SANDIMMUNE Side Effects

6754440-6 | Agranulocytosis, Anaemia, Bone Marrow Failure
on May 21, 2010 Female patient from SWITZERLAND , 77 years of age, was diagnosed with renal transplant and was treated with Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: agranulocytosis, anaemia, bone marrow failure. Sandimmune dosage: 250 Mg/day. During the same period patient was treated with PROGRAF (Unk) (View Prograf Review and Prograf Label ), ADALAT CC (30 Mg/day) (View Adalat Cc Review and Adalat Cc Label ), PREDNISONE (5 Mg/day) (View Prednisone Review and Prednisone Label ), IMUREK (View Imurek Review and Imurek Label ), METOPROLOL TARTRATE (View Metoprolol Tartrate Review and Metoprolol Tartrate Label ). Patient was hospitalized.

6738851-0 | Intestinal Operation
Patient was taking Sandimmune (View Usage). Patient had the following side effects: intestinal operation on May 13, 2010 from BRAZIL Additional patient health information: Male patient , 78 years of age, weighting 112.4 lb, was diagnosed with platelet count decreased, prostate infection, brain stem syndrome and. Sandimmune dosage: 50 Mg, Unk. During the same period patient was treated with SECONTEX (0.4 Mg, One Tablet Daily) (View Secontex Review and Secontex Label ), FINASTERIDE (5 Mg (1 Tablet Daily)) (View Finasteride Review and Finasteride Label ), DEFLAZACORT (30 Mg, Half A Tablet Daily) (View Deflazacort Review and Deflazacort Label ), VITAMIN B6 (1 Capsule Daily) (View Vitamin B6 Review and Vitamin B6 Label ), FOLIC ACID (1 Capsule Daily) (View Folic Acid Review and Folic Acid Label ), VITAMIN B 12 (50 Mg, Manipulated 20 Drops) (View Vitamin B-12 Review and Vitamin B-12 Label ). Patient was hospitalized.

6734248-8 | Chest Pain, Heart Rate Increased
Adverse event was reported on May 11, 2010 by a Female patient taking Sandimmune (View Usage) (Dosage: 50mg Every Other Day And With Dose 50mg And 75mg Every Other Day) was diagnosed with renal transplant and. Location: FINLAND , 44 years of age, After Sandimmune was administered, patient had the following side effects: chest pain (What is chest pain?), heart rate increased. During the same period patient was treated with MEDROL (View Medrol Review and Medrol Label ).

6733742-3 | Acute Graft Versus Host Disease In Liver, Adenovirus Infection, Bile Duct Obstruction, Bile Duct Stenosis, Bile Duct Stent Insertion, Biliary Drainage, Biliary Tract Dilation Procedure, Biliary Tract Disorder, Bilirubin Conjugated Increased
on May 10, 2010 Female patient from JAPAN , 36 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: acute graft versus host disease in liver, adenovirus infection, bile duct obstruction, bile duct stenosis, bile duct stent insertion, biliary drainage, biliary tract dilation procedure, biliary tract disorder, bilirubin conjugated increased. Sandimmune dosage: 30 Mg Daily. During the same period patient was treated with NEORAL (140 Mg/day) (View Neoral Review and Neoral Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), IRRADIATION (View Irradiation Review and Irradiation Label ). Patient was hospitalized.


6733741-1 | Acute Graft Versus Host Disease In Liver, Adenovirus Infection, Bile Duct Obstruction, Bile Duct Stenosis, Bile Duct Stent Insertion, Biliary Drainage, Biliary Tract Dilation Procedure, Biliary Tract Disorder, Bilirubin Conjugated Increased
on May 10, 2010 Female patient from JAPAN , 36 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune (View Usage). Patient had the following side effects: acute graft versus host disease in liver, adenovirus infection, bile duct obstruction, bile duct stenosis, bile duct stent insertion, biliary drainage, biliary tract dilation procedure, biliary tract disorder, bilirubin conjugated increased. Sandimmune dosage: 30 Mg Daily. During the same period patient was treated with NEORAL (140 Mg/day) (View Neoral Review and Neoral Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), IRRADIATION (View Irradiation Review and Irradiation Label ). Patient was hospitalized.

6723959-6 | Blood Creatinine Increased, Nephrotic Syndrome, Proteinuria, Renal Failure
Patient was taking Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: blood creatinine increased, nephrotic syndrome, proteinuria, renal failure on May 04, 2010 from GERMANY Additional patient health information: Male patient , weighting 176.4 lb, was diagnosed with psoriasis and. Sandimmune dosage: 75 Mg, Bid. During the same period patient was treated with CORTICOSTEROIDS (View Corticosteroids Review and Corticosteroids Label ).

