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From simple mix-ups to fatal overdoses, medication mistakes happen, on average, once a day to every hospital patient, a new report says. Nationwide, at least 1.5 million people annually are harmed from drug errors, more than half of them in nursing homes.
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Review Sirolimus Safety Reports submitted to FDA

Total Sirolimus reports: 174.
Sirolimus FDA safety alerts: 2002 2003 2007 .
Reported deaths: 19    Reported hospitalizations: 164.
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FDA Reported Sirolimus Side Effects: focal glomerulosclerosis, kidney transplant rejection, condition aggravated, proteinuria, anaemia, liver transplant rejection, pneumonia, asthenia, blood creatinine increased, haemodialysis, complications of transplanted kidney.
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Showing 1-100 of 174 Next >

Sirolimus Side Effects Report #5488529-9
Physician from SPAIN reported SIROLIMUS problem on Oct 15, 2007. Male patient, weighting 174.2 lb, was diagnosed with prophylaxis against transplant rejection, prostatism, hyperuricaemia and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: prostate cancer. SIROLIMUS dosage: 2 MG/FREQUENCY NOT PROVIDED. During the same period patient was treated with INDAPAMIDE, TEBETANE COMPUESTO, ALLOPURINOL. Patient recovered.

Sirolimus Side Effects Report #5489499-X
SIROLIMUS problem was reported by a Pharmacist from UNITED STATES on Oct 16, 2007. Female patient, 20 years of age, weighting 145.1 lb, was diagnosed with heart transplant, immunosuppression and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: ascites, colitis, gastritis erosive, pancreatitis. SIROLIMUS dosage: 3MG DAILY PO. During the same period patient was treated with PRAVASTATIN, PREDNISONE, HYDRALAZINE, MYCOPHENOLATE MOFETIL, METOCLOPRAMIDE, PROMETHAZINE, ATENOLOL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5495592-8
Physician from KOREA, REPUBLIC OF reported SIROLIMUS problem on Oct 16, 2007. Male patient, weighting 142.6 lb, was diagnosed with prophylaxis against transplant rejection, hypertension and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: glycosylated haemoglobin increased, hyperglycaemia. SIROLIMUS dosage: unknown. During the same period patient was treated with BISOPROLOL FUMARATE, AMLODIPINE, SEPTRIN. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5497096-5
SIROLIMUS problem was reported by a Physician from ARGENTINA on Oct 17, 2007. Male patient, weighting 154.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: cholecystitis. SIROLIMUS dosage: unknown. During the same period patient was treated with CELLCEPT. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5497369-6
Physician from FRANCE reported SIROLIMUS problem on Oct 23, 2007. Male patient, weighting 154.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: renal impairment. SIROLIMUS dosage: unknown. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5500961-3
SIROLIMUS problem was reported by a Physician from UNITED STATES on Oct 22, 2007. Male patient, weighting 162.3 lb, was diagnosed with prophylaxis against transplant rejection, pain and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, metabolic encephalopathy. SIROLIMUS dosage: unknown. During the same period patient was treated with PREDNISONE, ATENOLOL, MYCELEX, DARVOCET, FLONASE, THERAGRAN, PRAVACHOL, COUMADIN. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5502853-2
Physician from ARGENTINA reported SIROLIMUS problem on Oct 24, 2007. Male patient, weighting 116.8 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: cholecystitis. SIROLIMUS dosage: unknown. During the same period patient was treated with CELLCEPT. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5441431-0
