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
87855904	8785590	4	F	201106	20160830	20120914	20160906	PER		US-ALEXION-A201201700	ALEXION		31.23	YR		F	Y	0.00000		20160906		OT	US	US

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	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
87855904	8785590	1	PS	SOLIRIS	ECULIZUMAB	1	Intravenous (not otherwise specified)	1200 MG, SINGLE				T2-A67765C	125166	1200	MG	CONCENTRATE FOR SOLUTION FOR INFUSION	QD
87855904	8785590	2	SS	SOLIRIS	ECULIZUMAB	1	Intravenous (not otherwise specified)	900 MG, QW X 4					125166	900	MG	CONCENTRATE FOR SOLUTION FOR INFUSION	/wk
87855904	8785590	3	SS	SOLIRIS	ECULIZUMAB	1	Intravenous (not otherwise specified)	900 MG, Q2W				T2-A75446C	125166	900	MG	CONCENTRATE FOR SOLUTION FOR INFUSION	QOW
87855904	8785590	4	SS	CELLCEPT	MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE	1	Unknown	UNK			Y		0
87855904	8785590	5	C	CIPROFLOXACIN.	CIPROFLOXACIN	1	Unknown	250 MG, QD	41510.418	MG			0	250	MG		QD
87855904	8785590	6	C	TACROLIMUS.	TACROLIMUS	1	Unknown	UNK					0
87855904	8785590	7	C	PREDNISONE.	PREDNISONE	1	Unknown	UNK					0
87855904	8785590	8	C	METOPROLOL.	METOPROLOL	1	Unknown	UNK					0
87855904	8785590	9	C	CYMBALTA	DULOXETINE HYDROCHLORIDE	1	Unknown						0
87855904	8785590	10	C	MYCOPHENOLATE	MYCOPHENOLIC ACID	1	Unknown	UNK					0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
87855904	8785590	1	Haemolytic uraemic syndrome
87855904	8785590	4	Product used for unknown indication
87855904	8785590	5	Prophylaxis
87855904	8785590	6	Product used for unknown indication
87855904	8785590	7	Product used for unknown indication
87855904	8785590	8	Product used for unknown indication
87855904	8785590	9	Product used for unknown indication
87855904	8785590	10	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
87855904	8785590	OT

Reactions reported

Event ID	CASEID	PT
87855904	8785590	Blood lactate dehydrogenase increased
87855904	8785590	Cytomegalovirus infection
87855904	8785590	Haemoglobin decreased

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
87855904	8785590	1	201206	201206
87855904	8785590	2	201106	201107
87855904	8785590	3	201107
87855904	8785590	4		201208
87855904	8785590	5	20110623	20120801