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
127289471	12728947	1	I	20160811	20160906	20160909	20160909	EXP		JP-JNJFOC-20160907656	JANSSEN		80.00	YR	E	F	Y	0.00000		20160909		MD	JP	JP

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
127289471	12728947	1	PS	SIMPONI	GOLIMUMAB	1	Subcutaneous	N	125289	50	MG	SOLUTION FOR INJECTION
127289471	12728947	2	SS	PREDNISOLONE.	PREDNISOLONE	1	Oral		0	2	MG	TABLET	QD
127289471	12728947	3	SS	BUCILLAMINE	BUCILLAMINE	1	Oral		0	300	MG	TABLET	QD
127289471	12728947	4	SS	MUCOSTA	REBAMIPIDE	1	Oral		0	200	MG	TABLET	QD
127289471	12728947	5	SS	DEPAS	ETIZOLAM	1	Oral		0	1	MG	TABLET	QD
127289471	12728947	6	SS	VOLTAREN	DICLOFENAC SODIUM	1	Oral		0	75	MG	CAPSULE	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127289471	12728947	1	Rheumatoid arthritis
127289471	12728947	2	Rheumatoid arthritis
127289471	12728947	3	Rheumatoid arthritis
127289471	12728947	4	Gastric ulcer
127289471	12728947	5	Mental disorder
127289471	12728947	6	Pain

Outcome of event

Event ID	CASEID	OUTC COD
127289471	12728947	DE

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
127289471	12728947		Fall

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
127289471	12728947	1	201504	20160727
127289471	12728947	2		20160811
127289471	12728947	3		20160811
127289471	12728947	4		20160811
127289471	12728947	5		20160811
127289471	12728947	6		20160811