Rapamune Safety Reports submitted to FDA

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Total Rapamune reports: 476.
Rapamune FDA safety alerts: 2002 2003 2007 .
Reported deaths: 44 Reported hospitalizations: 371.
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FDA Reported Rapamune Side Effects: kidney transplant rejection, blood creatinine increased, pyrexia, diarrhoea, haemoglobin decreased, liver transplant rejection, complications of transplanted kidney, anaemia, renal tubular necrosis, oedema peripheral, haemodialysis.
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Showing 1-100 of 476 Next >

Rapamune Side Effects Report #5341790-3
Health Professional from UNITED STATES reported RAPAMUNE problem on May 29, 2007. Male patient, 50 years of age, weighting 157.0 lb, was diagnosed with immunosuppression and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: pneumonitis. RAPAMUNE dosage: 4MG DAILY PO. During the same period patient was treated with CALCINEURIN, MYFORTIC, PROGRAF, ALBUTEROL SULATE, AMLODIPINE, ATORVASTATIN, AZITHROMYCIN. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5343451-3
RAPAMUNE problem was reported by a Physician from UNITED KINGDOM on May 31, 2007. Female patient, weighting 154.3 lb, was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: decreased appetite, diarrhoea, renal impairment, vomiting. RAPAMUNE dosage: unknown. During the same period patient was treated with FUROSEMIDE, ALFACALCIDOL, PREDNISOLONE, RANITIDINE, AMLODIPINE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5347206-5
Physician from IRAN (ISLAMIC REPUBLIC OF) reported RAPAMUNE problem on May 27, 2007. Male patient, 59 years of age, weighting 106.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus inadequate control, kidney transplant rejection. RAPAMUNE dosage: unknown. During the same period patient was treated with PREDNISOLONE, BACTRIM, CELLCEPT. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5349505-X
RAPAMUNE problem was reported by a Physician from GERMANY on May 29, 2007. Male patient, weighting 191.8 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: liver transplant rejection. RAPAMUNE dosage: unknown. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5352068-6
Consumer or non-health professional from UNITED STATES reported RAPAMUNE problem on June 01, 2007. Female patient was treated with RAPAMUNE. RAPAMUNE dosage: 1 MG/FREQUENCY NOT PROVIDED. Patient died.

Rapamune Side Effects Report #5356573-8
RAPAMUNE problem was reported by a Physician from GERMANY on June 11, 2007. Male patient, 42 years of age, weighting 167.6 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: glomerulonephritis proliferative, nephrosclerosis, renal tubular atrophy. RAPAMUNE dosage: unknown. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5360416-6
Physician from BRAZIL reported RAPAMUNE problem on June 13, 2007. Male patient, weighting 165.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: cholecystitis acute, multi-organ failure, septic shock. RAPAMUNE dosage: unknown. During the same period patient was treated with SULFAMETHOXAZOLE AND TRIMETHOPRIM, CYCLOSPORINE. Patient was hospitalized. Patient died on 10/28/2004.

Rapamune Side Effects Report #5360656-6
RAPAMUNE problem was reported by a Physician from GERMANY on June 11, 2007. Male patient, weighting 163.1 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: condition aggravated, glomerulonephritis proliferative, nephrosclerosis. RAPAMUNE dosage: unknown. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5360862-0
Physician from UNITED STATES reported RAPAMUNE problem on June 07, 2007. Male patient, weighting 205.0 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, lung infiltration, lung neoplasm. RAPAMUNE dosage: unknown. During the same period patient was treated with QUININE SULPHATE, TOPROL, VYTORIN, METHOTREXATE, ISOSORBIDE MONONITRATE, NEURONTIN, PROTONIX. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5361483-6
RAPAMUNE problem was reported by a Physician from UNITED STATES on June 07, 2007. Male patient, weighting 191.1 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: renal failure. RAPAMUNE dosage: unknown. During the same period patient was treated with NEURONTIN, LOMOTIL, LANTUS, VITAMIN B CAP, ARANESP, NOVOLOG, AMBIEN, PERCOCET. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5361944-X
Physician from GERMANY reported RAPAMUNE problem on June 08, 2007. Male patient, weighting 165.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: liver transplant rejection. RAPAMUNE dosage: unknown. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5365186-3
RAPAMUNE problem was reported by a Physician from BRAZIL on June 20, 2007. Male patient, weighting 165.3 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: cholecystitis acute, multi-organ failure. RAPAMUNE dosage: unknown. During the same period patient was treated with SULFAMETHOXAZOLE AND TRIMETHOPRIM, CYCLOSPORINE. Patient was hospitalized. Patient died on 10/28/2004.

Rapamune Side Effects Report #5369962-2
Physician from BRAZIL reported RAPAMUNE problem on June 20, 2007. Male patient, weighting 142.0 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: pneumonia, venous thrombosis. RAPAMUNE dosage: unknown. During the same period patient was treated with PREDNISONE, SULFAMETHOXAZOLE AND TRIMETHOPRIM, CLONIDINE, FUROSEMIDE, ATENOLOL, CYCLOSPORINE, CIPROFIBRATE. Patient was hospitalized. Patient died on 11/06/2004.

