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Tositumomab Side Effects submitted to FDA

Total Tositumomab reports: 11.
Tositumomab FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 8.
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FDA Reported Tositumomab Side Effects: myelodysplastic syndrome, chills, disease progression, ear pain, asthenia, acute myeloid leukaemia, pleural effusion, malignant neoplasm progression, blood bilirubin increased, aspartate aminotransferase increased, pyrexia,
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Tositumomab Side Effects Report #5679280-0
Physician from UNITED STATES reported TOSITUMOMAB problem on Mar 19, 2008. Female patient, 53 years of age, was diagnosed with non-hodgkin's lymphoma and was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: cardiomyopathy, chest pain, dyspnoea. TOSITUMOMAB dosage: 450MG SINGLE DOSE. During the same period patient was treated with IODINE I, IODINE I. Patient was hospitalized. Patient recovered.



Tositumomab Side Effects Report #5513020-0
TOSITUMOMAB problem was reported by a Physician from UNITED STATES on Nov 08, 2007. Female patient, 34 years of age, weighting 155.9 lb, was diagnosed with non-hodgkin's lymphoma and was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: sepsis. TOSITUMOMAB dosage: unknown. During the same period patient was treated with IODINE I, IODINE I. Patient was hospitalized. Patient died.



Tositumomab Side Effects Report #5499469-3
Physician from UNITED STATES reported TOSITUMOMAB problem on Oct 19, 2007. Male patient, 81 years of age, was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: anaemia, bundle branch block, confusional state, dehydration, dyspnoea, gastrointestinal haemorrhage, hallucination, visual, hyponatraemia, malnutrition. TOSITUMOMAB dosage: 450MG SINGLE DOSE. During the same period patient was treated with IODINE I, IODINE I, ALTACE, ATENOLOL, AVANDIA. Patient was hospitalized. Patient died on 10/08/2007.



Tositumomab Side Effects Report #5447747-6
TOSITUMOMAB problem was reported by a Physician from UNITED STATES on Sept 04, 2007. Male patient, 45 years of age, weighting 215.8 lb, was diagnosed with non-hodgkin's lymphoma and was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: chest pain, pericarditis, pleurisy. TOSITUMOMAB dosage: unknown. During the same period patient was treated with IODINE I, IODINE I, COUMADIN, POTASSIUM IODIDE, LEVOXYL. Patient was hospitalized. Patient recovered.




Tositumomab Side Effects Report #5460669-X
Physician from UNITED STATES reported TOSITUMOMAB problem on Sept 10, 2007. Male patient, 43 years of age, weighting 193.3 lb, was diagnosed with non-hodgkin's lymphoma and was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: diarrhoea, gastritis, pancytopenia. TOSITUMOMAB dosage: unknown. During the same period patient was treated with IODINE I, IODINE I. Patient was hospitalized. Patient recovered.



Tositumomab Side Effects Report #5407108-2
TOSITUMOMAB problem was reported by a Consumer or non-health professional from UNITED STATES on July 24, 2007. Male patient, 50 years of age, was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: erythropoiesis abnormal, myelodysplastic syndrome, thrombocytopenia. TOSITUMOMAB dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, ADRIAMYCIN PFS, VINCRISTINE, PREDNISONE, RITUXAN, IFOSFAMIDE, CARBOPLATIN, ETOPOSIDE. Patient recovered.



Tositumomab Side Effects Report #5692336-1
Physician from UNITED STATES reported TOSITUMOMAB problem on Mar 27, 2008. Male patient, 66 years of age, weighting 198.9 lb, was diagnosed with non-hodgkin's lymphoma and was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: anaemia, cardiac failure congestive, pancytopenia, pneumonia. TOSITUMOMAB dosage: unknown. During the same period patient was treated with IODINE I, IODINE I. Patient was hospitalized. Patient recovered.



Tositumomab Side Effects Report #5320423-6
TOSITUMOMAB problem was reported by a Physician from UNITED STATES on Apr 30, 2007. Male patient, 59 years of age, weighting 233.7 lb, was diagnosed with non-hodgkin's lymphoma and was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: diffuse large b-cell lymphoma, myelodysplastic syndrome. TOSITUMOMAB dosage: 450MG SINGLE DOSE. During the same period patient was treated with IODINE I, IODINE I, DIGOXIN, SATOLOL, ACYCLOVIR, METOPROLOL SUCCINATE, ALLOPURINOL. Patient died on 04/22/2007.



Tositumomab Side Effects Report #5307491-2
Physician from UNITED STATES reported TOSITUMOMAB problem on Apr 17, 2007. Male patient, 43 years of age, weighting 193.3 lb, was diagnosed with non-hodgkin's lymphoma and was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: diarrhoea, gastritis. TOSITUMOMAB dosage: unknown. During the same period patient was treated with IODINE I, IODINE I. Patient was hospitalized. Patient recovered.




Tositumomab Side Effects Report #5307492-4
TOSITUMOMAB problem was reported by a Physician from UNITED STATES on Apr 16, 2007. Male patient, 62 years of age, was diagnosed with non-hodgkin's lymphoma and was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: disease progression, lung adenocarcinoma. TOSITUMOMAB dosage: 450MG SINGLE DOSE. During the same period patient was treated with IODINE I, IODINE I. Patient died on 12/14/2005.



Tositumomab Side Effects Report #5280251-7
Physician from UNITED STATES reported TOSITUMOMAB problem on Mar 21, 2007. Male patient, 60 years of age, weighting 210.5 lb, was diagnosed with non-hodgkin's lymphoma and was treated with TOSITUMOMAB. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, asthenia, chills, ear pain, myelodysplastic syndrome, pneumonia. TOSITUMOMAB dosage: 450MG SINGLE DOSE. During the same period patient was treated with IODINE I, IODINE I, TOPROL, ASPIRIN, PLAVIX, PRAVACHOL. Patient was hospitalized. Patient recovered.




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, Tositumomab was diagnosed with non-hodgkin's lymphoma and Tositumomab was diagnosed with non-hodgkin's lymphoma and