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
117754022	11775402	2	F	2000	20160823	20151125	20160907	EXP		US-JNJFOC-20151105315	JANSSEN		0.00		A	M	Y	0.00000		20160907		CN	US	US

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
117754022	11775402	1	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0	3	MG	TABLETS
117754022	11775402	2	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0	3	MG	TABLETS
117754022	11775402	3	SS	RISPERDAL	RISPERIDONE	1	Oral	1-6 MG, 3MG		U	0			TABLETS
117754022	11775402	4	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0			TABLETS
117754022	11775402	5	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0	3	MG	TABLETS
117754022	11775402	6	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0			TABLETS
117754022	11775402	7	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0	3	MG	TABLETS
117754022	11775402	8	SS	RISPERDAL	RISPERIDONE	1	Oral	1-6 MG, 3MG		U	0			TABLETS
117754022	11775402	9	SS	RISPERDAL	RISPERIDONE	1	Oral	1-6 MG, 3MG		U	0			TABLETS
117754022	11775402	10	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0			TABLETS
117754022	11775402	11	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0	3	MG	TABLETS
117754022	11775402	12	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0	3	MG	TABLETS
117754022	11775402	13	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0	3	MG	TABLETS
117754022	11775402	14	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0	3	MG	TABLETS
117754022	11775402	15	SS	RISPERDAL	RISPERIDONE	1	Oral			U	0			TABLETS
117754022	11775402	16	PS	RISPERDAL	RISPERIDONE	1	Oral	1-6 MG, 3MG		U	20272			TABLETS
117754022	11775402	17	SS	RISPERDAL CONSTA	RISPERIDONE	1	Intramuscular			U	0			MICROSPHERES
117754022	11775402	18	SS	RISPERDAL CONSTA	RISPERIDONE	1	Intramuscular	25-50 MG		U	21346			MICROSPHERES
117754022	11775402	19	SS	RISPERIDONE.	RISPERIDONE	1	Oral		U		0			TABLETS

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
117754022	11775402	1	Mental disorder
117754022	11775402	2	Mental disorder
117754022	11775402	3	Mental disorder
117754022	11775402	4	Mental disorder
117754022	11775402	5	Schizoaffective disorder depressive type
117754022	11775402	6	Schizoaffective disorder depressive type
117754022	11775402	7	Schizoaffective disorder depressive type
117754022	11775402	8	Schizoaffective disorder depressive type
117754022	11775402	9	Attention deficit/hyperactivity disorder
117754022	11775402	10	Attention deficit/hyperactivity disorder
117754022	11775402	11	Attention deficit/hyperactivity disorder
117754022	11775402	12	Attention deficit/hyperactivity disorder
117754022	11775402	13	Schizophrenia
117754022	11775402	14	Schizophrenia
117754022	11775402	15	Schizophrenia
117754022	11775402	16	Schizophrenia
117754022	11775402	17	Product used for unknown indication
117754022	11775402	18	Product used for unknown indication
117754022	11775402	19	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
117754022	11775402	OT

Reactions reported

Event ID	CASEID	PT
117754022	11775402	Gynaecomastia
117754022	11775402	Nephropathy
117754022	11775402	Obesity
117754022	11775402	Type 2 diabetes mellitus

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
117754022	11775402	2	1999	2000
117754022	11775402	3	1994	2014
117754022	11775402	4		20140728
117754022	11775402	6		20140728
117754022	11775402	7	1999	2000
117754022	11775402	8	1994	2014
117754022	11775402	9	1994	2014
117754022	11775402	10		20140728
117754022	11775402	12	1999	2000
117754022	11775402	14	1999	2000
117754022	11775402	15		20140728
117754022	11775402	16	1994	2014
117754022	11775402	17		20140728
117754022	11775402	18	1994	2014