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
107498532	10749853	2	F	201304	20160711	20150129	20160714	EXP		US-GLAXOSMITHKLINE-A1058344A	GLAXOSMITHKLINE		26.65	YR		F	Y	0.00000		20160714		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
107498532	10749853	1	PS	LAMICTAL	LAMOTRIGINE	1	Unknown	100 MG, U			20241	100	MG	TABLET
107498532	10749853	2	SS	LAMICTAL XR	LAMOTRIGINE	1		100 MG AND 300 MG, UNKNOWN DOSING	U	00173075600	0			PROLONGED-RELEASE TABLET
107498532	10749853	3	SS	LAMICTAL XR	LAMOTRIGINE	1		300 MG, U	U		0	300	MG	PROLONGED-RELEASE TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
107498532	10749853	1	Nervous system disorder
107498532	10749853	2	Epilepsy
107498532	10749853	3	Seizure

Outcome of event

Event ID	CASEID	OUTC COD
107498532	10749853	OT

Reactions reported

Event ID	CASEID	PT
107498532	10749853	Circumstance or information capable of leading to medication error
107498532	10749853	Drug administration error
107498532	10749853	Malaise
107498532	10749853	Seizure

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
107498532	10749853	1	20091017		0
107498532	10749853	2	2008		0