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
125433072	12543307	2	F	2011	20160719	20160711	20160727	EXP		US-SHIRE-US201607910	SHIRE		0.00			F	Y	0.00000		20160727		PH	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125433072	12543307	1	PS	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	1	Oral	30 MG, 1X/DAY:QD		21977	30	MG	CAPSULE	QD
125433072	12543307	2	SS	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	1	Oral	70 MG, 1X/DAY:QD		21977	70	MG	CAPSULE	QD
125433072	12543307	3	SS	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	1	Oral	40 MG, 1X/DAY:QD		21977	40	MG	CAPSULE	QD
125433072	12543307	4	SS	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	1	Oral	60 MG, 1X/DAY:QD		21977	60	MG	CAPSULE	QD
125433072	12543307	5	SS	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	1	Oral	70 MG, 1X/DAY:QD	3133599	21977	70	MG	CAPSULE	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125433072	12543307	1	Attention deficit/hyperactivity disorder

Outcome of event

Event ID	CASEID	OUTC COD
125433072	12543307	OT

Reactions reported

Event ID	CASEID	PT
125433072	12543307	Anxiety
125433072	12543307	Depression
125433072	12543307	Drug ineffective
125433072	12543307	HIV infection
125433072	12543307	Inappropriate schedule of drug administration
125433072	12543307	Intentional overdose
125433072	12543307	Product quality issue
125433072	12543307	Therapeutic response unexpected

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
125433072	12543307	1	2002	201403
125433072	12543307	2	201503	201601
125433072	12543307	3	201601	201603
125433072	12543307	4	201603	201605
125433072	12543307	5	201605