute myeloid leukaemia recurrent, pancytopenia, stem cell transplant, . PROGRAF dosage: unknown. During the same period patient was treated with CORTICOSTEROIDS. Patient died on 04/01/2005.