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
121369053	12136905	3	F	20160220	20160818	20160302	20160823	EXP		DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-12013DE	BOEHRINGER INGELHEIM		74.82	YR		M	Y	80.00000	KG	20160823		MD	DE	DE

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
121369053	12136905	1	PS	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	1	Oral	300 MG	Y	22512	150	MG	CAPSULE, HARD	BID
121369053	12136905	2	SS	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	1			Y	22512
121369053	12136905	3	SS	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	1			Y	22512

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
121369053	12136905	1	Atrial fibrillation
121369053	12136905	2	Thrombosis prophylaxis
121369053	12136905	3	Cerebrovascular accident prophylaxis

Outcome of event

Reactions reported

Event ID	CASEID	PT
121369053	12136905	Fall
121369053	12136905	Haemorrhagic diathesis
121369053	12136905	Paraplegia
121369053	12136905	Quadriplegia
121369053	12136905	Wound haemorrhage

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
121369053	12136905	1		20160220	0