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
118821333	11882133	3	F	20151208	20160721	20151231	20160722	EXP	DE-BFARM-15422735	DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-72732DE	BOEHRINGER INGELHEIM		81.00	YR		F	Y	61.00000	KG	20160722		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 FREQ
118821333	11882133	1	PS	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	1	Oral	220 MG	U	22512	110	MG	BID
118821333	11882133	2	C	ASPIRIN.	ASPIRIN	1	Oral	50 MG		0	50	MG	QD
118821333	11882133	3	C	ARELIX	PIRETANIDE	1	Oral	6 MG		0	6	MG	QD
118821333	11882133	4	C	METOPROLOL SUCCINATE.	METOPROLOL SUCCINATE	1	Oral	190 MG		0	95	MG	BID
118821333	11882133	5	C	EBRANTIL	URAPIDIL	1	Oral	60 MG		0	30	MG	BID
118821333	11882133	6	C	PANTOPRAZOL	PANTOPRAZOLE SODIUM	1	Oral	40 MG		0	40	MG	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
118821333	11882133	1	Atrial fibrillation
118821333	11882133	2	Cerebellar infarction
118821333	11882133	3	Hypertension
118821333	11882133	4	Atrial fibrillation
118821333	11882133	5	Hypertension
118821333	11882133	6	Gastritis

Outcome of event

Event ID	CASEID	OUTC COD
118821333	11882133	DE

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
118821333	11882133		Cerebral 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
118821333	11882133	1	201509		0