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
125782911	12578291	1	I	20160308	20160712	20160721	20160721	EXP		IT-APOTEX-2016AP009849	APOTEX		69.36	YR		F	Y	0.00000		20160721		CN	IT	IT

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	DECHAL	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125782911	12578291	1	PS	AMLODIPINA DOC GENERICI COMPRESSE	AMLODIPINE BESYLATE	1	Oral	10 MG, DAILY			Y				76719	10	MG	TABLET
125782911	12578291	2	SS	OLMESARTAN MEDOXOMIL.	OLMESARTAN MEDOXOMIL	1	Unknown	20 MG, DAILY			Y				0	20	MG	TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125782911	12578291	1	Hypertension
125782911	12578291	2	Hypertension

Outcome of event

Event ID	CASEID	OUTC COD
125782911	12578291	HO

Reactions reported

Event ID	CASEID	PT
125782911	12578291	Hyperhidrosis
125782911	12578291	Orthostatic hypotension
125782911	12578291	Syncope
125782911	12578291	Vision blurred

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
125782911	12578291	1	20160225	20160308	0
125782911	12578291	2	20160101	20160308	0