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
85775827	8577582	7	F	20120131	20160818	20120524	20160823	EXP		DK-JNJFOC-20120512192	JANSSEN		28.00	YR	A	F	Y	71.00000	KG	20160823		MD	DK	DK

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
85775827	8577582	1	PS	REMICADE	INFLIXIMAB	1	Intravenous (not otherwise specified)	N	103772	760	MG	LYOPHILIZED POWDER
85775827	8577582	2	C	AZATHIOPRINE.	AZATHIOPRINE	1	Oral		0	150	MG		QD
85775827	8577582	3	C	MESALAZINE	MESALAMINE	1	Oral		0	1600	MG		BID
85775827	8577582	4	C	HUMIRA	ADALIMUMAB	1	Subcutaneous		0	40	MG		QOW

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
85775827	8577582	1	Colitis ulcerative
85775827	8577582	2	Colitis ulcerative
85775827	8577582	3	Colitis ulcerative
85775827	8577582	4	Colitis ulcerative

Outcome of event

Event ID	CASEID	OUTC COD
85775827	8577582	HO
85775827	8577582	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
85775827	8577582		Colitis ulcerative
85775827	8577582		Rectal discharge

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
85775827	8577582	1	20110415	20110923
85775827	8577582	2	20110314	20120131
85775827	8577582	3		20120131
85775827	8577582	4	20111021	20111201