Rapamune Side Effects Report #5370636-2
RAPAMUNE problem was reported by a Physician from GERMANY on June 21, 2007. Male patient, weighting 158.7 lb, was diagnosed with prophylaxis against transplant rejection, hepatic neoplasm malignant recurrent, blood bilirubin increased, prophylaxis against gastrointestinal ulcer, cholangitis, inflammation, hyperuricaemia and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, blood bilirubin increased, c-reactive protein increased, hepatic artery stenosis, pleural effusion, pneumonia, transplant failure. RAPAMUNE dosage: unknown. During the same period patient was treated with URSODIOL, NEXIUM, CIPROFLOXACIN, TACROLIMUS, ALLOPURINOL. Patient was hospitalized. Patient died on 11/13/2006.

Rapamune Side Effects Report #5375937-X
Health Professional from UNITED STATES reported RAPAMUNE problem on June 27, 2007. Male patient, weighting 217.2 lb, was diagnosed with renal transplant and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: stomatitis. RAPAMUNE dosage: 8 MG DAILY PO. Patient recovered.

Rapamune Side Effects Report #5045285-6
RAPAMUNE problem was reported by a Consumer or non-health professional from UNITED STATES on June 23, 2006. Male patient, 67 years of age, weighting 234.6 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: unknown. During the same period patient was treated with ZENAPAX, MYCOPHENOLATE MOFETIL, CORTICOSTEROID NOS. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5047661-4
Consumer or non-health professional from UNITED STATES reported RAPAMUNE problem on June 30, 2006. Female patient, 55 years of age, weighting 179.0 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, blood alkaline phosphatase increased, condition aggravated, dehydration, diverticulum, gastritis erosive, gastroenteritis, haemorrhoids. RAPAMUNE dosage: unknown. During the same period patient was treated with CELLCEPT, PREDNISONE, AMLODIPINE BESYLATE, TENORMIN, LASIX, PREVACID. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5047668-7
RAPAMUNE problem was reported by a Consumer or non-health professional from UNITED STATES on June 21, 2006. Female patient, 77 years of age, weighting 134.9 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: anaemia, blood creatinine increased, blood urea increased, coagulopathy, gastrointestinal haemorrhage, haemorrhagic arteriovenous malformation, international normalised ratio increased, platelet count increased. RAPAMUNE dosage: 4 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with CELLCEPT, PREDNISONE, ZENAPAX, SULFONAMIDES, PROTONIX, COUMADIN, LANOXIN. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5048702-0
Health Professional from ARGENTINA reported RAPAMUNE problem on June 27, 2006. Male patient, 41 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: renal failure acute, urinary anastomotic leak, urinoma. RAPAMUNE dosage: 10 MG 1X PER 1 DAY ORAL. During the same period patient was treated with ATORVASTATIN CALCIUM, MEPREDNISONE, MYCOPHENOLATE MOFETIL, FUROSEMIDE, EPOGEN, BACTRIM, LEUCOVORIN, NIFEDIPINE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5048711-1
RAPAMUNE problem was reported by a Health Professional from NETHERLANDS on June 21, 2006. Male patient was diagnosed with renal transplant and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: pneumonitis. RAPAMUNE dosage: 8 MG 1X PER 1 DAY; SEE IMAGE. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient died.

Rapamune Side Effects Report #5048713-5
Health Professional from AUSTRALIA reported RAPAMUNE problem on June 22, 2006. Male patient, 48 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: intra-abdominal haemorrhage. RAPAMUNE dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, BACTRIM, VALTREX, NISTATIN, PANTOPRAZOLE, NIFEDIPINE, IRBESARTAN. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5048716-0
RAPAMUNE problem was reported by a Health Professional from CANADA on June 21, 2006. Female patient, 33 years of age, was diagnosed with renal transplant and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: vasculitis gastrointestinal. RAPAMUNE dosage: 2 MG PO OD ORAL. During the same period patient was treated with ALTACE, PREDNISONE, TACROLIMUS, PALAFER, CARDIZEM, TUMS, BICARBONATE IN PLASTIC CONTAINER, ARANESP. Patient recovered.

Rapamune Side Effects Report #5048807-4
Consumer or non-health professional from FRANCE reported RAPAMUNE problem on Nov 19, 2004. Male patient, 44 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: renal failure. RAPAMUNE dosage: 7 MG TOTAL DAILY AT THE TIME OF THE EVENT ONSET ORAL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5049303-0
RAPAMUNE problem was reported by a Health Professional from FRANCE on June 29, 2006. Male patient, 52 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection, proteinuria. RAPAMUNE dosage: 10 MG 1X PER 1 DAY ORAL. During the same period patient was treated with CELLCEPT, CORTANCYL, RAMIPRIL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5049304-2
Health Professional from FRANCE reported RAPAMUNE problem on June 29, 2006. Male patient, 57 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: bone pain. RAPAMUNE dosage: 12 MG TOTAL DAILY AT THE TIME OF THE EVENT ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5050534-4
RAPAMUNE problem was reported by a Physician from FRANCE on June 30, 2006. Male patient, 45 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus. RAPAMUNE dosage: 3 MG 1X PER 1 DAY. During the same period patient was treated with CYCLOSPORINE, MYCOPHENOLATE MOFETIL, PREDNISONE, ZENAPAX, TENORMIN, INEXIUM, PLAVIX. Patient recovered.

