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
126215481	12621548	1	I	20160614	20160722	20160804	20160804	EXP		IT-AUROBINDO-AUR-APL-2016-09823	AUROBINDO		20.39	YR		M	Y	0.00000		20160804		MD	IT	IT

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
126215481	12621548	1	SS	Delorazepam	DELORAZEPAM	1	Oral	34 MG, TOTAL	U	0	34	MG
126215481	12621548	2	PS	SERTRALINE	SERTRALINE HYDROCHLORIDE	1	Oral	800 MG, TOTAL	U	77206	800	MG
126215481	12621548	3	SS	RISPERDAL	RISPERIDONE	1	Oral	10 DF, TOTAL	U	0	10	DF	FILM-COATED TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126215481	12621548	1	Product used for unknown indication
126215481	12621548	2	Product used for unknown indication
126215481	12621548	3	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
126215481	12621548	HO

Reactions reported

Event ID	CASEID	PT
126215481	12621548	Drug abuse
126215481	12621548	Intentional self-injury
126215481	12621548	Sopor

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
126215481	12621548	1	20160614	20160614
126215481	12621548	2	20160614	20160614
126215481	12621548	3	20160614	20160614