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
126163911	12616391	1	I		20160729	20160802	20160802	EXP		PHHY2016BR105370	NOVARTIS		0.00			F	Y	80.00000	KG	20160802		CN	COUNTRY NOT SPECIFIED	BR

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
126163911	12616391	1	PS	DIOVAN	VALSARTAN	1	Oral	80 MG, QD	1519164	21283	80	MG	TABLET	QD
126163911	12616391	2	SS	DIOVAN	VALSARTAN	1				21283			TABLET
126163911	12616391	3	SS	DIOVAN HCT	HYDROCHLOROTHIAZIDEVALSARTAN	1	Oral	1 DF (HYDROCHLOROTHIAZIDE 25 MG, VALSARTAN 320 MG), QD	SA513 AND SA534	0	1	DF	TABLET	QD
126163911	12616391	4	SS	DIOVAN HCT	HYDROCHLOROTHIAZIDEVALSARTAN	1				0			TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126163911	12616391	1	Hypertension
126163911	12616391	2	Cardiac failure
126163911	12616391	3	Hypertension
126163911	12616391	4	Cardiac failure

Outcome of event

Reactions reported

Event ID	CASEID	PT
126163911	12616391	Atrial fibrillation
126163911	12616391	Cardiac failure
126163911	12616391	Condition aggravated
126163911	12616391	Pneumonia

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
126163911	12616391	1	201507		0