RAPAMUNE Side Effects

6542499-0 | Cardiac Arrest, Febrile Infection
on Jan 14, 2010 Female patient from GREECE , 41 years of age, was diagnosed with tuberous sclerosis (What is tuberous sclerosis?), febrile infection, epilepsy (What is epilepsy?) and was treated with Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: cardiac arrest (What is cardiac arrest?), febrile infection. Rapamune dosage: 4 Mg Daily. During the same period patient was treated with MERONEM (View Meronem Review and Meronem Label ), AUGMENTIN (View Augmentin Review and Augmentin Label ), TEGRETOL (View Tegretol Review and Tegretol Label ), GARDENAL (View Gardenal Review and Gardenal Label ).

6535181-7 | Back Pain, Diarrhoea, Fatigue, Myalgia, Pyrexia
Patient was taking Rapamune (View Usage). Patient had the following side effects: back pain (What is back pain?), diarrhoea, fatigue, myalgia, pyrexia on Jan 08, 2010 from FRANCE Additional patient health information: Male patient , 53 years of age, . Rapamune dosage: . Patient was hospitalized.

6534953-2 | Hyperkalaemia, Liver Function Test Abnormal, Nephropathy Toxic, Renal Failure Acute, Respiratory Failure, Venoocclusive Liver Disease
Adverse event was reported on Jan 11, 2010 by a Male patient taking Rapamune (View Usage) (Dosage: 41 Mg) . Location: UNITED STATES , weighting 255.7 lb, After Rapamune was administered, patient had the following side effects: hyperkalaemia, liver function test abnormal, nephropathy toxic, renal failure acute, respiratory failure, venoocclusive liver disease. Patient was hospitalized.

6534446-2 | Cholestasis, Disease Recurrence, Hiv Infection, Hyperlipidaemia, Hypertension, Myopathy, Renal Impairment
on Jan 04, 2010 Male patient from UNITED KINGDOM , child 9 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: cholestasis, disease recurrence, hiv infection (What is hiv infection?), hyperlipidaemia, hypertension, myopathy, renal impairment. Rapamune dosage: . During the same period patient was treated with PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), LAMIVUDINE (Not Provided) (View Lamivudine Review and Lamivudine Label ), ZIDOVUDINE (View Zidovudine Review and Zidovudine Label ), SUSTIVA (Not Provided) (View Sustiva Review and Sustiva Label ), CO TRIMOXAZOLE (View Co-trimoxazole Review and Co-trimoxazole Label ), DIDANOSINE (View Didanosine Review and Didanosine Label ), KIVEXA (View Kivexa Review and Kivexa Label ), NELFINAVIR MESYLATE (View Nelfinavir Mesylate Review and Nelfinavir Mesylate Label ). Patient was hospitalized.


6534446-2 | Cholestasis, Disease Recurrence, Hiv Infection, Hyperlipidaemia, Hypertension, Myopathy, Renal Impairment
on Jan 04, 2010 Male patient from UNITED KINGDOM , child 9 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Rapamune (View Usage). Patient had the following side effects: cholestasis, disease recurrence, hiv infection (What is hiv infection?), hyperlipidaemia, hypertension, myopathy, renal impairment. Rapamune dosage: . During the same period patient was treated with PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), LAMIVUDINE (Not Provided) (View Lamivudine Review and Lamivudine Label ), ZIDOVUDINE (View Zidovudine Review and Zidovudine Label ), SUSTIVA (Not Provided) (View Sustiva Review and Sustiva Label ), COTRIM (View Cotrim Review and Cotrim Label ), DIDANOSINE (View Didanosine Review and Didanosine Label ), ABACAVIR SULFATE AND LAMIVUDINE (View Abacavir Sulfate And Lamivudine Review and Abacavir Sulfate And Lamivudine Label ), NELFINAVIR MESYLATE (View Nelfinavir Mesylate Review and Nelfinavir Mesylate Label ). Patient was hospitalized.

6517907-1 | Gastroenteritis, Pyelonephritis
Patient was taking Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: gastroenteritis (What is gastroenteritis?), pyelonephritis on Dec 23, 2009 from UNITED STATES Additional patient health information: Female patient , weighting 220.2 lb, was diagnosed with prophylaxis against transplant rejection, neuropathy peripheral, hypothyroidism, sinus congestion, hypertension, proteinuria and. Rapamune dosage: . During the same period patient was treated with NEURONTIN (View Neurontin Review and Neurontin Label ), SYNTHROID (View Synthroid Review and Synthroid Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ), LORATADINE (View Loratadine Review and Loratadine Label ), COREG (View Coreg Review and Coreg Label ), LASIX (View Lasix Review and Lasix Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), RAMIPRIL (View Ramipril Review and Ramipril Label ). Patient was hospitalized.

6517502-4 | Decreased Immune Responsiveness
Adverse event was reported on Dec 23, 2009 by a Male patient taking Rapamune (View Usage) (Dosage: ) was diagnosed with liver transplant (What is liver transplant?) and. Location: GERMANY , weighting 28.66 lb, Patient experienced the following unwanted or unexpected effects: decreased immune responsiveness.

