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
114793912	11479391	2	F		20160727	20150909	20160805	EXP		US-JAZZ-2014-US-015488	JAZZ		0.00			F	Y	0.00000		20160805			US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
114793912	11479391	1	PS	XYREM	SODIUM OXYBATE	1	Oral	2 G, BID	21196	2	G	ORAL SOLUTION
114793912	11479391	2	SS	XYREM	SODIUM OXYBATE	1	Oral	DOSE ADJUSTMENTS	21196			ORAL SOLUTION
114793912	11479391	3	SS	XYREM	SODIUM OXYBATE	1	Oral	5.25 G, BID	21196	5.25	G	ORAL SOLUTION

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
114793912	11479391	1	Narcolepsy

Outcome of event

Event ID	CASEID	OUTC COD
114793912	11479391	OT

Reactions reported

Event ID	CASEID	PT
114793912	11479391	Food allergy
114793912	11479391	Oral infection
114793912	11479391	Tooth abscess
114793912	11479391	Tooth fracture
114793912	11479391	Unevaluable event

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
114793912	11479391	1	201303	201304
114793912	11479391	2	201304	201410
114793912	11479391	3	201410