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
126067241	12606724	1	I	201604	20160518	20160729	20160729	EXP		US-BAYER-2016-104093	BAYER		79.00	YR	E	M	Y	0.00000		20160729		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	RECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
126067241	12606724	1	SS	XARELTO	RIVAROXABAN	1	Oral	15 MG, QD	N	UNKNOWN	0	15	MG	FILM-COATED TABLET	QD
126067241	12606724	2	SS	XARELTO	RIVAROXABAN	1			N		0			FILM-COATED TABLET
126067241	12606724	3	PS	ACETYLSALICYLIC ACID({=100 mg)	ASPIRIN	1	Oral	81 MG, UNK			999999	81	MG
126067241	12606724	4	SS	MELOXICAM.	MELOXICAM	1	Oral	7.5 MG, QD			0	7.5	MG		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126067241	12606724	1	Cerebrovascular accident prophylaxis
126067241	12606724	2	Atrial fibrillation
126067241	12606724	3	Product used for unknown indication
126067241	12606724	4	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
126067241	12606724	HO
126067241	12606724	DE

Reactions reported

Event ID	CASEID	PT
126067241	12606724	Acute kidney injury
126067241	12606724	Cardiac failure
126067241	12606724	Gastrointestinal 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
126067241	12606724	1	2015	20160410	0