6491172-6 | Aspergillosis, Graft Versus Host Disease, Progressive Multifocal Leukoencephalopathy
on Dec 02, 2009 Male patient from ISRAEL , 23 years of age, was diagnosed with graft versus host disease and was treated with Rapamune (View Usage). Patient had the following side effects: aspergillosis, graft versus host disease, progressive multifocal leukoencephalopathy. Rapamune dosage: . During the same period patient was treated with CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), CELLCEPT (View Cellcept Review and Cellcept Label ). Patient was hospitalized.

6487325-3 | Anuria, Asthenia, Back Pain, Dizziness, Malaise, Pyrexia, Renal Failure Acute, Renal Tubular Necrosis, Throat Irritation
on Dec 03, 2009 Male patient from SPAIN , 44 years of age, weighting 165.3 lb, was diagnosed with renal transplant, hypertension, cardiovascular event prophylaxis, gastritis prophylaxis, hypercholesterolaemia and was treated with Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: anuria, asthenia, back pain (What is back pain?), dizziness (What is dizziness?), malaise, pyrexia, renal failure acute, renal tubular necrosis, throat irritation. Rapamune dosage: . During the same period patient was treated with CELLCEPT (View Cellcept Review and Cellcept Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), ACOVIL (View Acovil Review and Acovil Label ), ADIRO (View Adiro Review and Adiro Label ), ZANTAC (View Zantac Review and Zantac Label ), ZARATOR (View Zarator Review and Zarator Label ), NORVASC (View Norvasc Review and Norvasc Label ), IMIQUIMOD (View Imiquimod Review and Imiquimod Label ). Patient was hospitalized.

6483515-4 | Chest Pain, Dyspnoea Exertional
Patient was taking Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: chest pain (What is chest pain?), dyspnoea exertional on Dec 08, 2009 from UNITED STATES Additional patient health information: Female patient , weighting 211.9 lb, was diagnosed with prophylaxis against transplant rejection, diabetes mellitus, sinus congestion, hypersensitivity, constipation (What is constipation?), mineral supplementation, hypertension, dermatitis allergic and. Rapamune dosage: . During the same period patient was treated with ACTOS (View Actos Review and Actos Label ), ALLEGRA D 24 HOUR (180 Mg Every 1 Prn) (View Allegra D 24 Hour Review and Allegra D 24 Hour Label ), AMARYL (View Amaryl Review and Amaryl Label ), AMITIZA (24 Ug Every 1 Prn) (View Amitiza Review and Amitiza Label ), CALCIUM WITH VITAMIN D (View Calcium With Vitamin D Review and Calcium With Vitamin D Label ), CARVEDILOL (View Carvedilol Review and Carvedilol Label ), CORTIZONE 10 (1% Twice Daily, As Needed) (View Cortizone 10 Review and Cortizone 10 Label ). Patient was hospitalized.

6479827-0 | Anaemia Neonatal, Bradycardia Neonatal, Cardiac Murmur, Feeding Disorder Neonatal, Hypotonia Neonatal, Infantile Apnoeic Attack, Neonatal Hypotension, Neonatal Tachypnoea, Oxygen Saturation Decreased
Adverse event was reported on Nov 30, 2009 by a Male patient taking Rapamune (View Usage) (Dosage: ) was diagnosed with lymphangioleiomyomatosis and. Location: GERMANY , weighting 4.06 lb, Patient had the following side effects: anaemia neonatal, bradycardia neonatal, cardiac murmur, feeding disorder neonatal, hypotonia neonatal, infantile apnoeic attack, neonatal hypotension, neonatal tachypnoea, oxygen saturation decreased. Patient was hospitalized.

6478549-X | Multi-organ Failure, Pseudomonal Sepsis, Pulmonary Haemorrhage, Venoocclusive Disease
on Dec 02, 2009 Female patient from UNITED STATES , child 1 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: multi-organ failure, pseudomonal sepsis, pulmonary haemorrhage, venoocclusive disease. Rapamune dosage: Target Trough Levels Of 3-12ng/mg. During the same period patient was treated with CYCLOPHOSPHAMIDE (60mg/kg/d (total Dose 120mg/kg)) (View Cyclophosphamide Review and Cyclophosphamide Label ), THIOTEPA (5mg/kg/d (total Dose 10mg/kg)) (View Thiotepa Review and Thiotepa Label ), TACROLIMUS (Starting On Day -2 (starting Dose 0.03mg/kg D) Target Level 5-10 Ng/ml; Then Dose Tapered) (View Tacrolimus Review and Tacrolimus Label ), METHOTREXATE (5mg/m2 On Days +1, +3 And +6 After Transplant) (View Methotrexate Review and Methotrexate Label ).

