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
125532464	12553246	4	F	2008	20160926	20160713	20160926	EXP		US-PFIZER INC-2016335983	PFIZER		34.00	YR		F	Y	56.70000	KG	20160926		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125532464	12553246	1	PS	LYRICA	PREGABALIN	1	Oral	75 MG, 1X/DAY	N18485	21446	75	MG	CAPSULE, HARD	QD
125532464	12553246	2	SS	LYRICA	PREGABALIN	1	Oral	75 MG, 2X/DAY	M81422	21446	75	MG	CAPSULE, HARD	BID
125532464	12553246	3	SS	PRISTIQ EXTENDED-RELEASE	DESVENLAFAXINE SUCCINATE	1	Oral	150 MG, UNK	N68581	21992	150	MG	PROLONGED-RELEASE TABLET
125532464	12553246	4	SS	PRISTIQ EXTENDED-RELEASE	DESVENLAFAXINE SUCCINATE	1	Oral	50 MG, 3X/DAY		21992	50	MG	PROLONGED-RELEASE TABLET	TID
125532464	12553246	5	SS	PRISTIQ EXTENDED-RELEASE	DESVENLAFAXINE SUCCINATE	1	Oral	200 MG A DAY/ (50 MG) 4 A DAY		21992	200	MG	PROLONGED-RELEASE TABLET
125532464	12553246	6	C	CLONAZEPAM.	CLONAZEPAM	1	Oral	2 MG, 2X/DAY (ONCE IN THE MORNING AND ONCE AT NIGHT)		0	2	MG	TABLET	BID
125532464	12553246	7	C	METOPROLOL.	METOPROLOL	1	Oral	25 MG, 1X/DAY		0	25	MG	TABLET	QD
125532464	12553246	8	C	TIZANIDINE.	TIZANIDINE	1	Oral	4 MG, AS NEEDED (P.R.N 6 HOURS)		0	4	MG	TABLET
125532464	12553246	9	C	TIZANIDINE.	TIZANIDINE	1				0			TABLET
125532464	12553246	10	C	MYRBETRIQ	MIRABEGRON	1	Oral	75 MG, 1X/DAY		0	75	MG	TABLET	QD
125532464	12553246	11	C	MYRBETRIQ	MIRABEGRON	1	Oral	50 MG, UNK		0	50	MG	TABLET
125532464	12553246	12	C	CELEBREX	CELECOXIB	1				0
125532464	12553246	13	C	KLONOPIN	CLONAZEPAM	1		2 MG, UNK		0	2	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125532464	12553246	1	Neuralgia
125532464	12553246	2	Multiple sclerosis
125532464	12553246	3	Major depression
125532464	12553246	6	Anxiety
125532464	12553246	7	Anxiety
125532464	12553246	8	Urinary incontinence
125532464	12553246	9	Muscle relaxant therapy
125532464	12553246	10	Urinary incontinence
125532464	12553246	13	Anxiety

Outcome of event

Event ID	CASEID	OUTC COD
125532464	12553246	OT

Reactions reported

Event ID	CASEID	PT
125532464	12553246	Anger
125532464	12553246	Anxiety
125532464	12553246	Condition aggravated
125532464	12553246	Crying
125532464	12553246	Depression
125532464	12553246	Drug ineffective
125532464	12553246	Emotional distress
125532464	12553246	Intentional self-injury
125532464	12553246	Major depression
125532464	12553246	Multiple sclerosis
125532464	12553246	Pain
125532464	12553246	Personality change
125532464	12553246	Product use issue
125532464	12553246	Suicidal ideation
125532464	12553246	Suicide attempt

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
125532464	12553246	1	2008
125532464	12553246	2	201606
125532464	12553246	3	2008
125532464	12553246	4	2015
125532464	12553246	5	20160523
125532464	12553246	6	2008
125532464	12553246	7	201504
125532464	12553246	8	201502
125532464	12553246	10	201502