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
111092316	11109231	6	F	20140404	20160711	20150513	20160715	EXP		ES-JNJFOC-20150504333	JANSSEN		0.00		E	M	Y	86.00000	KG	20160715		MD	ES	ES

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
111092316	11109231	1	PS	REMICADE	INFLIXIMAB	1	Intravenous (not otherwise specified)	0,2,6 WEEKS				N	UNKNOWN		103772	5	MG/KG	LYOPHILIZED POWDER
111092316	11109231	2	C	LOPRAZOLAM	LOPRAZOLAM	1	Unknown								0	1	MG	UNSPECIFIED

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
111092316	11109231	1	Colitis ulcerative
111092316	11109231	2	Anxiety

Outcome of event

Event ID	CASEID	OUTC COD
111092316	11109231	HO

Reactions reported

Event ID	CASEID	PT
111092316	11109231	Drug ineffective
111092316	11109231	Hemipelvectomy
111092316	11109231	Ileostomy
111092316	11109231	Post procedural complication

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
111092316	11109231	1	20110207	20110321	0
111092316	11109231	2	2010		0