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
124548792	12454879	2	F	20160525	20160805	20160610	20160810	EXP		IT-GLAXOSMITHKLINE-IT2016GSK081381	GLAXOSMITHKLINE		59.32	YR		M	Y	0.00000		20160810		MD	IT	IT

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	DECHAL	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
124548792	12454879	1	PS	DICLOFENAC SODIUM.	DICLOFENAC SODIUM	1	Oral	150 MG, QD	600	MG	Y				22122	150	MG		QD
124548792	12454879	2	C	SIRDALUD	TIZANIDINE	1	Unknown	UNK			U				0			TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
124548792	12454879	1	Neck pain
124548792	12454879	2	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
124548792	12454879	HO
124548792	12454879	OT

Reactions reported

Event ID	CASEID	PT
124548792	12454879	Anaphylactic reaction
124548792	12454879	Facial bones fracture
124548792	12454879	Fall
124548792	12454879	Syncope
124548792	12454879	Urticaria

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
124548792	12454879	1	20160521	20160525	0