6478548-8 | Muscular Weakness, Neuropathy Peripheral, Pericardial Effusion, Pleural Effusion
on Dec 02, 2009 Male patient from UNITED STATES , child 10 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: muscular weakness, neuropathy peripheral, pericardial effusion, pleural effusion. Rapamune dosage: Target Trough Level Of 3-12 Ng/mg. During the same period patient was treated with CYCLOPHOSPHAMIDE (60mg/kg/d (total Dose 120mg/kg)) (View Cyclophosphamide Review and Cyclophosphamide Label ), THIOTEPA (5mg/kg/d (total Dose 10mg/kg)) (View Thiotepa Review and Thiotepa Label ), TACROLIMUS (Starting On Day -2 (starting Dose 0.03mg/kg D) Target Level 5-10 Ng/ml; Then Dose Tapered) (View Tacrolimus Review and Tacrolimus Label ), METHOTREXATE (5mg/m2 On Days +1, +3 And +6 After Transplant) (View Methotrexate Review and Methotrexate Label ).

6478547-6 | Bk Virus Infection, Cystitis, Interstitial Lung Disease
Patient was taking Rapamune (View Usage). Patient had the following side effects: bk virus infection, cystitis, interstitial lung disease on Dec 02, 2009 from UNITED STATES Additional patient health information: Female patient , child 10 years of age, was diagnosed with prophylaxis against transplant rejection and. Rapamune dosage: Target Trough Level Of 3-12ng/mg. During the same period patient was treated with CYCLOPHOSPHAMIDE (60mg/kg/d (total Dose 120mg/kg)) (View Cyclophosphamide Review and Cyclophosphamide Label ), THIOTEPA (5mg/kg/d (total Dose 10mg/kg)) (View Thiotepa Review and Thiotepa Label ), TACROLIMUS (Starting On Day -2 (starting Dose 0.03mg/kg D) Target Level 5-10 Ng/ml; Then Dose Tapered) (View Tacrolimus Review and Tacrolimus Label ), METHOTREXATE (5mg/m2 On Days +1, +3 And +6 After Transplant) (View Methotrexate Review and Methotrexate Label ).

6478546-4 | Acute Respiratory Distress Syndrome, Bacterial Sepsis, Multi-organ Failure, Respiratory Failure, Venoocclusive Disease
Adverse event was reported on Dec 02, 2009 by a Male patient taking Rapamune (View Usage) (Dosage: Loading Dose On Day -3 Was 7mg/m2 (12 Mg Max) Then Dose With Target Trough Levels Of 3-12 Ng/mg) was diagnosed with prophylaxis against transplant rejection and. Location: UNITED STATES , child 7 years of age, After Rapamune was administered, patient had the following side effects: acute respiratory distress syndrome, bacterial sepsis, multi-organ failure, respiratory failure, venoocclusive disease. During the same period patient was treated with CYCLOPHOSPHAMIDE (60mg/kg/d (total Dose 120mg/kg)) (View Cyclophosphamide Review and Cyclophosphamide Label ), THIOTEPA (5mg/kg/d (total Dose 10mg/kg)) (View Thiotepa Review and Thiotepa Label ), TACROLIMUS (Starting On Day -2 (starting Dose 0.03mg/kg D) Target Level 5-10 Ng/ml; Then Dose Tapered) (View Tacrolimus Review and Tacrolimus Label ), METHOTREXATE (5mg/m2 On Days +1, +3 And +6 After Transplant) (View Methotrexate Review and Methotrexate Label ).

6478545-2 | Aspergillosis, Multi-organ Failure, Sepsis, Thrombotic Microangiopathy, Venoocclusive Disease
on Dec 02, 2009 Male patient from UNITED STATES , child 11 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: aspergillosis, multi-organ failure, sepsis (What is sepsis?), thrombotic microangiopathy, venoocclusive disease. Rapamune dosage: Loading Dose On Day -3 Was 7mg/m2 (12 Mg Max) Then Dose With Target Trough Levels Of 3-12 Ng/mg. During the same period patient was treated with CYCLOPHOSPHAMIDE (60mg/kg/d (total Dose 120mg/kg)) (View Cyclophosphamide Review and Cyclophosphamide Label ), THIOTEPA (5mg/kg/d (total Dose 10mg/kg)) (View Thiotepa Review and Thiotepa Label ), TACROLIMUS (Starting On Day -2 (starting Dose 0.03mg/kg D) Target Level 5-10 Ng/ml; Then Dose Tapered) (View Tacrolimus Review and Tacrolimus Label ), METHOTREXATE (5mg/m2 On Days +1, +3 And +6 After Transplant) (View Methotrexate Review and Methotrexate Label ).

6478511-7 | Bk Virus Infection, Cystitis, Renal Failure, Thrombotic Microangiopathy
on Dec 02, 2009 Female patient from UNITED STATES , 18 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Rapamune (View Usage). Patient had the following side effects: bk virus infection, cystitis, renal failure, thrombotic microangiopathy. Rapamune dosage: Target Trough Level Of 3-12 Ng/mg. During the same period patient was treated with CYCLOPHOSPHAMIDE (60mg/kg/d (total Dose 120mg/kg)) (View Cyclophosphamide Review and Cyclophosphamide Label ), THIOTEPA (5mg/kg/d (total Dose 10mg/kg)) (View Thiotepa Review and Thiotepa Label ), TACROLIMUS (Starting On Day -2 (starting Dose 0.03mg/kg D) Target Level 5-10 Ng/ml; Then Dose Tapered) (View Tacrolimus Review and Tacrolimus Label ), METHOTREXATE (5mg/m2 On Days +1, +3 And +6 After Transplant) (View Methotrexate Review and Methotrexate Label ).

