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
126862272	12686227	2	F	2010	20160831	20160825	20160912	EXP		US-SHIRE-US201610929	SHIRE		0.00			M	Y	95.24000	KG	20160912		CN	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	DECHAL	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
126862272	12686227	1	PS	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	1	Oral	50 MG, UNKNOWN							21977	50	MG	CAPSULE
126862272	12686227	2	SS	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	1	Oral	40 MG, UNKNOWN					3139733		21977	40	MG	CAPSULE

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126862272	12686227	1	Attention deficit/hyperactivity disorder

Outcome of event

Event ID	CASEID	OUTC COD
126862272	12686227	OT

Reactions reported

Event ID	CASEID	PT
126862272	12686227	Chest pain
126862272	12686227	Disturbance in attention
126862272	12686227	Drug effect decreased
126862272	12686227	Headache
126862272	12686227	Product quality issue

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	DUR	DUR COD
126862272	12686227	1	2009	2012	0
126862272	12686227	2	201512		0