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
125322791	12532279	1	I	201606	20160630	20160706	20160706	EXP		US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-43063BP	BOEHRINGER INGELHEIM		55.10	YR		M	Y	0.00000		20160706		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125322791	12532279	1	PS	SPIRIVA	TIOTROPIUM BROMIDE MONOHYDRATE	1	Respiratory (inhalation)		507710A	21395	18	UG	INHALATION POWDER, HARD CAPSULE
125322791	12532279	2	SS	SPIRIVA	TIOTROPIUM BROMIDE MONOHYDRATE	1	Respiratory (inhalation)	36 MCG	507710A	21395	18	UG	INHALATION POWDER, HARD CAPSULE	BID
125322791	12532279	3	SS	SPIRIVA	TIOTROPIUM BROMIDE MONOHYDRATE	1	Oral	18 MCG	507710A	21395	18	UG	INHALATION POWDER, HARD CAPSULE	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125322791	12532279	1	Chronic obstructive pulmonary disease

Outcome of event

Event ID	CASEID	OUTC COD
125322791	12532279	HO

Reactions reported

Event ID	CASEID	PT
125322791	12532279	Eye disorder
125322791	12532279	Incorrect dose administered
125322791	12532279	Incorrect route of drug administration
125322791	12532279	Nervousness

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
125322791	12532279	1	201605
125322791	12532279	2	201606	20160630
125322791	12532279	3	20160630	20160630