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
119811374	11981137	4	F	20151218	20160810	20160129	20160819	EXP		PL-KADMON PHARMACEUTICALS, LLC-KAD201601-000230	KADMON		40.77	YR		M	Y	69.00000	KG	20160819		MD	PL	PL

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	NDA NUM	DOSE AMT	DOSE UNIT
119811374	11981137	1	PS	RIBAVIRIN.	RIBAVIRIN	1	Oral	77456	1000	MG
119811374	11981137	2	SS	Viekirax	OMBITASVIRPARITAPREVIRRITONAVIR	1	Oral	0
119811374	11981137	3	SS	Exviera	DASABUVIR	1	Oral	0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
119811374	11981137	1	Hepatitis C
119811374	11981137	2	Hepatitis C
119811374	11981137	3	Hepatitis C

Outcome of event

Reactions reported

Event ID	CASEID	PT
119811374	11981137	Biliary cirrhosis
119811374	11981137	Blood bilirubin increased
119811374	11981137	Cardiac arrest
119811374	11981137	Chronic hepatitis C
119811374	11981137	General physical health deterioration

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
119811374	11981137	1	20151209	20151218
119811374	11981137	2	20151209	20151224
119811374	11981137	3	20151209	20151224