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
127162081	12716208	1	I	20160425	20160829	20160906	20160906	EXP		PHHY2016CN120134	NOVARTIS		38.54	YR		F	Y	50.00000	KG	20160906		OT	CN	CN

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	DECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
127162081	12716208	1	PS	TEGRETOL	CARBAMAZEPINE	1	Oral	100 MG, BID	2600	MG	Y	X0945	16608	100	MG	TABLET	BID
127162081	12716208	2	C	ZOLOFT	SERTRALINE HYDROCHLORIDE	1	Oral	50 MG, QD	650	MG	Y	N07181	0	50	MG	TABLET	QD
127162081	12716208	3	C	KEPPRA	LEVETIRACETAM	1	Oral	0.5 G, BID	13	G	Y	179976	0	.5	G	TABLET	BID
127162081	12716208	4	C	METHYLCOBALAMIN.	METHYLCOBALAMIN	1	Oral	0.5 MG, BID	6	MG	Y	1601121	0	.5	MG	DISPERSIBLE TABLET	BID

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127162081	12716208	1	Muscle twitching
127162081	12716208	2	Depression
127162081	12716208	3	Muscle twitching
127162081	12716208	4	Nutritional supplementation

Outcome of event

Event ID	CASEID	OUTC COD
127162081	12716208	HO
127162081	12716208	DS

Reactions reported

Event ID	CASEID	PT
127162081	12716208	Liver function test abnormal
127162081	12716208	Oropharyngeal pain
127162081	12716208	Pruritus
127162081	12716208	Rash

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
127162081	12716208	1	20160413	20160427
127162081	12716208	2	20160413	20160529
127162081	12716208	3	20160413	20160429
127162081	12716208	4	20160420	20160427