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Cornea Side Effects Report #5631691-5
Physician from UNITED STATES reported CORNEA problem on Dec 14, 2007. Male patient, 34 years of age, was diagnosed with keratoconus and was treated with CORNEA. After drug was administered, patient experienced the following problems/side effects: graft dysfunction, pain, photosensitivity reaction, . CORNEA dosage: unknown. Patient was hospitalized. Patient recovered.

Tacrolimus Side Effects Report #5429548-8
TACROLIMUS problem was reported by a Physician from SWITZERLAND on Aug 09, 2007. Female patient, 37 years of age, was diagnosed with renal transplant and was treated with TACROLIMUS. After drug was administered, patient experienced the following problems/side effects: graft dysfunction, immune reconstitution syndrome, plasmapheresis, polyomavirus-associated nephropathy, . TACROLIMUS dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, CORTICOSTEROIDS. Patient recovered.

Thymoglobulin Side Effects Report #5423734-9
Health Professional from UNITED STATES reported THYMOGLOBULIN problem on Feb 28, 2004. Male patient, 51 years of age, weighting 223.5 lb, was diagnosed with renal transplant and was treated with THYMOGLOBULIN. After drug was administered, patient experienced the following problems/side effects: graft dysfunction, hypotension, post procedural complication, pulmonary oedema, troponin increased, . THYMOGLOBULIN dosage: 100 MG QD. During the same period patient was treated with RAPAMUNE. Patient was hospitalized. Patient recovered.

Thymoglobulin Side Effects Report #5423734-9
THYMOGLOBULIN problem was reported by a Health Professional from UNITED STATES on Feb 28, 2004. Male patient, 51 years of age, weighting 223.5 lb, was diagnosed with renal transplant and was treated with THYMOGLOBULIN. After drug was administered, patient experienced the following problems/side effects: graft dysfunction, hypotension, post procedural complication, pulmonary oedema, troponin increased, . THYMOGLOBULIN dosage: 100 MG QD. During the same period patient was treated with RAPAMUNE. Patient was hospitalized. Patient recovered.


Fenofibrate Side Effects Report #5334701-8
Health Professional from UNITED STATES reported FENOFIBRATE problem on May 04, 2007. Female patient, 55 years of age, was diagnosed with hypertriglyceridaemia and was treated with FENOFIBRATE. After drug was administered, patient experienced the following problems/side effects: graft dysfunction, . FENOFIBRATE dosage: 54 MG, QD. During the same period patient was treated with PREDNISONE, CYCLOSPORINE, AZATHIOPRINE, METOPROLOL TARTRATE, CLONIDINE, FLUVASTATIN, AMLODIPINE MALEATE, BENAZEPRIL. Patient recovered.

Fenofibrate Side Effects Report #5334702-X
FENOFIBRATE problem was reported by a Consumer or non-health professional from UNITED STATES on May 04, 2007. Female patient was diagnosed with blood triglycerides increased and was treated with FENOFIBRATE. After drug was administered, patient experienced the following problems/side effects: graft dysfunction, . FENOFIBRATE dosage: 54 MG, QD. During the same period patient was treated with PREDNISOLONE, CYCLOSPORINE, AZATHIOPRINE, VALSARTAN, METOPROLOL TARTRATE, CLONIDINE, FAMOTIDINE, CALCITONIN SALMON. Patient recovered.

Acetaminophen Side Effects Report #5670232-3
Health Professional from UNITED KINGDOM reported ACETAMINOPHEN problem on Mar 06, 2008. Female patient was diagnosed with immunosuppression and was treated with ACETAMINOPHEN. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, graft dysfunction, hepatic vein thrombosis, impaired healing, overdose, pleural effusion, pulmonary embolism, pulmonary sepsis, renal failure, . ACETAMINOPHEN dosage: unknown. During the same period patient was treated with CYCLOSPORINE, TACROLIMUS, AZATHIOPRINE, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Acetaminophen Side Effects Report #5670239-6
ACETAMINOPHEN problem was reported by a Health Professional from UNITED KINGDOM on Mar 06, 2008. Female patient was treated with ACETAMINOPHEN. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, graft dysfunction, multi-organ failure, overdose, . ACETAMINOPHEN dosage: unknown. Patient died.