SIROLIMUS problem was reported by a Physician from GERMANY on Aug 28, 2007. Male patient, weighting 203.7 lb, was diagnosed with prophylaxis against transplant rejection, hyperuricaemia, arthralgia and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: arthropathy. SIROLIMUS dosage: unknown. During the same period patient was treated with PANTOPRAZOLE, ALLOPURINOL, METAMIZOLE, MAGNESIUM SULPHATE, URSODIOL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5442117-9
Physician from SWITZERLAND reported SIROLIMUS problem on Aug 27, 2007. Male patient, weighting 176.4 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: convulsion, hypophosphataemia, syncope. SIROLIMUS dosage: unknown. During the same period patient was treated with ASPIRIN, ACYCLOVIR, DESLORATADINE, ESOMEPRAZOLE MAGNESIUM, VALACYCLOVIR, SALMETEROL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5443153-9
SIROLIMUS problem was reported by a Physician from HONG KONG on Aug 28, 2007. Female patient, weighting 110.1 lb, was diagnosed with prophylaxis against transplant rejection, hypertension, antiviral prophylaxis and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: oedema peripheral, proteinuria. SIROLIMUS dosage: unknown. During the same period patient was treated with NIFEDIPINE, LAMIVUDINE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5443280-6
Physician from SWITZERLAND reported SIROLIMUS problem on Aug 24, 2007. Female patient, weighting 149.9 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: hernia, seroma. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, CYCLOSPORINE, LACTULOSE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5443634-8
SIROLIMUS problem was reported by a Health Professional from AUSTRALIA on Aug 29, 2007. Male patient was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: fatigue, lethargy, pneumonitis. SIROLIMUS dosage: 3 MG DAILY. During the same period patient was treated with SIMVASTATIN, PROGOUT, CYCLOSPORINE, PREDNISOLONE, RAMIPRIL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5444429-1
Physician from SWITZERLAND reported SIROLIMUS problem on Aug 31, 2007. Female patient, weighting 152.1 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: seroma. SIROLIMUS dosage: unknown. During the same period patient was treated with URSODIOL, ACETAMINOPHEN, METAMIDE, PANTOPRAZOLE, LACTULOSE, AMOXICILLIN, METRONIDAZOLE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5444980-4
SIROLIMUS problem was reported by a Physician from KOREA, REPUBLIC OF on Aug 29, 2007. Female patient, weighting 137.2 lb, was diagnosed with prophylaxis against transplant rejection, infection prophylaxis, antifungal prophylaxis, anaemia prophylaxis, antibiotic prophylaxis and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection, urinary tract infection enterococcal. SIROLIMUS dosage: unknown. During the same period patient was treated with SEPTRIN, NYSTATIN, PYRIDOXINE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5446469-5
Health Professional from UNITED KINGDOM reported SIROLIMUS problem on Sept 04, 2007. Male patient, child 10 years of age, weighting 66.14 lb, was diagnosed with kidney transplant rejection, bone disorder, hypertension, infection prophylaxis, nephrogenic anaemia and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: malignant hypertension, reversible posterior leukoencephalopathy syndrome. SIROLIMUS dosage: unknown. During the same period patient was treated with ALFACALCIDOL, BENDROFLUAZIDE, RANITIDINE, NEORECORMON, NIFEDIPINE, NYSTATIN, PREDNISOLONE. Patient recovered.

