Safety Rates Drug Report: adverse events in 2005 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	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
4629872	5768083	F	2	4629872-2	20030425	20050324	20050407	EXP	2005042086	SSR PFIZER INC	56	YR	M	N			20050405	MD				JAPAN

Drug(s) used by person

Event ID	DRUG SEQ	ROLE COD	DRUGNAME	VAL VBM	ROUTE	DOSE VBM	DECHAL	RECHAL	NDA NUM
4629872	1005856633	PS	VIRACEPT	1	ORAL	ORAL	D	D	20779
4629872	1005884724	SS	DIDANOSINE	1	ORAL	400 MG (1 IN 1 D), ORAL	N	D
4629872	1005884725	SS	LAMIVUDINE	1	ORAL	300 MG (150 MG, 2 IN 1 D), ORAL	N	D
4629872	1005884727	SS	ABACAVIR (ABACAVIR)	2	ORAL	600 MG (1 IN 1 D), ORAL	N	D
4629872	1005884728	SS	EFAVIRENZ (EFAVIRENZ)	2	ORAL	600 MG (1 IN 1 D), ORAL	D	D
4629872	1005884732	SS	KALETRA	1	ORAL	ORAL	D	D
4629872	1005884735	C	TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)	2
4629872	1005884736	C	ALL OTHER THERAPETIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)	2
4629872	1005884738	C	BACTRIM	1

Indications of drugs used

Outcome of event

Event ID	OUTC COD
4629872	HO

Reactions reported

Event ID	PT
4629872	ACTIVITIES OF DAILY LIVING IMPAIRED
4629872	ARRHYTHMIA
4629872	BRADYCARDIA
4629872	ELECTROCARDIOGRAM R ON T PHENOMENON
4629872	EXTRASYSTOLES
4629872	PALPITATIONS
4629872	SICK SINUS SYNDROME
4629872	SINOATRIAL BLOCK
4629872	SINUS ARREST
4629872	VENTRICULAR EXTRASYSTOLES

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

Therapies reported

Event ID	DRUG SEQ	START DT	END DT
4629872	1005856633	20030425
4629872	1005884724	20020716	20030409
4629872	1005884725	20010208	20030409
4629872	1005884727	20010406	20030409
4629872	1005884728	20010323
4629872	1005884732	20020513	20020715