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
125695512	12569551	2	F	2015	20160915	20160719	20160919	EXP		BR-JNJFOC-20160713204	JANSSEN		17.00	YR	T	M	Y	0.00000		20160919		CN	BR	BR

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DECHAL	RECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
125695512	12569551	1	PS	TOPAMAX	TOPIRAMATE	1	Oral	U	U	UNKNOWN	20505	100	MG	UNSPECIFIED
125695512	12569551	2	SS	CLOBAZAM	CLOBAZAM	1	Unknown	U			0	10	MG	UNSPECIFIED
125695512	12569551	3	C	KETOCAL		2	Unknown	D			0			UNSPECIFIED

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125695512	12569551	1	Epilepsy
125695512	12569551	2	Epilepsy
125695512	12569551	3	Product used for unknown indication

Outcome of event

Reactions reported

Event ID	CASEID	PT
125695512	12569551	Aphasia
125695512	12569551	Central nervous system lesion
125695512	12569551	Coma
125695512	12569551	Pleural effusion
125695512	12569551	Pneumonia
125695512	12569551	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
125695512	12569551	1	2015		0
125695512	12569551	2	2015		0