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
127920292	12792029	2	F	2007	20160926	20160929	20160930	EXP		US-JNJFOC-20160806472	JANSSEN		14.08	YR		M	Y	0.00000		20160930		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 FORM
127920292	12792029	1	SS	RISPERDAL	RISPERIDONE	1	Oral	1 MG- 2 MG	U	U	0	TABLETS
127920292	12792029	2	SS	RISPERDAL	RISPERIDONE	1	Oral	1 MG- 2 MG	U	U	0	TABLETS
127920292	12792029	3	PS	RISPERDAL	RISPERIDONE	1	Oral	1 MG- 2 MG	U	U	20272	TABLETS
127920292	12792029	4	SS	RISPERIDONE.	RISPERIDONE	1	Oral		U		0	TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127920292	12792029	1	Anxiety
127920292	12792029	2	Conduct disorder
127920292	12792029	3	Bipolar disorder
127920292	12792029	4	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
127920292	12792029	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
127920292	12792029		Gynaecomastia
127920292	12792029		Obesity

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
127920292	12792029	1	2006	2008
127920292	12792029	2	2006	2008
127920292	12792029	3	2006	2008