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
127831961	12783196	1	I	20160919	0	20160927	20160927	DIR	US-FDA-351613		FDA-CTU		6.67	MON		M	N	0.00000		20160927	N	MD	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
127831961	12783196	1	PS	Loperamide	LOPERAMIDE	1	Oral				Y	Y			999999	160	MG		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127831961	12783196	1	Diarrhoea

Outcome of event

Reactions reported

Event ID	CASEID	PT
127831961	12783196	Arrhythmia
127831961	12783196	Back pain
127831961	12783196	Chills
127831961	12783196	Diarrhoea
127831961	12783196	Hot flush
127831961	12783196	Hyperhidrosis
127831961	12783196	Nausea
127831961	12783196	Restlessness
127831961	12783196	Syncope
127831961	12783196	Ventricular tachycardia
127831961	12783196	Vomiting
127831961	12783196	Withdrawal syndrome

Reporting Sources (this data is often not reported and may therefore be missing here)

Event ID	CASEID	RPSR COD
127831961	12783196	HP

Therapies reported

Event ID	CASEID	DSG DRUG SEQ	START DT	END DT	DUR	DUR COD
127831961	12783196	1			2	YR