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
127707171	12770717	1	I	2014	20160908	20160922	20160922	EXP	DE-BFARM-16309342	DE-TEVA-692259GER	TEVA		0.00			M	Y	0.00000		20160922		CN	DE	DE

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	DECHAL	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
127707171	12770717	1	PS	isotretinoin	ISOTRETINOIN	1		HIGH DOSE							76135
127707171	12770717	2	SS	isotretinoin	ISOTRETINOIN	1		10 MILLIGRAM DAILY;							76135	10	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127707171	12770717	1	Rosacea

Outcome of event

Event ID	CASEID	OUTC COD
127707171	12770717	OT

Reactions reported

Event ID	CASEID	PT
127707171	12770717	Back pain
127707171	12770717	Chest discomfort
127707171	12770717	Hydromyelia
127707171	12770717	Muscle spasms
127707171	12770717	Musculoskeletal stiffness
127707171	12770717	Spinal osteoarthritis

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
127707171	12770717	1	2010		0
127707171	12770717	2	2010	201605	0