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
126731671	12673167	1	I	201606	20160808	20160822	20160822	EXP		NL-TOLMAR, INC.-2016NL007916	TOLMAR		0.00			M	Y	0.00000		20160822		CN	NL	NL

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
126731671	12673167	1	PS	ELIGARD	LEUPROLIDE ACETATE	1	Subcutaneous	45 MG, 1X6 MONTHS			U				21731	45	MG	INJECTION
126731671	12673167	2	SS	ZOLADEX	GOSERELIN ACETATE	1	Unknown	10.8 MG, FOR 12 WEEKS			U	U			0	10.8	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126731671	12673167	1	Prostate cancer
126731671	12673167	2	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
126731671	12673167	OT

Reactions reported

Event ID	CASEID	PT
126731671	12673167	Drug prescribing error
126731671	12673167	Gait disturbance
126731671	12673167	Loose tooth
126731671	12673167	Metastasis
126731671	12673167	Neuralgia
126731671	12673167	Night blindness
126731671	12673167	Ocular hyperaemia
126731671	12673167	Paraesthesia
126731671	12673167	Tooth loss

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
126731671	12673167	1	20160610		0
126731671	12673167	2	20160523		0