Sirolimus Side Effects Report #5449997-1
SIROLIMUS problem was reported by a Health Professional from UNITED KINGDOM on Sept 07, 2007. Male patient, child 10 years of age, weighting 66.14 lb, was diagnosed with kidney transplant rejection, bone disorder, hypertension, infection prophylaxis, acidosis, nephrogenic anaemia and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: malignant hypertension, reversible posterior leukoencephalopathy syndrome. SIROLIMUS dosage: unknown. During the same period patient was treated with ALFACALCIDOL, BENDROFLUAZIDE, BICARBONATE, NEORECORMON, NIFEDIPINE, NYSTATIN, PREDNISOLONE. Patient recovered.

Sirolimus Side Effects Report #5449998-3
Physician from MEXICO reported SIROLIMUS problem on Sept 05, 2007. Male patient, weighting 128.3 lb, was diagnosed with prophylaxis against transplant rejection, diabetes mellitus, hypertension and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: clear cell carcinoma of the kidney, gastrointestinal haemorrhage, haemoglobin decreased, pancreatic cyst, pancreatic necrosis, pancreatitis chronic. SIROLIMUS dosage: unknown. During the same period patient was treated with ASPIRIN, METFORMIN, METOPROLOL SUCCINATE, PRAZOSIN, ISOSORBIDE DINITRATE, ENALAPRIL, CLORINDIONE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5450231-7
SIROLIMUS problem was reported by a Physician from HONG KONG on Sept 05, 2007. Female patient, weighting 110.1 lb, was diagnosed with prophylaxis against transplant rejection, hypertension, antiviral prophylaxis, hepatitis b and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: oedema peripheral, proteinuria. SIROLIMUS dosage: unknown. During the same period patient was treated with NIFEDIPINE, LAMIVUDINE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5450353-0
Physician from UNITED STATES reported SIROLIMUS problem on Sept 07, 2007. Male patient, weighting 203.9 lb, was diagnosed with prophylaxis against transplant rejection, hypertension and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: metastatic malignant melanoma. SIROLIMUS dosage: unknown. During the same period patient was treated with HYDROXYZINE, ASCORBIC ACID, HYDROCHLOROTHIAZIDE, ASPIRIN, AUGMENTIN, PREDNISONE, INDERAL, ACTIGALL. Patient died on 05/18/2006.

Sirolimus Side Effects Report #5451155-1
SIROLIMUS problem was reported by a Physician from MEXICO on Sept 05, 2007. Male patient, weighting 123.5 lb, was diagnosed with prophylaxis against transplant rejection, pain, diabetes mellitus, nausea and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: pancreatic fistula, wound abscess. SIROLIMUS dosage: unknown. During the same period patient was treated with OMEPRAZOLE, MYCOPHENOLATE MOFETIL, TRAMADOL, NPH INSULIN, ASPIRIN, METOCLOPRAMIDE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5451519-6
Health Professional from UNITED KINGDOM reported SIROLIMUS problem on Sept 10, 2007. Female patient, weighting 26.01 lb, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: crying, emotional distress, erythema, pruritus, rash erythematous. SIROLIMUS dosage: unknown. During the same period patient was treated with AMBISOME, AMOXICILLIN, AMPHOTERICIN B, COLISTIN SULPHATE, DOMPERIDONE, EPADERM, ERYTHROMYCIN. Patient recovered.

Sirolimus Side Effects Report #5455341-6
SIROLIMUS problem was reported by a Physician from ARGENTINA on Sept 14, 2007. Female patient, weighting 194.4 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, septic shock. SIROLIMUS dosage: unknown. During the same period patient was treated with BEZAFIBRATE, AMFETAMINIL, GLIMEPIRIDE, OMEPRAZOLE, EPOGEN, ATENOLOL, FLUOXETINE. Patient was hospitalized. Patient died on 09/14/2007.

Sirolimus Side Effects Report #5456396-5
Physician from GERMANY reported SIROLIMUS problem on Sept 10, 2007. Male patient, weighting 165.3 lb, was diagnosed with prophylaxis against transplant rejection, cardiac disorder, hyperlipidaemia, antiviral prophylaxis and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: hepatic cancer metastatic. SIROLIMUS dosage: 2 MG/FREQUENCY NOT PROVIDED. During the same period patient was treated with METOPROLOL SUCCINATE, FLUVASTATIN, RAMIPRIL, ASPIRIN, FAMCICLOVIR. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5458317-8
SIROLIMUS problem was reported by a Health Professional from ITALY on Sept 10, 2007. Female patient, 54 years of age, was diagnosed with haemophilus infection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: renal impairment. SIROLIMUS dosage: unknown. During the same period patient was treated with PREDNISONE, OMEPRAZOLE, NITRGLYCERIN TRANSDERMAL SYSTEM, NITRGLYCERIN TRANSDERMAL SYSTEM, CLARITHROMYCIN. Patient recovered.

Sirolimus Side Effects Report #5458960-6
Physician from GERMANY reported SIROLIMUS problem on Sept 10, 2007. Male patient, weighting 180.8 lb, was diagnosed with prophylaxis against transplant rejection, hypertension and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: liver transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with ENALAPRIL MALEATE, FUROSEMIDE, ASPIRIN, HUMULIN R, LEVOTHYROXINE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5463324-5
SIROLIMUS problem was reported by a Health Professional from EGYPT on Sept 10, 2007. Male patient, 36 years of age, was diagnosed with diabetes mellitus and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, INSULIN, BASILIXIMAB. Patient recovered.

