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
125219911	12521991	1	I		20160629	20160701	20160701	EXP		US-ASTELLAS-2016US025317	ASTELLAS		61.00	YR		M	Y	0.00000		20160701		CN	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	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125219911	12521991	1	PS	PROGRAF	TACROLIMUSTACROLIMUS ANHYDROUS	1	Oral								50708	1	MG	CAPSULE	BID
125219911	12521991	2	SS	RAPAMUNE	SIROLIMUS	1	Unknown	UNK, UNKNOWN FREQ.							0			FORMULATION UNKNOWN

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125219911	12521991	1	Liver transplant
125219911	12521991	2	Liver transplant

Outcome of event

Event ID	CASEID	OUTC COD
125219911	12521991	OT
125219911	12521991	DE

Reactions reported

Event ID	CASEID	PT
125219911	12521991	Drug level decreased
125219911	12521991	Hepatic neoplasm
125219911	12521991	Intestinal obstruction
125219911	12521991	Liver transplant rejection
125219911	12521991	Renal failure

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	DUR	DUR COD
125219911	12521991	1	201103	201606	0