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
127303561	12730356	1	I	201608	20160906	20160909	20160909	EXP		FR-GLAXOSMITHKLINE-FR2016GSK130912	GLAXOSMITHKLINE		60.44	YR		M	Y	0.00000		20160909		OT	FR	FR

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	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
127303561	12730356	1	PS	Zelitrex	VALACYCLOVIR HYDROCHLORIDE	1		500 MG, 1D	3500	MG	U	20487	500	MG	FILM-COATED TABLET	QD
127303561	12730356	2	SS	Sandimmun	CYCLOSPORINE	1	Intravenous (not otherwise specified)	220 MG, 1D	440	MG	U	0	220	MG	SOLUTION FOR INJECTION	QD
127303561	12730356	3	SS	NEORAL	CYCLOSPORINE	1	Oral	400 MG, 1D			U	0	400	MG	CAPSULE	QD
127303561	12730356	4	SS	THYMOGLOBULINE	LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN	1	Intravenous (not otherwise specified)	UNK				0
127303561	12730356	5	SS	Simvastatine	SIMVASTATIN	1	Oral	40 MG, 1D			U	0	40	MG	TABLET	QD
127303561	12730356	6	SS	Zyloric	ALLOPURINOL	1	Oral	UNK			U	0			TABLET
127303561	12730356	7	SS	Tiorfan	RACECADOTRIL	1		300 MG, 1D	600	MG	U	0	300	MG	CAPSULE	QD
127303561	12730356	8	SS	DIOSMECTITE	MONTMORILLONITE	1	Oral	3 DF, 1D	6	DF	U	0	3	DF		QD
127303561	12730356	9	SS	Bisoprolol	BISOPROLOL	1	Oral	1 DF, 1D			U	0	1	DF		QD
127303561	12730356	10	SS	AERIUS	DESLORATADINE	1	Oral	10 MG, 1D	80	MG	U	0	10	MG	TABLET	QD
127303561	12730356	11	C	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUMTAZOBACTAM SODIUM	1		UNK				0
127303561	12730356	12	C	Gentamicine	GENTAMICIN	1		UNK				0
127303561	12730356	13	C	Vancomycine	VANCOMYCIN	1		UNK				0
127303561	12730356	14	C	VFEND	VORICONAZOLE	1		UNK				0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127303561	12730356	1	Product used for unknown indication
127303561	12730356	2	Product used for unknown indication
127303561	12730356	3	Product used for unknown indication
127303561	12730356	5	Hypercholesterolaemia
127303561	12730356	6	Product used for unknown indication
127303561	12730356	7	Product used for unknown indication
127303561	12730356	9	Product used for unknown indication
127303561	12730356	10	Product used for unknown indication
127303561	12730356	11	Lung disorder
127303561	12730356	12	Lung disorder
127303561	12730356	13	Lung disorder
127303561	12730356	14	Lung disorder

Outcome of event

Event ID	CASEID	OUTC COD
127303561	12730356	DE
127303561	12730356	OT

Reactions reported

Event ID	CASEID	PT
127303561	12730356	Acute kidney injury
127303561	12730356	Confusional state
127303561	12730356	Renal tubular necrosis
127303561	12730356	Rhabdomyolysis
127303561	12730356	Shock

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
127303561	12730356	1	20160727	20160822
127303561	12730356	2	20160801	20160810
127303561	12730356	3	20160812	20160818
127303561	12730356	4	20160730	20160731
127303561	12730356	5		20160821
127303561	12730356	6		20160818
127303561	12730356	7	20160801	20160803
127303561	12730356	8	20160801	20160803
127303561	12730356	9		20160822
127303561	12730356	10	20160726	20160803
127303561	12730356	12	20160815
127303561	12730356	13	20160815
127303561	12730356	14	20160817	20160822