6718466-0 | Abdominal Pain Upper, Bedridden, Gait Disturbance, Haemodialysis, Hepatic Enzyme Increased, Muscle Fibrosis, Nausea, Osteosynthesis
Adverse event was reported on May 03, 2010 by a Female patient taking Sandimmune (View Usage) (Dosage: 100 Mg) was diagnosed with renal transplant, hyperlipidaemia, hypothyroidism, hypertension, myocardial infarction and. Location: GERMANY , 49 years of age, weighting 216.1 lb, Patient experienced the following unwanted or unexpected effects: abdominal pain upper, bedridden, gait disturbance, haemodialysis, hepatic enzyme increased, muscle fibrosis, nausea (What is nausea?), osteosynthesis. During the same period patient was treated with SIMVASTATIN (40 Mg) (View Simvastatin Review and Simvastatin Label ), LEVOTHYROXINE SODIUM (25 Ug) (View Levothyroxine Sodium Review and Levothyroxine Sodium Label ), CELLCEPT (1000 Mg) (View Cellcept Review and Cellcept Label ), BISOPROLOL (10 Mg) (View Bisoprolol Review and Bisoprolol Label ), FUROSEMID (40 Mg) (View Furosemid Review and Furosemid Label ), ACETYLSALICYLIC ACID (100 Mg) (View Acetylsalicylic Acid Review and Acetylsalicylic Acid Label ). Patient was hospitalized.

6712089-5 | Abdominal Pain Upper, Activities Of Daily Living Impaired, Asthenia, Gait Disturbance, Gallbladder Disorder, Pain In Extremity, Pyrexia, Vomiting
on Apr 26, 2010 Female patient from BRAZIL , 75 years of age, weighting 158.7 lb, was treated with Sandimmune (View Usage). Patient had the following side effects: abdominal pain upper, activities of daily living impaired, asthenia, gait disturbance, gallbladder disorder, pain in extremity, pyrexia, vomiting. Sandimmune dosage: 25 Mg. During the same period patient was treated with GRANULOKINE (Unk,unk) (View Granulokine Review and Granulokine Label ). Patient was hospitalized.

6709378-7 | Abdominal Pain, Abnormal Faeces, Asthma, Chills, Cytomegalovirus Infection, Fatigue, Hyperhidrosis, Hypotonia
on Apr 22, 2010 Female patient from GERMANY , 49 years of age, weighting 150.6 lb, was diagnosed with renal transplant, immunosuppression, asthma (What is asthma?), osteoporosis prophylaxis, bronchitis (What is bronchitis?) and was treated with Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: abdominal pain (What is abdominal pain?), abnormal faeces, asthma (What is asthma?), chills, cytomegalovirus infection (What is cytomegalovirus infection?), fatigue, hyperhidrosis, hypotonia. Sandimmune dosage: 250 Mg, Bid. During the same period patient was treated with CELLCEPT (2000 Mg/day) (View Cellcept Review and Cellcept Label ), BEROTEC (100 Ug, Qd) (View Berotec Review and Berotec Label ), CALCIMAGON D3 (1 Df, Qd) (View Calcimagon-d3 Review and Calcimagon-d3 Label ), CIPROFLOXACIN (250 Mg, Bid) (View Ciprofloxacin Review and Ciprofloxacin Label ), ECOTRIN (1 Df, Bid) (View Ecotrin Review and Ecotrin Label ). Patient was hospitalized.

6708956-9 | Bacterial Infection, Blood Bilirubin Increased, Blood Creatinine Increased, C-reactive Protein Increased, Pyrexia, Sepsis, Urinary Tract Infection, Urosepsis
Patient was taking Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: bacterial infection (What is bacterial infection?), blood bilirubin increased, blood creatinine increased, c-reactive protein increased, pyrexia, sepsis (What is sepsis?), urinary tract infection (What is urinary tract infection?), urosepsis on Apr 20, 2010 from GERMANY Additional patient health information: Female patient , 58 years of age, weighting 143.3 lb, was diagnosed with renal transplant, hypertension, prophylaxis against gastrointestinal ulcer, cardiovascular event prophylaxis and. Sandimmune dosage: 75 Mg, Bid. During the same period patient was treated with CELLCEPT (1000 Mg, Bid) (View Cellcept Review and Cellcept Label ), PREDNISOLONE (4 Mg, Qd) (View Prednisolone Review and Prednisolone Label ), AMLODIPINE (5 Mg, Qd) (View Amlodipine Review and Amlodipine Label ), PANTOZOL (40 Mg, Qd) (View Pantozol Review and Pantozol Label ), RAMIPRIL (10 Mg, Qd) (View Ramipril Review and Ramipril Label ), CARVEDILOL (25 Mg, Bid) (View Carvedilol Review and Carvedilol Label ), LOCOL (40 Mg, Qd) (View Locol Review and Locol Label ), DIOVANE (80 Mg, Qd) (View Diovane Review and Diovane Label ). Patient was hospitalized.

6706414-9 | Abdominal Pain, Incisional Hernia, Lymphocele, Seroma
Adverse event was reported on Apr 23, 2010 by a Female patient taking Sandimmune (View Usage) (Dosage: 325 Mg, Bid) was diagnosed with renal transplant and. Location: GERMANY , weighting 200.6 lb, Patient had the following side effects: abdominal pain (What is abdominal pain?), incisional hernia, lymphocele, seroma. During the same period patient was treated with MYFORTIC (360 Mg, Tid) (View Myfortic Review and Myfortic Label ), NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ). Patient was hospitalized.

