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
124511133	12451113	3	F	201401	20160701	20160609	20160715	EXP		US-BAYER-2016-111904	BAYER		52.00	YR	A	M	Y	104.30000	KG	20160715		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
124511133	12451113	1	PS	ACETYLSALICYLIC ACID (} 100 mg)	ASPIRIN	1		81 MG, QD	U	21317	81	MG	TABLET	QD
124511133	12451113	2	SS	COZAAR	LOSARTAN POTASSIUM	1	Oral	50 MG, QD		0	50	MG		QD
124511133	12451113	3	SS	FUROSEMIDE.	FUROSEMIDE	1	Oral	40 MG, BID		0	40	MG		BID
124511133	12451113	4	SS	ROPINIROLE.	ROPINIROLE	1	Oral			0
124511133	12451113	5	SS	ROPINIROLE.	ROPINIROLE	1	Oral	2 TABLETS IN THE MORNING AND 2 TABLETS AT NIGHT		0
124511133	12451113	6	SS	LYRICA	PREGABALIN	1	Oral	75 MG (1 CAPSULE), BID		0	75	MG		BID
124511133	12451113	7	SS	LYRICA	PREGABALIN	1	Oral	150 MG (2 CAPSULES), BID		0	150	MG		BID
124511133	12451113	8	SS	LYRICA	PREGABALIN	1	Oral	75 MG (1 CAPSULE), BID		0	75	MG		BID
124511133	12451113	9	C	FAMOTIDINE.	FAMOTIDINE	1	Oral	40 MG, QD		0	40	MG		QD
124511133	12451113	10	C	ZANTAC	RANITIDINE HYDROCHLORIDE	1	Oral	150 MG, BID		0	150	MG		BID
124511133	12451113	11	C	CARVEDILOL.	CARVEDILOL	1		12.5 MG, BID		0	12.5	MG		BID
124511133	12451113	12	C	SPIRONOLACTONE.	SPIRONOLACTONE	1	Oral	50 MG, BID		0	50	MG		BID
124511133	12451113	13	C	UBIDECARENONE	UBIDECARENONE	1	Oral	100 MG, ONCE A DAY		0	100	MG
124511133	12451113	14	C	FENOFIBRATE.	FENOFIBRATE	1	Oral	160 MG, QD		0	160	MG		QD
124511133	12451113	15	C	ATORVASTATIN	ATORVASTATIN	1	Oral	40 MG, ONCE A DAY		0	40	MG
124511133	12451113	16	C	ACETAMINOPHEN AND CODEINE	ACETAMINOPHENCODEINE PHOSPHATE	1	Oral	300-60 MG EVERY 4 HOURS 6 TIMES A DAY		0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
124511133	12451113	1	Anticoagulant therapy
124511133	12451113	2	Blood pressure abnormal
124511133	12451113	3	Diuretic therapy
124511133	12451113	4	Restless legs syndrome
124511133	12451113	5	Restless legs syndrome
124511133	12451113	6	Restless legs syndrome
124511133	12451113	7	Restless legs syndrome
124511133	12451113	8	Restless legs syndrome
124511133	12451113	9	Gastric disorder
124511133	12451113	10	Gastrooesophageal reflux disease
124511133	12451113	11	General physical condition abnormal
124511133	12451113	12	Diuretic therapy
124511133	12451113	13	Routine health maintenance
124511133	12451113	14	Blood triglycerides increased
124511133	12451113	15	Blood cholesterol increased
124511133	12451113	16	Pain

Outcome of event

Event ID	CASEID	OUTC COD
124511133	12451113	OT

Reactions reported

Event ID	CASEID	PT
124511133	12451113	Dizziness
124511133	12451113	Feeling abnormal
124511133	12451113	Nausea
124511133	12451113	Sleep apnoea syndrome
124511133	12451113	Somnolence
124511133	12451113	Spinal fusion surgery
124511133	12451113	Vision blurred

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
124511133	12451113	1	201310
124511133	12451113	2	2013
124511133	12451113	3	201310
124511133	12451113	5	20160412
124511133	12451113	6	2015
124511133	12451113	7	20160412	20160416
124511133	12451113	8	20160417
124511133	12451113	11	201310
124511133	12451113	12	201310
124511133	12451113	14	2014
124511133	12451113	15	2014