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
124124405	12412440	5	F	20160518	20160811	20160527	20160817	EXP		CA-TAKEDA-2016MPI004515	TAKEDA		79.00	YR		M	Y	74.40000	KG	20160817		MD	CA	CA

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
124124405	12412440	1	PS	Ixazomib	IXAZOMIB	1	Oral	2.3 MG, UNK	U	3147885	208462	2.3	MG	CAPSULE
124124405	12412440	2	SS	Lenalidomide	LENALIDOMIDE	1	Oral	10 MG, UNK	U		0	10	MG	CAPSULE
124124405	12412440	3	SS	DEXAMETHASONE.	DEXAMETHASONE	1	Oral	20 MG, UNK		102738	0	20	MG	TABLET
124124405	12412440	4	C	ACETYLSALICYLIC ACID	ASPIRIN	1	Oral	81 MG, QD			0	81	MG		QD
124124405	12412440	5	C	AVODART	DUTASTERIDE	1	Oral	0.5 MG, QD			0	.5	MG		QD
124124405	12412440	6	C	CYMBALTA	DULOXETINE HYDROCHLORIDE	1	Oral	60 MG, QD			0	60	MG		QD
124124405	12412440	7	C	FENTANYL.	FENTANYL	1	Transdermal	UNK			0
124124405	12412440	8	C	SYNTHROID	LEVOTHYROXINE SODIUM	1	Oral	125 ?G, QD			0	125	UG		QD
124124405	12412440	9	C	FLOMAX	TAMSULOSIN HYDROCHLORIDE	1	Oral	0.4 MG, QD			0	.4	MG		QD
124124405	12412440	10	C	VITAMIN B12	CYANOCOBALAMIN	1	Oral	UNK, QD			0				QD
124124405	12412440	11	C	LYRICA	PREGABALIN	1	Oral	75 MG, BID			0	75	MG		BID
124124405	12412440	12	C	PANTOPRAZOLE	PANTOPRAZOLE SODIUM	1	Oral	40 MG, QD			0	40	MG		QD
124124405	12412440	13	C	VALACYCLOVIR	VALACYCLOVIR HYDROCHLORIDE	1	Oral	500 MG, QD			0	500	MG		QD
124124405	12412440	14	C	VALACYCLOVIR	VALACYCLOVIR HYDROCHLORIDE	1					0
124124405	12412440	15	C	ZOPICLONE	ZOPICLONE	1	Oral	7.5 MG, UNK	U		0	7.5	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
124124405	12412440	1	Plasma cell myeloma
124124405	12412440	2	Plasma cell myeloma
124124405	12412440	3	Plasma cell myeloma
124124405	12412440	4	Thrombosis prophylaxis
124124405	12412440	5	Benign prostatic hyperplasia
124124405	12412440	6	Depression
124124405	12412440	8	Hypothyroidism
124124405	12412440	9	Benign prostatic hyperplasia
124124405	12412440	10	Prophylaxis
124124405	12412440	13	Herpes zoster
124124405	12412440	14	Prophylaxis
124124405	12412440	15	Insomnia

Outcome of event

Event ID	CASEID	OUTC COD
124124405	12412440	HO

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
124124405	12412440		Delirium
124124405	12412440		Pneumonia

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
124124405	12412440	1	20131128	20160512
124124405	12412440	2	20131128	20160518
124124405	12412440	3	20131127	20150416
124124405	12412440	4	20131127
124124405	12412440	5	2006
124124405	12412440	6	2008
124124405	12412440	7	2006
124124405	12412440	8	2006
124124405	12412440	10	2013
124124405	12412440	11	20140905
124124405	12412440	12	20140926
124124405	12412440	13	20131106
124124405	12412440	15	20140806