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
127366052	12736605	2	F		20160907	20160913	20160916	PER		US-JNJFOC-20160700232	JANSSEN		0.00			F	Y	0.00000		20160916		OT	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	RECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
127366052	12736605	1	SS	TRAMADOL HYDROCHLORIDE.	TRAMADOL HYDROCHLORIDE	1	Unknown		U	U	UNKNOWN	0	100	MG	UNSPECIFIED
127366052	12736605	2	SS	TRAMADOL HYDROCHLORIDE.	TRAMADOL HYDROCHLORIDE	1	Unknown		U	U	UNKNOWN	0	50	MG	UNSPECIFIED	QID
127366052	12736605	3	PS	TRAMADOL HYDROCHLORIDE.	TRAMADOL HYDROCHLORIDE	1	Unknown		U	U	UNKNOWN	20281	100	MG	UNSPECIFIED	QID
127366052	12736605	4	SS	LYRICA	PREGABALIN	1	Unknown		N		M46086	0			UNSPECIFIED
127366052	12736605	5	SS	LYRICA	PREGABALIN	1	Unknown		N		M46086	0	150	MG	UNSPECIFIED	QD
127366052	12736605	6	C	PROZAC	FLUOXETINE HYDROCHLORIDE	1	Unknown	FROM 25 YEARS (REPORTER TOLD HER THAT SINCE SHE WAS GOING THROUGH ALL THAT SHE COULD TAKE 2 A DAY)				0	20	MG	UNSPECIFIED	QD
127366052	12736605	7	C	PRILOSEC	OMEPRAZOLE MAGNESIUM	1	Unknown					0	20	MG	UNSPECIFIED	QD
127366052	12736605	8	C	SILYBUM MARIANUM	MILK THISTLE	1	Unknown					0	2000	MG	UNSPECIFIED	QD
127366052	12736605	9	C	VICODIN	ACETAMINOPHENHYDROCODONE BITARTRATE	1	Unknown	STARTED TAKING 10 YEARS AGO, TOOK ^TWO^ 10 MG 4 TIMES A DAY				0	20	MG	UNSPECIFIED	QID
127366052	12736605	10	C	VICODIN	ACETAMINOPHENHYDROCODONE BITARTRATE	1	Unknown					0			UNSPECIFIED
127366052	12736605	11	C	VICODIN	ACETAMINOPHENHYDROCODONE BITARTRATE	1	Unknown					0			UNSPECIFIED
127366052	12736605	12	C	VICODIN	ACETAMINOPHENHYDROCODONE BITARTRATE	1	Unknown	STARTED TAKING 10 YEARS AGO, TOOK ^TWO^ 10 MG 4 TIMES A DAY				0	20	MG	UNSPECIFIED	QID
127366052	12736605	13	C	ATENOLOL.	ATENOLOL	1	Unknown	TOOK FOR 3 YEARS				0	100	MG	UNSPECIFIED	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127366052	12736605	1	Arthralgia
127366052	12736605	2	Arthralgia
127366052	12736605	3	Arthralgia
127366052	12736605	4	Fibromyalgia
127366052	12736605	5	Fibromyalgia
127366052	12736605	6	Depression
127366052	12736605	7	Gastric ulcer
127366052	12736605	8	Hepatitis C
127366052	12736605	9	Hand deformity
127366052	12736605	10	Hand deformity
127366052	12736605	11	Myelopathy
127366052	12736605	12	Myelopathy
127366052	12736605	13	Hypertension

Outcome of event

Event ID	CASEID	OUTC COD
127366052	12736605	OT

Reactions reported

Event ID	CASEID	PT
127366052	12736605	Drug dependence
127366052	12736605	Drug ineffective
127366052	12736605	Feeling abnormal

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
127366052	12736605	4		201602
127366052	12736605	5	20160616
127366052	12736605	8	2013