Drug information for SYMBYAX

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
CAPSULE; ORAL	EQ 25MG BASE;EQ 12MG BASE	Prescription		FLUOXETINE HYDROCHLORIDE; OLANZAPINE	olanzapine-fluoxetine combination	LILLY	21520 2011-10-05 Letter 2011-10-05 Label 2011-06-29 Medication Guide 2011-06-29 Label 2011-06-29 Label 2011-06-29 Medication Guide 2011-06-27 Letter 2011-06-27 Letter 2011-04-26 Label 2011-04-26 Label 2011-04-25 Letter 2011-04-25 Letter 2010-12-07 Letter 2010-12-07 Letter 2010-12-04 Label 2010-12-04 Label 2010-02-01 Letter 2010-01-29 Label 2009-12-04 Medication Guide 2009-09-22 Label 2009-04-06 Other 2009-03-20 Label 2008-08-19 Letter 2008-03-24 Label 2008-03-24 Letter 2008-03-19 Label 2008-03-19 Letter 2007-08-07 Letter 2007-08-07 Letter 2007-08-03 Label 2007-08-03 Label 2007-05-09 Other Important Information from FDA 2007-04-20 Label 2007-04-20 Label 2007-04-20 Letter 2007-04-20 Letter 2006-12-28 Letter 2006-12-04 Label 2006-09-21 Label 2005-06-16 Review 2005-02-23 Letter 2004-01-16 Patient Package Insert 2004-01-02 Label 2004-01-02 Letter
CAPSULE; ORAL	EQ 25MG BASE;EQ 3MG BASE	Prescription		FLUOXETINE HYDROCHLORIDE; OLANZAPINE	olanzapine-fluoxetine combination	LILLY	"
CAPSULE; ORAL	EQ 25MG BASE;EQ 6MG BASE	Prescription		FLUOXETINE HYDROCHLORIDE; OLANZAPINE	olanzapine-fluoxetine combination	LILLY	"
CAPSULE; ORAL	EQ 50MG BASE;EQ 12MG BASE	Prescription		FLUOXETINE HYDROCHLORIDE; OLANZAPINE	olanzapine-fluoxetine combination	LILLY	"
CAPSULE; ORAL	EQ 50MG BASE;EQ 6MG BASE	Prescription	(Reference Drug)	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	olanzapine-fluoxetine combination	LILLY	"

