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Review Idarubicin Safety Reports submitted to FDA

Total Idarubicin reports: 12.
Idarubicin FDA safety alerts: No.
Reported deaths: 8    Reported hospitalizations: 6.
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FDA Reported Idarubicin Side Effects: febrile neutropenia, anaemia, cardiac arrest, pain, multi-organ failure, thrombocytopenia, acute myeloid leukaemia, infection, intestinal obstruction, skin ulcer, skin graft failure.
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Idarubicin Side Effects Report #5588548-8
Consumer or non-health professional from UNITED KINGDOM reported IDARUBICIN problem on Jan 07, 2008. Male patient, 69 years of age, weighting 152.8 lb, was diagnosed with multiple myeloma, hyperuricaemia, nausea and was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: no adverse event. IDARUBICIN dosage: unknown. During the same period patient was treated with DEXAMETHASONE, ALLOPURINOL, CYCLIZINE. Patient recovered.

Idarubicin Side Effects Report #5536214-7
IDARUBICIN problem was reported by a Health Professional from UNITED KINGDOM on Nov 27, 2007. Male patient, 36 years of age, was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, acute myeloid leukaemia, febrile neutropenia, multi-organ failure, neutropenic sepsis, no therapeutic response. IDARUBICIN dosage: unknown. During the same period patient was treated with CYTARABINE, FLUDARABINE PHOSPHATE, NEUPOGEN. Patient was hospitalized. Patient died on 04/23/2007.

Idarubicin Side Effects Report #5550056-8
Health Professional from UNITED KINGDOM reported IDARUBICIN problem on Nov 27, 2007. Male patient, 36 years of age, was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: no adverse reaction. IDARUBICIN dosage: unknown. During the same period patient was treated with CYTARABINE, FILGRASTIM, FLUDARABINE. Patient recovered.

Idarubicin Side Effects Report #5503254-3
IDARUBICIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Oct 16, 2007. Male patient, 69 years of age, weighting 152.8 lb, was diagnosed with multiple myeloma, hyperuricaemia, nausea and was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: cough, dyspnoea, malaise, neutropenic sepsis, overdose, white blood cell count decreased. IDARUBICIN dosage: unknown. During the same period patient was treated with DEXAMETHASONE, ALLOPURINOL, CYCLIZINE. Patient died on 01/09/2007.

Idarubicin Side Effects Report #5442252-5
Consumer or non-health professional from AUSTRALIA reported IDARUBICIN problem on Aug 23, 2007. Male patient, weighting 251.3 lb, was diagnosed with acute myeloid leukaemia, neutrophil count increased, stomatitis and was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, infection, thrombocytopenia. IDARUBICIN dosage: unknown. During the same period patient was treated with CYTARABINE, ETOPOSIDE, NEUPOGEN, NEULASTA, NILSTAT, CHLORHEXIDINE GLUCONATE, ITRACONAZOLE. Patient was hospitalized. Patient recovered.

Idarubicin Side Effects Report #5442261-6
IDARUBICIN problem was reported by a Consumer or non-health professional from AUSTRALIA on Aug 23, 2007. Male patient, weighting 251.3 lb, was diagnosed with acute myeloid leukaemia, neutrophil count increased, stomatitis and was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, infection, thrombocytopenia. IDARUBICIN dosage: unknown. During the same period patient was treated with CYTARABINE, ETOPOSIDE, NEUPOGEN, NEULASTA, NILSTAT, CHLORHEXIDINE GLUCONATE, ITRACONAZOLE. Patient was hospitalized. Patient recovered.

Idarubicin Side Effects Report #5442407-X
Consumer or non-health professional from AUSTRALIA reported IDARUBICIN problem on Aug 23, 2007. Female patient, weighting 163.1 lb, was diagnosed with acute myeloid leukaemia and was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, intestinal obstruction. IDARUBICIN dosage: unknown. During the same period patient was treated with CYTARABINE, ETOPOSIDE, PALIFERMIN, PEGFILGRASTIM. Patient was hospitalized. Patient died on 08/19/2007.

Idarubicin Side Effects Report #5449336-6
IDARUBICIN problem was reported by a Physician from JAPAN on Aug 30, 2007. Male patient, weighting 117.3 lb, was diagnosed with acute myeloid leukaemia, prophylaxis, fungal infection, sepsis, vomiting, hyperuricaemia and was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: jaundice. IDARUBICIN dosage: unknown. During the same period patient was treated with VORICONAZOLE, DIFLUCAN, MAXIPIME, CYLOCIDE, NASEA, ALLOPURINOL. Patient recovered.

Idarubicin Side Effects Report #5403209-3
Consumer or non-health professional from AUSTRALIA reported IDARUBICIN problem on July 20, 2007. Female patient, weighting 174.2 lb, was diagnosed with acute myeloid leukaemia and was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: brain hypoxia, cardiac arrest, cognitive disorder. IDARUBICIN dosage: unknown. During the same period patient was treated with CYTARABINE, ETOPOSIDE. Patient recovered.

Idarubicin Side Effects Report #5407546-8
IDARUBICIN problem was reported by a Consumer or non-health professional from AUSTRALIA on July 26, 2007. Female patient, weighting 174.2 lb, was diagnosed with acute myeloid leukaemia and was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest. IDARUBICIN dosage: unknown. During the same period patient was treated with CYTARABINE, ETOPOSIDE, TAZOCIN, PHOSPHATE, ACETAMINOPHEN, POSACONAZOLE, PANTOPRAZOL. Patient recovered.

Idarubicin Side Effects Report #5425656-6
Consumer or non-health professional from reported IDARUBICIN problem on Aug 14, 2007. Female patient, weighting 163.1 lb, was diagnosed with acute myeloid leukaemia and was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, intestinal obstruction. IDARUBICIN dosage: unknown. During the same period patient was treated with CYTARABINE, ETOPOSIDE, PALIFERMIN, PEGFILGRASTIM. Patient was hospitalized. Patient died on 08/19/2007.

Idarubicin Side Effects Report #5428099-4
IDARUBICIN problem was reported by a Health Professional from UNITED KINGDOM on Aug 16, 2007. Male patient, 36 years of age, was treated with IDARUBICIN. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, acute myeloid leukaemia, febrile neutropenia, multi-organ failure, neutropenic sepsis. IDARUBICIN dosage: unknown. During the same period patient was treated with CYTARABINE, FILGRASTIM, FLUDARABINE PHOSPHATE. Patient was hospitalized. Patient died on 04/23/2007.


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no adverse event, abdominal discomfort, acute myeloid leukaemia, febrile neutropenia, multi-organ failure, neutropenic sepsis, no therapeutic response, , was diagnosed with multiple myeloma, hyperuricaemia, nausea and was diagnosed with multiple myeloma, hyperuricaemia, nausea and