6478508-7 | Adenovirus Infection, Ascites, Bk Virus Infection, Cystitis, Influenza, Multi-organ Failure, Pulmonary Haemorrhage, Respiratory Failure, Rotavirus Infection
Patient was taking Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: adenovirus infection, ascites, bk virus infection, cystitis, influenza, multi-organ failure, pulmonary haemorrhage, respiratory failure, rotavirus infection (What is rotavirus infection?) on Dec 02, 2009 from UNITED STATES Additional patient health information: Male patient , 18 years of age, was diagnosed with prophylaxis against transplant rejection and. Rapamune dosage: Target Trough Levels Of 3-12ng/mg. During the same period patient was treated with CYCLOPHOSPHAMIDE (60mg/kg/d (total Dose 120mg/kg)) (View Cyclophosphamide Review and Cyclophosphamide Label ), THIOTEPA (5mg/kg/d (total Dose 10mg/kg)) (View Thiotepa Review and Thiotepa Label ), TACROLIMUS (Starting On Day -2 (starting Dose 0.03mg/kg D) Target Level 5-10 Ng/ml; Then Dose Tapered) (View Tacrolimus Review and Tacrolimus Label ), METHOTREXATE (5mg/m2 On Days +1, +3 And +6 After Transplant) (View Methotrexate Review and Methotrexate Label ).

6471540-9 | Kidney Fibrosis, Renal Tubular Atrophy
Adverse event was reported on Nov 23, 2009 by a Male patient taking Rapamune (View Usage) (Dosage: ) was diagnosed with prophylaxis against transplant rejection and. Location: BRAZIL , weighting 172.0 lb, Patient experienced the following unwanted or unexpected effects: kidney fibrosis, renal tubular atrophy. During the same period patient was treated with MYCOPHENOLIC ACID (View Mycophenolic Acid Review and Mycophenolic Acid Label ), PREDNISONE (View Prednisone Review and Prednisone Label ).

6471539-2 | Bullous Lung Disease, Placental Chorioangioma, Pleural Effusion, Pneumothorax
on Nov 30, 2009 Female patient from GERMANY , weighting 141.1 lb, was diagnosed with lymphangioleiomyomatosis and was treated with Rapamune (View Usage). Patient had the following side effects: bullous lung disease, placental chorioangioma, pleural effusion, pneumothorax. Rapamune dosage: . Patient was hospitalized.

6454632-X | Decreased Immune Responsiveness
on Nov 19, 2009 Female patient from GERMANY , child 2 years of age, was diagnosed with liver transplant (What is liver transplant?) and was treated with Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: decreased immune responsiveness. Rapamune dosage: .

6420416-1 | Alveolitis, Cardiac Failure, Endocarditis, Pneumonia, Pulmonary Oedema
Patient was taking Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: alveolitis, cardiac failure, endocarditis (What is endocarditis?), pneumonia (What is pneumonia?), pulmonary oedema on Oct 27, 2009 from GERMANY Additional patient health information: Male patient , weighting 187.4 lb, was diagnosed with renal transplant and. Rapamune dosage: . During the same period patient was treated with MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), FUROSEMIDE (View Furosemide Review and Furosemide Label ), TAMSULOSIN (View Tamsulosin Review and Tamsulosin Label ), SODIUM BICARBONATE IN PLASTIC CONTAINER (View Sodium Bicarbonate In Plastic Container Review and Sodium Bicarbonate In Plastic Container Label ), ACETYLSALICYLIC ACID (View Acetylsalicylic Acid Review and Acetylsalicylic Acid Label ), CALCITRIOL (View Calcitriol Review and Calcitriol Label ), FINASTERIDE (View Finasteride Review and Finasteride Label ), METHYLPREDNISOLONE 4MG TAB (View Methylprednisolone 4mg Tab Review and Methylprednisolone 4mg Tab Label ). Patient was hospitalized.

6419496-9 | Blood Creatinine Increased, Renal Impairment, Renal Tubular Necrosis, Tubulointerstitial Nephritis
Adverse event was reported on Oct 22, 2009 by a Male patient taking Rapamune (View Usage) (Dosage: ) was diagnosed with renal transplant, pancreas transplant (What is pancreas transplant?), blood pressure (What is blood pressure?), anaemia and. Location: UNITED KINGDOM , 50 years of age, weighting 148.2 lb, Patient had the following side effects: blood creatinine increased, renal impairment, renal tubular necrosis, tubulointerstitial nephritis. During the same period patient was treated with ATENOLOL (View Atenolol Review and Atenolol Label ), RECORMON (View Recormon Review and Recormon Label ), ADCAL (1 Df 3/ Days) (View Adcal Review and Adcal Label ), FUROSEMIDE (View Furosemide Review and Furosemide Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ).