Rapamune Side Effects Report #5050537-X
Physician from FRANCE reported RAPAMUNE problem on June 29, 2006. Female patient, 53 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: chronic allograft nephropathy, haemodialysis, kidney transplant rejection. RAPAMUNE dosage: unknown. During the same period patient was treated with ANTITHYMOCYTE IMMUNOGLOBULIN, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5050686-6
RAPAMUNE problem was reported by a Consumer or non-health professional from CANADA on June 30, 2006. Female patient, 19 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: dehydration, graft dysfunction, kidney transplant rejection, renal tubular disorder. RAPAMUNE dosage: unknown. During the same period patient was treated with PREDNISONE, TACROLIMUS, CALCITRIOL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5050698-2
Consumer or non-health professional from FRANCE reported RAPAMUNE problem on June 29, 2006. Female patient, 50 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: arteriovenous fistula, complications of transplanted kidney, device migration, pneumonia, pulmonary embolism, renal infarct, staphylococcal infection, superinfection, vascular graft complication. RAPAMUNE dosage: 5 MG 1X PER 1 DAY ORAL. During the same period patient was treated with CELLCEPT. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5050699-4
RAPAMUNE problem was reported by a Consumer or non-health professional from CANADA on June 30, 2006. Male patient, child 11 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: unknown. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5050784-7
Consumer or non-health professional from FRANCE reported RAPAMUNE problem on June 29, 2006. Male patient, 64 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: removal of renal transplant, renal failure. RAPAMUNE dosage: 15 MG DAILY THEN 12 MG DAILY. During the same period patient was treated with PREDNISONE, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5051272-4
RAPAMUNE problem was reported by a Consumer or non-health professional from FRANCE on July 06, 2006. Male patient, 70 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: intestinal obstruction, procedural complication, retroperitoneal haematoma. RAPAMUNE dosage: unknown. During the same period patient was treated with CELLCEPT, CORTANCYL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5051274-8
Consumer or non-health professional from BRAZIL reported RAPAMUNE problem on July 03, 2006. Female patient, 30 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, diabetes mellitus. RAPAMUNE dosage: 6 + 4 + 2 MG 1X PER 1 DAY ORAL - SEE IMAGE. During the same period patient was treated with PREDNISONE, NYSTATIN, SULFAMETHOXAZOLE, OMEPRAZOLE, NORFLOXACIN, ASPIRIN. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5051285-2
RAPAMUNE problem was reported by a Consumer or non-health professional from FRANCE on July 22, 2004. Female patient, 56 years of age, was diagnosed with renal transplant and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection, lymphocele, renal failure acute. RAPAMUNE dosage: 10 MG 1X PER 1 DAY ORAL. During the same period patient was treated with PREDNISONE, CELLCEPT, AMLODIPINE BESYLATE, TAHOR, EPOETIN BETA. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5052087-3
Consumer or non-health professional from FRANCE reported RAPAMUNE problem on July 06, 2006. Female patient, 61 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: sciatica. RAPAMUNE dosage: 4 MG TOTAL DAILY AT THE TIME OF THE EVENT ONSET ORAL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5053173-4
RAPAMUNE problem was reported by a Consumer or non-health professional from UNITED STATES on June 30, 2006. Male patient, 67 years of age, weighting 236.0 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: 89 MG ONCE DAILY, STUDY SUPPLY; ORAL. During the same period patient was treated with CELLCEPT, ZENAPAX, CORTICOSTEROID NOS. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5053593-8
Consumer or non-health professional from BRAZIL reported RAPAMUNE problem on June 29, 2006. Male patient, 23 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: nephropathy toxic, renal impairment, urinary tract infection enterococcal. RAPAMUNE dosage: unknown. During the same period patient was treated with CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5053603-8
RAPAMUNE problem was reported by a Consumer or non-health professional from FRANCE on July 22, 2004. Male patient, 53 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: hydrocele. RAPAMUNE dosage: 4 MG TOTAL DAILY AT THE TIME OF THE EVENT, ORAL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5053967-5
Physician from UNITED KINGDOM reported RAPAMUNE problem on July 07, 2006. Male patient, 46 years of age, was diagnosed with renal transplant and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: arthralgia, condition aggravated, infection, mobility decreased, muscle atrophy, muscular weakness, oedema peripheral. RAPAMUNE dosage: 4 MG 1X PER 1 DAY ORAL. During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, BISOPROLOL FUMARATE. Patient was hospitalized and became disabled. Patient recovered.

Rapamune Side Effects Report #5055112-9
RAPAMUNE problem was reported by a Consumer or non-health professional from SPAIN on July 06, 2006. Male patient, 73 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: dyspnoea, renal impairment, sputum purulent. RAPAMUNE dosage: 3 MG 1X PER 1 DAY ORAL. During the same period patient was treated with CYCLOSPORINE, ATORVASTATIN CALCIUM, TAMSULOSIN, ARANESP, PREDNISONE, LOSARTAN POTASSIUM, ACETYLSALICYLSYRE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5055178-6
Health Professional from CHILE reported RAPAMUNE problem on July 03, 2006. Female patient, 26 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: haemodialysis, lung disorder, pyrexia, renal tubular necrosis, sputum purulent. RAPAMUNE dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, NIFEDIPINE, FUROSEMIDE, HYDRAZIDE, METHYLDOPA, DOXAZOSIN, CLONIDINE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5055187-7
RAPAMUNE problem was reported by a Health Professional from ARGENTINA on July 06, 2006. Male patient, 27 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: 8 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL, AMLODIPINE, COTRIM. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5055188-9
Health Professional from FRANCE reported RAPAMUNE problem on July 06, 2006. Male patient, 57 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: complications of transplanted kidney, haemodialysis. RAPAMUNE dosage: unknown. Patient recovered.