Drug Adverse Effects information for SYMBYAX

Role code	Indications	Reaction	# Reports
PS	AFFECTIVE DISORDER	ASPHYXIA	9
PS	AFFECTIVE DISORDER	OFF LABEL USE	9
PS	BIPOLAR DISORDER	INTENTIONAL DRUG MISUSE	1
PS	BIPOLAR DISORDER	ROAD TRAFFIC ACCIDENT	1
PS	BIPOLAR DISORDER	SOMNOLENCE	1
PS	DEPRESSION	ANGER	1
PS	DEPRESSION	COMPLETED SUICIDE	2
PS	DEPRESSION	FALL	1
PS	DEPRESSION	OFF LABEL USE	1
PS	DEPRESSION	SELF INJURIOUS BEHAVIOUR	1
PS	IMPULSE-CONTROL DISORDER	ANGER	2
PS	IMPULSE-CONTROL DISORDER	COMPLETED SUICIDE	2
PS	IMPULSE-CONTROL DISORDER	FALL	2
PS	IMPULSE-CONTROL DISORDER	OFF LABEL USE	2
PS	IMPULSE-CONTROL DISORDER	SELF INJURIOUS BEHAVIOUR	2
PS	MAJOR DEPRESSION	ABDOMINAL PAIN	1
PS	MAJOR DEPRESSION	ALANINE AMINOTRANSFERASE INCREASED	1
PS	MAJOR DEPRESSION	ASPARTATE AMINOTRANSFERASE INCREASED	1
PS	MAJOR DEPRESSION	BILIRUBIN CONJUGATED INCREASED	1
PS	MAJOR DEPRESSION	BLOOD ALKALINE PHOSPHATASE INCREASED	1
PS	MAJOR DEPRESSION	BLOOD BILIRUBIN INCREASED	1
PS	MAJOR DEPRESSION	FATIGUE	1
PS	MAJOR DEPRESSION	JAUNDICE	1
PS	SCHIZOPHRENIA	ACUTE LUNG INJURY	1
PS	SCHIZOPHRENIA	ASPIRATION BRONCHIAL	1
PS	SCHIZOPHRENIA	DYSPNOEA	1
PS	SCHIZOPHRENIA	INTENTIONAL OVERDOSE	1
PS	SCHIZOPHRENIA	MOBILITY DECREASED	1
PS	SCHIZOPHRENIA	OFF LABEL USE	1
PS	SCHIZOPHRENIA	SUICIDE ATTEMPT	1
PS	SCHIZOPHRENIA	VOMITING	1
SS	AFFECTIVE DISORDER	ABNORMAL BEHAVIOUR	1
SS	AFFECTIVE DISORDER	AGGRESSION	1
SS	AFFECTIVE DISORDER	COMPLETED SUICIDE	1
SS	AFFECTIVE DISORDER	IMPULSIVE BEHAVIOUR	1
SS	AGGRESSION	ABNORMAL BEHAVIOUR	1
SS	AGGRESSION	AGGRESSION	1
SS	AGGRESSION	COMPLETED SUICIDE	1
SS	AGGRESSION	IMPULSIVE BEHAVIOUR	1
SS	ANXIETY	ABNORMAL BEHAVIOUR	1
SS	ANXIETY	AGGRESSION	1
SS	ANXIETY	COMPLETED SUICIDE	1
SS	ANXIETY	IMPULSIVE BEHAVIOUR	1
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	ABNORMAL BEHAVIOUR	1
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	AGGRESSION	1
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	COMPLETED SUICIDE	1
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	IMPULSIVE BEHAVIOUR	1
SS	IMPULSIVE BEHAVIOUR	ABNORMAL BEHAVIOUR	1
SS	IMPULSIVE BEHAVIOUR	AGGRESSION	1
SS	IMPULSIVE BEHAVIOUR	COMPLETED SUICIDE	1
SS	IMPULSIVE BEHAVIOUR	IMPULSIVE BEHAVIOUR	1
C	ANXIETY	BILIARY DYSKINESIA	1
C	ANXIETY	GALLBLADDER DISORDER	1
C	ANXIETY	PAIN	1
C	BREAST CANCER	ARRHYTHMIA	1
C	BREAST CANCER	ARTHRITIS	1
C	BREAST CANCER	ASTHMA	1
C	BREAST CANCER	BACK PAIN	1
C	BREAST CANCER	BARRETT'S OESOPHAGUS	1
C	BREAST CANCER	CARDIAC PROCEDURE COMPLICATION	1
C	BREAST CANCER	DYSPHONIA	1
C	BREAST CANCER	GASTROOESOPHAGEAL REFLUX DISEASE	1
C	BREAST CANCER	HIATUS HERNIA	1
C	BREAST CANCER	INTERVERTEBRAL DISC PROTRUSION	1
C	BREAST CANCER	MOBILITY DECREASED	1
C	BREAST CANCER	PAIN	1
C	BREAST CANCER	PHARYNGEAL POLYP	1
C	BREAST CANCER	VOCAL CORD POLYP	1
C	DEPRESSION	DEEP VEIN THROMBOSIS	1
C	DEPRESSION	INJURY	1
C	DEPRESSION	PAIN	1
C	DEPRESSION	PULMONARY EMBOLISM	1
C	HEADACHE	BILIARY DYSKINESIA	1
C	HEADACHE	GALLBLADDER DISORDER	1
C	HEADACHE	PAIN	1
C	MENSTRUATION IRREGULAR	BILIARY DYSKINESIA	1
C	MENSTRUATION IRREGULAR	GALLBLADDER DISORDER	1
C	MENSTRUATION IRREGULAR	PAIN	1
C	MIGRAINE	BILIARY DYSKINESIA	1
C	MIGRAINE	GALLBLADDER DISORDER	1
C	MIGRAINE	PAIN	1
C	PRODUCT USED FOR UNKNOWN INDICATION	ANXIETY	4
C	PRODUCT USED FOR UNKNOWN INDICATION	CHEST PAIN	4
C	PRODUCT USED FOR UNKNOWN INDICATION	DYSPNOEA	4
C	PRODUCT USED FOR UNKNOWN INDICATION	EMOTIONAL DISTRESS	4
C	PRODUCT USED FOR UNKNOWN INDICATION	FEAR	4
C	PRODUCT USED FOR UNKNOWN INDICATION	LUNG DISORDER	4
C	PRODUCT USED FOR UNKNOWN INDICATION	MENTAL DISORDER	4
C	PRODUCT USED FOR UNKNOWN INDICATION	PAIN	4
C	PRODUCT USED FOR UNKNOWN INDICATION	PULMONARY EMBOLISM	4
C	RECTAL HAEMORRHAGE	ARRHYTHMIA	1
C	RECTAL HAEMORRHAGE	ARTHRITIS	1
C	RECTAL HAEMORRHAGE	ASTHMA	1
C	RECTAL HAEMORRHAGE	BACK PAIN	1
C	RECTAL HAEMORRHAGE	BARRETT'S OESOPHAGUS	1
C	RECTAL HAEMORRHAGE	CARDIAC PROCEDURE COMPLICATION	1
C	RECTAL HAEMORRHAGE	DYSPHONIA	1
C	RECTAL HAEMORRHAGE	GASTROOESOPHAGEAL REFLUX DISEASE	1
C	RECTAL HAEMORRHAGE	HIATUS HERNIA	1
C	RECTAL HAEMORRHAGE	INTERVERTEBRAL DISC PROTRUSION	1
C	RECTAL HAEMORRHAGE	MOBILITY DECREASED	1
C	RECTAL HAEMORRHAGE	PAIN	1
C	RECTAL HAEMORRHAGE	PHARYNGEAL POLYP	1
C	RECTAL HAEMORRHAGE	VOCAL CORD POLYP	1
C	SLEEP DISORDER THERAPY	DEEP VEIN THROMBOSIS	1
C	SLEEP DISORDER THERAPY	INJURY	1
C	SLEEP DISORDER THERAPY	PAIN	1
C	SLEEP DISORDER THERAPY	PULMONARY EMBOLISM	1

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