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Ciclosporin Side Effects submitted to FDA

Total Ciclosporin reports: 9.
Ciclosporin FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 2.
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FDA Reported Ciclosporin Side Effects: rhabdomyolysis, renal failure acute, coronary artery disease,
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Ciclosporin Side Effects Report #5655703-8
Consumer or non-health professional from BELGIUM reported CICLOSPORIN problem on Mar 04, 2008. Female patient, 42 years of age, was diagnosed with infection prophylaxis and was treated with CICLOSPORIN. After drug was administered, patient experienced the following problems/side effects: neurotoxicity. CICLOSPORIN dosage: unknown. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE, CEFEPIME, METRONIDAZOLE. Patient was hospitalized. Patient died on 06/01/2005.



Ciclosporin Side Effects Report #5601329-1
CICLOSPORIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 08, 2008. Male patient, 27 years of age, was diagnosed with haemorrhagic diathesis and was treated with CICLOSPORIN. After drug was administered, patient experienced the following problems/side effects: nephropathy toxic, nephrotic syndrome. CICLOSPORIN dosage: 200 MG THREE TIMES DAILY, DECREASED . During the same period patient was treated with CICLOSPORIN A. Patient recovered.



Ciclosporin Side Effects Report #5482111-5
Consumer or non-health professional from JAPAN reported CICLOSPORIN problem on Oct 03, 2007. Female patient, 46 years of age, was treated with CICLOSPORIN. After drug was administered, patient experienced the following problems/side effects: blood lactate dehydrogenase increased, focal glomerulosclerosis, haptoglobin decreased, proteinuria, red blood cell abnormality, thrombotic microangiopathy. CICLOSPORIN dosage: unknown. Patient recovered.



Ciclosporin Side Effects Report #5483290-6
CICLOSPORIN problem was reported by a Consumer or non-health professional from JAPAN on Oct 03, 2007. Male patient, child 10 years of age, was diagnosed with nephrotic syndrome and was treated with CICLOSPORIN. After drug was administered, patient experienced the following problems/side effects: superior sagittal sinus thrombosis. CICLOSPORIN dosage: unknown. During the same period patient was treated with PREDNISOLONE. Patient recovered.




Ciclosporin Side Effects Report #5483308-0
Consumer or non-health professional from JAPAN reported CICLOSPORIN problem on Oct 03, 2007. Male patient, 56 years of age, was diagnosed with focal glomerulosclerosis and was treated with CICLOSPORIN. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus enterocolitis, dialysis, disease progression, focal glomerulosclerosis, large intestinal ulcer haemorrhage, melaena, renal failure chronic. CICLOSPORIN dosage: unknown. During the same period patient was treated with DIURETICS, STEROIDS NOS, STEROIDS NOS, PLASMAPHERESIS. Patient recovered.



Ciclosporin Side Effects Report #5483334-1
CICLOSPORIN problem was reported by a Health Professional from BRAZIL on Oct 08, 2007. Male patient, 46 years of age, was diagnosed with heart transplant and was treated with CICLOSPORIN. After drug was administered, patient experienced the following problems/side effects: american trypanosomiasis, brain mass, cerebral haematoma, computerised tomogram abnormal, csf protein decreased, dysarthria, dysphagia, encephalitis, headache. CICLOSPORIN dosage: 210 MG/D. During the same period patient was treated with PREDNISONE, MYCOPHENOLATE MOFETIL. Patient died.



Ciclosporin Side Effects Report #5485171-0
Consumer or non-health professional from JAPAN reported CICLOSPORIN problem on Oct 10, 2007. Male patient, 57 years of age, was diagnosed with stem cell transplant and was treated with CICLOSPORIN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, aspergillosis, hepatic function abnormal, myocarditis mycotic. CICLOSPORIN dosage: unknown. During the same period patient was treated with ENDOXAN, METHOTREXATE, PROGRAF. Patient died.



Ciclosporin Side Effects Report #5487668-6
CICLOSPORIN problem was reported by a Consumer or non-health professional from JAPAN on Oct 05, 2007. Male patient, 40 years of age, was diagnosed with renal transplant and was treated with CICLOSPORIN. After drug was administered, patient experienced the following problems/side effects: blood urine present, disease recurrence, glomerulonephritis proliferative, pneumocystis jiroveci pneumonia, protein urine present, tonsillectomy. CICLOSPORIN dosage: unknown. During the same period patient was treated with PREDNISOLONE, BREDININ, CELLCEPT, METHYLPREDNISOLONE SUCCINATE. Patient recovered.



Ciclosporin Side Effects Report #5469262-6
Physician from CANADA reported CICLOSPORIN problem on Sept 06, 2007. Female patient, 58 years of age, was diagnosed with dyslipidaemia, thrombosis prophylaxis and was treated with CICLOSPORIN. After drug was administered, patient experienced the following problems/side effects: coronary artery disease, renal failure acute, rhabdomyolysis. CICLOSPORIN dosage: unknown. During the same period patient was treated with ATORVASTATIN CALCIUM, CLOPIDOGREL. Patient was hospitalized. Patient died.




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, Ciclosporin was diagnosed with infection prophylaxis and Ciclosporin was diagnosed with haemorrhagic diathesis and