Rapamune Side Effects Report #5055195-6
RAPAMUNE problem was reported by a Consumer or non-health professional from FRANCE on July 06, 2006. Male patient, 57 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: unknown. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5055210-X
Physician from UNITED STATES reported RAPAMUNE problem on July 11, 2006. Male patient, 51 years of age, weighting 185.2 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: haematocrit decreased, kidney transplant rejection, rash papular, white blood cell count decreased. RAPAMUNE dosage: 6 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with TOPROL, NORVASC, COZAAR, ASPIRIN, CELLCEPT, VALCYTE, PEPCID, PREDNISONE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5055221-4
RAPAMUNE problem was reported by a Consumer or non-health professional from SPAIN on July 07, 2006. Male patient, 68 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: hernial eventration. RAPAMUNE dosage: 6 MG 1X PER 1 DAY. During the same period patient was treated with METHYLPREDNISOLONE, CELLCEPT, OMEPRAZOLE, PREDNISONE, DISTRANEURINE, MYCOSTATIN, RISPERDAL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5055226-3
Consumer or non-health professional from NEW ZEALAND reported RAPAMUNE problem on July 04, 2006. Male patient, 71 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: cardiac failure, congestive cardiomyopathy, coronary artery disease, coronary artery stenosis, dilatation ventricular, electrocardiogram st segment abnormal, exercise tolerance decreased, myocardial ischaemia, tachycardia. RAPAMUNE dosage: 2 MG IN AM AND 3 MG AT NIGHT. During the same period patient was treated with SIMVASTATIN, ROXITHROMYCIN, INHIBACE, INHIBACE PLUS. Patient recovered.

Rapamune Side Effects Report #5055227-5
RAPAMUNE problem was reported by a Consumer or non-health professional from MEXICO on July 11, 2006. Female patient was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: cardiac failure. RAPAMUNE dosage: 2 MG 1X PER 1 DAY. During the same period patient was treated with PREDNISONE, MYCOPHENOLATE MOFETIL. Patient died.

Rapamune Side Effects Report #5055697-2
Physician from UNITED STATES reported RAPAMUNE problem on July 07, 2006. Male patient, 30 years of age, weighting 214.2 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: anaemia, dialysis, kidney transplant rejection, leukopenia, renal tubular necrosis, renal vein occlusion, thrombocytopenia, vascular stenosis. RAPAMUNE dosage: 10 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with HYDRALAZINE, LABETALOL, NILSTAT, BACTRIM, NEXIUM, NIFEDIPINE, FENOLDOPAM, CLONIDINE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5056347-1
RAPAMUNE problem was reported by a Consumer or non-health professional from BRAZIL on July 03, 2006. Female patient, 31 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: chronic allograft nephropathy, haematocrit decreased, microangiopathy. RAPAMUNE dosage: 2 MG 1X PER 1 DAY ; 4X MG 1X PER 1 DAY. During the same period patient was treated with PREDNISONE, SULFAMETHOXAZOLE, SIMVASTATIN, ATENOLOL. Patient recovered.

Rapamune Side Effects Report #5056349-5
Consumer or non-health professional from SINGAPORE reported RAPAMUNE problem on July 13, 2006. Male patient, 44 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: atelectasis, blood gases abnormal, calcinosis, cholecystitis, eosinophilia, granuloma, hypoxia, leukopenia, lung consolidation. RAPAMUNE dosage: 2 MG 2X PER 1 DAY. During the same period patient was treated with CELLCEPT, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5056355-0
RAPAMUNE problem was reported by a Consumer or non-health professional from SINGAPORE on July 11, 2006. Male patient, 44 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, atelectasis, blood alkaline phosphatase increased, cholecystitis, eosinophilia, hypoxia. RAPAMUNE dosage: 2 MG 2X PER 1 DAY. During the same period patient was treated with CELLCEPT, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5056360-4
Consumer or non-health professional from ARGENTINA reported RAPAMUNE problem on July 10, 2006. Male patient, 50 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, pyrexia, small intestinal obstruction. RAPAMUNE dosage: 5 MG 1X PER 1 DAY. During the same period patient was treated with MEPREDNISONE, MYCOPHENOLATE MOFETIL, ATENOLOL, ENALAPRIL MALEATE, ATORVASTATIN CALCIUM, BACTRIM, LEUCOVORIN CALCIUM, ALPRAZOLAM. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5056540-8
RAPAMUNE problem was reported by a Consumer or non-health professional from UNITED STATES on July 07, 2006. Female patient, 35 years of age, weighting 118.1 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection, tubulointerstitial nephritis. RAPAMUNE dosage: unknown. During the same period patient was treated with CELLCEPT, PREDNISONE, SEPTRA, PROTONIX, COZAAR, LOPRESSOR, ARANESP. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5059025-8
Pharmacist from UNITED STATES reported RAPAMUNE problem on July 14, 2006. Female patient, 51 years of age, weighting 116.8 lb, was diagnosed with renal and pancreas transplant and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: colitis. RAPAMUNE dosage: 4 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with PROGRAF, ASPIRIN, LOPRESSOR, PREDNISONE, NEXIUM, ZELNORM, DEMADEX, BACTRIM DS. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5059027-1
RAPAMUNE problem was reported by a Physician from UNITED STATES on July 07, 2006. Male patient, 30 years of age, weighting 214.2 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: anaemia, dialysis, kidney transplant rejection, leukopenia, renal tubular necrosis, renal vessel disorder, thrombocytopenia, vascular stenosis. RAPAMUNE dosage: 10 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with HYDRALAZINE, LABETALOL, NILSTAT, BACTRIM, NEXIUM, NIFEDIPINE, FENOLDOPAM, CLONIDINE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5059953-3
Consumer or non-health professional from SPAIN reported RAPAMUNE problem on July 13, 2006. Female patient, 62 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: lung infiltration. RAPAMUNE dosage: 3 MG 1X PER 1 DAY, ORAL; SEE IMAGE. During the same period patient was treated with PROGRAF, CELLCEPT. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5059975-2
RAPAMUNE problem was reported by a Consumer or non-health professional from SPAIN on July 07, 2006. Male patient, 52 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: complications of transplanted kidney, haemodialysis, renal tubular necrosis, seroma, urinary fistula, urinary tract infection enterococcal, urinary tract infection staphylococcal. RAPAMUNE dosage: 5 MG 1X PER 1 DAY ORAL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5059995-8
Consumer or non-health professional from MEXICO reported RAPAMUNE problem on July 10, 2006. Female patient was diagnosed with heart transplant and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: heart transplant rejection. RAPAMUNE dosage: 4MG, 2MG ORAL. During the same period patient was treated with PREDNISONE, MYCOPHENOLATE MOFETIL. Patient died.

