Sirolimus Side Effects
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Sirolimus Safety Reports reported to FDA
Total Sirolimus reports: 168.Sirolimus FDA safety alerts: 2002 2003 2007 .
Reported deaths: 11 Reported hospitalizations: 118.
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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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Sirolimus Side Effects Report #5129930-2Consumer or non-health professional from ITALY reported SIROLIMUS problem on Oct 11, 2006. Male patient, 50 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: hydrocele, lymphocele. SIROLIMUS dosage: 1 MG 1X PER 1 DAY ORAL. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5133051-2
SIROLIMUS problem was reported by a Consumer or non-health professional from NETHERLANDS on Oct 13, 2006. Male patient, 57 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: anaemia, proteinuria, pyrexia. SIROLIMUS dosage: unknown. During the same period patient was treated with LISINOPRIL. Patient recovered.
Sirolimus Side Effects Report #5133071-8
Consumer or non-health professional from BELGIUM reported SIROLIMUS problem on Oct 12, 2006. Female patient, 65 years of age, was diagnosed with renal transplant and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: impaired healing, ureteral necrosis. SIROLIMUS dosage: unknown. During the same period patient was treated with CELLCEPT. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5133131-1
SIROLIMUS problem was reported by a Consumer or non-health professional from BELGIUM on Oct 13, 2006. Male patient, 35 years of age, 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: 15 MG 1X PER 1 DAY; ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5134224-5
Consumer or non-health professional from BELGIUM reported SIROLIMUS problem on Oct 13, 2006. Male patient, 51 years of age, 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 MYCOPHENOLATE MOFETIL, MEDROL. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5153393-4
SIROLIMUS problem was reported by a Consumer or non-health professional from FRANCE on Nov 06, 2006. Male patient, 52 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: pyelocaliectasis, renal failure, serratia sepsis, ureteric stenosis, urinary tract infection bacterial, urosepsis. SIROLIMUS dosage: 4 MG DAILY AT THE TIME OF EVENT ONSET. During the same period patient was treated with CELLCEPT, CORTANCYL. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5162137-1
Health Professional from FRANCE reported SIROLIMUS problem on Nov 09, 2006. Female patient, 40 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: anaemia, arteriovenous fistula, biopsy kidney abnormal, complications of transplanted kidney, condition aggravated, effusion, haemodialysis, haemorrhage. SIROLIMUS dosage: 15 MG DAILY FOR 2 DAYS AND THEN 8 MG DAILY ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5165131-X
SIROLIMUS problem was reported by a Consumer or non-health professional from ITALY on Nov 20, 2006. Male patient, 38 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, dialysis, kidney transplant rejection. SIROLIMUS dosage: 4 MG 1X PER 1 DAY ORAL. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5165654-3
Health Professional from ITALY reported SIROLIMUS problem on Nov 22, 2006. Male patient, 38 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: dialysis, kidney transplant rejection. SIROLIMUS dosage: 4 MG 1X PER 1 DAY. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5188135-X
SIROLIMUS problem was reported by a Consumer or non-health professional from ITALY on Dec 11, 2006. Female patient, 59 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: anaemia, haemodialysis, kidney transplant rejection, leukopenia, nephroangiosclerosis, nephropathy toxic, pyelonephritis acute, renal tubular necrosis. SIROLIMUS dosage: unknown. During the same period patient was treated with CYCLOSPORINE. Patient was hospitalized. Patient recovered.
Sirolimus Side Effects Report #5191360-5
Consumer or non-health professional from ITALY reported SIROLIMUS problem on Dec 12, 2006. Male patient, 54 years of age, 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 #5375816-8
SIROLIMUS problem was reported by a Physician from ITALY 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
Physician from FRANCE reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Physician from FRANCE 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
Health Professional from UNITED STATES reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Physician from BRAZIL 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
Physician from TAIWAN, PROVINCE OF CHINA reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Physician from TAIWAN, PROVINCE OF CHINA 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
Physician from KOREA, REPUBLIC OF reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Physician from SPAIN 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
Physician from UNITED STATES reported SIROLIMUS problem 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 #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 #5441431-0
Physician from GERMANY reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Physician from SWITZERLAND 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
Physician from HONG KONG reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Physician from SWITZERLAND 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
Health Professional from AUSTRALIA reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Physician from SWITZERLAND 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
Physician from KOREA, REPUBLIC OF reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Health Professional from UNITED KINGDOM 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
Health Professional from UNITED KINGDOM reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Physician from MEXICO 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
Physician from HONG KONG reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Physician from UNITED STATES 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
Physician from MEXICO reported SIROLIMUS problem 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
SIROLIMUS problem was reported by a Health Professional from UNITED KINGDOM 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.
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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.
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