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
125632523	12563252	3	F	2015	20160927	20160715	20160928	EXP		US-PFIZER INC-2016338340	PFIZER		59.00	YR		M	Y	68.00000	KG	20160928		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125632523	12563252	1	PS	LIPITOR	ATORVASTATIN CALCIUM	1		20 MG, 1X/DAY	Y	RX7840927	20702	20	MG	FILM-COATED TABLET	QD
125632523	12563252	2	SS	LIPITOR	ATORVASTATIN CALCIUM	1			Y		20702			FILM-COATED TABLET
125632523	12563252	3	C	TYLENOL EXTRA STRENGTH	ACETAMINOPHEN	1	Oral	500MG ONE OR TWO TABLETS, AS NEEDED			0			TABLET
125632523	12563252	4	C	TYLENOL EXTRA STRENGTH	ACETAMINOPHEN	1					0			TABLET
125632523	12563252	5	C	ADVIL	IBUPROFEN	1	Oral	200MG ONE OR TWO TABLETS BY MOUTH TWICE A DAY, AS NEEDED		J25511	0			TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125632523	12563252	1	Blood cholesterol increased
125632523	12563252	2	Hyperlipidaemia
125632523	12563252	3	Arthralgia
125632523	12563252	4	Abdominal pain upper
125632523	12563252	5	Pain

Outcome of event

Event ID	CASEID	OUTC COD
125632523	12563252	HO
125632523	12563252	OT

Reactions reported

Event ID	CASEID	PT
125632523	12563252	Activities of daily living impaired
125632523	12563252	Arthralgia
125632523	12563252	Blood creatine phosphokinase increased
125632523	12563252	Dermatomyositis
125632523	12563252	Fatigue
125632523	12563252	Gait disturbance
125632523	12563252	Muscle injury
125632523	12563252	Muscular weakness
125632523	12563252	Myalgia
125632523	12563252	Rash
125632523	12563252	Suicide attempt

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
125632523	12563252	1	20140829
125632523	12563252	3	201510
125632523	12563252	5	201510