Sirolimus Side Effects Report #5463325-7
Health Professional from EGYPT reported SIROLIMUS problem on Sept 10, 2007. Male patient, 32 years of age, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, BASILIXIMAB. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5463326-9
SIROLIMUS problem was reported by a Health Professional from EGYPT on Sept 10, 2007. Male patient, 34 years of age, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: 10 MG/DAY GRADUALLY ADJUSTED TO ACHIEVE TARGET LEVEL OF 6-12 NG/ML. During the same period patient was treated with MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, PREDNISONE, BASILIXIMAB. Patient recovered.

Sirolimus Side Effects Report #5463331-2
Health Professional from EGYPT reported SIROLIMUS problem on Sept 10, 2007. Male patient, 32 years of age, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS, PREDNISOLONE, BASILIXIMAB. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5463332-4
SIROLIMUS problem was reported by a Health Professional from EGYPT on Sept 10, 2007. Female patient, 37 years of age, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis, graft complication. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, BASILIXIMAB. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5465888-4
Health Professional from UNITED KINGDOM reported SIROLIMUS problem on Sept 18, 2007. Male patient, child 10 years of age, weighting 66.14 lb, was diagnosed with kidney transplant rejection, bone disorder, hypertension, infection prophylaxis, acidosis, nephrogenic anaemia and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: malignant hypertension, reversible posterior leukoencephalopathy syndrome. SIROLIMUS dosage: unknown. During the same period patient was treated with ALFACALCIDOL, BENDROFLUAZIDE, BICARBONATE, NEORECORMON, NIFEDIPINE, NYSTATIN, PREDNISOLONE. Patient recovered.

