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Prograf Side Effects summary
Total Prograf reports: 1536.Prograf FDA safety alerts: 2006 .
Reported deaths: 564 Reported hospitalizations: 674.
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Prograf Side Effects: condition aggravated, diarrhoea haemorrhagic, cytomegalovirus infection, interstitial lung disease, graft versus host disease, reversible posterior leukoencephalopathy syndrome, thrombotic microangiopathy, lymphoproliferative disorder, sepsis, kidney transplant rejection, infection in an immunocompromised host,
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Self-reported PROGRAF Side Effects
Prograf Side Effects Report #SELF358 -1974-08-01
PROGRAF problem was reported on 1974-08-01
Patient reported the following PROGRAF side effects:extreme anxietyRead more
Prograf Side Effects Report #SELF421 -2008-11-01
PROGRAF problem was reported on 2008-11-01
Patient reported the following PROGRAF side effects:problem in my stomachRead more
Prograf Side Effects reported to FDA
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Prograf Side Effects Report #5689776-3Health Professional from COLOMBIA reported PROGRAF problem on Mar 17, 2008. Female patient, child 4 years of age, was diagnosed with liver transplant and was treated with PROGRAF. PROGRAF dosage: unknown. During the same period patient was treated with PREDNISOLONE, CELLCEPT. Patient died.
Prograf Side Effects Report #5691608-4
PROGRAF problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 17, 2008. Female patient was diagnosed with renal and pancreas transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: cardiac hypertrophy, hepatic enzyme abnormal, ill-defined disorder, oedema peripheral, pulmonary hypertension. PROGRAF dosage: 1 MG, BID; 0.5 MG, BID. During the same period patient was treated with PREDNISOLONE ACETATE, NAMENDA, LEVOXYL, CYTOMEL. Patient recovered.
Prograf Side Effects Report #5691940-4
Physician from JAPAN reported PROGRAF problem on Mar 13, 2008. Female patient, 25 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: anogenital warts, caesarean section, influenza, pregnancy. PROGRAF dosage: 2 MG, /QD, ORAL. Patient recovered.
Prograf Side Effects Report #5615334-2
PROGRAF problem was reported by a Physician from UNITED STATES on Jan 23, 2008. Female patient, 63 years of age, was diagnosed with pancreas islet cell transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: anaemia, aphthous stomatitis, dehydration, gastroenteritis, renal disorder, renal failure acute. PROGRAF dosage: 1 MG,. During the same period patient was treated with SIROLIMUS, MYCOPHENOLATE MOFETIL, DACLIZUMAB, ENBREL. Patient recovered.

Prograf Side Effects Report #5615735-2
Physician from UNITED STATES reported PROGRAF problem on Jan 22, 2008. Female patient, 41 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, haemorrhage, transplant rejection. PROGRAF dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL. Patient recovered.
Prograf Side Effects Report #5615737-6
PROGRAF problem was reported by a Physician from UNITED STATES on Jan 24, 2008. Male patient, 52 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 lower, ascites, cardiomegaly, complications of transplanted kidney, haematuria, haemodialysis, mitral valve calcification, pericardial effusion, peritoneal fluid analysis abnormal. PROGRAF dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, RAPAMUNE, THYMOGLOBULIN. Patient died.
Prograf Side Effects Report #5615738-8
Physician from UNITED STATES reported PROGRAF problem on Jan 23, 2008. Female patient, 58 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: bile duct stenosis, chronic obstructive pulmonary disease, glucose tolerance impaired, hepatic cancer metastatic, hepatic neoplasm malignant, hepatic steatosis, hypercholesterolaemia, hyperlipidaemia, hypertension. PROGRAF dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, CORTICOSTEROIDS. Patient recovered.
Prograf Side Effects Report #5615865-5
PROGRAF problem was reported by a Physician from COLOMBIA on Jan 30, 2008. Female patient, 47 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus gastrointestinal infection, diarrhoea, disease recurrence, gastric haemorrhage, gastritis erosive, glomerulonephritis membranoproliferative, intestinal ulcer, malaise, vomiting. PROGRAF dosage: 6 MG, BID, ORAL; 3 MG, BID, ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.
Prograf Side Effects Report #5615895-3
Physician from JAPAN reported PROGRAF problem on Jan 16, 2008. Female patient, 14 years of age, was diagnosed with bone marrow transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: inappropriate antidiuretic hormone secretion. PROGRAF dosage: 0.02 MG/KG, CONTINUOUS, IV DRIP. During the same period patient was treated with METHOTREXATEMULATION, METHYLPREDNISOLONE, GRANULOCYTE COLONY STIMULATION FACTOR. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5616236-8
PROGRAF problem was reported by a Physician from CANADA on Jan 25, 2008. Female patient, 58 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: abscess, bacterial infection, blood albumin increased, diarrhoea, erythema, escherichia infection, fatigue, inflammation, liver disorder. PROGRAF dosage: 2 MG, BID, ORAL. During the same period patient was treated with SPIRONOLACTONE, FUROSEMIDE, RIFAMPICIN, URSODIOL. Patient recovered.
Prograf Side Effects Report #5616237-X
Health Professional from COLOMBIA reported PROGRAF problem on Jan 24, 2008. Male patient, child 12 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: pneumonia, respiratory failure, septic shock, transplant rejection, white blood cell count decreased. PROGRAF dosage: unknown. Patient was hospitalized. Patient died on 12/20/2007.
Prograf Side Effects Report #5619129-5
PROGRAF problem was reported by a Health Professional from UNITED STATES on Jan 25, 2008. Female patient, 50 years of age, weighting 222.9 lb, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: back injury, blood culture positive, blood glucose fluctuation, culture urine positive, eating disorder, fall, hepatic encephalopathy, hepatic failure, hepatitis acute. PROGRAF dosage: 4 MG, BID, ORAL; 2 MG, BID, ORAL; 1 MG, BID, ORAL; 0.5 MG. During the same period patient was treated with PREDNISOLONE ACETATE, CELLCEPT, CARDIZEM, NORVASC, HYDRALAZINE. Patient was hospitalized. Patient died on 10/29/2007.
Prograf Side Effects Report #5619130-1
Health Professional from UNITED STATES reported PROGRAF problem on Jan 24, 2008. Male patient, 14 years of age, was diagnosed with heart transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: apnoea, carotid artery stenosis, grand mal convulsion, haemorrhage intracranial, heart transplant rejection, intracranial pressure increased, nuclear magnetic resonance imaging brain abnormal. PROGRAF dosage: 1 MG, BID, OTHER; 2.5 MG, OTHER,OTHER; 3 MG, OTHER;OTHER; 2 MG, TID, ORAL. During the same period patient was treated with LASIX, ZANTAC, VANCOMYCIN, CELLCEPT. Patient was hospitalized. Patient recovered.
Prograf Side Effects Report #5619244-6
PROGRAF problem was reported by a Physician from JAPAN on Dec 20, 2007. Female patient, 57 years of age, was diagnosed with rheumatoid arthritis and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: neuropathy peripheral. PROGRAF dosage: 1.5 MG, ORAL. During the same period patient was treated with PREDNISOLONE. Patient recovered.

Prograf Side Effects Report #5621714-1
Consumer or non-health professional from JAPAN reported PROGRAF problem on Feb 06, 2008. Female patient, 56 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: lymphoma, pneumonia. PROGRAF dosage: unknown. During the same period patient was treated with CELLCEPT, METHYLPREDNISOLONE, SIMULECT. Patient died on 01/01/2006.
Prograf Side Effects Report #5621996-6
PROGRAF problem was reported by a Pharmacist from JAPAN on Jan 21, 2008. Female patient, 72 years of age, was diagnosed with rheumatoid arthritis, angina pectoris and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, epilepsy, incorrect dose administered, loss of consciousness. PROGRAF dosage: 1.5 MG, UID/QD, ORAL, 0.5 MG, UID/QD, ORAL, 1.5 MG, UID/QD,ORAL, 1 MG, UID/QD, ORAL. During the same period patient was treated with BUFFERIN, HYDERGINE, CALMDOWN, MEVALOTIN, AZULFIDINE ENLET. Patient recovered.
Prograf Side Effects Report #5621997-8
Physician from CHINA reported PROGRAF problem on Jan 21, 2008. Male patient, 15 years of age, weighting 74.96 lb, was diagnosed with small intestine transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus enteritis, transplant rejection. PROGRAF dosage: unknown. During the same period patient was treated with ZENAPAX, PREDNISONE, MYCOPHENOLATE MOFETIL, ANTIBIOTICS, ANTIVIRALS, ANTIFUNGALS, GROWTH HORMONE. Patient recovered.
Prograf Side Effects Report #5622134-6
PROGRAF problem was reported by a Physician from BRAZIL on Jan 22, 2008. Male patient, 48 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: cholestasis. PROGRAF dosage: unknown. During the same period patient was treated with PREDNISONE, FENTANYL, PROPOFOL, CISATRACURIUM, OXYGEN, ISOFLURANE, DANTROLENE. Patient recovered.
Prograf Side Effects Report #5622141-3
Physician from JAPAN reported PROGRAF problem on Jan 22, 2008. Male patient, 59 years of age, was diagnosed with rheumatoid arthritis and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: electrocardiogram pq interval prolonged, supraventricular tachyarrhythmia, ventricular extrasystoles. PROGRAF dosage: 3 MG, /D, ORAL. During the same period patient was treated with PREDNISOLONE, LOXONIN, MUCOSTA. Patient recovered.

Prograf Side Effects Report #5625409-X
PROGRAF problem was reported by a Health Professional from UNITED STATES on Jan 30, 2008. Female patient, 60 years of age, was diagnosed with rheumatoid arthritis and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: condition aggravated, interstitial lung disease. PROGRAF dosage: 1 MG, UID/QD;. During the same period patient was treated with ENBREL, METHOTREXATE. Patient died on 12/08/2007.
Prograf Side Effects Report #5625410-6
Physician from UNITED STATES reported PROGRAF problem on Jan 28, 2008. Female patient, 37 years of age, was diagnosed with heart transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: alopecia, hair disorder, immunosuppression, madarosis, rash papular. PROGRAF dosage: unknown. During the same period patient was treated with MYCOPHENOLIC ACID, PREDNISONE. Patient recovered.
Prograf Side Effects Report #5625915-8
PROGRAF problem was reported by a Physician from JAPAN on Jan 25, 2008. Female patient, 69 years of age, weighting 112.4 lb, was diagnosed with rheumatoid arthritis and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: brain abscess, brain oedema, brain stem syndrome, dysarthria, nocardiosis. PROGRAF dosage: 3 MG, UID/QD, ORAL. During the same period patient was treated with RHEUMATREX, PREDNISOLONE. Patient was hospitalized and became disabled. Patient recovered.
Prograf Side Effects Report #5625919-5
Physician from GERMANY reported PROGRAF problem on Dec 20, 2007. Female patient, 63 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: hepatitis c virus, no therapeutic response, pancytopenia, pyrexia, renal failure chronic, splenomegaly, type 1 diabetes mellitus. PROGRAF dosage: unknown. During the same period patient was treated with GABAPENTIN, AZATHIOPRINE, INTERFERON ALFA, RIBAVIRIN, PEGINTERFERON ALFA, CORTICOSTEROIDS. Patient recovered.
Prograf Side Effects Report #5626052-9
PROGRAF problem was reported by a Consumer or non-health professional from JAPAN on Feb 08, 2008. Female patient, 56 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: lymphoma, lymphoproliferative disorder, malaise, pneumonia, renal cell carcinoma. PROGRAF dosage: unknown. During the same period patient was treated with CELLCEPT, METHYLPREDNISOLONE, SIMULECT. Patient died on 01/01/2006.
Prograf Side Effects Report #5626067-0
Physician from JAPAN reported PROGRAF problem on Jan 23, 2008. Female patient, 39 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: accidental exposure, anaemia, epilepsy, incorrect dose administered, thrombotic microangiopathy. PROGRAF dosage: unknown. Patient recovered.
Prograf Side Effects Report #5626157-2
PROGRAF problem was reported by a Physician from JAPAN on Jan 23, 2008. Male patient, 48 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: thrombotic microangiopathy. PROGRAF dosage: unknown. Patient recovered.
Prograf Side Effects Report #5626161-4
Physician from FRANCE reported PROGRAF problem on Jan 23, 2008. Male patient, child 8 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune, autoimmune thrombocytopenia, diarrhoea haemorrhagic, evans syndrome, lymphoproliferative disorder, marrow hyperplasia, therapeutic response decreased. PROGRAF dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, IMMUNOGLOBULIN, CORTICOSTEROID NOS, RITUXIMAB. Patient recovered.
Prograf Side Effects Report #5626168-7
PROGRAF problem was reported by a Physician from BRAZIL on Jan 29, 2008. Male patient, 43 years of age, was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: convulsion, nervous system disorder, psychomotor hyperactivity. PROGRAF dosage: unknown. Patient recovered.
Prograf Side Effects Report #5626170-5
Physician from BRAZIL reported PROGRAF problem on Jan 29, 2008. Male patient, 53 years of age, was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: convulsion, nervous system disorder, psychomotor hyperactivity. PROGRAF dosage: unknown. Patient recovered.
Prograf Side Effects Report #5626172-9
PROGRAF problem was reported by a Physician from COLOMBIA on Jan 31, 2008. Male patient, 52 years of age, was diagnosed with immunosuppression and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: ear infection, meningitis. PROGRAF dosage: 3 MG, UID/QD, ORAL. Patient was hospitalized. Patient recovered.
Prograf Side Effects Report #5626176-6
Health Professional from COLOMBIA reported PROGRAF problem on Feb 01, 2008. Female patient, 39 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: arthritis bacterial, dialysis, metabolic acidosis, sepsis. PROGRAF dosage: 2 MG, OTHER, ORAL. Patient was hospitalized. Patient died on 01/01/2008.
Prograf Side Effects Report #5626486-2
PROGRAF problem was reported by a Physician from JAPAN on Jan 23, 2008. Female patient, 23 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: biliary anastomosis complication, cholangitis, multi-organ failure, thrombotic microangiopathy. PROGRAF dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, PROSTAGLANDIN I. Patient died on 09/09/2002.
Prograf Side Effects Report #5626493-X
Physician from JAPAN reported PROGRAF problem on Jan 23, 2008. Male patient, 46 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, cerebral haemorrhage, coagulopathy, haemolytic anaemia, hyperbilirubinaemia, intra-abdominal haemorrhage, renal impairment, retroperitoneal haematoma. PROGRAF dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, GABEXATE MESILATE, PROSTAGLANDIN I. Patient died on 05/30/2001.
Prograf Side Effects Report #5626495-3
PROGRAF problem was reported by a Consumer or non-health professional from COLOMBIA on Jan 28, 2008. Female patient, 29 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: depressive symptom, feeling hot. PROGRAF dosage: unknown. During the same period patient was treated with CELLCEPT, MYFORTIC. Patient recovered.
Prograf Side Effects Report #5626496-5
Physician from JAPAN reported PROGRAF problem on Dec 05, 2007. Female patient, weighting 132.3 lb, was diagnosed with rheumatoid arthritis and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: dyspnoea, hepatitis b, hepatorenal syndrome, malaise, oedema peripheral, urine output decreased, weight increased. PROGRAF dosage: 3 MG, UID/QD, ORAL. During the same period patient was treated with ENBREL, PREDNISOLONE, VOLTAREN, ETODOLAC, METHOTREXATE, ISCOTIN, FOLIC ACID, KOLANTYL. Patient was hospitalized. Patient recovered.
Prograf Side Effects Report #5626503-X
PROGRAF problem was reported by a Physician from JAPAN on Jan 25, 2008. Female patient, 65 years of age, was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: dementia, depression. PROGRAF dosage: unknown. During the same period patient was treated with PREDNISOLONE. Patient recovered.
Prograf Side Effects Report #5626513-2
Health Professional from SWITZERLAND reported PROGRAF problem on Jan 25, 2008. Male patient, 70 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: acanthosis, conjunctival neoplasm, papilloma. PROGRAF dosage: unknown. Patient recovered.
Prograf Side Effects Report #5628777-8
PROGRAF problem was reported by a Physician from UNITED STATES on Feb 08, 2008. Male patient, 49 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: aneurysm. PROGRAF dosage: 2 MG BID ORAL. During the same period patient was treated with CELLCEPT, LASIX, ATENOLOL, VITAMINS, ASCORBIC ACID, VALIUM. Patient died on 01/05/2008.
Prograf Side Effects Report #5629958-X
Physician from JAPAN reported PROGRAF problem on Jan 28, 2008. Female patient was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: pancytopenia, renal disorder. PROGRAF dosage: unknown. Patient was hospitalized. Patient recovered.
Prograf Side Effects Report #5629985-2
PROGRAF problem was reported by a Physician from ITALY on Nov 21, 2007. Female patient, 42 years of age, was diagnosed with immunosuppression and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: clostridial infection, cytomegalovirus infection, multi-organ failure. PROGRAF dosage: unknown. During the same period patient was treated with SIMULECT, MYCOPHENOLATE MOFETIL, PREDNISOLONE ACETATE. Patient was hospitalized. Patient died.
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Prograf Side Effects