6706380-6 | Blood Creatinine Increased, Proteinuria
on Apr 20, 2010 Male patient from RUSSIAN FEDERATION , 24 years of age, was treated with Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: blood creatinine increased, proteinuria. Sandimmune dosage: . During the same period patient was treated with MYFORTIC (View Myfortic Review and Myfortic Label ), METHYLPREDNISOLONE ACETATE (View Methylprednisolone Acetate Review and Methylprednisolone Acetate Label ), ENALAPRIL MALEATE (View Enalapril Maleate Review and Enalapril Maleate Label ), METOPROLOL (View Metoprolol Review and Metoprolol Label ), RANITIDINE (View Ranitidine Review and Ranitidine Label ), ALPHA D3 (View Alpha D3 Review and Alpha D3 Label ).

6702978-X | Abdominal Pain Upper, Dyspnoea, Hypersensitivity, Lip Swelling
on Apr 29, 2010 Female patient from UNITED STATES , child 10 years of age, weighting 194.0 lb, was diagnosed with immunosuppression and was treated with Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal pain upper, dyspnoea, hypersensitivity, lip swelling. Sandimmune dosage: 200 Mg Iv X 1 Off And On. Patient was hospitalized.

6695052-2 | Hepatitis, Osteoporosis
Patient was taking Sandimmune (View Usage). Patient had the following side effects: hepatitis (What is hepatitis?), osteoporosis (What is osteoporosis?) on Apr 13, 2010 from RUSSIAN FEDERATION Additional patient health information: Male patient , 44 years of age, . Sandimmune dosage: . Patient was hospitalized.

6691612-3 | Glomerular Filtration Rate Decreased, Nephropathy Toxic, Proteinuria, Renal Failure Chronic, Renal Transplant
Adverse event was reported on Apr 08, 2010 by a Female patient taking Sandimmune (View Usage) (Dosage: 5 Mg/kg, Daily) was diagnosed with nephrotic syndrome, henoch-schonlein purpura and. Location: DENMARK , 14 years of age, After Sandimmune was administered, patient had the following side effects: glomerular filtration rate decreased, nephropathy toxic, proteinuria, renal failure chronic, renal transplant. During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ). Patient was hospitalized.

6689011-3 | Abscess, Asthenia, Blood Creatinine Increased, Cytomegalovirus Infection, Haemorrhage, Hepatomegaly, Parvovirus B19 Test Positive, Pyrexia, Renal Cyst
on Apr 09, 2010 Male patient from GERMANY , 61 years of age, weighting 147.7 lb, was diagnosed with renal transplant, nephrogenic anaemia, cardiovascular event prophylaxis, hypertension, osteopenia and was treated with Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: abscess (What is abscess?), asthenia, blood creatinine increased, cytomegalovirus infection (What is cytomegalovirus infection?), haemorrhage, hepatomegaly, parvovirus b19 test positive, pyrexia, renal cyst. Sandimmune dosage: 100 Mg, Bid. During the same period patient was treated with CELLCEPT (750 Mg, Bid) (View Cellcept Review and Cellcept Label ), ARANESP (30 Ug, Qd) (View Aranesp Review and Aranesp Label ), ASPIRIN (100 Mg, Qd) (View Aspirin Review and Aspirin Label ), BISOPROLOL (2.5 Mg, Bid) (View Bisoprolol Review and Bisoprolol Label ), CALCIMAGON D3 (1 Df, Bid) (View Calcimagon-d3 Review and Calcimagon-d3 Label ), DECORTIN H (5 Mg, Qd) (View Decortin-h Review and Decortin-h Label ). Patient was hospitalized.

6686174-0 | Blood Creatinine Increased, Bone Marrow Toxicity, Cardiac Failure Congestive, Cardiac Hypertrophy, Chills, Cytomegalovirus Infection, Diarrhoea, Encephalopathy, Epstein-barr Virus Associated Lymphoproliferative Disorder
on Apr 12, 2010 Male patient from GERMANY , 18 years of age, was diagnosed with stem cell transplant, prophylaxis against graft versus host disease and was treated with Sandimmune (View Usage). Patient had the following side effects: blood creatinine increased, bone marrow toxicity, cardiac failure congestive, cardiac hypertrophy, chills, cytomegalovirus infection (What is cytomegalovirus infection?), diarrhoea, encephalopathy, epstein-barr virus associated lymphoproliferative disorder. Sandimmune dosage: 150 Mg, Unk. During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), PREDNISOLON (View Prednisolon Review and Prednisolon Label ), CYCLOPHOSPHAMIDE (60 Mg/kg/d At 2 Days) (View Cyclophosphamide Review and Cyclophosphamide Label ), ANTI THYMOCYTE GLOBULIN NOS (1000 Mg/d) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), IRRADIATION (12 Gy, Unk) (View Irradiation Review and Irradiation Label ). Patient was hospitalized.

