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
126358921	12635892	1	I		20160801	20160809	20160809	EXP		AU-ACTELION-A-CH2016-140251	ACTELION		77.00	YR	E	F	Y	0.00000		20160808		MD	AU	AU

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
126358921	12635892	1	PS	OPSUMIT	MACITENTAN	1	Oral	10 MG, OD							204410	10	MG	TABLET	QD
126358921	12635892	2	SS	REVATIO	SILDENAFIL CITRATE	1	Oral	20 MG, TID							0	20	MG		TID

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126358921	12635892	1	Pulmonary arterial hypertension
126358921	12635892	2	Pulmonary arterial hypertension

Outcome of event

Event ID	CASEID	OUTC COD
126358921	12635892	HO

Reactions reported

Event ID	CASEID	PT
126358921	12635892	Arthralgia
126358921	12635892	Condition aggravated
126358921	12635892	Disease progression
126358921	12635892	Escherichia urinary tract infection
126358921	12635892	Hypervolaemia
126358921	12635892	Pulmonary arterial hypertension
126358921	12635892	Right ventricular 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
126358921	12635892	1	20160630		0
126358921	12635892	2	20160704		0