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
126348631	12634863	1	I	20100503	20160721	20160808	20160808	EXP		IT-IGI LABORATORIES, INC.-1055923	IGI LABORATORIES		69.00	YR		M	Y	0.00000		20160808		CN	IT	IT

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FREQ
126348631	12634863	1	PS	ZANTAC	RANITIDINE HYDROCHLORIDE	1	Unknown	U	19090	300	MG	BID
126348631	12634863	2	SS	CETIRIZINE HCL	CETIRIZINE HYDROCHLORIDE	1	Unknown	U	0			BID
126348631	12634863	3	SS	ULTRAVIST	IOPROMIDE	1	Intravenous (not otherwise specified)		0	66	ML

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126348631	12634863	1	Premedication

Outcome of event

Event ID	CASEID	OUTC COD
126348631	12634863	DE
126348631	12634863	OT

Reactions reported

Event ID	CASEID	PT
126348631	12634863	Abdominal pain
126348631	12634863	Anaphylactic shock
126348631	12634863	Cardiac arrest
126348631	12634863	Cardiac fibrillation
126348631	12634863	Drug ineffective for unapproved indication
126348631	12634863	Dyspnoea
126348631	12634863	Loss of consciousness
126348631	12634863	Malaise
126348631	12634863	Miosis
126348631	12634863	Off label use
126348631	12634863	Product use issue
126348631	12634863	Wrong patient received medication

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
126348631	12634863	1	2010
126348631	12634863	2	2010
126348631	12634863	3	20100503	20100503