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
125530492	12553049	2	F		20160809	20160713	20160822	EXP		BR-JNJFOC-20160706403	JANSSEN		0.00		A	F	Y	0.00000		20160822		MD	BR	BR

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	RECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
125530492	12553049	1	SS	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	1	Intramuscular	N	UNKNOWN	0	100	MG	INJECTION
125530492	12553049	2	SS	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	1	Intramuscular	N	UNKNOWN	0			INJECTION
125530492	12553049	3	PS	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	1	Intramuscular	N	UNKNOWN	22264	150	MG	INJECTION

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125530492	12553049	1	Schizophrenia
125530492	12553049	2	Schizophrenia
125530492	12553049	3	Schizophrenia

Outcome of event

Event ID	CASEID	OUTC COD
125530492	12553049	OT

Reactions reported

Event ID	CASEID	PT
125530492	12553049	Aggression
125530492	12553049	Delirium
125530492	12553049	Drug ineffective
125530492	12553049	Hallucination

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
125530492	12553049	3	20160608		0