6409420-7 | Acute Hepatic Failure
on Oct 19, 2009 Male patient from UNITED STATES , weighting 184.3 lb, was diagnosed with liver transplant (What is liver transplant?) and was treated with Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: acute hepatic failure. Rapamune dosage: Alternate 1 Mg And 2 Mg Daily Po (months). During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), EPO (View Epo Review and Epo Label ), CALCITRIOL (View Calcitriol Review and Calcitriol Label ), PRILOSEC (View Prilosec Review and Prilosec Label ), METOPROLOL (View Metoprolol Review and Metoprolol Label ), DRISDOL (View Drisdol Review and Drisdol Label ), GLIPIZIDE (View Glipizide Review and Glipizide Label ), CALCIUM (View Calcium Review and Calcium Label ). Patient was hospitalized.

6382847-8 | Cardiac Arrest, Febrile Infection
on Sep 24, 2009 Female patient from GREECE , 41 years of age, was diagnosed with tuberous sclerosis (What is tuberous sclerosis?), epilepsy (What is epilepsy?) and was treated with Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: cardiac arrest (What is cardiac arrest?), febrile infection. Rapamune dosage: 4 Mg Daily. During the same period patient was treated with GARDENAL (View Gardenal Review and Gardenal Label ), TEGRETOL (View Tegretol Review and Tegretol Label ).

6382846-6 | Abortion Spontaneous
Patient was taking Rapamune (View Usage). Patient had the following side effects: abortion spontaneous on Sep 24, 2009 from UNITED STATES Additional patient health information: Female patient , weighting 165.1 lb, was diagnosed with prophylaxis against transplant rejection, hypertension and. Rapamune dosage: . During the same period patient was treated with PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ), CLONIDINE (View Clonidine Review and Clonidine Label ), MULTI VITAMINS (View Multi-vitamins Review and Multi-vitamins Label ), NEORAL (30mg In The Am And 25 Mg In The Pm) (View Neoral Review and Neoral Label ), LABETALOL HCL (View Labetalol Hcl Review and Labetalol Hcl Label ).

6375889-X | Nephropathy Toxic, Renal Failure Acute, Transplant Failure
Adverse event was reported on Sep 18, 2009 by a Female patient taking Rapamune (View Usage) (Dosage: Dose And Frequency Not Specified) was diagnosed with prophylaxis against transplant rejection, immunosuppression and. Location: UNITED STATES , 62 years of age, After Rapamune was administered, patient had the following side effects: nephropathy toxic, renal failure acute, transplant failure. During the same period patient was treated with PREDNISONE TAB (Dose And Frequency Not Specified) (View Prednisone Tab Review and Prednisone Tab Label ), MYCOPHENOLIC ACID (Dose And Frequency Not Specified) (View Mycophenolic Acid Review and Mycophenolic Acid Label ), SIMULECT (Dose And Frequency Not Specified) (View Simulect Review and Simulect Label ), TACROLIMUS (Dose And Frequency Not Specified (switched To Rapamune 5 Months Post Transplant)) (View Tacrolimus Review and Tacrolimus Label ).

6375875-X | Nephropathy Toxic, Renal Failure Acute
on Sep 18, 2009 Male patient from UNITED STATES , 30 years of age, was diagnosed with prophylaxis against transplant rejection, immunosuppression and was treated with Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: nephropathy toxic, renal failure acute. Rapamune dosage: Dose And Frequency Not Specified (switched To Rapamune One Month Post Transplant). During the same period patient was treated with PREDNISONE TAB (Dose And Frequency Not Specified) (View Prednisone Tab Review and Prednisone Tab Label ), MYCOPHENOLIC ACID (Dose And Frequency Not Specified) (View Mycophenolic Acid Review and Mycophenolic Acid Label ), SIMULECT (Dose And Frequency Not Specified) (View Simulect Review and Simulect Label ), TACROLIMUS (Dose And Frequency Not Specified) (View Tacrolimus Review and Tacrolimus Label ).

6371363-5 | Upper Gastrointestinal Haemorrhage
on Sep 21, 2009 Male patient from SPAIN , weighting 138.9 lb, was diagnosed with prophylaxis against transplant rejection, dyslipidaemia, anaemia, hypertension and was treated with Rapamune (View Usage). Patient had the following side effects: upper gastrointestinal haemorrhage. Rapamune dosage: . During the same period patient was treated with SIMVASTATIN (View Simvastatin Review and Simvastatin Label ), ACTOL (View Actol Review and Actol Label ), ATENOLOL (View Atenolol Review and Atenolol Label ). Patient was hospitalized.

6354587-2 | Bacteraemia, Condition Aggravated, Leukopenia, Neutropenia, Pharyngitis
Patient was taking Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: bacteraemia, condition aggravated, leukopenia, neutropenia, pharyngitis on Sep 09, 2009 from CANADA Additional patient health information: Male patient , weighting 180.3 lb, was diagnosed with prophylaxis against transplant rejection, immunosuppression, antifungal prophylaxis and. Rapamune dosage: . During the same period patient was treated with MYCOPHENOLIC ACID (1440 Mg Bid) (View Mycophenolic Acid Review and Mycophenolic Acid Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), BACTRIM DS (View Bactrim Ds Review and Bactrim Ds Label ). Patient was hospitalized.

