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
117266165	11726616	5	F		20160816	20151112	20160830	EXP		PHEH2015US022848	NOVARTIS		0.00			F	Y	0.00000		20160830		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	NDA NUM	DOSE FORM
117266165	11726616	1	PS	ZOFRAN	ONDANSETRON HYDROCHLORIDE	1	Oral	UNK	U	20007
117266165	11726616	2	SS	ONDANSETRON HYDROCHLORIDE.	ONDANSETRON HYDROCHLORIDE	1	Oral	UNK		20007	TABLET
117266165	11726616	3	SS	ONDANSETRON HYDROCHLORIDE.	ONDANSETRON HYDROCHLORIDE	1	Unknown	UNK		20007	SOLUTION FOR INJECTION

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
117266165	11726616	1	Vomiting in pregnancy
117266165	11726616	2	Product used for unknown indication
117266165	11726616	3	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
117266165	11726616	OT

Reactions reported

Event ID	CASEID	PT
117266165	11726616	Anxiety
117266165	11726616	Emotional distress
117266165	11726616	Injury
117266165	11726616	Maternal exposure during pregnancy
117266165	11726616	Pain
117266165	11726616	Product use issue

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
117266165	11726616	2	201004	201101	0
117266165	11726616	3	201004	201101	0