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Review Sandimmune Safety Reports submitted to FDA

Total Sandimmune reports: 109.
Sandimmune FDA safety alerts: No.
Reported deaths: 45    Reported hospitalizations: 49.
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FDA Reported Sandimmune Side Effects: alanine aminotransferase increased, blood creatinine increased, cholangitis, rash, bile duct stent insertion, disease progression, aspartate aminotransferase increased, convulsion, respiratory failure, dyspnoea, neurological symptom.
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Showing 1-100 of 109 Next >

Sandimmune Side Effects Report #5385047-3
Consumer or non-health professional from JAPAN reported SANDIMMUNE problem on July 04, 2007. Female patient, 30 years of age, weighting 90.39 lb, was diagnosed with stem cell transplant and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: acute respiratory failure, blood pressure increased, brain natriuretic peptide increased, capillary permeability increased, chest discomfort, chest pain, dyspnoea, hyperventilation, hypoventilation. SANDIMMUNE dosage: 2.4 ML/DAY. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Sandimmune Side Effects Report #5385123-5
SANDIMMUNE problem was reported by a Physician from GERMANY on July 05, 2007. Male patient, 48 years of age, weighting 176.4 lb, was diagnosed with liver transplant and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, bile duct obstruction, bile duct stent insertion, cholangitis, cholestasis, disease progression, endoscopic retrograde cholangiopancreatography, hepatic cirrhosis. SANDIMMUNE dosage: 500 MG, BID. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5389451-9
Physician from GERMANY reported SANDIMMUNE problem on July 12, 2007. Male patient, 60 years of age, weighting 154.3 lb, was diagnosed with liver transplant and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, neuroendocrine carcinoma, rash, ultrasound liver abnormal. SANDIMMUNE dosage: 200 MG/DAILY. During the same period patient was treated with METHYLPREDNISOLONE. Patient was hospitalized. Patient died on 04/23/2007.

Sandimmune Side Effects Report #5389738-X
SANDIMMUNE problem was reported by a Physician from GERMANY on July 12, 2007. Male patient, 60 years of age, weighting 154.3 lb, was diagnosed with liver transplant and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, neuroendocrine carcinoma, rash, ultrasound liver abnormal. SANDIMMUNE dosage: 200 MG/DAILY. During the same period patient was treated with METHYLPREDNISOLONE. Patient was hospitalized. Patient died on 04/23/2007.

Sandimmune Side Effects Report #5391004-3
Physician from CROATIA (local name: Hrvatska) reported SANDIMMUNE problem on July 04, 2007. Female patient, 57 years of age, weighting 166.4 lb, was diagnosed with renal transplant, hypertension, dyspepsia and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, cytomegalovirus infection, diabetes mellitus, muscular weakness, rhabdomyolysis. SANDIMMUNE dosage: 150 MG, QD. During the same period patient was treated with CELLCEPT, DECORTIN, NITROFURANTOIN, LACIDIPINE, FUROSEMIDE, CONTROLOC, LESCOL, CORTEF. Patient was hospitalized and became disabled. Patient recovered.

Sandimmune Side Effects Report #5394951-1
SANDIMMUNE problem was reported by a Physician from SPAIN on July 17, 2007. Female patient was diagnosed with autoimmune hepatitis and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, erythema, hypertension, rash. SANDIMMUNE dosage: unknown. Patient recovered.

Sandimmune Side Effects Report #5397400-2
Physician from SWITZERLAND reported SANDIMMUNE problem on July 20, 2007. Female patient, 85 years of age, was diagnosed with renal transplant, depression and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: agitation, akinesia, anxiety, c-reactive protein increased, clonus, confusional state, disorientation. SANDIMMUNE dosage: 125 MG/D. During the same period patient was treated with CIPRALEX, CEFUROXIME AXETIL, IMUREK, PERFALGAN, VANCOMYCIN, ROCEPHIN, MEMANTINE. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5398883-4
SANDIMMUNE problem was reported by a Consumer or non-health professional from JAPAN on July 23, 2007. Male patient, 54 years of age, was diagnosed with liver transplant and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: blood lactate dehydrogenase increased, hepatitis c, hepatitis c rna positive, multi-organ failure, red blood cell schistocytes present, thrombotic microangiopathy. SANDIMMUNE dosage: unknown. During the same period patient was treated with FRESH FROZEN PLASMA. Patient was hospitalized. Patient died.

Sandimmune Side Effects Report #5398888-3
Consumer or non-health professional from JAPAN reported SANDIMMUNE problem on July 23, 2007. Male patient, 54 years of age, was diagnosed with liver transplant and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: blood lactate dehydrogenase increased, hepatitis c, hepatitis c rna positive, multi-organ failure, red blood cell schistocytes present, thrombotic microangiopathy. SANDIMMUNE dosage: unknown. During the same period patient was treated with FRESH FROZEN PLASMA. Patient was hospitalized. Patient died.

Showing 1-100 of 109 Next >


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acute respiratory failure, blood pressure increased, brain natriuretic peptide increased, capillary permeability increased, chest discomfort, chest pain, dyspnoea, hyperventilation, hypoventilation, , was diagnosed with stem cell transplant and was diagnosed with liver transplant and was diagnosed with liver transplant and