Acetaminophen Side Effects Report #5688232-6
Health Professional from UNITED KINGDOM reported ACETAMINOPHEN problem on Mar 19, 2008. Female patient was treated with ACETAMINOPHEN. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, graft dysfunction, multi-organ failure, overdose, . ACETAMINOPHEN dosage: unknown. Patient was hospitalized. Patient died.


Sensipar Side Effects Report #5569504-2
SENSIPAR problem was reported by a Physician from UNITED STATES on Dec 13, 2007. Female patient, 53 years of age, was diagnosed with hyperparathyroidism secondary and was treated with SENSIPAR. After drug was administered, patient experienced the following problems/side effects: diarrhoea, graft dysfunction, nephrocalcinosis, renal failure acute, . SENSIPAR dosage: unknown. During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, PREDNISONE. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5572506-3
Physician from BRAZIL reported PROGRAF problem on Dec 05, 2007. Male patient, 28 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: diarrhoea, graft dysfunction, myalgia, nephropathy toxic, no therapeutic response, pyelonephritis, . PROGRAF dosage: unknown. During the same period patient was treated with SIROLIMUS, PREDNISOLONE ACETATE, MYCOPHENOLATE MOFETIL, METHYLPREDNISOLONE, PREDNISONE. Patient was hospitalized. Patient recovered.

Cyclosporine Side Effects Report #5524924-7
CYCLOSPORINE problem was reported by a Consumer or non-health professional from JAPAN on Nov 16, 2007. Female patient, child 5 years of age, was diagnosed with renal transplant and was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus, graft dysfunction, lymphocele, . CYCLOSPORINE dosage: unknown. During the same period patient was treated with SIMULECT, MYCOPHENOLATE MOFETIL, STEROIDS NOS. Patient recovered.

Cyclosporine Side Effects Report #5526229-7
Consumer or non-health professional from JAPAN reported CYCLOSPORINE problem on Nov 16, 2007. Female patient, child 5 years of age, was diagnosed with renal transplant and was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus, graft dysfunction, lymphocele, . CYCLOSPORINE dosage: unknown. During the same period patient was treated with SIMULECT, MYCOPHENOLATE MOFETIL, STEROIDS NOS. Patient recovered.

Prograf Side Effects Report #5491451-5
PROGRAF problem was reported by a Health Professional from UNITED STATES on Oct 10, 2007. Male patient, 60 years of age, was diagnosed with prophylaxis against transplant rejection, renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, graft dysfunction, pyelonephritis, . PROGRAF dosage: 5.5 MG, ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL, THYMOGLOBULIN, PROTONIX, NORVASC, TOPROL, FLAGYL, NYSTATIN. Patient was hospitalized. Patient recovered.


Sensipar Side Effects Report #5471936-8
Physician from UNITED STATES reported SENSIPAR problem on Sept 17, 2007. Female patient, 53 years of age, was diagnosed with hyperparathyroidism secondary and was treated with SENSIPAR. After drug was administered, patient experienced the following problems/side effects: diarrhoea, graft dysfunction, hypercalcaemia, nephrocalcinosis, renal failure acute, . SENSIPAR dosage: unknown. During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, PREDNISONE. Patient was hospitalized. Patient recovered.

Cyclosporine Side Effects Report #5777321-3
CYCLOSPORINE problem was reported by a Health Professional from JAPAN on June 09, 2008. Female patient, child 5 years of age, was diagnosed with renal transplant and was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus, graft dysfunction, lymphocele, . CYCLOSPORINE dosage: unknown. During the same period patient was treated with SIMULECT, PROGRAF, MYCOPHENOLATE MOFETIL, STEROIDS NOS. Patient recovered.

