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
127337501	12733750	1	I	20140414	20140512	20160912	20160912	EXP		ZA-GILEAD-2014-0102606	GILEAD		53.00	YR	A	M	Y	40.50000	KG	20160912		MD	ZA	ZA

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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
127337501	12733750	1	PS	EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZEMTRICITABINETENOFOVIR DISOPROXIL FUMARATE	1	Oral	1 DF, QD			U	21937	1	DF	TABLET	QD
127337501	12733750	2	SS	EFAVIRENZ	EFAVIRENZ	1	Oral	600 MG, QD	1340400	MG		0	600	MG		QD
127337501	12733750	3	SS	STAVUDINE.	STAVUDINE	1	Oral	600 MG, QD	1340400	MG		0	600	MG		QD
127337501	12733750	4	SS	LAMIVUDINE.	LAMIVUDINE	1	Oral	300 MG, QD	670200	MG		0	300	MG		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127337501	12733750	1	HIV infection
127337501	12733750	2	HIV infection
127337501	12733750	3	HIV infection
127337501	12733750	4	HIV infection

Outcome of event

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
127337501	12733750		Acute kidney injury
127337501	12733750		Diarrhoea

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
127337501	12733750	1	20140414
127337501	12733750	2	20080302	20140414
127337501	12733750	3	20080302	20140414
127337501	12733750	4	20080302	20140414