Safety Rates Drug Report: adverse events in 2010 Q2 - FDA prescription drugs adverse events in an open, searchable, online, public database

Drug Injury Quarter

Person who experienced the adverse event (patient)

Event ID	CASE	I F COD	FOLL SEQ	IMAGE	EVENT DT	MFR DT	FDA DT	REPT COD	MFR NUM	MFR SNDR	AGE	AGE COD	GNDR COD	E SUB	WT	WT COD	REPT DT	OCCP COD	DEATH DT	TO MFR	CONFID	REPORTER COUNTRY
6761368	7418917	I		6761368-4	20100113	20100521	20100607	EXP	AUR-APL-2010-01365	AUROBINDO PHARMA USA	54	YR	M	N	83	KG	20100603	MD

Drug(s) used by person

Event ID	DRUG SEQ	ROLE COD	DRUGNAME	VAL VBM	ROUTE	DOSE VBM	DECHAL	RECHAL	NDA NUM
6761368	1013829811	PS	METFORMIN	2	ORAL	500MG, QD, ORAL	Y	D	77095
6761368	1013861136	SS	CRESTOR	1	ORAL	10MG, QD, ORAL	Y	D
6761368	1013861138	SS	JANUMET	1	ORAL	50/1000MG, BID, ORAL	Y	D
6761368	1013861202	SS	ACTOS	1	ORAL	15 MG, DAILY, ORAL	Y	D
6761368	1013861207	SS	OMACOR	1	ORAL	1000MG,QID, ORAL	Y	D
6761368	1013861208	SS	ALLOPURINOL	1	ORAL	150MG,DAILY, ORAL	Y	D
6761368	1013861210	SS	RASILEZ	2	ORAL	150MG, DAILY, ORAL	Y	D
6761368	1013861211	C	RAMIPRIL	1
6761368	1013861215	C	METOHEXAL SUCC 95	2

Indications of drugs used

Outcome of event

Event ID	OUTC COD
6761368	HO

Reactions reported

Event ID	PT
6761368	ALANINE AMINOTRANSFERASE INCREASED
6761368	ASPARTATE AMINOTRANSFERASE INCREASED
6761368	FATIGUE
6761368	GAMMA-GLUTAMYLTRANSFERASE INCREASED

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

Therapies reported

Event ID	DRUG SEQ	START DT	END DT
6761368	1013829811	20080701	20100422
6761368	1013861136	20091008	20100423
6761368	1013861138	20090101	20100423
6761368	1013861202	20090713	20100423
6761368	1013861207	20080701	20100423
6761368	1013861208		20100423
6761368	1013861210	20070101	20100423