Acetaminophen Side Effects Report #5731325-5
Health Professional from UNITED KINGDOM reported ACETAMINOPHEN problem on Apr 30, 2008. Female patient was diagnosed with immunosuppression and was treated with ACETAMINOPHEN. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, graft dysfunction, hepatic vein thrombosis, impaired healing, overdose, pleural effusion, pulmonary embolism, pulmonary sepsis, renal failure, . ACETAMINOPHEN dosage: unknown. During the same period patient was treated with CYCLOSPORINE, TACROLIMUS, AZATHIOPRINE, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Acetaminophen Side Effects Report #5731330-9
ACETAMINOPHEN problem was reported by a Health Professional from UNITED KINGDOM on Apr 30, 2008. Female patient was treated with ACETAMINOPHEN. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, graft dysfunction, multi-organ failure, overdose, . ACETAMINOPHEN dosage: unknown. Patient was hospitalized. Patient died.

Prograf Side Effects Report #5371071-3
Physician from GERMANY reported PROGRAF problem on June 11, 2007. Female patient, 43 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: bronchospasm, graft dysfunction, haemodynamic instability, hypersensitivity, platelet adhesiveness abnormal, respiratory failure, . PROGRAF dosage: unknown. Patient was hospitalized. Patient recovered.


Fenofibrate Side Effects Report #5334703-1
FENOFIBRATE problem was reported by a Health Professional from UNITED STATES on May 04, 2007. Male patient, 23 years of age, was treated with FENOFIBRATE. After drug was administered, patient experienced the following problems/side effects: glomerulosclerosis, graft dysfunction, renal tubular disorder, . FENOFIBRATE dosage: 67 MG, QD. During the same period patient was treated with PREDNISOLONE, CYCLOSPORINE, AZATHIOPRINE, SIROLIMUS, PRAVASTATIN, AMLODIPINE MALEATE, LABETALOL, ALLOPURINOL. Patient recovered.

Prograf Side Effects Report #5633047-8
Consumer or non-health professional from COLOMBIA reported PROGRAF problem on Feb 07, 2008. Male patient, 46 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: complications of transplanted kidney, fungal infection, graft dysfunction, graft thrombosis, hypovolaemic shock, peripheral artery aneurysm, postoperative wound complication, postoperative wound infection, sepsis, . PROGRAF dosage: unknown. During the same period patient was treated with CELLCEPT. Patient was hospitalized. Patient died on 11/07/2007.

Certican Side Effects Report #5565936-7
CERTICAN problem was reported by a Physician from TURKEY on Dec 10, 2007. Male patient, 40 years of age, weighting 145.5 lb, was diagnosed with renal transplant and was treated with CERTICAN. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, escherichia urinary tract infection, graft dysfunction, pyrexia, renal function test abnormal, . CERTICAN dosage: 1440 MG /DAY. During the same period patient was treated with SANDIMMUNE, MYFORTIC. Patient was hospitalized. Patient recovered.

Certican Side Effects Report #5505508-3
Physician from TURKEY reported CERTICAN problem on Oct 24, 2007. Male patient, 40 years of age, weighting 145.5 lb, was diagnosed with renal transplant and was treated with CERTICAN. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, escherichia urinary tract infection, graft dysfunction, pyrexia, renal function test abnormal, . CERTICAN dosage: 1440 MG /DAY. During the same period patient was treated with SANDIMMUNE. Patient was hospitalized. Patient recovered.

Certican Side Effects Report #5505510-1
CERTICAN problem was reported by a Physician from TURKEY on Oct 24, 2007. Male patient, 40 years of age, weighting 145.5 lb, was diagnosed with renal transplant and was treated with CERTICAN. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, escherichia urinary tract infection, graft dysfunction, pyrexia, renal function test abnormal, . CERTICAN dosage: 1440 MG /DAY. During the same period patient was treated with SANDIMMUNE. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5506130-5
Physician from BRAZIL reported PROGRAF problem on Oct 16, 2007. Male patient, 28 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea, graft dysfunction, myalgia, nephropathy toxic, no therapeutic response, pyelonephritis, . PROGRAF dosage: unknown. During the same period patient was treated with SIROLIMUS, PREDNISONE, MYCOPHENOLATE MOFETIL, METHYLPREDNISOLONE. Patient was hospitalized. Patient recovered.

