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
126034512	12603451	2	F	20150525	20160819	20160728	20160824	EXP		IT-GILEAD-2016-0224793	GILEAD		66.00	YR	E	M	Y	0.00000		20160824		PH	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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
126034512	12603451	1	PS	SOVALDI	SOFOSBUVIR	1	Oral	400 MG, QD	16400	MG	204671	400	MG	TABLET	QD
126034512	12603451	2	SS	OLYSIO	SIMEPREVIR	1	Oral	150 MG, QD	6150	MG	0	150	MG		QD
126034512	12603451	3	SS	COPEGUS	RIBAVIRIN	1	Oral	800 MG, QD	32800	MG	0	800	MG		QD
126034512	12603451	4	C	IPERTEN	MANIDIPINE	1	Oral	20 MG, UNK			0	20	MG
126034512	12603451	5	C	ENTACT	ESCITALOPRAM OXALATE	1	Oral	10 MG, UNK			0	10	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126034512	12603451	1	Hepatitis C
126034512	12603451	2	Hepatitis C
126034512	12603451	3	Hepatitis C
126034512	12603451	4	Product used for unknown indication
126034512	12603451	5	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
126034512	12603451	OT
126034512	12603451	HO

Reactions reported

Event ID	CASEID	PT
126034512	12603451	Dizziness
126034512	12603451	Dry skin
126034512	12603451	Hypotension
126034512	12603451	Syncope

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
126034512	12603451	1	20150415	20150708
126034512	12603451	2	20150415	20150708
126034512	12603451	3	20150415	20150708