Sirolimus Side Effects Report #5466060-4
SIROLIMUS problem was reported by a Physician from UNITED KINGDOM on Sept 20, 2007. Male patient, weighting 192.5 lb, was diagnosed with renal transplant, prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5466627-3
Physician from BELGIUM reported SIROLIMUS problem on Sept 21, 2007. Male patient, weighting 194.0 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with CORTICOSTEROIDS, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5467402-6
SIROLIMUS problem was reported by a Physician from GERMANY on Sept 14, 2007. Male patient, weighting 152.1 lb, was diagnosed with prophylaxis against transplant rejection, hypertension, immunosuppression, bile output abnormal and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: hepatitis c virus, liver transplant rejection. SIROLIMUS dosage: 2MG. During the same period patient was treated with METOPROLOL SUCCINATE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, URSODIOL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5467464-6
Physician from BELGIUM reported SIROLIMUS problem on Sept 21, 2007. Male patient, weighting 132.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with MEDROL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5467890-5
SIROLIMUS problem was reported by a Health Professional from INDIA on Sept 17, 2007. Male patient, 31 years of age, weighting 149.9 lb, was diagnosed with immunosuppression and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: escherichia urinary tract infection, hypokalaemia, renal tubular disorder. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5468005-X
Health Professional from UNITED STATES reported SIROLIMUS problem on Sept 17, 2007. Male patient, 55 years of age, was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: pulmonary alveolar haemorrhage. SIROLIMUS dosage: unknown. During the same period patient was treated with LISINOPRIL, DILTIAZEM, PAROXETINE, LEVOFLOXACIN, NIACIN, CALCITRIOL, NEORAL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5468105-4
SIROLIMUS problem was reported by a Physician from UNITED KINGDOM on Sept 20, 2007. Male patient, weighting 192.5 lb, was diagnosed with renal transplant, prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5469406-6
Physician from HONG KONG reported SIROLIMUS problem on Sept 19, 2007. Female patient, weighting 110.1 lb, was diagnosed with prophylaxis against transplant rejection, hypertension, antiviral prophylaxis, hepatitis b and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: oedema peripheral, proteinuria. SIROLIMUS dosage: unknown. During the same period patient was treated with NIFEDIPINE, LAMIVUDINE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5404024-7
SIROLIMUS problem was reported by a Physician from UNITED STATES on July 30, 2007. Male patient was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: pneumonia, renal failure acute, tuberculosis. SIROLIMUS dosage: 2 MG QOD ALTERNATING WITH 3 MG QOD. During the same period patient was treated with SYNTHROID, LEXAPRO, ZYPREXA, FOSAMAX, PREDNISONE, NPH INSULIN. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5409855-5
Physician from KOREA, REPUBLIC OF reported SIROLIMUS problem on Apr 05, 2007. Female patient, weighting 142.4 lb, was diagnosed with prophylaxis against transplant rejection, anaemia prophylaxis, dyspepsia, prophylaxis against gastrointestinal ulcer, constipation and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: condition aggravated, diabetes mellitus inadequate control. SIROLIMUS dosage: unknown. During the same period patient was treated with FOLIC ACID, FEROBA, MOTILIUM, METHYLPREDNISOLONE, FAMOTIDINE, PYRIDOXINE, MAGNESIUM OXIDE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5409993-7
SIROLIMUS problem was reported by a Physician from KOREA, REPUBLIC OF on Apr 05, 2007. Female patient, weighting 142.4 lb, was diagnosed with prophylaxis against transplant rejection, anaemia prophylaxis, dyspepsia, prophylaxis against gastrointestinal ulcer, constipation and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: condition aggravated, diabetes mellitus inadequate control. SIROLIMUS dosage: unknown. During the same period patient was treated with FOLIC ACID, FEROBA, MOTILIUM, METHYLPREDNISOLONE, FAMOTIDINE, PYRIDOXINE, MAGNESIUM OXIDE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5410919-0
Physician from MEXICO reported SIROLIMUS problem on Aug 07, 2007. Female patient, weighting 132.7 lb, was diagnosed with prophylaxis against transplant rejection, hypertension, hyperuricaemia, hypercholesterolaemia, hyperlipidaemia, gastritis and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: azotaemia, complications of transplant surgery. SIROLIMUS dosage: unknown. During the same period patient was treated with DILTIAZEM, ENALAPRIL MALEATE, CANDESARTAN CILEXETIL, ALLOPURINOL, MACRODANTIN, PRAVASTATINE, BEZAFIBRATE, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5421121-0
SIROLIMUS problem was reported by a Physician from GERMANY on Aug 17, 2007. Female patient, 45 years of age, weighting 132.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: lymphocele, urinary tract obstruction. SIROLIMUS dosage: 1 MG DAILY. During the same period patient was treated with CELLCEPT. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5422076-5
Physician from SPAIN reported SIROLIMUS problem on Aug 16, 2007. Female patient, weighting 167.6 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: heart transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with PREDNISONE, ASPIRIN, TORSEMIDE, PRAVASTATIN, MYCOPHENOLATE MOFETIL, ENALAPRIL MALEATE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5423527-2
SIROLIMUS problem was reported by a Physician from ARGENTINA on Aug 17, 2007. Female patient, weighting 143.3 lb, was diagnosed with prophylaxis against transplant rejection, osteoporosis, antifungal prophylaxis, irritable bowel syndrome, hypertension, prophylaxis against gastrointestinal ulcer and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with ALENDRONATE, SULFAMETHOXAZOLE AND TRIMETHOPRIM, FOLIC ACID, BROMAZEPAM, AMOROLFINE, CARVEDILOL, OMEPRAZOLE, CALCIUM. Patient recovered.

Sirolimus Side Effects Report #5426334-X
Physician from FRANCE reported SIROLIMUS problem on Aug 20, 2007. Female patient, 40 years of age, was diagnosed with chronic allograft nephropathy, immunosuppression and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. During the same period patient was treated with AZATHIOPRINE. Patient recovered.

Sirolimus Side Effects Report #5426335-1
SIROLIMUS problem was reported by a Physician from FRANCE on Aug 20, 2007. Female patient, 51 years of age, was diagnosed with chronic allograft nephropathy and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. Patient recovered.

Sirolimus Side Effects Report #5426336-3
Physician from FRANCE reported SIROLIMUS problem on Aug 20, 2007. Male patient, 34 years of age, was diagnosed with chronic allograft nephropathy, immunosuppression and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient recovered.