Rapamune Side Effects Report #5060131-2
RAPAMUNE problem was reported by a Consumer or non-health professional from PORTUGAL on July 07, 2006. Male patient, 36 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: 4 MG 1X PER 1 DAY ORAL; 3 MG 1X PER 1 DAY ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5060303-7
Consumer or non-health professional from TURKEY reported RAPAMUNE problem on July 14, 2006. Male patient, 47 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: 8 MG 1X PER 1 DAY ORAL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5061496-8
RAPAMUNE problem was reported by a Consumer or non-health professional from UNITED STATES on July 14, 2006. Male patient, 56 years of age, weighting 167.6 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood urea increased, dyspnoea exertional, fluid overload, haematocrit decreased, haemoglobin decreased, inflammation, platelet count decreased. RAPAMUNE dosage: 16 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with PROGRAF, METOPROLOL, ZENAPAX, CORTICOSTEROID NOS. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5061593-7
Consumer or non-health professional from UNITED STATES reported RAPAMUNE problem on July 18, 2006. Male patient, 50 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: aortic dilatation, bacteria urine identified, blood chloride increased, blood creatinine increased, blood urea increased, candidiasis, carbon dioxide decreased, clostridium difficile colitis, hyperkalaemia. RAPAMUNE dosage: 12 MG 1X PER DAY, ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, ZENAPAX, DIOVAN, ATENOLOL, BACTRIM, ZOCOR, NOVOLOG. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5061706-7
RAPAMUNE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 13, 2006. Male patient, 69 years of age, was diagnosed with chronic allograft nephropathy and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: clostridium difficile colitis. RAPAMUNE dosage: unknown. Patient recovered.

Rapamune Side Effects Report #5061713-4
Consumer or non-health professional from ARGENTINA reported RAPAMUNE problem on July 14, 2006. Male patient, 41 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: complications of transplanted kidney, renal failure acute, urinary anastomotic leak, urinoma. RAPAMUNE dosage: 10 MG 1X PER 1 DAY ORAL. During the same period patient was treated with CORTICOSTEROID NOS, ATORVASTATIN CALCIUM, MEPREDNISONE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, FUROSEMIDE, EPOGEN, BACTRIM. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5061714-6
RAPAMUNE problem was reported by a Consumer or non-health professional from IRAN (ISLAMIC REPUBLIC OF) on July 16, 2006. Male patient, 48 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: acute abdomen, blood creatinine increased, complications of transplanted kidney, perinephric abscess, sepsis. RAPAMUNE dosage: 2 MG 1X PER 1 DAY ORAL. During the same period patient was treated with CYCLOSPORINE, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5061719-5
Consumer or non-health professional from FRANCE reported RAPAMUNE problem on July 18, 2006. Female patient was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: anaemia, pleurisy, pneumonitis. RAPAMUNE dosage: unknown. Patient recovered.

Rapamune Side Effects Report #5061723-7
RAPAMUNE problem was reported by a Consumer or non-health professional from MEXICO on July 11, 2006. Male patient was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: heart transplant rejection. RAPAMUNE dosage: 2 MG 1X PER 1 DAY ORAL. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5061724-9
Consumer or non-health professional from CHILE reported RAPAMUNE problem on July 12, 2006. Female patient, 18 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: arteriovenous fistula site haemorrhage, postoperative wound complication, wound haemorrhage. RAPAMUNE dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, NIFEDIPINE, PROPRANOLOL, RANITIDINE, COTRIM, CLOXACILLIN. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5062118-2
RAPAMUNE problem was reported by a Consumer or non-health professional from SPAIN on July 18, 2006. Male patient, 58 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: blood lactate dehydrogenase increased, cardiac arrest, colitis ulcerative, cytomegalovirus infection, haemolysis, haemorrhagic infarction, hepatitis. RAPAMUNE dosage: unknown. During the same period patient was treated with DOXAZOSIN, AMLODIPINE, CLORAZEPATE. Patient was hospitalized. Patient died.

