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
125476192	12547619	2	F	20160628	20160803	20160712	20160808	EXP		IN-ROCHE-1790040	ROCHE		36.01	YR		F	Y	0.00000		20160808		CN	IN	IN

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
125476192	12547619	1	PS	Omalizumab	OMALIZUMAB	1	Subcutaneous		S0001	103976	300	MG	SOLUTION FOR INJECTION
125476192	12547619	2	SS	Omalizumab	OMALIZUMAB	1	Subcutaneous	UNK	S0001	103976	300	MG	SOLUTION FOR INJECTION
125476192	12547619	3	SS	Omalizumab	OMALIZUMAB	1	Subcutaneous	UNK	S0001	103976	300	MG	SOLUTION FOR INJECTION

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125476192	12547619	1	Urticaria

Outcome of event

Event ID	CASEID	OUTC COD
125476192	12547619	OT

Reactions reported

Event ID	CASEID	PT
125476192	12547619	Lip swelling
125476192	12547619	Pruritus
125476192	12547619	Pyrexia
125476192	12547619	Swelling
125476192	12547619	Swelling face
125476192	12547619	Urticaria

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
125476192	12547619	1	20160528
125476192	12547619	2	20160628
125476192	12547619	3	20160802