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Review Elspar Safety Reports submitted to FDA

Total Elspar reports: 48.
Elspar FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 14.
Take Elspar Side Effects Survey, Discuss Elspar with others
FDA Reported Elspar Side Effects: convulsion, pancreatic pseudocyst, soft tissue disorder, neutropenia, ischaemic stroke, pancreatitis, superior sagittal sinus thrombosis, fungal infection, cerebrovascular accident, cerebral ischaemia, urinary incontinence.
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Elspar Side Effects Report #5636720-0
Consumer or non-health professional from FRANCE reported ELSPAR problem on Feb 05, 2008. Male patient, 25 years of age, was diagnosed with t-cell type acute leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with CORTICOSTEROID, DOXORUBICIN, CYCLOPHOSPHAMIDE, VINCRISTINE. Patient recovered.

Elspar Side Effects Report #5593248-4
ELSPAR problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 15, 2008. Female patient, weighting 160.9 lb, was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: blood culture positive, mouth ulceration, mucosal inflammation, neutrophil count abnormal, pharyngeal ulceration, pyrexia, staphylococcal infection. ELSPAR dosage: 36000 MILLION IU. During the same period patient was treated with METHOTREXATE. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5598148-1
Consumer or non-health professional from UNITED STATES reported ELSPAR problem on Jan 17, 2008. Female patient, weighting 160.9 lb, was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: mouth ulceration, mucosal inflammation, pharyngeal ulceration, pharyngolaryngeal pain, staphylococcal infection. ELSPAR dosage: 36000 MILLION IU. During the same period patient was treated with METHOTREXATE. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5603400-7
ELSPAR problem was reported by a Consumer or non-health professional from ITALY on Jan 08, 2008. Male patient, child 10 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: blood cholesterol increased, coagulopathy, hypertriglyceridaemia, pancreatitis, plasmapheresis. ELSPAR dosage: unknown. During the same period patient was treated with PREDNISONE, VINCRISTINE, DAUNORUBICIN, METHOTREXATE. Patient recovered.

Elspar Side Effects Report #5603879-0
Consumer or non-health professional from UNITED STATES reported ELSPAR problem on Jan 25, 2008. Female patient, weighting 160.9 lb, was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: blood culture positive, deep vein thrombosis, hypocalcaemia, jugular vein thrombosis, mouth ulceration, mucosal inflammation, neutrophil count abnormal, pharyngeal ulceration, platelet count abnormal. ELSPAR dosage: 36000 MILLION IU. During the same period patient was treated with METHOTREXATE. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5605459-X
ELSPAR problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 24, 2008. Female patient, weighting 160.9 lb, was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: blood culture positive, deep vein thrombosis, haemorrhage, infection, jugular vein thrombosis, mouth ulceration, mucosal inflammation, neutrophil count decreased, oral intake reduced. ELSPAR dosage: 36000 MILLION IU. During the same period patient was treated with METHOTREXATE. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5608741-5
Consumer or non-health professional from UNITED STATES reported ELSPAR problem on Jan 29, 2008. Female patient, weighting 160.9 lb, was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: blood culture positive, blood potassium abnormal, deep vein thrombosis, haemoglobin abnormal, hypocalcaemia, infection, jugular vein thrombosis, lymphopenia, mouth ulceration. ELSPAR dosage: 36000 MILLION IU. During the same period patient was treated with METHOTREXATE. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5572416-1
ELSPAR problem was reported by a Consumer or non-health professional from TURKEY on Dec 04, 2007. Female patient, child 10 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood urea increased, hyperglycaemic hyperosmolar nonketotic syndrome. ELSPAR dosage: unknown. During the same period patient was treated with PREDNISONE. Patient recovered.

Elspar Side Effects Report #5573076-6
Health Professional from UNITED KINGDOM reported ELSPAR problem on Dec 07, 2007. Male patient, child 5 years of age, weighting 44.09 lb, was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: blood cholesterol increased, blood triglycerides increased, hyperlipidaemia. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE. Patient recovered.

Elspar Side Effects Report #5573595-2
ELSPAR problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 05, 2007. Male patient, 17 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: dysplastic naevus syndrome, malignant melanoma. ELSPAR dosage: unknown. During the same period patient was treated with PREDNISONE, METHOTREXATE, MERCAPTOPURINE, VINCRISTINE, DAUNORUBICIN, CYCLOPHOSPHAMIDE. Patient recovered.

