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
103804014	10380401	4	F	20140220	20160815	20140813	20160822	EXP		JP-JNJFOC-20140805137	JANSSEN		52.00	YR	A	M	Y	0.00000		20160822		MD	JP	JP

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
103804014	10380401	1	SS	PREZISTA	DARUNAVIR ETHANOLATE	1	Oral	N	0	400	MG	TABLETS	BID
103804014	10380401	2	PS	PREZISTA	DARUNAVIR ETHANOLATE	1	Oral	N	21976	800	MG	TABLETS	QD
103804014	10380401	3	SS	NORVIR	RITONAVIR	1	Oral		0	100	MG	UNSPECIFIED	QD
103804014	10380401	4	SS	TRUVADA	EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE	1	Oral		0	1	DF	TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
103804014	10380401	1	HIV infection
103804014	10380401	2	HIV infection
103804014	10380401	3	HIV infection
103804014	10380401	4	HIV infection

Outcome of event

Event ID	CASEID	OUTC COD
103804014	10380401	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
103804014	10380401		Renal impairment

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
103804014	10380401	1	20121116
103804014	10380401	2	20140605
103804014	10380401	3	20121106
103804014	10380401	4	20121116