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Fludarabine Side Effects

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Fludarabine Safety Reports reported to FDA

Total Fludarabine reports: 160.
Fludarabine FDA safety alerts: No.
Reported deaths: 41    Reported hospitalizations: 87.
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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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Fludarabine Side Effects Report #5444639-3
Health Professional from UNITED STATES reported FLUDARABINE problem on Sept 04, 2007. Male patient, weighting 176.4 lb, was diagnosed with acute myeloid leukaemia and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: post procedural sepsis, pulmonary embolism, pyrexia, subdural haematoma, vena cava filter insertion. FLUDARABINE dosage: 63MG DAILY IV. During the same period patient was treated with MELPAHLAN, CAMPATH. Patient died on 08/28/2007.

Fludarabine Side Effects Report #5448632-6
FLUDARABINE problem was reported by a Health Professional from UNITED STATES on Sept 06, 2007. Male patient, weighting 178.0 lb, was diagnosed with aplastic anaemia and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, myocardial infarction, pulmonary embolism. FLUDARABINE dosage: 63 MG DAILY IV DRIP. During the same period patient was treated with MELPHALAN, CAMPATH. Patient died on 08/22/2007.

Fludarabine Side Effects Report #5450414-6
Consumer or non-health professional from UNITED KINGDOM reported FLUDARABINE problem on Aug 28, 2007. Female patient, 78 years of age, was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: granulocytes maturation arrest, leukopenia, neutropenic sepsis, renal impairment. FLUDARABINE dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, AMITRIPTYLINE. Patient recovered.

Fludarabine Side Effects Report #5454196-3
FLUDARABINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Sept 12, 2007. Female patient, 78 years of age, was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: autoimmune disorder, granulocytes maturation arrest, leukopenia, neutropenic sepsis, renal impairment. FLUDARABINE dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, AMITRIPTYLINE. Patient recovered.

Fludarabine Side Effects Report #5454197-5
Health Professional from UNITED KINGDOM reported FLUDARABINE problem on Sept 05, 2007. Male patient, 60 years of age, weighting 175.3 lb, was diagnosed with chronic lymphocytic leukaemia and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: anaemia, aplasia pure red cell. FLUDARABINE dosage: 50 MG, CYCLES 1-4. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOPHOSPHAMIDE, INHIBACE, OMEPRAZOLE, CARTIA. Patient recovered.

Fludarabine Side Effects Report #5464481-7
FLUDARABINE problem was reported by a Physician from UNITED KINGDOM on Sept 06, 2007. Male patient, child 12 years of age, was diagnosed with x-linked chromosomal disorder, prophylaxis against graft versus host disease, infection prophylaxis and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: convulsion, epstein-barr viraemia, pulmonary mycosis. FLUDARABINE dosage: 150 MG/M2, UNK. During the same period patient was treated with MELPHALAN, CAMPATH, CYCLOSPORINE, MYCOPHENOLATE MOFETIL, ACYCLOVIR, CIPROFLOXACIN, IMMUNOGLOBULINS. Patient recovered.

Fludarabine Side Effects Report #5465231-0
Health Professional from UNITED STATES reported FLUDARABINE problem on Sept 19, 2007. Male patient, weighting 132.3 lb, was diagnosed with acute myeloid leukaemia and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, ascites, bacterial infection, blood creatinine increased, blood culture positive, depressed level of consciousness, hepatomegaly, international normalised ratio increased, oedema due to hepatic disease. FLUDARABINE dosage: 25 MG/M2 DAILY TIMES 5 IV. During the same period patient was treated with BUSULFAN, CAMPATH. Patient died on 09/16/2007.

Fludarabine Side Effects Report #5468605-7
FLUDARABINE problem was reported by a Consumer or non-health professional from JAPAN on Sept 19, 2007. Male patient, child 12 years of age, was diagnosed with chronic myeloid leukaemia, stem cell transplant and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, bone marrow failure, stomatitis. FLUDARABINE dosage: TOTAL: 125 MG/M2. During the same period patient was treated with MELPHALAN, GLEEVEC, METHOTREXATE, CYCLOSPORINE. Patient recovered.

Fludarabine Side Effects Report #5468900-1
Physician from UNITED STATES reported FLUDARABINE problem on Sept 14, 2007. Male patient, 75 years of age, was diagnosed with prophylaxis and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: malignant melanoma. FLUDARABINE dosage: unknown. During the same period patient was treated with IMMUNOGLOBULINS. Patient recovered.

Fludarabine Side Effects Report #5468905-0
FLUDARABINE problem was reported by a Health Professional from POLAND on Sept 21, 2007. Female patient, 63 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with FLUDARABINE. After drug was administered, patient experienced the following problems/side effects: cardiovascular insufficiency, chronic lymphocytic leukaemia, lung infection, lymphadenopathy, pancytopenia, pyrexia, respiratory failure, tuberculosis test positive. FLUDARABINE dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOPHOSPHAMIDE, CAMPATH. Patient was hospitalized and became disabled. Patient died on 08/18/2007.

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ALABAMA
ALASKA
AMERICAN SAMOA
ARIZONA
ARKANSAS
CALIFORNIA
COLORADO
CONNECTICUT
DELAWARE
DISTRICT OF COLUMBIA
FEDERATED STATES OF MICRONESIA
FLORIDA
GEORGIA
GUAM
HAWAII
IDAHO
ILLINOIS
INDIANA
IOWA
KANSAS
KENTUCKY
LOUISIANA
MAINE
MARSHALL ISLANDS
MARYLAND
MASSACHUSETTS
MICHIGAN
MINNESOTA
MISSISSIPPI
MISSOURI
MONTANA
NEBRASKA
NEVADA
NEW HAMPSHIRE
NEW JERSEY
NEW MEXICO
NEW YORK
NORTH CAROLINA
NORTH DAKOTA
NORTHERN MARIANA ISLANDS
OHIO
OKLAHOMA
OREGON
PALAU
PENNSYLVANIA
PUERTO RICO
RHODE ISLAND
SOUTH CAROLINA
SOUTH DAKOTA
TENNESSEE
TEXAS
UTAH
VERMONT
VIRGIN ISLANDS
VIRGINIA
WASHINGTON
WEST VIRGINIA
WISCONSIN
WYOMING
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