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
127401041	12740104	1	I	20150123	20151002	20160913	20160913	EXP		PHHY2015FR134881	NOVARTIS		62.30	YR		M	Y	0.00000		20160913		MD	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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
127401041	12740104	1	PS	MYFORTIC	MYCOPHENOLATE SODIUM	1	Unknown	720 MG, QD	357480	MG	50791	720	MG	TABLET	QD
127401041	12740104	2	SS	MYFORTIC	MYCOPHENOLATE SODIUM	1	Unknown	720 MG, QD	357480	MG	50791	720	MG	TABLET	QD
127401041	12740104	3	SS	MYFORTIC	MYCOPHENOLATE SODIUM	1	Unknown	360 MG, QD	357480	MG	50791	360	MG	TABLET	QD
127401041	12740104	4	SS	PROGRAF	TACROLIMUSTACROLIMUS ANHYDROUS	1	Unknown	10 MG, QD	2206	MG	0	10	MG		QD
127401041	12740104	5	SS	PROGRAF	TACROLIMUSTACROLIMUS ANHYDROUS	1	Unknown	8 MG, QD	2206	MG	0	8	MG		QD
127401041	12740104	6	SS	PROGRAF	TACROLIMUSTACROLIMUS ANHYDROUS	1	Oral	3 MG, BID	2206	MG	0	3	MG		BID
127401041	12740104	7	SS	CORTANCYL	PREDNISONE	1	Unknown	5 MG, QD	2295	MG	0	5	MG		QD
127401041	12740104	8	SS	CORTANCYL	PREDNISONE	1	Unknown	2.5 MG, QD	2295	MG	0	2.5	MG		QD
127401041	12740104	9	SS	IMUREL	AZATHIOPRINE SODIUM	1	Unknown	100 MG, QD	5100	MG	0	100	MG		QD
127401041	12740104	10	SS	IMUREL	AZATHIOPRINE SODIUM	1			5100	MG	0
127401041	12740104	11	SS	MERCAPTOPURINE.	MERCAPTOPURINE	1	Unknown	50 MG, QD			0	50	MG		QD
127401041	12740104	12	SS	MERCAPTOPURINE.	MERCAPTOPURINE	1					0
127401041	12740104	13	SS	NO TREATMENT RECEIVED	UNSPECIFIED INGREDIENT	1	Unknown				0
127401041	12740104	14	SS	VOLTAREN	DICLOFENAC SODIUM	1	Unknown				0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127401041	12740104	1	Liver transplant
127401041	12740104	2	Immunosuppressant drug therapy
127401041	12740104	4	Liver transplant
127401041	12740104	5	Immunosuppressant drug therapy
127401041	12740104	7	Liver transplant
127401041	12740104	8	Immunosuppressant drug therapy
127401041	12740104	9	Liver transplant
127401041	12740104	10	Immunosuppressant drug therapy
127401041	12740104	11	Liver transplant
127401041	12740104	12	Immunosuppressant drug therapy
127401041	12740104	13	Product used for unknown indication
127401041	12740104	14	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
127401041	12740104	DE

Reactions reported

Event ID	CASEID	PT
127401041	12740104	Chronic kidney disease
127401041	12740104	Diarrhoea
127401041	12740104	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	END DT
127401041	12740104	1	20140111	20140811
127401041	12740104	2	20140905	20150521
127401041	12740104	3	20150522	20150709
127401041	12740104	4	20140125	20140831
127401041	12740104	5	20140901	20140902
127401041	12740104	6	20140903
127401041	12740104	7	20140125	20150428
127401041	12740104	8	20150429
127401041	12740104	9	20150718	20150906
127401041	12740104	11	20150910