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
118134904	11813490	4	F	20150617	20160715	20151209	20160720	EXP		PHHO2015FR015024	NOVARTIS		58.62	YR		M	Y	80.00000	KG	20160720		MD	FR	FR

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
118134904	11813490	1	PS	EVEROLIMUS	EVEROLIMUS	1	Oral	0.75 MG, BID		21560	.75	MG	TABLET	BID
118134904	11813490	2	SS	NEORAL	CYCLOSPORINE	1	Oral	100 MG, BID	Y	0	100	MG		BID
118134904	11813490	3	SS	NEORAL	CYCLOSPORINE	1	Oral	75 MG, BID	Y	0	75	MG		BID
118134904	11813490	4	SS	NEORAL	CYCLOSPORINE	1	Oral	50 MG, BID	Y	0	50	MG		BID
118134904	11813490	5	SS	NEORAL	CYCLOSPORINE	1	Oral	UNK	Y	0
118134904	11813490	6	SS	SOLUPRED	PREDNISOLONE	1	Unknown			0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
118134904	11813490	1	Renal transplant
118134904	11813490	2	Renal transplant
118134904	11813490	6	Renal transplant

Outcome of event

Reactions reported

Event ID	CASEID	PT
118134904	11813490	Cerebrovascular accident
118134904	11813490	Multiple organ dysfunction syndrome
118134904	11813490	Pneumocystis jirovecii pneumonia
118134904	11813490	Pneumonia
118134904	11813490	Venous thrombosis limb

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
118134904	11813490	1	20141105	201509
118134904	11813490	2	20141105	201509
118134904	11813490	3	20150924	20151001
118134904	11813490	4	20151002