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
120942434	12094243	4	F	20160129	20160727	20160219	20160729	EXP	DE-BFARM-16046734	DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-09413DE	BOEHRINGER INGELHEIM		76.00	YR		F	Y	90.00000	KG	20160729		MD	DE	DE

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
120942434	12094243	1	PS	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	1	Oral	300 MG			N				22512	150	MG		BID
120942434	12094243	2	SS	PLAVIX	CLOPIDOGREL BISULFATE	1	Oral	75 MG			N				0	75	MG		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
120942434	12094243	1	Atrial fibrillation
120942434	12094243	2	Stent placement

Outcome of event

Event ID	CASEID	OUTC COD
120942434	12094243	LT

Reactions reported

Event ID	CASEID	PT
120942434	12094243	Acute kidney injury
120942434	12094243	Haemothorax
120942434	12094243	Pulmonary sepsis

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
120942434	12094243	1	20150919	20160128	0
120942434	12094243	2	20150918	20160128	0