Elspar Side Effects Report #5523216-X
Consumer or non-health professional from UNITED STATES reported ELSPAR problem on Nov 16, 2007. Female patient, weighting 244.7 lb, was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: abasia, atrial fibrillation, bacterial infection, blood culture positive, diarrhoea, hypokalaemia, hypotension, lethargy, neutropenia. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE SULPHATE, BACTRIM DS, CYCLOPHOSPHAMIDE, DAUNORUBICIN, DEXAMETHASONE. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5488675-X
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488676-1
Health Professional from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488677-3
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488679-7
Health Professional from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488680-3
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: neurotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488692-X
Health Professional from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: neurotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488693-1
ELSPAR problem was reported by a Health Professional from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: neurotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488699-2
Health Professional from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488700-6
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: neurotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488705-5
Physician from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: neurotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488706-7
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient died.

Elspar Side Effects Report #5488707-9
Physician from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient died.

Elspar Side Effects Report #5488708-0
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488709-2
Physician from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488710-9
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488711-0
Physician from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: neurotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488716-X
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488717-1
Physician from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488718-3
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488724-9
Physician from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488725-0
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488726-2
Physician from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488727-4
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488728-6
Physician from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488729-8
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488734-1
Health Professional from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: neurotoxicity. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488735-3
ELSPAR problem was reported by a Physician from SINGAPORE on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5488736-5
Physician from SINGAPORE reported ELSPAR problem on Oct 04, 2007. Female patient was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: infection. ELSPAR dosage: unknown. During the same period patient was treated with VINCRISTINE, DEXAMETHASONE, DAUNORUBICIN. Patient recovered.

Elspar Side Effects Report #5409627-1
ELSPAR problem was reported by a Physician from UNITED STATES on July 24, 2007. Female patient, 57 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: chills, fatigue, hepatic function abnormal, lung consolidation, lung neoplasm, neutropenia, opportunistic infection, pulmonary mass. ELSPAR dosage: unknown. During the same period patient was treated with DAUNORUBICIN, VINCRISTINE, PREDNISONE, IMATINIB MESYLATE. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5416507-4
Health Professional from POLAND reported ELSPAR problem on Aug 01, 2007. Female patient, child 7 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: convulsion, cyst, ischaemic stroke, pancreatic pseudocyst, pancreatitis, treatment failure. ELSPAR dosage: unknown. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5416510-4
ELSPAR problem was reported by a Health Professional from POLAND on Aug 01, 2007. Female patient, child 5 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: cardiovascular insufficiency, hepatomegaly, liver disorder, pancreatic pseudocyst, respiratory failure, transaminases increased. ELSPAR dosage: unknown. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5417517-3
Health Professional from SPAIN reported ELSPAR problem on June 15, 2007. Female patient, child 11 years of age, weighting 110.2 lb, was diagnosed with granulocytopenia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: phlebitis, pyrexia. ELSPAR dosage: unknown. During the same period patient was treated with CANCIDAS, AMPHOTERICIN B, AMPHOTERICIN B. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5430015-6
ELSPAR problem was reported by a Consumer or non-health professional from POLAND on Aug 13, 2007. Female patient, child 7 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: convulsion, ischaemic stroke, pancreatic cyst, pancreatic pseudocyst, pancreatitis. ELSPAR dosage: unknown. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5378358-9
Consumer or non-health professional from UNITED STATES reported ELSPAR problem on July 02, 2007. Male patient, weighting 192.5 lb, was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, dehydration, electrolyte imbalance, hepatic encephalopathy, mental status changes, weight decreased. ELSPAR dosage: 90120 MG. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5390861-4
ELSPAR problem was reported by a Consumer or non-health professional from JAPAN on July 06, 2007. Male patient, child 11 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: pancreatic pseudocyst, pancreatitis acute. ELSPAR dosage: unknown. Patient recovered.

Elspar Side Effects Report #5378358-9
Consumer or non-health professional from UNITED STATES reported ELSPAR problem on July 02, 2007. Male patient, weighting 192.5 lb, was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, dehydration, electrolyte imbalance, hepatic encephalopathy, mental status changes, weight decreased. ELSPAR dosage: 90120 MG. Patient was hospitalized. Patient recovered.

Elspar Side Effects Report #5390861-4
ELSPAR problem was reported by a Consumer or non-health professional from JAPAN on July 06, 2007. Male patient, child 11 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with ELSPAR. After drug was administered, patient experienced the following problems/side effects: pancreatic pseudocyst, pancreatitis acute. ELSPAR dosage: unknown. Patient recovered.


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infection, blood culture positive, mouth ulceration, mucosal inflammation, neutrophil count abnormal, pharyngeal ulceration, pyrexia, staphylococcal infection, , was diagnosed with t-cell type acute leukaemia and was diagnosed with acute lymphocytic leukaemia and