Safety Rates Drug Report: adverse events in 2016 Q1 - 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
118558063	11855806	3	F	2011	20160125	20151221	20160128	EXP		CN-GLAXOSMITHKLINE-CN2015GSK178393	GLAXOSMITHKLINE		45.00	YR		M	Y	0.00000		20160128		CN	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	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
118558063	11855806	1	PS	HEPTODIN	LAMIVUDINE	1	Oral	100 MG, QD							21003	100	MG	TABLET	QD
118558063	11855806	2	SS	HEPTODIN	LAMIVUDINE	1		UNK					15050057		21003			TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
118558063	11855806	1	Hepatitis B

Outcome of event

Event ID	CASEID	OUTC COD
118558063	11855806	HO

Reactions reported

Event ID	CASEID	PT
118558063	11855806	Alanine aminotransferase increased
118558063	11855806	Jaundice
118558063	11855806	Perihepatic discomfort
118558063	11855806	Pyrexia
118558063	11855806	Suspected counterfeit product
118558063	11855806	Swelling
118558063	11855806	Transaminases increased

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	DUR	DUR COD
118558063	11855806	1	2010		0