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
126647431	12664743	1	I	201511	20160811	20160818	20160818	EXP		FR-MEDAC PHARMA, INC.-1056485	MEDAC		44.00	YR		F	Y	0.00000		20160818		OT	COUNTRY NOT SPECIFIED	FR

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
126647431	12664743	1	PS	Metoject	METHOTREXATE SODIUM	1	Subcutaneous	N	205776	1	DF	SOLUTION FOR INJECTION
126647431	12664743	2	SS	PENTASA	MESALAMINE	1	Oral	N	0	2	DF	GRANULES	BID
126647431	12664743	3	SS	REMICADE	INFLIXIMAB	1		N	0	100	MG	POWDER FOR SOLUTION FOR INFUSION

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126647431	12664743	1	Colitis

Outcome of event

Event ID	CASEID	OUTC COD
126647431	12664743	LT
126647431	12664743	DS

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
126647431	12664743		Lung adenocarcinoma
126647431	12664743		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
126647431	12664743	1	201501	201504	0
126647431	12664743	3	20100322	20150107	0