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
125057362	12505736	2	F	20130827	20160616	20160628	20160701	EXP		CA-JNJFOC-20160615317	JANSSEN		34.69	YR	A	F	Y	64.00000	KG	20160701		OT	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
125057362	12505736	1	SS	REMICADE	INFLIXIMAB	1	Intravenous (not otherwise specified)					N	FLM04015		0	300	MG	LYOPHILIZED POWDER
125057362	12505736	2	PS	REMICADE	INFLIXIMAB	1	Intravenous (not otherwise specified)					N	FLM04015		103772	300	MG	LYOPHILIZED POWDER

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125057362	12505736	1	Crohn's disease
125057362	12505736	2	Crohn's disease

Outcome of event

Event ID	CASEID	OUTC COD
125057362	12505736	OT

Reactions reported

Event ID	CASEID	PT
125057362	12505736	Abdominal pain
125057362	12505736	Off label use
125057362	12505736	Pneumonia
125057362	12505736	Product use issue

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
125057362	12505736	1	20160507		0
125057362	12505736	2	20130827		0