Rapamune Side Effects Report #5062148-0
Consumer or non-health professional from HUNGARY reported RAPAMUNE problem on July 16, 2006. Female patient, 52 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, complications of transplanted kidney, dizziness, gastroenteritis, hypotension, ureteric dilatation. RAPAMUNE dosage: 2 MG 1X PER 1 DAY ORAL. During the same period patient was treated with MEDROL ACETATE, CELLCEPT, TRIMETAZIDINE DIHYDROCHLORIDE, COVEREX, MINIPRESS, ERYTHROPOIETIN, LESCOL, BETALOC. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5063078-0
RAPAMUNE problem was reported by a Pharmacist from UNITED STATES on July 12, 2006. Male patient, 50 years of age, was diagnosed with liver transplant and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: renal failure chronic. RAPAMUNE dosage: unknown. During the same period patient was treated with BARACLUDE, CELLCEPT. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5063335-8
Physician from UNITED STATES reported RAPAMUNE problem on July 13, 2006. Male patient, 45 years of age, weighting 205.2 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, haemodialysis, kidney transplant rejection, urinary tract infection. RAPAMUNE dosage: 3 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with PREDNISONE, ZENAPAX. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5063623-5
RAPAMUNE problem was reported by a Health Professional from BRAZIL on July 13, 2006. Male patient, 61 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection, polyomavirus-associated nephropathy. RAPAMUNE dosage: 1 MG 1X PER 1 DAY ORAL. During the same period patient was treated with SULFAMETHOXAZOLE, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5063625-9
Consumer or non-health professional from UNITED KINGDOM reported RAPAMUNE problem on July 13, 2006. Male patient, 63 years of age, was diagnosed with renal transplant and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus infection, epstein-barr virus infection, haemoptysis, pneumocystis jiroveci pneumonia, respiratory failure. RAPAMUNE dosage: unknown. Patient recovered.

Rapamune Side Effects Report #5063652-1
RAPAMUNE problem was reported by a Physician from CANADA on July 12, 2006. Female patient, 37 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: anuria, extrinsic iliac vein compression, haemodialysis, haemoglobin decreased, hydronephrosis, iatrogenic injury, oedema peripheral, operative haemorrhage. RAPAMUNE dosage: 5 MG 1X PER 1 DAY ORAL. During the same period patient was treated with LASIX, PROGRAF, PREDNISONE, ASPIRIN, LIPITOR, LOPRESSOR. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5064826-6
Consumer or non-health professional from UNITED STATES reported RAPAMUNE problem on July 12, 2006. Male patient, 65 years of age, weighting 185.2 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, angiopathy, atrial fibrillation, atrial flutter, blood lactate dehydrogenase increased, blood urea increased, central line infection, chest x-ray abnormal, coronary artery occlusion. RAPAMUNE dosage: unknown. During the same period patient was treated with CELLCEPT. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5064981-8
RAPAMUNE problem was reported by a Consumer or non-health professional from IRAN (ISLAMIC REPUBLIC OF) on July 15, 2006. Male patient, 53 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: unknown. During the same period patient was treated with CYCLOSPORINE, ROCALTROL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5065010-2
Consumer or non-health professional from BRAZIL reported RAPAMUNE problem on July 19, 2006. Male patient, 59 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: complications of transplanted kidney, haemodialysis. RAPAMUNE dosage: unknown. During the same period patient was treated with CYCLOSPORINE, AMLODIPINE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5065807-9
RAPAMUNE problem was reported by a Consumer or non-health professional from GREECE on July 13, 2006. Male patient, 28 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: 9 MG 1X PER 1 DAY. During the same period patient was treated with MYCOPHENOLATE MOFETIL, METHYLPREDNISOLONE, CEFUROXIME AXETIL, FLUVASTATIN, GEMFIBROZIL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5065815-8
Consumer or non-health professional from UNITED KINGDOM reported RAPAMUNE problem on July 18, 2006. Female patient, 52 years of age, was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, catheter related complication, complications of transplanted kidney, haemodialysis, hypertension, kidney transplant rejection, malaise, pancreatitis, pharyngolaryngeal pain. RAPAMUNE dosage: 3 MG 1X PER 1 DAY. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISOLONE, ZENAPAX, LANSOPRAZOLE, ATENOLOL, IRBESARTAN, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5066846-4
RAPAMUNE problem was reported by a Consumer or non-health professional from UNITED STATES on July 19, 2006. Female patient, 35 years of age, weighting 99.21 lb, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: platelet count decreased, post procedural complication, retroperitoneal haematoma. RAPAMUNE dosage: 5 MG 1X PER 1 DAY. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5067623-0
Consumer or non-health professional from IRAN (ISLAMIC REPUBLIC OF) reported RAPAMUNE problem on July 26, 2006. Male patient, 48 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: acute abdomen, complications of transplanted kidney, perinephric abscess, sepsis. RAPAMUNE dosage: 2 MG 1X PER 1 DAY ORAL; ORAL. During the same period patient was treated with CYCLOSPORINE, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5067634-5
RAPAMUNE problem was reported by a Consumer or non-health professional from IRAN (ISLAMIC REPUBLIC OF) on July 26, 2006. Male patient, 48 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: acute abdomen, blood creatinine increased, perinephric abscess, sepsis. RAPAMUNE dosage: 2 MG 1X PER 1 DAY ORAL. During the same period patient was treated with CYCLOSPORINE, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5069950-X
Consumer or non-health professional from ARGENTINA reported RAPAMUNE problem on Mar 27, 2006. Female patient, 39 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: cardiac failure, dyspnoea, hypoalbuminaemia, oedema peripheral, pleural effusion, proteinuria. RAPAMUNE dosage: 2 MG 1X PER 1 DAY, ORAL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5069957-2
RAPAMUNE problem was reported by a Consumer or non-health professional from TURKEY on July 24, 2006. Male patient, 47 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: 8 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with OMEPRAZOLE, NYSTATIN, BACTRIM, ACYCLOVIR, WARFARIN. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5069960-2
Consumer or non-health professional from TURKEY reported RAPAMUNE problem on July 24, 2006. Male patient, 15 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: 8 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with BACTRIM, NYSTATIN, ACYCLOVIR, FAMOTIDINE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5070302-7
RAPAMUNE problem was reported by a Physician from UNITED STATES on July 21, 2006. Male patient, 43 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: abscess, gangrene, skin ulcer. RAPAMUNE dosage: unknown. During the same period patient was treated with ZENAPAX, MYCOPHENOLATE MOFETIL, CORTICOSTEROIDS. Patient recovered.

