Safety Rates Drug Report: adverse events in 2004 Q4 - 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
4542792	5706635	F		4542792-7	20041101	20041208	20041231	EXP	PHBS2004JP16522	NOVARTIS PHARMACEUTICALS CORP.	27	YR	F	Y	54	KG	20041229	MD

Drug(s) used by person

Event ID	DRUG SEQ	ROLE COD	DRUGNAME	VAL VBM	ROUTE	DOSE VBM
4542792	1005547059	PS	VOLTAREN	1	ORAL	75 MG/DAY
4542792	1005547060	SS	TERNELIN	2	ORAL	3 MG/DAY
4542792	1005547061	SS	MUCOSTA	2	ORAL	300 MG/DAY
4542792	1005547062	C	MECOBALAMIN	2	ORAL	1000 UG/DAY

Indications of drugs used

Event ID	DRUG SEQ	INDI PT
4542792	1005547059	INTERVERTEBRAL DISC PROTRUSION
4542792	1005547060	INTERVERTEBRAL DISC PROTRUSION
4542792	1005547061	INTERVERTEBRAL DISC PROTRUSION

Outcome of event

Event ID	OUTC COD
4542792	HO

Reactions reported

Event ID	PT
4542792	ALANINE AMINOTRANSFERASE INCREASED
4542792	ASPARTATE AMINOTRANSFERASE INCREASED
4542792	BACK PAIN
4542792	CONDITION AGGRAVATED
4542792	GAMMA-GLUTAMYLTRANSFERASE INCREASED
4542792	LIVER DISORDER

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

Event ID	RPSR COD
4542792	HP

Therapies reported

Event ID	DRUG SEQ	START DT	END DT	DUR	DUR COD
4542792	1005547059	20041108	20041207	43200	MIN
4542792	1005547060	20041108	20041207	43200	MIN
4542792	1005547061	20041108	20041207	43200	MIN
4542792	1005547062	20041115