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
125534031	12553403	1	I	20160618	20160712	20160713	20160713	EXP		FR-JNJFOC-20160709319	JANSSEN		26.59	YR	A	M	Y	0.00000		20160713		OT	FR	FR

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125534031	12553403	1	PS	RISPERDAL	RISPERIDONE	1	Oral		Y	N	20272	2	MG	TABLETS	QD
125534031	12553403	2	SS	TEGRETOL	CARBAMAZEPINE	1	Oral	200 MG IN THE MORNING AND 400 MG IN THE EVENING	Y		0	600	MG	TABLET
125534031	12553403	3	C	VALIUM	DIAZEPAM	1	Oral	LONG TERM TREATMENT			0	10	MG	TABLET	QD
125534031	12553403	4	C	ATARAX	HYDROXYZINEHYDROXYZINE HYDROCHLORIDE	1	Oral	LONG TERM TREATMENT			0	25	MG	FILM COATED TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125534031	12553403	1	Product used for unknown indication
125534031	12553403	2	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
125534031	12553403	HO

Reactions reported

Event ID	CASEID	PT
125534031	12553403	Face oedema
125534031	12553403	Pruritus
125534031	12553403	Rash maculo-papular
125534031	12553403	Skin exfoliation

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
125534031	12553403	1	20160515	20160618	0
125534031	12553403	2	20160515	20160618	0