Safety Rates Drug Report: adverse events in 2016 Q3 - FDA prescription drugs adverse events in an open, searchable, online, public database

Drug Injury Quarter

Person who experienced the adverse event (patient)

Event ID	CASEID	CASEVERSION	I F COD	EVENT DT	MFR DT	INIT FDA DT	FDA DT	REPT COD	AUTH NUM	MFR NUM	MFR SNDR	LIT REF	AGE	AGE COD	AGE GRP	GNDR COD	E SUB	WT	WT COD	REPT DT	TO MFR	OCCP COD	REPORTER COUNTRY	OCCR COUNTRY
125009853	12500985	3	F	20160610	20160802	20160627	20160809	EXP		US-PFIZER INC-2016310463	PFIZER		19.00	YR		F	Y	78.91000	KG	20160809		OT	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FREQ
125009853	12500985	1	PS	ZOLOFT	SERTRALINE HYDROCHLORIDE	1	Oral	50 MG, EVERY MORNING	3825	MG	19839	50	MG	QD
125009853	12500985	2	SS	ZOLOFT	SERTRALINE HYDROCHLORIDE	1	Oral	100 MG, EVERY MORNING	3825	MG	19839	100	MG	QD
125009853	12500985	3	SS	ZOLOFT	SERTRALINE HYDROCHLORIDE	1	Oral	150 MG, EVERY MORNING	3825	MG	19839	150	MG	QD
125009853	12500985	4	SS	ZOLOFT	SERTRALINE HYDROCHLORIDE	1	Oral	100 MG, EVERY MORNING	3825	MG	19839	100	MG	QD
125009853	12500985	5	SS	ZOLOFT	SERTRALINE HYDROCHLORIDE	1	Oral	125 MG, EVERY MORNING	3825	MG	19839	125	MG	QD
125009853	12500985	6	SS	ZOLOFT	SERTRALINE HYDROCHLORIDE	1	Oral	150 MG, EVERY MORNING	3825	MG	19839	150	MG	QD
125009853	12500985	7	SS	ZOLOFT	SERTRALINE HYDROCHLORIDE	1	Oral	200 MG, EVERY MORNING	3825	MG	19839	200	MG	QD
125009853	12500985	8	SS	OLANZAPINE.	OLANZAPINE	1	Oral	5 MG, 1X/DAY AT BEDTIME	5	MG	0	5	MG	QD
125009853	12500985	9	SS	OLANZAPINE.	OLANZAPINE	1	Oral	7.5 MG, AT BEDTIME	5	MG	0	7.5	MG
125009853	12500985	10	SS	OLANZAPINE.	OLANZAPINE	1	Oral	10 MG, AT BEDTIME	5	MG	0	10	MG
125009853	12500985	11	SS	OLANZAPINE.	OLANZAPINE	1	Oral	12.5 MG, AT BEDTIME	5	MG	0	12.5	MG
125009853	12500985	12	SS	OLANZAPINE.	OLANZAPINE	1	Oral	10 MG, AT BEDTIME	5	MG	0	10	MG
125009853	12500985	13	C	LITHIUM.	LITHIUM	1	Oral	150MG QHS	150	MG	0	150	MG	QD
125009853	12500985	14	C	LITHIUM.	LITHIUM	1	Oral	300 MG QHS	150	MG	0	300	MG	QD
125009853	12500985	15	C	ABILIFY	ARIPIPRAZOLE	1	Oral	10 MG, 1X/DAY (EVERY MORNING)			0	10	MG	QD
125009853	12500985	16	C	CLONAZEPAM.	CLONAZEPAM	1	Oral	0.5 MG, AT BEDTIME AS NEEDED			0	.5	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125009853	12500985	1	Major depression
125009853	12500985	2	Psychotic disorder
125009853	12500985	8	Major depression
125009853	12500985	9	Psychotic disorder
125009853	12500985	13	Major depression
125009853	12500985	15	Major depression
125009853	12500985	16	Insomnia

Outcome of event

Event ID	CASEID	OUTC COD
125009853	12500985	HO

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125009853	12500985		Overdose
125009853	12500985		Suicide attempt

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

no results found

Therapies reported

Event ID	CASEID	DSG DRUG SEQ	START DT	END DT
125009853	12500985	1	20160404	20160405
125009853	12500985	2	20160406	20160417
125009853	12500985	3	20160418	20160420
125009853	12500985	4	20160422	20160429
125009853	12500985	5	20160430	20160502
125009853	12500985	6	20160503	20160508
125009853	12500985	7	20160509
125009853	12500985	8	20160404	20160404
125009853	12500985	9	20160405	20160405
125009853	12500985	10	20160406	20160511
125009853	12500985	11	20160512	20160513
125009853	12500985	12	20160514	20160608
125009853	12500985	13	20160608	20160608
125009853	12500985	14	20160609
125009853	12500985	15	20160609
125009853	12500985	16	20160609