Rapamune Side Effects Report #5071821-X
Consumer or non-health professional from NEW ZEALAND reported RAPAMUNE problem on July 27, 2006. Male patient, 71 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: cardiac failure, congestive cardiomyopathy, coronary artery stenosis, dilatation ventricular, myocardial ischaemia, ventricular hypokinesia. RAPAMUNE dosage: 2 MG IN AM AND 3 MG AT NIGHT. During the same period patient was treated with SIMVASTATIN, ROXITHROMYCIN, INHIBACE, INHIBACE PLUS. Patient recovered.

Rapamune Side Effects Report #5072853-8
RAPAMUNE problem was reported by a Health Professional from SPAIN on July 24, 2006. Male patient, 72 years of age, was diagnosed with renal transplant and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: chronic allograft nephropathy, deep vein thrombosis, haemodialysis, herpes virus infection, kaposi's sarcoma, kidney transplant rejection, pneumonitis. RAPAMUNE dosage: 5 MG 1X PER 1 DAY. During the same period patient was treated with PREDNISONE, MYCOPHENOLATE MOFETIL, TACROLIMUS. Patient recovered.

Rapamune Side Effects Report #5072903-9
Health Professional from IRAN (ISLAMIC REPUBLIC OF) reported RAPAMUNE problem on July 25, 2006. Female patient, 48 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: 2 MG 1X PER 1 DAY ORAL; 6 MG INITIALLY ORAL. During the same period patient was treated with CYCLOSPORINE, PREDNISONE. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5072904-0
RAPAMUNE problem was reported by a Health Professional from ARGENTINA on Aug 01, 2006. Female patient, 62 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, hepatic encephalopathy, immunosuppression, pyrexia. RAPAMUNE dosage: 10 MG 1X PER 1 DAY ORAL. During the same period patient was treated with MEPREDNISONE, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5073894-7
Consumer or non-health professional from FRANCE reported RAPAMUNE problem on July 31, 2006. Female patient was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: renal failure acute. RAPAMUNE dosage: unknown. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5074393-9
RAPAMUNE problem was reported by a Consumer or non-health professional from TURKEY on July 24, 2006. Male patient, 47 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, blood cholesterol increased, blood glucose increased, blood lactate dehydrogenase increased, complications of transplanted kidney. RAPAMUNE dosage: 5 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with PENTOXIFYLLINE, NADROPARIN CALCIUM, CELLCEPT, OMEPRAZOLE, NYSTATIN, BACTRIM, MENTOPIN ACETYLCYSTEIN. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5074399-X
Consumer or non-health professional from UNITED KINGDOM reported RAPAMUNE problem on July 31, 2006. Male patient, 54 years of age, was diagnosed with immunosuppression and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: kidney transplant rejection. RAPAMUNE dosage: 4 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with SILDENAFIL CITRATE, FUROSEMIDE, ATORVASTATIN CALCIUM, RANITIDINE, AMLODIPINE, MYCOPHENOLATE MOFETIL. Patient recovered.

Rapamune Side Effects Report #5074411-8
RAPAMUNE problem was reported by a Consumer or non-health professional from FRANCE on July 28, 2006. Female patient was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: leukopenia, rectal haemorrhage, thrombocytopenia. RAPAMUNE dosage: unknown. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5074412-X
Consumer or non-health professional from FRANCE reported RAPAMUNE problem on July 31, 2006. Female patient was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: fluid overload, pneumonitis. RAPAMUNE dosage: unknown. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5074436-2
RAPAMUNE problem was reported by a Consumer or non-health professional from TURKEY on July 24, 2006. Male patient, 41 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: aeromona infection, impaired healing, incision site haematoma. RAPAMUNE dosage: 5 MG 1X PER 1 DAY, ORAL. During the same period patient was treated with OMEPRAZOLE, ACETYLCYSTEINE, FUROSEMIDE, BACTRIM, ACYCLOVIR, NYSTATIN, AMPICILLIN W, PIPERACILLIN W. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5076171-3
Consumer or non-health professional from UNITED STATES reported RAPAMUNE problem on July 25, 2006. Female patient, 48 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: anaemia, arteritis, haemodialysis, kidney transplant rejection, platelet count decreased, renal infarct. RAPAMUNE dosage: unknown. During the same period patient was treated with CELLCEPT, SIMULECT. Patient was hospitalized. Patient recovered.