6348754-1 | Amenorrhoea
Adverse event was reported on Sep 09, 2009 by a Female patient taking Rapamune (View Usage) (Dosage: ) was diagnosed with prophylaxis against transplant rejection and. Location: UNITED KINGDOM , weighting 131.0 lb, Patient experienced the following unwanted or unexpected effects: amenorrhoea. During the same period patient was treated with ALFACALCIDOL (View Alfacalcidol Review and Alfacalcidol Label ).

6347034-8 | Dyspnoea, Pulmonary Function Test Decreased
on Sep 09, 2009 Female patient from UNITED STATES , 63 years of age, weighting 169.8 lb, was diagnosed with lung transplant (What is lung transplant?) and was treated with Rapamune (View Usage). Patient had the following side effects: dyspnoea, pulmonary function test decreased. Rapamune dosage: 0.5 Mg Q48 Hours Po. Patient was hospitalized.

6343680-6 | Bacteraemia, Condition Aggravated, Leukopenia, Neutropenia, Pharyngitis
on Aug 27, 2009 Male patient from CANADA , weighting 180.3 lb, was diagnosed with prophylaxis against transplant rejection, immunosuppression, antifungal prophylaxis, mouth ulceration and was treated with Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: bacteraemia, condition aggravated, leukopenia, neutropenia, pharyngitis. Rapamune dosage: . During the same period patient was treated with MYCOPHENOLIC ACID (1440 Mg Bid) (View Mycophenolic Acid Review and Mycophenolic Acid Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), BACTRIM DS (View Bactrim Ds Review and Bactrim Ds Label ), TRIAMCINOLONE ACETONIDE (Bid) (View Triamcinolone Acetonide Review and Triamcinolone Acetonide Label ). Patient was hospitalized.

6335089-6 | Arthralgia, Bone Pain, Low Turnover Osteopathy
Patient was taking Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: arthralgia, bone pain, low turnover osteopathy on Oct 19, 2005 from GERMANY Additional patient health information: Female patient , weighting 105.8 lb, was diagnosed with prophylaxis against transplant rejection and. Rapamune dosage: . During the same period patient was treated with DILATREND (View Dilatrend Review and Dilatrend Label ), REKAWAN (View Rekawan Review and Rekawan Label ), NEPHROTRANS (View Nephrotrans Review and Nephrotrans Label ), CALCIUM ACETATE (View Calcium Acetate Review and Calcium Acetate Label ), BONDIOL (View Bondiol Review and Bondiol Label ), DECORTIN H (View Decortin-h Review and Decortin-h Label ), LASIX (View Lasix Review and Lasix Label ). Patient was hospitalized.

6333376-9 | Gastric Antral Vascular Ectasia, Haemoglobin Decreased, Upper Gastrointestinal Haemorrhage
Adverse event was reported on Aug 28, 2009 by a Male patient taking Rapamune (View Usage) (Dosage: ) was diagnosed with prophylaxis against transplant rejection, dyslipidaemia, anaemia, hypertension and. Location: SPAIN , weighting 138.9 lb, Patient had the following side effects: gastric antral vascular ectasia, haemoglobin decreased, upper gastrointestinal haemorrhage. During the same period patient was treated with SIMVASTATIN (View Simvastatin Review and Simvastatin Label ), ACTOL (View Actol Review and Actol Label ), ATENOLOL (View Atenolol Review and Atenolol Label ). Patient was hospitalized.

6332543-8 | Bacteraemia, Pharyngitis
on Aug 23, 2009 Male patient from CANADA , weighting 180.3 lb, was diagnosed with prophylaxis against transplant rejection, immunosuppression, antifungal prophylaxis, mouth ulceration and was treated with Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: bacteraemia, pharyngitis. Rapamune dosage: . During the same period patient was treated with MYCOPHENOLIC ACID (1440 Mg Bid) (View Mycophenolic Acid Review and Mycophenolic Acid Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), BACTRIM DS (View Bactrim Ds Review and Bactrim Ds Label ), TRIAMCINOLONE ACETONIDE (Bid) (View Triamcinolone Acetonide Review and Triamcinolone Acetonide Label ). Patient was hospitalized.

6329691-5 | Bacteraemia, Pharyngitis
on Aug 20, 2009 Male patient from CANADA , weighting 180.3 lb, was diagnosed with prophylaxis against transplant rejection, immunosuppression, antifungal prophylaxis, mouth ulceration and was treated with Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: bacteraemia, pharyngitis. Rapamune dosage: . During the same period patient was treated with MYCOPHENOLIC ACID (1440 Mg Bid) (View Mycophenolic Acid Review and Mycophenolic Acid Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), BACTRIM DS (View Bactrim Ds Review and Bactrim Ds Label ), TRIAMCINOLONE ACETONIDE (Bid) (View Triamcinolone Acetonide Review and Triamcinolone Acetonide Label ). Patient was hospitalized.

