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
126952183	12695218	3	F	20160613	20160901	20160829	20160906	EXP		IT-009507513-1608ITA012528	MERCK		83.00	YR		M	Y	0.00000		20160906		OT	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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
126952183	12695218	1	PS	REBETOL	RIBAVIRIN	1	Oral	800 MG, QD	117600	MG	Y	U		20903	800	MG	CAPSULE	QD
126952183	12695218	2	SS	SOVALDI	SOFOSBUVIR	1	Oral	400 MG, QD	58800	MG	Y		VDKWD000106655	0	400	MG	FILM-COATED TABLET	QD
126952183	12695218	3	C	INSULIN DEGLUDEC	INSULIN DEGLUDEC	1	Subcutaneous	UNK						0
126952183	12695218	4	C	ramipril ABC		2	Oral	UNK						0			TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126952183	12695218	1	Chronic hepatitis C
126952183	12695218	2	Chronic hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
126952183	12695218	HO

Reactions reported

Event ID	CASEID	PT
126952183	12695218	Cardiac failure
126952183	12695218	Dyspnoea
126952183	12695218	Oedema peripheral
126952183	12695218	Pleural effusion

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
126952183	12695218	1	20160119	20160613
126952183	12695218	2	20160119	20160613
126952183	12695218	3	2014
126952183	12695218	4	2011