Drug information for DACOGEN

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; INTRAVENOUS	50MG/VIAL	Prescription	(Reference Drug)	DECITABINE	decitabine	EISAI INC	21790 2010-03-18 Label 2010-03-18 Letter 2006-06-16 Review 2006-05-05 Letter 2006-05-04 Label

Drug Adverse Effects information for DACOGEN

Role code	Indications	Reaction	# Reports
PS	ACUTE MYELOID LEUKAEMIA	ACUTE TONSILLITIS	1
PS	ACUTE MYELOID LEUKAEMIA	ANAEMIA	1
PS	ACUTE MYELOID LEUKAEMIA	ARTHRITIS	1
PS	ACUTE MYELOID LEUKAEMIA	BACTERIAL INFECTION	1
PS	ACUTE MYELOID LEUKAEMIA	BLOOD CULTURE POSITIVE	1
PS	ACUTE MYELOID LEUKAEMIA	BODY TEMPERATURE INCREASED	1
PS	ACUTE MYELOID LEUKAEMIA	CANDIDIASIS	1
PS	ACUTE MYELOID LEUKAEMIA	DYSPNOEA	1
PS	ACUTE MYELOID LEUKAEMIA	FEELING COLD	1
PS	ACUTE MYELOID LEUKAEMIA	HYPOTENSION	1
PS	ACUTE MYELOID LEUKAEMIA	INTERSTITIAL LUNG DISEASE	1
PS	ACUTE MYELOID LEUKAEMIA	JOINT SWELLING	1
PS	ACUTE MYELOID LEUKAEMIA	NEUTROPENIA	1
PS	ACUTE MYELOID LEUKAEMIA	OEDEMA PERIPHERAL	1
PS	ACUTE MYELOID LEUKAEMIA	PAIN IN EXTREMITY	1
PS	ACUTE MYELOID LEUKAEMIA	PYREXIA	1
PS	ACUTE MYELOID LEUKAEMIA	SYNOVIAL RUPTURE	1
PS	ACUTE MYELOID LEUKAEMIA	THROMBOCYTOPENIA	1
PS	COLORECTAL CANCER METASTATIC	ANAEMIA	2
PS	COLORECTAL CANCER METASTATIC	BACTERAEMIA	4
PS	COLORECTAL CANCER METASTATIC	BACTERIAL TEST POSITIVE	2
PS	COLORECTAL CANCER METASTATIC	BLOOD CREATINE INCREASED	2
PS	COLORECTAL CANCER METASTATIC	BLOOD CREATININE INCREASED	2
PS	COLORECTAL CANCER METASTATIC	CITROBACTER TEST POSITIVE	4
PS	COLORECTAL CANCER METASTATIC	CONFUSIONAL STATE	4
PS	COLORECTAL CANCER METASTATIC	CULTURE WOUND POSITIVE	2
PS	COLORECTAL CANCER METASTATIC	DEEP VEIN THROMBOSIS	4
PS	COLORECTAL CANCER METASTATIC	ELECTROLYTE IMBALANCE	2
PS	COLORECTAL CANCER METASTATIC	ENTEROBACTER TEST POSITIVE	4
PS	COLORECTAL CANCER METASTATIC	HYDRONEPHROSIS	2
PS	COLORECTAL CANCER METASTATIC	HYPERHIDROSIS	4
PS	COLORECTAL CANCER METASTATIC	HYPOCALCAEMIA	4
PS	COLORECTAL CANCER METASTATIC	HYPOKALAEMIA	4
PS	COLORECTAL CANCER METASTATIC	HYPOTENSION	4
PS	COLORECTAL CANCER METASTATIC	KLEBSIELLA TEST POSITIVE	4
PS	COLORECTAL CANCER METASTATIC	OEDEMA PERIPHERAL	4
PS	COLORECTAL CANCER METASTATIC	PROTEINURIA	4
PS	COLORECTAL CANCER METASTATIC	PYREXIA	4
PS	COLORECTAL CANCER METASTATIC	SERRATIA TEST POSITIVE	4
PS	COLORECTAL CANCER METASTATIC	SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	4
