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
124878042	12487804	2	F		20160829	20160622	20160906	EXP		PHHY2016BR025990	NOVARTIS		0.00			F	Y	48.00000	KG	20160906		MD	BR	BR

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	DOSE FREQ
124878042	12487804	1	PS	TRILEPTAL	OXCARBAZEPINE	1	Oral	20 ML (6 ML IN THE MORNING, 7 ML IN THE AFTERNOON AND 7 ML AT NIGHT, GRADUALLY INCREMENTED), UKN	H7212/ H7214	21285	20	ML	SUSPENSION
124878042	12487804	2	SS	TRILEPTAL	OXCARBAZEPINE	1	Oral	8 ML, UNK	H7212/ H7214	21285	8	ML	SUSPENSION
124878042	12487804	3	SS	TRILEPTAL	OXCARBAZEPINE	1	Oral	22 ML (7 ML IN THE MORNING, 7 ML AT LUNCH AND 8 ML AT NIGHT), UKN	H7212/ H7214	21285	22	ML	SUSPENSION
124878042	12487804	4	C	URBANIL	CLOBAZAM	1	Oral	1 DF (ONE TABLET), QD		0	1	DF	TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
124878042	12487804	1	Seizure
124878042	12487804	4	Seizure

Outcome of event

Event ID	CASEID	OUTC COD
124878042	12487804	OT

Reactions reported

Event ID	CASEID	PT
124878042	12487804	Ataxia
124878042	12487804	Cognitive disorder
124878042	12487804	Hormone level abnormal
124878042	12487804	Seizure
124878042	12487804	Wrong technique in product usage process

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