Sirolimus Side Effects Report #5427155-4
SIROLIMUS problem was reported by a Physician from FRANCE on Aug 20, 2007. Male patient, 29 years of age, was diagnosed with chronic allograft nephropathy, renal transplant and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient recovered.

Sirolimus Side Effects Report #5427156-6
Physician from FRANCE reported SIROLIMUS problem on Aug 20, 2007. Female patient, 48 years of age, was diagnosed with chronic allograft nephropathy, renal transplant and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: focal glomerulosclerosis. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient recovered.

Sirolimus Side Effects Report #5427182-7
SIROLIMUS problem was reported by a Physician from BELGIUM on Aug 24, 2007. Female patient, 65 years of age, weighting 164.9 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: ureterectomy, urinary incontinence, urinary tract infection. SIROLIMUS dosage: unknown. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5427183-9
Physician from FRANCE reported SIROLIMUS problem on Aug 23, 2007. Female patient was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: campylobacter intestinal infection. SIROLIMUS dosage: 3 MG. During the same period patient was treated with DACLIZUMAB, CORTANCYL, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5427809-X
SIROLIMUS problem was reported by a Physician from KOREA, REPUBLIC OF on Aug 17, 2007. Female patient, weighting 159.4 lb, was diagnosed with prophylaxis against transplant rejection, infection prophylaxis, antifungal prophylaxis, anaemia prophylaxis, antibiotic prophylaxis and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, kidney transplant rejection, urinary tract infection enterococcal. SIROLIMUS dosage: unknown. During the same period patient was treated with SEPTRIN, NYSTATIN, PYRIDOXINE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5375816-8
Physician from ITALY reported SIROLIMUS problem on June 27, 2007. Female patient, weighting 141.1 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: ascites, lymphocele, lymphoedema, pericardial effusion, pleural effusion. SIROLIMUS dosage: unknown. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5377305-3
SIROLIMUS problem was reported by a Physician from FRANCE on June 22, 2007. Male patient, weighting 123.5 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: cardiac failure, condition aggravated. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5380863-6
Physician from FRANCE reported SIROLIMUS problem on July 03, 2007. Male patient, weighting 123.5 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: cardiac failure, condition aggravated. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5382797-X
SIROLIMUS problem was reported by a Health Professional from UNITED STATES on July 02, 2007. Female patient, 39 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: encephalopathy, reversible posterior leukoencephalopathy syndrome. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, ANTITHYMOCYTE IMMUNOGLOBULIN, FLUDARABINE PHOSPHATE, MELPHALAN. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5388352-X
Physician from BRAZIL reported SIROLIMUS problem on July 05, 2007. Male patient, weighting 160.9 lb, was diagnosed with prophylaxis against transplant rejection, diabetes mellitus, hypercholesterolaemia and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, deep vein thrombosis, pulmonary hypertension. SIROLIMUS dosage: unknown. During the same period patient was treated with PREDNISONE, GLIMEPIRIDE, SIMVASTATIN, WARFARIN. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5391251-0
SIROLIMUS problem was reported by a Physician from TAIWAN, PROVINCE OF CHINA on July 16, 2007. Female patient, weighting 132.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. SIROLIMUS dosage: unknown. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5397498-1
Physician from TAIWAN, PROVINCE OF CHINA reported SIROLIMUS problem on July 24, 2007. Female patient, weighting 130.1 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. SIROLIMUS dosage: unknown. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5399200-6
SIROLIMUS problem was reported by a Physician from KOREA, REPUBLIC OF on July 19, 2007. Male patient, weighting 165.3 lb, was diagnosed with prophylaxis against transplant rejection, infection prophylaxis, hypertension and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: seroma. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOSTATIN, PANCRELIPASE, TRIMETHOPRIM, DURICEF, SANDIMMUNE, PREDNISOLONE, CARVEDILOL, ALMAGEL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5399449-2
Physician from SPAIN reported SIROLIMUS problem on July 18, 2007. Female patient, weighting 169.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: heart transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with PREDNISONE, ASPIRIN, TORSEMIDE, PRAVASTATIN, MYCOPHENOLATE MOFETIL, ENALAPRIL MALEATE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5400123-4
SIROLIMUS problem was reported by a Physician from UNITED STATES on July 19, 2007. Male patient, weighting 191.2 lb, was diagnosed with prophylaxis against transplant rejection, hyperlipidaemia, hypertension and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: pancreatic carcinoma metastatic. SIROLIMUS dosage: unknown. During the same period patient was treated with ZOCOR, LANTUS, COZAAR, SEPTRA, NOVOLOG. Patient was hospitalized. Patient died on 07/16/2007.