PS	COLORECTAL CANCER METASTATIC	TUMOUR HAEMORRHAGE	2
PS	COLORECTAL CANCER METASTATIC	URINARY TRACT INFECTION	2
PS	ILL-DEFINED DISORDER	HAEMOLYTIC ANAEMIA	2
PS	MYELODYSPLASTIC SYNDROME	ABDOMINAL DISTENSION	1
PS	MYELODYSPLASTIC SYNDROME	ABDOMINAL PAIN	2
PS	MYELODYSPLASTIC SYNDROME	ARRHYTHMIA	1
PS	MYELODYSPLASTIC SYNDROME	BACTERIAL TEST POSITIVE	1
PS	MYELODYSPLASTIC SYNDROME	BLOOD ALBUMIN DECREASED	1
PS	MYELODYSPLASTIC SYNDROME	BLOOD PRESSURE INADEQUATELY CONTROLLED	1
PS	MYELODYSPLASTIC SYNDROME	BODY TEMPERATURE DECREASED	1
PS	MYELODYSPLASTIC SYNDROME	CARDIAC ARREST	1
PS	MYELODYSPLASTIC SYNDROME	CHILLS	1
PS	MYELODYSPLASTIC SYNDROME	CHOLANGITIS ACUTE	1
PS	MYELODYSPLASTIC SYNDROME	CHOLECYSTITIS	1
PS	MYELODYSPLASTIC SYNDROME	COLITIS	2
PS	MYELODYSPLASTIC SYNDROME	DIARRHOEA	1
PS	MYELODYSPLASTIC SYNDROME	DIZZINESS	1
PS	MYELODYSPLASTIC SYNDROME	ENTEROCOLITIS	1
PS	MYELODYSPLASTIC SYNDROME	HAEMOGLOBIN DECREASED	1
PS	MYELODYSPLASTIC SYNDROME	HEART RATE INCREASED	1
PS	MYELODYSPLASTIC SYNDROME	LIVER ABSCESS	1
PS	MYELODYSPLASTIC SYNDROME	MALAISE	1
PS	MYELODYSPLASTIC SYNDROME	NEUTROPHIL COUNT DECREASED	2
PS	MYELODYSPLASTIC SYNDROME	PANCYTOPENIA	1
PS	MYELODYSPLASTIC SYNDROME	PERIPHERAL COLDNESS	1
PS	MYELODYSPLASTIC SYNDROME	PYREXIA	2
PS	MYELODYSPLASTIC SYNDROME	RESPIRATORY RATE INCREASED	1
PS	MYELODYSPLASTIC SYNDROME	SHOCK	2
PS	MYELODYSPLASTIC SYNDROME	SUDDEN CARDIAC DEATH	1
PS	MYELODYSPLASTIC SYNDROME	URINE OUTPUT DECREASED	1
PS	MYELODYSPLASTIC SYNDROME	VENTRICULAR FIBRILLATION	1
PS	MYELOID LEUKAEMIA	COLITIS	9
PS	MYELOID LEUKAEMIA	ENTERITIS	5
PS	MYELOID LEUKAEMIA	GASTROINTESTINAL DISORDER	2
PS	MYELOID LEUKAEMIA	GASTROINTESTINAL TOXICITY	5
PS	MYELOID LEUKAEMIA	HEPATOBILIARY DISEASE	5
PS	MYELOID LEUKAEMIA	MUCOSAL INFLAMMATION	9
PS	MYELOID LEUKAEMIA	TOXICITY TO VARIOUS AGENTS	21
SS	NAUSEA	BLOOD BILIRUBIN INCREASED	1
SS	NAUSEA	PANCYTOPENIA	1
SS	NAUSEA	RASH	1
C	ARRHYTHMIA	FLUID RETENTION	1
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	DISEASE PROGRESSION	3
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	MYELODYSPLASTIC SYNDROME	4
C	MYELODYSPLASTIC SYNDROME	MEDICATION ERROR	1
C	MYELODYSPLASTIC SYNDROME	MYELODYSPLASTIC SYNDROME	1
C	PRODUCT USED FOR UNKNOWN INDICATION	MEDICATION ERROR	2

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