6661324-0 | Hepatic Failure, Liver Transplant, Liver Transplant Rejection
Patient was taking Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: hepatic failure, liver transplant (What is liver transplant?), liver transplant rejection on Mar 29, 2010 from GERMANY Additional patient health information: Male patient , weighting 152.1 lb, was diagnosed with liver transplant (What is liver transplant?) and. Sandimmune dosage: Unk, Unk. Patient was hospitalized.

6645246-7 | Blood Beta-d-glucan Abnormal, Bone Marrow Failure, Clostridial Infection, Inflammation, Melaena, Pancytopenia, Peritonitis, Shock Haemorrhagic
Adverse event was reported on Mar 09, 2010 by a Male patient taking Sandimmune (View Usage) (Dosage: 150 Mg, Unk) was diagnosed with histiocytosis haematophagic and. Location: JAPAN , child 11 years of age, Patient experienced the following unwanted or unexpected effects: blood beta-d-glucan abnormal, bone marrow failure, clostridial infection, inflammation, melaena, pancytopenia, peritonitis, shock haemorrhagic. During the same period patient was treated with DEXAMETHASONE (View Dexamethasone Review and Dexamethasone Label ). Patient was hospitalized.

6644977-2 | Abortion Spontaneous
on Mar 10, 2010 Female patient from SWITZERLAND , 37 years of age, was diagnosed with renal transplant and was treated with Sandimmune (View Usage). Patient had the following side effects: abortion spontaneous. Sandimmune dosage: 225 Mg/day. During the same period patient was treated with AZATHIOPRINE (75 Mg/day) (View Azathioprine Review and Azathioprine Label ), PREDNISONE TAB (7.5 Mg/day) (View Prednisone Tab Review and Prednisone Tab Label ), EPREX (5000 Iu/2 Weeks) (View Eprex Review and Eprex Label ).

6633231-0 | Abscess Drainage, Altered State Of Consciousness, Aspergillosis, Bronchopulmonary Aspergillosis, Cerebral Haemorrhage, Coma, Continuous Haemodiafiltration, Convulsion, Depressed Level Of Consciousness
on Mar 10, 2010 Female patient from JAPAN , 66 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: abscess drainage, altered state of consciousness, aspergillosis, bronchopulmonary aspergillosis, cerebral haemorrhage, coma, continuous haemodiafiltration, convulsion, depressed level of consciousness. Sandimmune dosage: 50 Mg Daily. During the same period patient was treated with METHYLPREDNISOLONE (1000 Ml/day) (View Methylprednisolone Review and Methylprednisolone Label ). Patient was hospitalized.

6633225-5 | Abscess Drainage, Altered State Of Consciousness, Aspergillosis, Bronchopulmonary Aspergillosis, Cerebral Haemorrhage, Coma, Continuous Haemodiafiltration, Convulsion, Depressed Level Of Consciousness
Patient was taking Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: abscess drainage, altered state of consciousness, aspergillosis, bronchopulmonary aspergillosis, cerebral haemorrhage, coma, continuous haemodiafiltration, convulsion, depressed level of consciousness on Mar 10, 2010 from JAPAN Additional patient health information: Female patient , 66 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and. Sandimmune dosage: 50 Mg Daily. During the same period patient was treated with METHYLPREDNISOLONE (1000 Ml/day) (View Methylprednisolone Review and Methylprednisolone Label ). Patient was hospitalized.

6633121-3 | Accidental Overdose
Adverse event was reported on Mar 02, 2010 by a Male patient taking Sandimmune (View Usage) (Dosage: 4x 5ml (1000 Mg)) was diagnosed with oncologic complication and. Location: GERMANY , 57 years of age, Patient had the following side effects: accidental overdose.

6623841-9 | Acute Respiratory Failure, Idiopathic Pneumonia Syndrome, Mechanical Ventilation, Oxygen Consumption Decreased, Pyrexia, Transfusion-related Acute Lung Injury
on Feb 25, 2010 Female patient from JAPAN , 49 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: acute respiratory failure, idiopathic pneumonia syndrome, mechanical ventilation, oxygen consumption decreased, pyrexia, transfusion-related acute lung injury. Sandimmune dosage: Unk. During the same period patient was treated with METHOTREXATE (Unk) (View Methotrexate Review and Methotrexate Label ), RED BLOOD CELLS (View Red Blood Cells Review and Red Blood Cells Label ), PLATELETS (View Platelets Review and Platelets Label ). Patient was hospitalized.

6618993-0 | Blister, Conjunctival Hyperaemia, Eczema, Erythema, Herpes Zoster, Neck Pain
on Mar 01, 2010 Male patient from JAPAN , weighting 152.1 lb, was diagnosed with renal transplant, antibiotic prophylaxis, insomnia, gastritis prophylaxis and was treated with Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: blister, conjunctival hyperaemia, eczema (What is eczema?), erythema, herpes zoster, neck pain. Sandimmune dosage: Unk. During the same period patient was treated with MYCOPHENOLATE MOFETIL (1500 Mg, Daily) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), PREDONINE (5 Mg, Daily) (View Predonine Review and Predonine Label ), BAKTAR (View Baktar Review and Baktar Label ), HALCION (View Halcion Review and Halcion Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), ALLOID (View Alloid Review and Alloid Label ). Patient was hospitalized.

6616141-4 | Idiopathic Pneumonia Syndrome, Transfusion-related Acute Lung Injury
Patient was taking Sandimmune (View Usage). Patient had the following side effects: idiopathic pneumonia syndrome, transfusion-related acute lung injury on Feb 23, 2010 from JAPAN Additional patient health information: Female patient , 49 years of age, . Sandimmune dosage: . During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ). Patient was hospitalized.

6616122-0 | Idiopathic Pneumonia Syndrome, Transfusion-related Acute Lung Injury
Adverse event was reported on Feb 23, 2010 by a Female patient taking Sandimmune (View Usage) (Dosage: ) . Location: JAPAN , 49 years of age, After Sandimmune was administered, patient had the following side effects: idiopathic pneumonia syndrome, transfusion-related acute lung injury. During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ). Patient was hospitalized.

6611581-1 | Blood Product Transfusion, Continuous Haemodiafiltration, Diarrhoea, Histiocytosis Haematophagic, Intraventricular Haemorrhage, Mechanical Ventilation, Multi-organ Failure, Pancytopenia, Pyrexia
on Feb 26, 2010 Male patient from JAPAN , child 2 years of age, was diagnosed with acute lymphocytic leukaemia, histiocytosis haematophagic and was treated with Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: blood product transfusion, continuous haemodiafiltration, diarrhoea, histiocytosis haematophagic, intraventricular haemorrhage, mechanical ventilation, multi-organ failure, pancytopenia, pyrexia. Sandimmune dosage: 4 Mg/kg Daily. During the same period patient was treated with NEORAL (5 Mg/kg Daily) (View Neoral Review and Neoral Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), METHYLPREDNISOLONE (2 Mg/kg, Unk) (View Methylprednisolone Review and Methylprednisolone Label ), DEXAMETHASONE (10 Mg/m2/day) (View Dexamethasone Review and Dexamethasone Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), VP 16 (50 Mg/m2/day) (View Vp-16 Review and Vp-16 Label ).

6608815-6 | Haemodialysis, Histiocytosis Haematophagic, Multi-organ Failure, Pyrexia, Staphylococcal Sepsis, Venoocclusive Liver Disease
on Feb 23, 2010 Male patient from JAPAN , child 2 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Sandimmune (View Usage). Patient had the following side effects: haemodialysis, histiocytosis haematophagic, multi-organ failure, pyrexia, staphylococcal sepsis, venoocclusive liver disease. Sandimmune dosage: 4 Mg/kg Daily. During the same period patient was treated with NEORAL (5 Mg/kg Daily) (View Neoral Review and Neoral Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), METHYLPREDNISOLONE (2 Mg/kg, Unk) (View Methylprednisolone Review and Methylprednisolone Label ), IMATINIB MESILATE (View Imatinib Mesilate Review and Imatinib Mesilate Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ), DOXORUBICIN HCL (Unk) (View Doxorubicin Hcl Review and Doxorubicin Hcl Label ).

6602421-5 | Accidental Overdose
Patient was taking Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: accidental overdose on Feb 16, 2010 from GERMANY Additional patient health information: Male patient , 57 years of age, was diagnosed with oncologic complication and. Sandimmune dosage: 4x 5ml (1000 Mg).

6599263-6 | Acute Myeloid Leukaemia Recurrent, Anaemia, Blood Bilirubin Increased, Hypokalaemia, Pulmonary Alveolar Haemorrhage, Pyrexia, Renal Impairment
Adverse event was reported on Feb 18, 2010 by a Male patient taking Sandimmune (View Usage) (Dosage: Unk) was diagnosed with pneumonia (What is pneumonia?), fungal infection (What is fungal infection?) and. Location: UNITED KINGDOM , weighting 125.7 lb, Patient experienced the following unwanted or unexpected effects: acute myeloid leukaemia recurrent, anaemia, blood bilirubin increased, hypokalaemia, pulmonary alveolar haemorrhage, pyrexia, renal impairment. During the same period patient was treated with AMPHOTERICIN B (50 Mg/day) (View Amphotericin B Review and Amphotericin B Label ), ITRIZOLE (200 Mg/day) (View Itrizole Review and Itrizole Label ), MEROPENEM (1.5 G/day) (View Meropenem Review and Meropenem Label ), VANCOMYCIN HYDROCHLORIDE (2 G/day) (View Vancomycin Hydrochloride Review and Vancomycin Hydrochloride Label ).

6593176-1 | Eczema, Herpes Zoster, Neck Pain
on Feb 15, 2010 Male patient from JAPAN , weighting 152.1 lb, was diagnosed with renal transplant, antibiotic prophylaxis, insomnia, gastritis prophylaxis and was treated with Sandimmune (View Usage). Patient had the following side effects: eczema (What is eczema?), herpes zoster, neck pain. Sandimmune dosage: Unk. During the same period patient was treated with MYCOPHENOLATE MOFETIL (1500 Mg, Daily) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), PREDONINE (5 Mg, Daily) (View Predonine Review and Predonine Label ), BAKTAR (View Baktar Review and Baktar Label ), HALCION (View Halcion Review and Halcion Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), ALLOID (View Alloid Review and Alloid Label ). Patient was hospitalized.

