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
125028762	12502876	2	F	200911	20160628	20160628	20160701	EXP		HU-ACTELION-A-CH2016-137789	ACTELION		58.00	YR	A	F	Y	0.00000		20160701		OT	HU	HU

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
125028762	12502876	1	PS	TRACLEER	BOSENTAN	1	Oral	125 MG, BID	650125	MG					21290	125	MG	TABLET	BID
125028762	12502876	2	SS	TRACLEER	BOSENTAN	1	Oral	62.5 MG, BID	650125	MG					21290	62.5	MG	TABLET	BID

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125028762	12502876	1	Pulmonary arterial hypertension

Outcome of event

Reactions reported

Event ID	CASEID	PT
125028762	12502876	Acute kidney injury
125028762	12502876	Anuria
125028762	12502876	Atrial septal defect repair
125028762	12502876	Diarrhoea
125028762	12502876	Haemodialysis
125028762	12502876	Inflammatory marker increased
125028762	12502876	Metabolic acidosis
125028762	12502876	Nausea
125028762	12502876	Pancreatitis
125028762	12502876	Renal function test abnormal
125028762	12502876	Respiratory failure
125028762	12502876	Sepsis

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
125028762	12502876	1	20090612	20160612	0
125028762	12502876	2	20090316	20090611	0