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
125620251	12562025	1	I	20160708	20160713	20160715	20160715	EXP		CO-JNJFOC-20160712205	JANSSEN		43.27	YR	A	M	Y	58.00000	KG	20160715		OT	CO	CO

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
125620251	12562025	1	SS	RISPERDAL CONSTA	RISPERIDONE	1	Intramuscular	N	0	25	MG	MICROSPHERES
125620251	12562025	2	PS	RISPERDAL CONSTA	RISPERIDONE	1	Intramuscular	N	21346	37.5	MG	MICROSPHERES
125620251	12562025	3	SS	CLOZAPINE.	CLOZAPINE	1	Unknown		0	1	MG	UNKNOWN
125620251	12562025	4	SS	CLOZAPINE.	CLOZAPINE	1	Unknown		0	2	MG	UNKNOWN

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125620251	12562025	1	Schizophrenia
125620251	12562025	2	Schizophrenia
125620251	12562025	3	Product used for unknown indication
125620251	12562025	4	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
125620251	12562025	HO

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125620251	12562025		Anxiety
125620251	12562025		Mood altered

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
125620251	12562025	1	20151201		0
125620251	12562025	2	20160708		0