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
119848452	11984845	2	F		20160731	20160201	20160815	EXP		US-APOPHARMA USA, INC.-2016AP006055	APOTEX		5.00	MON		F	Y	0.00000		20160815		MD	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
119848452	11984845	1	PS	ALKERAN	MELPHALAN	1	Intra-arterial	0.4 MG/KG, OTHER	U	U	20207	.4	MG/KG	INJECTION
119848452	11984845	2	C	TOPOTECAN	TOPOTECANTOPOTECAN HYDROCHLORIDE	1	Intra-arterial	0.2 MG, OTHER		U	0	.2	MG
119848452	11984845	3	C	EPINEPHRINE.	EPINEPHRINE	1	Nasal			U	0
119848452	11984845	4	C	NEOSYNEPHRINE	PHENYLEPHRINE HYDROCHLORIDE	1	Nasal			U	0
119848452	11984845	5	C	NEOSYNEPHRINE	PHENYLEPHRINE HYDROCHLORIDE	1				U	0
119848452	11984845	6	C	NEOSYNEPHRINE	PHENYLEPHRINE HYDROCHLORIDE	1				U	0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
119848452	11984845	1	Retinoblastoma
119848452	11984845	2	Retinoblastoma
119848452	11984845	3	Vasoconstriction
119848452	11984845	4	Hyperaemia
119848452	11984845	5	Rash
119848452	11984845	6	Oedema

Outcome of event

Event ID	CASEID	OUTC COD
119848452	11984845	OT

Reactions reported

Event ID	CASEID	PT
119848452	11984845	Bronchospasm
119848452	11984845	Hypersensitivity
119848452	11984845	Neutropenia

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

no results found

no results found

Therapies reported

no results found

no results found