6317282-1 | Chest Pain, Dyspnoea Exertional
Patient was taking Rapamune (View Usage). Patient had the following side effects: chest pain (What is chest pain?), dyspnoea exertional on Aug 14, 2009 from UNITED STATES Additional patient health information: Female patient , weighting 211.9 lb, was diagnosed with prophylaxis against transplant rejection, diabetes mellitus, sinus congestion, hypersensitivity, constipation (What is constipation?), mineral supplementation, hypertension, dermatitis allergic and. Rapamune dosage: . During the same period patient was treated with ACTOS (View Actos Review and Actos Label ), ALLEGRA D 24 HOUR (180 Mg Every 1 Prn) (View Allegra D 24 Hour Review and Allegra D 24 Hour Label ), AMARYL (View Amaryl Review and Amaryl Label ), AMITIZA (24 Ug Every 1 Prn) (View Amitiza Review and Amitiza Label ), CALCIUM WITH VITAMIN D (View Calcium With Vitamin D Review and Calcium With Vitamin D Label ), CARVEDILOL (View Carvedilol Review and Carvedilol Label ), CORTIZONE 10 (1% Twice Daily, As Needed) (View Cortizone 10 Review and Cortizone 10 Label ). Patient was hospitalized.

6313900-2 | Agranulocytosis, Aphthous Stomatitis, Febrile Neutropenia
Adverse event was reported on Aug 13, 2009 by a Female patient taking Rapamune (View Usage) (Dosage: ) was diagnosed with transplant and. Location: SPAIN , 53 years of age, After Rapamune was administered, patient had the following side effects: agranulocytosis, aphthous stomatitis, febrile neutropenia. During the same period patient was treated with PREDNISONE (10 Mg) (View Prednisone Review and Prednisone Label ), PANTOPRAZOLE SODIUM (View Pantoprazole Sodium Review and Pantoprazole Sodium Label ), LEDERFOLIN (15 Mg) (View Lederfolin Review and Lederfolin Label ), CELLCEPT (View Cellcept Review and Cellcept Label ). Patient was hospitalized.

6313627-7 | Blood Creatinine Abnormal
on Aug 07, 2009 Male patient from BELGIUM , weighting 209.4 lb, was diagnosed with prophylaxis against transplant rejection, infection prophylaxis, medical diet, back pain (What is back pain?), hypothyroidism, analgesia, mineral supplementation and was treated with Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: blood creatinine abnormal. Rapamune dosage: . During the same period patient was treated with EUSAPRIM (View Eusaprim Review and Eusaprim Label ), BEFORTE (View Beforte Review and Beforte Label ), ADVIL (View Advil Review and Advil Label ), ELTHYRONE (View Elthyrone Review and Elthyrone Label ), ASAFLOW (View Asaflow Review and Asaflow Label ), ZALDIAR (View Zaldiar Review and Zaldiar Label ), PROGRAF (View Prograf Review and Prograf Label ), CACIT VITAMINE D3 (1 Grain Every 1 Day) (View Cacit Vitamine D3 Review and Cacit Vitamine D3 Label ). Patient was hospitalized.

6304675-1 | Pulmonary Tuberculosis
on Aug 04, 2009 Female patient from SPAIN , 70 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Rapamune (View Usage). Patient had the following side effects: pulmonary tuberculosis. Rapamune dosage: . During the same period patient was treated with SEGURIL (View Seguril Review and Seguril Label ), ALDACTONE (View Aldactone Review and Aldactone Label ), CARDURA (View Cardura Review and Cardura Label ), CELLCEPT (View Cellcept Review and Cellcept Label ), PREDNISONE (View Prednisone Review and Prednisone Label ). Patient was hospitalized.

6301957-4 | Condition Aggravated, Interstitial Lung Disease, Renal Failure Acute, Tuberculosis
Patient was taking Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: condition aggravated, interstitial lung disease, renal failure acute, tuberculosis (What is tuberculosis?) on Jul 30, 2009 from SPAIN Additional patient health information: Male patient , 23 years of age, was diagnosed with prophylaxis against transplant rejection, pulmonary tuberculosis and. Rapamune dosage: . During the same period patient was treated with MYAMBUTOL (View Myambutol Review and Myambutol Label ), PYRAZINAMIDE (View Pyrazinamide Review and Pyrazinamide Label ), PROTIONAMIDE (View Protionamide Review and Protionamide Label ), CEMIDON (View Cemidon Review and Cemidon Label ), AVELOX (View Avelox Review and Avelox Label ). Patient was hospitalized.