6581800-9 | Blood Creatinine Increased, Glomerulonephritis Proliferative, Therapeutic Agent Toxicity
on Feb 09, 2010 Male patient from GERMANY , weighting 166.4 lb, was diagnosed with renal transplant and was treated with Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: blood creatinine increased, glomerulonephritis proliferative, therapeutic agent toxicity. Sandimmune dosage: . During the same period patient was treated with CERTICAN (1.5 Mg, Qd) (View Certican Review and Certican Label ), MYFORTIC (View Myfortic Review and Myfortic Label ). Patient was hospitalized.

6580376-X | Lymphocele
Patient was taking Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: lymphocele on Feb 02, 2010 from GERMANY Additional patient health information: Male patient , weighting 123.5 lb, was diagnosed with renal transplant and. Sandimmune dosage: 75 Mg, Bid. During the same period patient was treated with MYFORTIC (360 Mg, Qid) (View Myfortic Review and Myfortic Label ), NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), URBASON (12 Mg, Unk) (View Urbason Review and Urbason Label ). Patient was hospitalized.

6574948-6 | Cardiovascular Insufficiency, Complications Of Transplanted Lung, Dehydration, Graft Dysfunction, Graft Ischaemia, Hypoxia, Pulmonary Function Test Abnormal, Renal Failure, Reperfusion Injury
Adverse event was reported on Feb 03, 2010 by a Female patient taking Sandimmune (View Usage) (Dosage: 50 Mg Daily) was diagnosed with lung transplant (What is lung transplant?) and. Location: JAPAN , weighting 92.59 lb, Patient had the following side effects: cardiovascular insufficiency, complications of transplanted lung, dehydration, graft dysfunction, graft ischaemia, hypoxia, pulmonary function test abnormal, renal failure, reperfusion injury. During the same period patient was treated with IMURAN (100 Mg Daily) (View Imuran Review and Imuran Label ), SIMULECT (20 Mg) (View Simulect Review and Simulect Label ), SOL MELCORT (125 Mg) (View Sol-melcort Review and Sol-melcort Label ).

6569913-9 | Bk Virus Infection, Blood Creatinine Increased, Cytomegalovirus Infection, Hydronephrosis, Incisional Drainage, Lymphocele
on Jan 29, 2010 Male patient from SWEDEN , weighting 174.2 lb, was diagnosed with renal transplant, prophylaxis against transplant rejection and was treated with Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: bk virus infection, blood creatinine increased, cytomegalovirus infection (What is cytomegalovirus infection?), hydronephrosis, incisional drainage, lymphocele. Sandimmune dosage: 300 Mg. During the same period patient was treated with NO TREATMENT RECEIVED NOMED (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), MYFORTIC (720 Mg, Bid) (View Myfortic Review and Myfortic Label ), PREDNISOLON (View Prednisolon Review and Prednisolon Label ). Patient was hospitalized.

6568672-3 | Cytomegalovirus Infection, Cytomegalovirus Test Positive, Urinary Tract Infection
on Jan 21, 2010 Male patient from GERMANY , 67 years of age, weighting 137.8 lb, was diagnosed with renal transplant, cardiac failure, hyperuricaemia, hypertension, coronary artery disease (What is coronary artery disease?), osteoporosis (What is osteoporosis?) and was treated with Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: cytomegalovirus infection (What is cytomegalovirus infection?), cytomegalovirus test positive, urinary tract infection (What is urinary tract infection?). Sandimmune dosage: 75 Mg Am, 50 Mg Pm. During the same period patient was treated with CELLCEPT (1000 Mg, Bid) (View Cellcept Review and Cellcept Label ), ALDACTONE (25 Mg, Qd) (View Aldactone Review and Aldactone Label ), ALLOPURINOL (100 Mg, Qd) (View Allopurinol Review and Allopurinol Label ), AMLODIPINE (5 Mg, Qd) (View Amlodipine Review and Amlodipine Label ), AAS (100 Mg, Qd) (View Aas Review and Aas Label ), BONDRONAT (2 Mg, Q3mo) (View Bondronat Review and Bondronat Label ), CYNT (0.3 Mg, Qd) (View Cynt Review and Cynt Label ), EBRANTIL (60 Mg, Qid) (View Ebrantil Review and Ebrantil Label ). Patient was hospitalized.

6567300-0 | Dehydration, Infection, Stupor, Tongue Dry, Tremor
Patient was taking Sandimmune (View Usage). Patient had the following side effects: dehydration, infection (What is infection?), stupor, tongue dry, tremor on Jan 20, 2010 from GERMANY Additional patient health information: Male patient , 74 years of age, was diagnosed with renal transplant, depression (What is depression?), hyperthyroidism, hyperuricaemia, wound infection staphylococcal, pain (What is pain?) and. Sandimmune dosage: 100 Mg, Bid. During the same period patient was treated with PREDNISOLONE (2.5 Mg, Qd) (View Prednisolone Review and Prednisolone Label ), RISPERDAL (0.5 Mg, Bid) (View Risperdal Review and Risperdal Label ), TAVANIC (500 Mg, Qd) (View Tavanic Review and Tavanic Label ), CALCIUM ACETATE (500 Mg, Tid) (View Calcium Acetate Review and Calcium Acetate Label ), THIAMAZOLE (20 Mg, Qd) (View Thiamazole Review and Thiamazole Label ), ALLOPURINOL (100 Mg, Qd) (View Allopurinol Review and Allopurinol Label ), COTRIM (1 Df, Tid) (View Cotrim Review and Cotrim Label ), PARACETAMOL (500 Mg, Tid) (View Paracetamol Review and Paracetamol Label ). Patient was hospitalized.

6565460-9 | Anuria, Endocarditis, Multi-organ Failure, Pneumocystis Jiroveci Pneumonia, Pyrexia, Respiratory Fatigue, Sepsis, Tachyarrhythmia
Adverse event was reported on Jan 29, 2010 by a Female patient taking Sandimmune (View Usage) (Dosage: 350) was diagnosed with renal transplant and. Location: GERMANY , weighting 201.7 lb, After Sandimmune was administered, patient had the following side effects: anuria, endocarditis (What is endocarditis?), multi-organ failure, pneumocystis jiroveci pneumonia, pyrexia, respiratory fatigue, sepsis (What is sepsis?), tachyarrhythmia. During the same period patient was treated with MYFORTIC (1440) (View Myfortic Review and Myfortic Label ), NO TREATMENT RECEIVED NOMED (No Treatment Received) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), DECORTIN (15) (View Decortin Review and Decortin Label ). Patient was hospitalized.

6565451-8 | Endocarditis, Multi-organ Failure, Pneumonia
on Jan 29, 2010 Male patient from GERMANY , weighting 201.7 lb, was diagnosed with renal transplant and was treated with Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: endocarditis (What is endocarditis?), multi-organ failure, pneumonia (What is pneumonia?). Sandimmune dosage: 300 Mg/daily. During the same period patient was treated with MYFORTIC (Unk) (View Myfortic Review and Myfortic Label ), NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), DECORTIN (50 Mg/daily) (View Decortin Review and Decortin Label ). Patient was hospitalized.

6564622-4 | Abdominal Pain, Acute Graft Versus Host Disease, Acute Myeloid Leukaemia Recurrent, Clostridial Infection, Diarrhoea, Sepsis
on Jan 27, 2010 Male patient from JAPAN , 65 years of age, was diagnosed with stem cell transplant, sepsis (What is sepsis?), graft versus host disease and was treated with Sandimmune (View Usage). Patient had the following side effects: abdominal pain (What is abdominal pain?), acute graft versus host disease, acute myeloid leukaemia recurrent, clostridial infection, diarrhoea, sepsis (What is sepsis?). Sandimmune dosage: 6 Mg/kg. During the same period patient was treated with VANCOMYCIN (View Vancomycin Review and Vancomycin Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), BUSULFAN (View Busulfan Review and Busulfan Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ).

6564545-0 | Depressed Level Of Consciousness, Diarrhoea, Dysphagia, Eye Movement Disorder, Gastrostomy Tube Insertion, Pneumonia Aspiration, Pseudomembranous Colitis, Pyrexia, Toxic Encephalopathy
Patient was taking Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: depressed level of consciousness, diarrhoea, dysphagia, eye movement disorder, gastrostomy tube insertion, pneumonia aspiration, pseudomembranous colitis, pyrexia, toxic encephalopathy on Jan 18, 2010 from JAPAN Additional patient health information: Male patient , 65 years of age, weighting 114.6 lb, . Sandimmune dosage: 3 Ml Daily. During the same period patient was treated with VANCOMYCIN (View Vancomycin Review and Vancomycin Label ). Patient was hospitalized.

6552453-0 | Abdominal Symptom, Colitis Ulcerative, Gastrointestinal Surgery, Gingival Hyperplasia, Gingival Swelling, Intestinal Stoma, Oral Pain, Stomatitis
Adverse event was reported on Jan 15, 2010 by a Male patient taking Sandimmune (View Usage) (Dosage: Unk) was diagnosed with colitis ulcerative and. Location: JAPAN , 16 years of age, Patient experienced the following unwanted or unexpected effects: abdominal symptom, colitis ulcerative, gastrointestinal surgery, gingival hyperplasia, gingival swelling, intestinal stoma, oral pain, stomatitis. During the same period patient was treated with PREDNISOLONE (View Prednisolone Review and Prednisolone Label ). Patient was hospitalized.

6550820-2 | Thrombotic Thrombocytopenic Purpura
on Jan 20, 2010 Female patient from JAPAN , 73 years of age, was diagnosed with hepatitis fulminant and was treated with Sandimmune (View Usage). Patient had the following side effects: thrombotic thrombocytopenic purpura. Sandimmune dosage: 4 Mg/kg/day. During the same period patient was treated with PREDONINE (45 Mg/day) (View Predonine Review and Predonine Label ), KANAMYCIN (1500 Mg, Unk) (View Kanamycin Review and Kanamycin Label ), DIOVAN (80 Mg, Unk) (View Diovan Review and Diovan Label ), MEVALOTIN (10 Mg, Unk) (View Mevalotin Review and Mevalotin Label ), LORCAM (4 Mg, Unk) (View Lorcam Review and Lorcam Label ), MUCOSTA (100 Mg, Unk) (View Mucosta Review and Mucosta Label ), PARIET (10 Mg, Unk) (View Pariet Review and Pariet Label ), MAGMITT (330 Mg, Unk) (View Magmitt Review and Magmitt Label ).

6547409-8 | Lymphocele
on Jan 15, 2010 Male patient from GERMANY , weighting 123.5 lb, was diagnosed with renal transplant and was treated with Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: lymphocele. Sandimmune dosage: 75 Mg, Bid. During the same period patient was treated with MYFORTIC (360 Mg, Qid) (View Myfortic Review and Myfortic Label ), NO TREATMENT RECEIVED NOMED (No Treatment) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), URBASON (12 Mg, Unk) (View Urbason Review and Urbason Label ). Patient was hospitalized.

6545701-4 | Endocarditis
Patient was taking Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: endocarditis (What is endocarditis?) on Jan 18, 2010 from GERMANY Additional patient health information: Male patient , weighting 201.7 lb, was diagnosed with renal transplant and. Sandimmune dosage: 300 Mg/daily. During the same period patient was treated with MYFORTIC (Unk) (View Myfortic Review and Myfortic Label ), NO TREATMENT RECEIVED NOMED (Unk) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), DECORTIN (50 Mg/daily) (View Decortin Review and Decortin Label ). Patient was hospitalized.

6544631-1 | Anuria, Cytomegalovirus Infection, Endocarditis, Multi-organ Failure, Pneumocystis Jiroveci Pneumonia, Pyrexia, Respiratory Fatigue, Sepsis, Tachyarrhythmia
Adverse event was reported on Jan 18, 2010 by a Female patient taking Sandimmune (View Usage) (Dosage: 350) was diagnosed with renal transplant and. Location: GERMANY , weighting 201.7 lb, Patient had the following side effects: anuria, cytomegalovirus infection (What is cytomegalovirus infection?), endocarditis (What is endocarditis?), multi-organ failure, pneumocystis jiroveci pneumonia, pyrexia, respiratory fatigue, sepsis (What is sepsis?), tachyarrhythmia. During the same period patient was treated with MYFORTIC (1440) (View Myfortic Review and Myfortic Label ), NO TREATMENT RECEIVED NOMED (No Treatment Received) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), DECORTIN (15) (View Decortin Review and Decortin Label ). Patient was hospitalized.

6534866-6 | Anuria, Cytomegalovirus Infection, Endocarditis, Multi-organ Failure, Pneumocystis Jiroveci Pneumonia, Pyrexia, Respiratory Fatigue, Sepsis, Tachyarrhythmia
on Jan 08, 2010 Female patient from GERMANY , weighting 201.7 lb, was diagnosed with renal transplant and was treated with Sandimmune (View Usage). After Sandimmune was administered, patient had the following side effects: anuria, cytomegalovirus infection (What is cytomegalovirus infection?), endocarditis (What is endocarditis?), multi-organ failure, pneumocystis jiroveci pneumonia, pyrexia, respiratory fatigue, sepsis (What is sepsis?), tachyarrhythmia. Sandimmune dosage: 350. During the same period patient was treated with MYFORTIC (1440) (View Myfortic Review and Myfortic Label ), NO TREATMENT RECEIVED NOMED (No Treatment Received) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), DECORTIN (15) (View Decortin Review and Decortin Label ). Patient was hospitalized.

6534860-5 | Depressed Level Of Consciousness, Diarrhoea, Dysphagia, Eye Movement Disorder, Gastrostomy Tube Insertion, Pneumonia Aspiration, Pseudomembranous Colitis, Toxic Encephalopathy
on Jan 06, 2010 Male patient from JAPAN , 65 years of age, weighting 114.6 lb, was treated with Sandimmune (View Usage). Patient experienced the following unwanted or unexpected effects: depressed level of consciousness, diarrhoea, dysphagia, eye movement disorder, gastrostomy tube insertion, pneumonia aspiration, pseudomembranous colitis, toxic encephalopathy. Sandimmune dosage: 3 Ml Daily. During the same period patient was treated with VANCOMYCIN (View Vancomycin Review and Vancomycin Label ). Patient was hospitalized.

6523631-1 | Endocarditis
Patient was taking Sandimmune (View Usage). Patient had the following side effects: endocarditis (What is endocarditis?) on Dec 30, 2009 from GERMANY Additional patient health information: Male patient , weighting 201.7 lb, was diagnosed with renal transplant and. Sandimmune dosage: 100mg. During the same period patient was treated with MYFORTIC (Unk) (View Myfortic Review and Myfortic Label ), NO TREATMENT RECEIVED NOMED (Unk) (View No Treatment Received Nomed Review and No Treatment Received Nomed Label ), DECORTIN (10mg) (View Decortin Review and Decortin Label ). Patient was hospitalized.