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
88250596	8825059	6	F	20120124	20160630	20121004	20160707	EXP		PHHY2012CA007629	NOVARTIS		32.05	YR		F	Y	0.00000		20160707		MD	CA	CA

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
88250596	8825059	1	PS	GILENYA	FINGOLIMOD HYDROCHLORIDE	1	Oral	0.5 MG, QD			Y				22527	.5	MG	CAPSULE	QD
88250596	8825059	2	SS	GILENYA	FINGOLIMOD HYDROCHLORIDE	1	Oral	0.5 MG, QD			Y				22527	.5	MG	CAPSULE	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
88250596	8825059	1	Relapsing-remitting multiple sclerosis

Outcome of event

Event ID	CASEID	OUTC COD
88250596	8825059	OT

Reactions reported

Event ID	CASEID	PT
88250596	8825059	Central nervous system lesion
88250596	8825059	Dizziness
88250596	8825059	Headache
88250596	8825059	Hypoaesthesia
88250596	8825059	Multiple sclerosis relapse
88250596	8825059	Paraesthesia

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
88250596	8825059	1	20120124	20130129	0
88250596	8825059	2	20130424	201508	0