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
125506201	12550620	1	I	20151002	20160707	20160712	20160712	EXP		CH-ALLERGAN-1662543US	ALLERGAN		37.00	YR		F	Y	0.00000		20160712		CN	CH	CH

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125506201	12550620	1	PS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.1 ML, SINGLE	U	103000	.1	ML	POWDER FOR INJECTION	QD
125506201	12550620	2	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.1 ML, SINGLE	U	103000	.1	ML	POWDER FOR INJECTION	QD
125506201	12550620	3	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.1 ML, SINGLE	U	103000	.1	ML	POWDER FOR INJECTION	QD
125506201	12550620	4	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.2 ML, SINGLE	U	103000	.2	ML	POWDER FOR INJECTION	QD
125506201	12550620	5	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.2 ML, SINGLE	U	103000	.2	ML	POWDER FOR INJECTION	QD
125506201	12550620	6	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.2 ML, SINGLE	U	103000	.2	ML	POWDER FOR INJECTION	QD
125506201	12550620	7	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.2 ML, SINGLE	U	103000	.2	ML	POWDER FOR INJECTION	QD
125506201	12550620	8	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.1 ML, SINGLE	U	103000	.1	ML	POWDER FOR INJECTION	QD
125506201	12550620	9	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.1 ML, SINGLE	U	103000	.1	ML	POWDER FOR INJECTION	QD
125506201	12550620	10	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.1 ML, SINGLE	U	103000	.1	ML	POWDER FOR INJECTION	QD
125506201	12550620	11	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.1 ML, SINGLE	U	103000	.1	ML	POWDER FOR INJECTION	QD
125506201	12550620	12	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.5 ML, SINGLE	U	103000	.5	ML	POWDER FOR INJECTION	QD
125506201	12550620	13	SS	BOTOX	ONABOTULINUMTOXINA	1	Intramuscular	0.5 ML, SINGLE	U	103000	.5	ML	POWDER FOR INJECTION	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125506201	12550620	1	Cervicogenic headache

Outcome of event

Event ID	CASEID	OUTC COD
125506201	12550620	OT

Reactions reported

Event ID	CASEID	PT
125506201	12550620	Dysphagia
125506201	12550620	Muscular weakness
125506201	12550620	Myalgia
125506201	12550620	Off label use
125506201	12550620	Pain of skin
125506201	12550620	Sleep disorder

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
125506201	12550620	1	20150929	20150929
125506201	12550620	2	20150929	20150929
125506201	12550620	3	20150929	20150929
125506201	12550620	4	20150929	20150929
125506201	12550620	5	20150929	20150929
125506201	12550620	6	20150929	20150929
125506201	12550620	7	20150929	20150929
125506201	12550620	8	20150929	20150929
125506201	12550620	9	20150929	20150929
125506201	12550620	10	20150929	20150929
125506201	12550620	11	20150929	20150929
125506201	12550620	12	20150929	20150929
125506201	12550620	13	20150929	20150929