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
123859065	12385906	5	F	20160516	20160627	20160519	20160923	EXP		PL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-31345PN	BOEHRINGER INGELHEIM		79.92	YR		F	Y	72.00000	KG	20160923		MD	PL	PL

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
123859065	12385906	1	PS	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	1	Oral	300 MG							22512	150	MG	TABLET	BID

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
123859065	12385906	1	Atrial fibrillation

Outcome of event

Reactions reported

Event ID	CASEID	PT
123859065	12385906	Accident at home
123859065	12385906	Blood pressure abnormal
123859065	12385906	Cerebral haemorrhage
123859065	12385906	Fall
123859065	12385906	Intracranial haematoma
123859065	12385906	Retrograde amnesia
123859065	12385906	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	DUR	DUR COD
123859065	12385906	1	2014		0