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
121011563	12101156	3	F	2016	20160728	20160222	20160805	PER		US-AMGEN-USASL2016019214	AMGEN		74.00	YR	E	M	Y	0.00000		20160805		MD	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
121011563	12101156	1	PS	ENBREL	ETANERCEPT	1	Unknown	50 MG, QWK	U	1062178	103795	50	MG	SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE	/wk
121011563	12101156	2	SS	ENBREL	ETANERCEPT	1	Unknown	50 MG, QWK	U	1064421	103795	50	MG	SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE	/wk
121011563	12101156	3	SS	PREDNISONE.	PREDNISONE	1	Unknown	UNK			0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
121011563	12101156	1	Rheumatoid arthritis
121011563	12101156	3	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
121011563	12101156	OT

Reactions reported

Event ID	CASEID	PT
121011563	12101156	Blood pressure abnormal
121011563	12101156	Condition aggravated
121011563	12101156	Feeling abnormal
121011563	12101156	Headache
121011563	12101156	Mobility decreased
121011563	12101156	Ocular discomfort
121011563	12101156	Oral herpes
121011563	12101156	Pyrexia
121011563	12101156	Renal injury

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
121011563	12101156	1	201601		0
121011563	12101156	2		20160720	0