Sirolimus Side Effects Report #5375816-8
Physician from ITALY reported SIROLIMUS problem on June 27, 2007. Female patient, weighting 141.1 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: ascites, lymphocele, lymphoedema, pericardial effusion, pleural effusion. SIROLIMUS dosage: unknown. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5377305-3
SIROLIMUS problem was reported by a Physician from FRANCE on June 22, 2007. Male patient, weighting 123.5 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: cardiac failure, condition aggravated. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5380863-6
Physician from FRANCE reported SIROLIMUS problem on July 03, 2007. Male patient, weighting 123.5 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: cardiac failure, condition aggravated. SIROLIMUS dosage: unknown. During the same period patient was treated with TACROLIMUS. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5382797-X
SIROLIMUS problem was reported by a Health Professional from UNITED STATES on July 02, 2007. Female patient, 39 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: encephalopathy, reversible posterior leukoencephalopathy syndrome. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, ANTITHYMOCYTE IMMUNOGLOBULIN, FLUDARABINE PHOSPHATE, MELPHALAN. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5388352-X
Physician from BRAZIL reported SIROLIMUS problem on July 05, 2007. Male patient, weighting 160.9 lb, was diagnosed with prophylaxis against transplant rejection, diabetes mellitus, hypercholesterolaemia and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, deep vein thrombosis, pulmonary hypertension. SIROLIMUS dosage: unknown. During the same period patient was treated with PREDNISONE, GLIMEPIRIDE, SIMVASTATIN, WARFARIN. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5391251-0
SIROLIMUS problem was reported by a Physician from TAIWAN, PROVINCE OF CHINA on July 16, 2007. Female patient, weighting 132.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. SIROLIMUS dosage: unknown. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5397498-1
Physician from TAIWAN, PROVINCE OF CHINA reported SIROLIMUS problem on July 24, 2007. Female patient, weighting 130.1 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. SIROLIMUS dosage: unknown. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5399200-6
SIROLIMUS problem was reported by a Physician from KOREA, REPUBLIC OF on July 19, 2007. Male patient, weighting 165.3 lb, was diagnosed with prophylaxis against transplant rejection, infection prophylaxis, hypertension and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: seroma. SIROLIMUS dosage: unknown. During the same period patient was treated with MYCOSTATIN, PANCRELIPASE, TRIMETHOPRIM, DURICEF, SANDIMMUNE, PREDNISOLONE, CARVEDILOL, ALMAGEL. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5399449-2
Physician from SPAIN reported SIROLIMUS problem on July 18, 2007. Female patient, weighting 169.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: heart transplant rejection. SIROLIMUS dosage: unknown. During the same period patient was treated with PREDNISONE, ASPIRIN, TORSEMIDE, PRAVASTATIN, MYCOPHENOLATE MOFETIL, ENALAPRIL MALEATE. Patient was hospitalized. Patient recovered.

Sirolimus Side Effects Report #5400123-4
SIROLIMUS problem was reported by a Physician from UNITED STATES on July 19, 2007. Male patient, weighting 191.2 lb, was diagnosed with prophylaxis against transplant rejection, hyperlipidaemia, hypertension and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: pancreatic carcinoma metastatic. SIROLIMUS dosage: unknown. During the same period patient was treated with ZOCOR, LANTUS, COZAAR, SEPTRA, NOVOLOG. Patient was hospitalized. Patient died on 07/16/2007.

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