6295268-3 | Prostate Cancer
Adverse event was reported on Jul 31, 2009 by a Male patient taking Rapamune (View Usage) (Dosage: ) was diagnosed with prophylaxis against transplant rejection, hypertension, osteoporosis prophylaxis and. Location: AUSTRIA , weighting 198.4 lb, Patient experienced the following unwanted or unexpected effects: prostate cancer (What is prostate cancer?). During the same period patient was treated with TAREG (View Tareg Review and Tareg Label ), CALCIUM CARBONATE/COLECALCIFEROL (View Calcium Carbonate/colecalciferol Review and Calcium Carbonate/colecalciferol Label ), CELLCEPT (1000 Mg) (View Cellcept Review and Cellcept Label ). Patient was hospitalized.

6288838-X | Chest Pain, Dyspnoea Exertional
on Jul 20, 2009 Female patient from UNITED STATES , weighting 211.9 lb, was diagnosed with prophylaxis against transplant rejection, diabetes mellitus, sinus congestion, hypersensitivity, constipation (What is constipation?), mineral supplementation, hypertension, dermatitis allergic and was treated with Rapamune (View Usage). Patient had the following side effects: chest pain (What is chest pain?), dyspnoea exertional. Rapamune dosage: . During the same period patient was treated with ACTOS (View Actos Review and Actos Label ), ALLEGRA D 24 HOUR (180 Mg Every 1 Prn) (View Allegra D 24 Hour Review and Allegra D 24 Hour Label ), AMARYL (View Amaryl Review and Amaryl Label ), AMITIZA (24 Ug Every 1 Prn) (View Amitiza Review and Amitiza Label ), CALCIUM WITH VITAMIN D (View Calcium With Vitamin D Review and Calcium With Vitamin D Label ), CARVEDILOL (View Carvedilol Review and Carvedilol Label ), CORTIZONE 10 (1% Twice Daily, As Needed) (View Cortizone 10 Review and Cortizone 10 Label ). Patient was hospitalized.

6288738-5 | Hypocoagulable State, Renal Haematoma
on Jul 23, 2009 Male patient from SPAIN , 66 years of age, was diagnosed with prophylaxis against transplant rejection, atrial fibrillation (What is atrial fibrillation?), urinary tract infection (What is urinary tract infection?) and was treated with Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: hypocoagulable state, renal haematoma. Rapamune dosage: . During the same period patient was treated with CELLCEPT (View Cellcept Review and Cellcept Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), SINTROM (View Sintrom Review and Sintrom Label ), IMIPENEM (View Imipenem Review and Imipenem Label ). Patient was hospitalized.

6285241-3 | Gastroenteritis, Multi-organ Failure
Patient was taking Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: gastroenteritis (What is gastroenteritis?), multi-organ failure on Jul 23, 2009 from SLOVAKIA (Slovak Republic) Additional patient health information: Male patient , 51 years of age, was diagnosed with prophylaxis against transplant rejection and. Rapamune dosage: .

6283904-7 | Asthenia, Bk Virus Infection, Gait Disturbance, Herpes Zoster, Insomnia, Malaise, Nephropathy, Nightmare, Pain
Adverse event was reported on Jul 22, 2009 by a Male patient taking Rapamune (View Usage) (Dosage: ) . Location: UNITED STATES , 64 years of age, weighting 101.0 lb, Patient had the following side effects: asthenia, bk virus infection, gait disturbance, herpes zoster, insomnia, malaise, nephropathy, nightmare, pain (What is pain?). Patient was hospitalized.

6236142-8 | Renal Failure Acute
on Jun 18, 2009 Male patient from GERMANY , weighting 134.5 lb, was diagnosed with prophylaxis against transplant rejection and was treated with Rapamune (View Usage). After Rapamune was administered, patient had the following side effects: renal failure acute. Rapamune dosage: 6mg. During the same period patient was treated with ZOLOFT (75mg) (View Zoloft Review and Zoloft Label ), NEORECORMON (View Neorecormon Review and Neorecormon Label ), ALLOPURINOL (150mg) (View Allopurinol Review and Allopurinol Label ), BELOC ZOK (95mg) (View Beloc Zok Review and Beloc Zok Label ), URBASON (8mg) (View Urbason Review and Urbason Label ). Patient was hospitalized.

6234694-5 | Diabetes Mellitus, Diarrhoea
on Jun 15, 2009 Female patient from ISRAEL , 45 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with Rapamune (View Usage). Patient experienced the following unwanted or unexpected effects: diabetes mellitus, diarrhoea. Rapamune dosage: .

6232017-9 | Caesarean Section, Placental Disorder, Placental Hypertrophy, Pregnancy, Premature Labour, Thrombosis
Patient was taking Rapamune (View Usage). Patient had the following side effects: caesarean section, placental disorder, placental hypertrophy, pregnancy (What is pregnancy?), premature labour, thrombosis on Jun 10, 2009 from GERMANY Additional patient health information: Female patient , 31 years of age, was diagnosed with prophylaxis against transplant rejection and. Rapamune dosage: 2 Mg 1x Per 1 Day Oral. During the same period patient was treated with PROGRAF (View Prograf Review and Prograf Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), CALCITRIOL (View Calcitriol Review and Calcitriol Label ), VIGANTOLETTEN (COLECALCIFEROL) (View Vigantoletten (colecalciferol) Review and Vigantoletten (colecalciferol) Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ).