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Review Fludarabine Safety Reports submitted to FDA

Total Fludarabine reports: 128.
Fludarabine FDA safety alerts: No.
Reported deaths: 92    Reported hospitalizations: 39.
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FDA Reported Fludarabine Side Effects: pyrexia, ascites, myelodysplastic syndrome, blood creatinine increased, blood culture positive, neutropenia, blood bilirubin increased, renal failure acute, anaemia, anaemia haemolytic autoimmune, bacterial infection.
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Showing 1-100 of 128 Next >

Fludarabine Side Effects Report #5412702-9
Physician from UNITED STATES reported FLUDARABINE problem on Aug 07, 2007. Male patient, 72 years of age, weighting 121.3 lb, was diagnosed with constipation, palliative care and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: neoplasm malignant. FLUDARABINE dosage: 40 MG QD X 5. During the same period patient was treated with TRIMEBUTINE, FUROSEMIDE, LAEVOLAC EPS, PREDNISONE, FENTANYL, OXALIPLATIN. Patient was hospitalized. Patient died on 07/26/2007.

Fludarabine Side Effects Report #5416785-1
FLUDARABINE problem was reported by a Health Professional from UNITED STATES on Aug 15, 2007. Male patient was diagnosed with stem cell transplant and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: blood culture positive, jc virus infection, progressive multifocal leukoencephalopathy. FLUDARABINE dosage: 53 MG DAILY IV DRIP. During the same period patient was treated with CAMPATH, BUSULFAN. Patient died on 08/11/2007.

Fludarabine Side Effects Report #5423137-7
Health Professional from UNITED KINGDOM reported FLUDARABINE problem on May 21, 2007. Male patient, weighting 192.9 lb, was diagnosed with b-cell lymphoma and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: ascites, constipation, deep vein thrombosis, febrile neutropenia, intestinal obstruction, white blood cell count decreased. FLUDARABINE dosage: unknown. During the same period patient was treated with NOVANTRONE, ALLOPURINOL, DEXAMETHASONE, PARACETAMOL, SPIRONOLACTONE, SULFAMETHOXAZOLE. Patient recovered.

Fludarabine Side Effects Report #5424702-3
FLUDARABINE problem was reported by a Health Professional from UNITED STATES on Aug 22, 2007. Female patient, weighting 159.8 lb, was diagnosed with stem cell transplant and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: blood culture positive, escherichia infection, hypotension, infusion related reaction, pyrexia, stem cell transplant, tachycardia. FLUDARABINE dosage: 50 MG DAILY IV DRIP. During the same period patient was treated with THIOTEPA. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5425336-7
Health Professional from RUSSIAN FEDERATION reported FLUDARABINE problem on Aug 17, 2007. Male patient, 55 years of age, weighting 143.3 lb, was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, thrombocytopenia. FLUDARABINE dosage: 42.5 MG, 1X/DAY. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient died on 12/30/2006.

Fludarabine Side Effects Report #5425350-1
FLUDARABINE problem was reported by a Physician from UNITED KINGDOM on Aug 10, 2007. Female patient was diagnosed with chronic lymphocytic leukaemia, prophylaxis and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: coronary artery thrombosis. FLUDARABINE dosage: 25 MG/M2, 1X/DAY. During the same period patient was treated with COTRIM, CYCLOPHOSPHAMIDE. Patient died.

Fludarabine Side Effects Report #5428680-2
Physician from AUSTRIA reported FLUDARABINE problem on Aug 22, 2007. Male patient was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: pemphigus. FLUDARABINE dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, RITUXIMAB. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5428690-5
FLUDARABINE problem was reported by a Health Professional from UNITED STATES on Aug 22, 2007. Female patient, 73 years of age, was treated with FLUDARABINE. FLUDARABINE dosage: unknown. During the same period patient was treated with CAMPATH. Patient died on 04/28/2007.

Fludarabine Side Effects Report #5303648-5
Physician from UNITED STATES reported FLUDARABINE problem on Apr 11, 2007. Male patient, 72 years of age, was diagnosed with constipation, palliative care and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: ascites. FLUDARABINE dosage: 40 MG QD X 5. During the same period patient was treated with TRIMEBUTINE, FUROSEMIDE, LAEVOLAC EPS, PREDNISONE. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5328364-5
FLUDARABINE problem was reported by a Health Professional from UNITED STATES on May 15, 2007. Male patient was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood potassium increased, blood urea increased, gallbladder disorder, haematocrit decreased, haemoglobin decreased, nausea, platelet count decreased. FLUDARABINE dosage: unknown. During the same period patient was treated with BUSULFAN, CAMPATH. Patient died on 05/11/2007.

Fludarabine Side Effects Report #5378380-2
Consumer or non-health professional from UNITED STATES reported FLUDARABINE problem on July 02, 2007. Male patient, weighting 147.0 lb, was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: bacteria sputum identified, herpes zoster, methicillin-resistant staphylococcal aureus test positive, urinary tract infection staphylococcal. FLUDARABINE dosage: 225 MG. During the same period patient was treated with RITUXIMAB. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5384596-1
FLUDARABINE problem was reported by a Physician from UNITED KINGDOM on July 03, 2007. Female patient, 45 years of age, was diagnosed with stem cell transplant and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: sarcoidosis. FLUDARABINE dosage: unknown. During the same period patient was treated with BUSULPHAN, PENICILLIN V, ACYCLOVIR, CAMPATH. Patient recovered.

Fludarabine Side Effects Report #5386285-6
Health Professional from UNITED STATES reported FLUDARABINE problem on July 10, 2007. Male patient, weighting 168.4 lb, was diagnosed with stem cell transplant and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: gait disturbance, visual disturbance. FLUDARABINE dosage: 53MG DAILY IV DRIP. During the same period patient was treated with CAMPATH, BUSULFAN, PORGRAF, ACTIGALL, DIFLUCAN, VALTREX, BACTRIM. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5389355-1
FLUDARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on July 13, 2007. Male patient, weighting 183.0 lb, was diagnosed with acute myeloid leukaemia and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: hypoxia, pulmonary embolism, pyrexia. FLUDARABINE dosage: unknown. During the same period patient was treated with MELPHALAN, CAMPATH. Patient recovered.

Fludarabine Side Effects Report #5390674-3
Physician from UNITED KINGDOM reported FLUDARABINE problem on July 12, 2007. Male patient was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: petit mal epilepsy. FLUDARABINE dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Fludarabine Side Effects Report #5392193-7
FLUDARABINE problem was reported by a Pharmacist from UNITED STATES on July 17, 2007. Male patient, 45 years of age, weighting 152.3 lb, was diagnosed with bone marrow transplant, myelofibrosis and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: brain natriuretic peptide increased, cardiac failure congestive, ejection fraction decreased. FLUDARABINE dosage: 60MG INFUSED OVER 30 MI IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, MELPHALAN. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5399459-5
Physician from UNITED STATES reported FLUDARABINE problem on July 18, 2007. Male patient, 72 years of age, weighting 121.3 lb, was diagnosed with constipation, palliative care and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: neoplasm malignant. FLUDARABINE dosage: 40 MG QD X 5. During the same period patient was treated with TRIMEBUTINE, FUROSEMIDE, LAEVOLAC EPS, PREDNISONE, FENTANYL TRANSDERMAL SYSTEM, OXALIPLATIN. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5403929-0
FLUDARABINE problem was reported by a Health Professional from UNITED STATES on July 31, 2007. Female patient, weighting 120.6 lb, was diagnosed with bone marrow conditioning regimen, stem cell transplant and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: cryptogenic organising pneumonia. FLUDARABINE dosage: 54 MG DAILY IV DRIP. During the same period patient was treated with FLUDARABINE PHOSPHATE, THIOTEPA. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5303648-5
Physician from UNITED STATES reported FLUDARABINE problem on Apr 11, 2007. Male patient, 72 years of age, was diagnosed with constipation, palliative care and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: ascites. FLUDARABINE dosage: 40 MG QD X 5. During the same period patient was treated with TRIMEBUTINE, FUROSEMIDE, LAEVOLAC EPS, PREDNISONE. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5328364-5
FLUDARABINE problem was reported by a Health Professional from UNITED STATES on May 15, 2007. Male patient was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood potassium increased, blood urea increased, gallbladder disorder, haematocrit decreased, haemoglobin decreased, nausea, platelet count decreased. FLUDARABINE dosage: unknown. During the same period patient was treated with BUSULFAN, CAMPATH. Patient died on 05/11/2007.

Fludarabine Side Effects Report #5378380-2
Consumer or non-health professional from UNITED STATES reported FLUDARABINE problem on July 02, 2007. Male patient, weighting 147.0 lb, was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: bacteria sputum identified, herpes zoster, methicillin-resistant staphylococcal aureus test positive, urinary tract infection staphylococcal. FLUDARABINE dosage: 225 MG. During the same period patient was treated with RITUXIMAB. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5384596-1
FLUDARABINE problem was reported by a Physician from UNITED KINGDOM on July 03, 2007. Female patient, 45 years of age, was diagnosed with stem cell transplant and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: sarcoidosis. FLUDARABINE dosage: unknown. During the same period patient was treated with BUSULPHAN, PENICILLIN V, ACYCLOVIR, CAMPATH. Patient recovered.

Fludarabine Side Effects Report #5386285-6
Health Professional from UNITED STATES reported FLUDARABINE problem on July 10, 2007. Male patient, weighting 168.4 lb, was diagnosed with stem cell transplant and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: gait disturbance, visual disturbance. FLUDARABINE dosage: 53MG DAILY IV DRIP. During the same period patient was treated with CAMPATH, BUSULFAN, PORGRAF, ACTIGALL, DIFLUCAN, VALTREX, BACTRIM. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5389355-1
FLUDARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on July 13, 2007. Male patient, weighting 183.0 lb, was diagnosed with acute myeloid leukaemia and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: hypoxia, pulmonary embolism, pyrexia. FLUDARABINE dosage: unknown. During the same period patient was treated with MELPHALAN, CAMPATH. Patient recovered.

Fludarabine Side Effects Report #5390674-3
Physician from UNITED KINGDOM reported FLUDARABINE problem on July 12, 2007. Male patient was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: petit mal epilepsy. FLUDARABINE dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Fludarabine Side Effects Report #5392193-7
FLUDARABINE problem was reported by a Pharmacist from UNITED STATES on July 17, 2007. Male patient, 45 years of age, weighting 152.3 lb, was diagnosed with bone marrow transplant, myelofibrosis and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: brain natriuretic peptide increased, cardiac failure congestive, ejection fraction decreased. FLUDARABINE dosage: 60MG INFUSED OVER 30 MI IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, MELPHALAN. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5399459-5
Physician from UNITED STATES reported FLUDARABINE problem on July 18, 2007. Male patient, 72 years of age, weighting 121.3 lb, was diagnosed with constipation, palliative care and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: neoplasm malignant. FLUDARABINE dosage: 40 MG QD X 5. During the same period patient was treated with TRIMEBUTINE, FUROSEMIDE, LAEVOLAC EPS, PREDNISONE, FENTANYL TRANSDERMAL SYSTEM, OXALIPLATIN. Patient was hospitalized. Patient recovered.

Fludarabine Side Effects Report #5403929-0
FLUDARABINE problem was reported by a Health Professional from UNITED STATES on July 31, 2007. Female patient, weighting 120.6 lb, was diagnosed with bone marrow conditioning regimen, stem cell transplant and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: cryptogenic organising pneumonia. FLUDARABINE dosage: 54 MG DAILY IV DRIP. During the same period patient was treated with FLUDARABINE PHOSPHATE, THIOTEPA. Patient was hospitalized. Patient recovered.

Showing 1-100 of 128 Next >


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neoplasm malignant, blood culture positive, jc virus infection, progressive multifocal leukoencephalopathy, , was diagnosed with constipation, palliative care and was diagnosed with stem cell transplant and was diagnosed with b-cell lymphoma and