Rapamune Side Effects Report #5076378-5
RAPAMUNE problem was reported by a Health Professional from GREECE on Aug 03, 2006. Female patient, 41 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with RAPAMUNE. After drug was administered, patient experienced the following problems/side effects: graft thrombosis, kidney transplant rejection, leg amputation, peripheral ischaemia, renal tubular necrosis, sepsis. RAPAMUNE dosage: 10 MG 1X PER 1 DAY; 4 MG 1X PER 1 DAY ; 5 MG 1X PER 1 DAY. During the same period patient was treated with MYCOPHENOLATE MOFETIL, OMEPRAZOLE, AMIKACIN, CEFTAZIDIME, CLONAZEPAM. Patient was hospitalized and became disabled. Patient recovered.

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Drug Information: Sirolimus

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a602026.html

(sir oh' li mus)

IMPORTANT WARNING:

Sirolimus may increase the risk of infection and lymphoma. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, frequent or painful urination, or other signs of infection.Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to sirolimus.Talk to your doctor about the risks of taking sirolimus.

Why is this medication prescribed?

Sirolimus is used in combination with other medications to prevent rejection of kidney transplants. Sirolimus is in a class of medications called immunosuppressants. It works by suppressing the body's immune system.

How should this medicine be used?

Sirolimus comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once a day, either always with food or always without food. To help you remember to take sirolimus, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sirolimus exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take sirolimus even if you feel well. Do not stop taking sirolimus without talking to your doctor.

To use the bottles of solution, follow these steps:

Open the solution bottle. On first use, insert the plastic tube with stopper tightly into the bottle until it is even with the top of the bottle. Do not remove from the bottle.
For each use, tightly insert one of the amber syringes with the plunger fully pushed in into the opening in the plastic tube.
Draw up the amount of solution your doctor has prescribed by gently pulling out the plunger of the syringe until the bottom of the black line of the plunger is even with the correct mark on the syringe. Keep the bottle upright. If bubbles form in the syringe, empty the syringe into the bottle and repeat this step.
Empty the syringe into a glass or plastic cup containing at least 2 ounces (1/4 cup) of water or orange juice. Do not use apple juice, grapefruit juice, or other liquids. Stir vigorously for 1 minute and drink immediately.
Refill the cup with at least 4 ounces (1/2 cup) of water or orange juice. Stir vigorously and drink the rinse solution.
Throw away the used syringe.

If you need to carry a filled syringe with you, snap a cap onto the syringe and put the syringe in the carrying case. Use the medication in the syringe within 24 hours.

To use the pouches of solution, follow these steps:

Before opening the pouch, squeeze the pouch from the neck area to push the contents into the lower part of the pouch.
Fold the marked area on the pouch and carefully cut with scissors.
Squeeze the entire contents of the pouch into a glass or plastic cup containing at least 2 ounces (1/4 cup) of water or orange juice. Do not use apple juice, grapefruit juice, or other liquids. Stir vigorously for 1 minute and drink immediately.
Refill the cup with at least 4 ounces (1/2 cup) of water or orange juice. Stir vigorously and drink the rinse solution.

Other uses for this medicine

Sirolimus also is used sometimes to treat psoriasis. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking sirolimus,

tell your doctor and pharmacist if you are allergic to sirolimus or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: amphotericin B (Abelcet, AmBisome, Amphocin, Fungizone); antifungals such as clotrimazole (Lotrimin), fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); bromocriptine (Parlodel); cimetidine (Tagamet); cisapride (Propulsid); clarithromycin (Biaxin); danazol (Danocrine); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin); metoclopramide (Reglan); nicardipine (Cardene); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); rifapentine (Priftin); troleandomycin (TAO); and verapamil (Calan, Covera, Isoptin, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
if you are taking cyclosporine (Neoral) soft gelatin capsules or solution, take them 4 hours before sirolimus.
tell your doctor what herbal products you are taking, especially St. John's wort.
tell your doctor if you have or have ever had high cholesterol or triglycerides or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use an effective method of birth control before starting to take sirolimus, while taking sirolimus, and for 12 weeks after stopping sirolimus. If you become pregnant while taking sirolimus, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sirolimus.
plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Sirolimus may increase your risk for skin cancer.
do not have any vaccinations (e.g., measles or flu shots) without talking to your doctor.

What special dietary instructions should I follow?

Avoid drinking large amounts of grapefruit juice while taking this medicine.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Sirolimus may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

stomach pain
weakness
back pain
headache
constipation
diarrhea
upset stomach
vomiting
swelling of the hands, feet, ankles, or lower legs
weight gain
joint pain
difficulty falling asleep or staying asleep
tremor
rash
fever

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

pale skin
unusual bleeding or bruising
cough
shortness of breath

Sirolimus may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store tablets at room temperature and away from excess heat and moisture (not in the bathroom). Keep liquid medication in the refrigerator, closed tightly, and throw away any unused medication one month after the bottle is opened. Do not freeze. If needed, you may store the pouches for up to 24 hours and the bottles for up to 15 days at room temperature. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to sirolimus.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

Rapamune®

Other name(s):

Rapamycin

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