Erl Side Effects Report #5524727-3
ERL problem was reported by a Physician from TURKEY on Nov 13, 2007. Male patient, 40 years of age, weighting 145.5 lb, was diagnosed with renal transplant and was treated with ERL. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, escherichia urinary tract infection, graft dysfunction, pyrexia, renal function test abnormal, . ERL dosage: 1440 MG /DAY. During the same period patient was treated with SANDIMMUNE. Patient was hospitalized. Patient recovered.

Azathioprine Side Effects Report #5479872-8
Consumer or non-health professional from reported AZATHIOPRINE problem on Oct 01, 2007. Female patient, 59 years of age, was diagnosed with immunosuppression, renal impairment and was treated with AZATHIOPRINE. After drug was administered, patient experienced the following problems/side effects: chronic allograft nephropathy, complications of transplanted kidney, graft dysfunction, proteinuria, scedosporium infection, transplant rejection, . AZATHIOPRINE dosage: unknown. During the same period patient was treated with CYCLOSPORINE, METHYLPREDNISOLONE, MYCOPHENOLATE MOFETIL. Patient recovered.

Prograf Side Effects Report #5487258-5
PROGRAF problem was reported by a Physician from UNITED STATES on Sept 28, 2007. Female patient, 53 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: condition aggravated, diarrhoea, graft dysfunction, hyperparathyroidism, nephrocalcinosis, . PROGRAF dosage: unknown. During the same period patient was treated with CINACALCET, MYCOPHENOLATE MOFETIL, PREDNISONE. Patient was hospitalized. Patient recovered.

Phenytoin Side Effects Report #5794641-7
Health Professional from GERMANY reported PHENYTOIN problem on June 11, 2008. Female patient, child 9 years of age, was diagnosed with prophylaxis and was treated with PHENYTOIN. After drug was administered, patient experienced the following problems/side effects: graft dysfunction, hepatitis, pancytopenia, . PHENYTOIN dosage: unknown. During the same period patient was treated with HYDROXYCARBAMIDE, CYCLOSPORINE, TACROLIMUS, FLUCONAZOLE, BUSULFAN, FLUDARABINE PHOSPHATE. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5711825-4
PROGRAF problem was reported by a Physician from COLOMBIA on Apr 09, 2008. Male patient, 46 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: arterial disorder, complications of transplanted kidney, graft dysfunction, hypovolaemic shock, mycotic aneurysm, peripheral artery aneurysm, post procedural haemorrhage, postoperative wound infection, sepsis, . PROGRAF dosage: unknown. During the same period patient was treated with CELLCEPT. Patient was hospitalized. Patient died on 11/07/2007.

Prograf Side Effects Report #5711838-2
Consumer or non-health professional from COLOMBIA reported PROGRAF problem on Apr 07, 2008. Male patient, 28 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea, graft dysfunction, myalgia, nephropathy toxic, pyelonephritis, . PROGRAF dosage: unknown. During the same period patient was treated with SIROLIMUS, PREDNISOLONE ACETATE, MYCOPHENOLATE MOFETIL, METHYLPREDNISOLONE. Patient was hospitalized. Patient recovered.

Erl Side Effects Report #5281477-9
ERL problem was reported by a Physician from TURKEY on Mar 21, 2007. Male patient, 40 years of age, weighting 145.5 lb, was diagnosed with renal transplant and was treated with ERL. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, escherichia urinary tract infection, graft dysfunction, . ERL dosage: 1440 MG /DAY. During the same period patient was treated with SANDIMMUNE. Patient was hospitalized. Patient recovered.