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
125809831	12580983	1	I	201512	20160715	20160721	20160721	EXP		US-MYLANLABS-2016M1029746	MYLAN		0.00				Y	0.00000		20160721		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125809831	12580983	1	PS	AMNESTEEM	ISOTRETINOIN	1	Oral	40 MG, QD	N	75945	40	MG	CAPSULE	QD
125809831	12580983	2	SS	MYORISAN	ISOTRETINOIN	1	Oral	40 MG, QD	N	0	40	MG		QD
125809831	12580983	3	C	ORAL CONTRACEPTIVE NOS	UNSPECIFIED INGREDIENT	1	Oral	UNK		0				QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125809831	12580983	1	Acne
125809831	12580983	2	Acne
125809831	12580983	3	Contraception

Outcome of event

Event ID	CASEID	OUTC COD
125809831	12580983	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125809831	12580983		Arthralgia
125809831	12580983		Rheumatoid arthritis

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
125809831	12580983	1	20151110	201603	0
125809831	12580983	2	201510	20151110	0