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
127896551	12789655	1	I	20150824	20160921	20160928	20160928	EXP		JP-MYLANLABS-2016M1040959	MYLAN		0.00				Y	0.00000		20160928		OT	JP	JP

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
127896551	12789655	1	PS	Cilostazol MYLAN	CILOSTAZOL	1	Oral	50 MG, BID	D	77019	50	MG	TABLET	BID
127896551	12789655	2	SS	Magnesium Oxide MYLAN	MAGNESIUM OXIDE	1	Oral	500 MG, BID	D	0	500	MG	TABLET	BID
127896551	12789655	3	SS	ELIQUIS	APIXABAN	1	Oral	2.5 MG, BID	D	0	2.5	MG	TABLET	BID
127896551	12789655	4	SS	ELIQUIS	APIXABAN	1			D	0			TABLET
127896551	12789655	5	SS	AMLODIPINE	AMLODIPINE BESYLATE	1	Oral	5 MG, QD	D	0	5	MG	TABLET	QD
127896551	12789655	6	SS	MECOBALAMIN	METHYLCOBALAMIN	1	Oral	500 ?G, TID	D	0	500	UG	TABLET	TID
127896551	12789655	7	SS	LIMAPROST ALFADEX	LIMAPROST	1	Oral	5 ?G, TID	D	0	5	UG	TABLET	TID
127896551	12789655	8	SS	AZOSEMIDE	AZOSEMIDE	1	Oral	15 MG, QD	D	0	15	MG	TABLET	QD
127896551	12789655	9	SS	ALLOPURINOL.	ALLOPURINOL	1	Oral	100 MG, BID	D	0	100	MG	TABLET	BID
127896551	12789655	10	SS	PREGABALIN.	PREGABALIN	1	Oral	150 MG, BID	D	0	150	MG	CAPSULE	BID
127896551	12789655	11	SS	WARFARIN POTASSIUM	WARFARIN POTASSIUM	1	Oral	2 MG, QD	D	0	2	MG	TABLET	QD
127896551	12789655	12	SS	WARFARIN POTASSIUM	WARFARIN POTASSIUM	1	Oral	2 MG, QD	D	0	2	MG	TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127896551	12789655	1	Lumbar spinal stenosis
127896551	12789655	2	Constipation
127896551	12789655	3	Ischaemic stroke
127896551	12789655	4	Embolism
127896551	12789655	5	Hypertension
127896551	12789655	6	Lumbar spinal stenosis
127896551	12789655	7	Lumbar spinal stenosis
127896551	12789655	8	Oedema
127896551	12789655	9	Hyperuricaemia
127896551	12789655	10	Lumbar spinal stenosis
127896551	12789655	11	Atrial fibrillation

Outcome of event

Reactions reported

Event ID	CASEID	PT
127896551	12789655	Cardiac failure congestive
127896551	12789655	Cardiac valve disease
127896551	12789655	Ear haemorrhage
127896551	12789655	Haematemesis
127896551	12789655	Haemorrhagic diathesis
127896551	12789655	Heart valve stenosis
127896551	12789655	International normalised ratio increased
127896551	12789655	Interstitial lung disease
127896551	12789655	Right ventricular failure

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
127896551	12789655	3	20151001
127896551	12789655	11		20150924
127896551	12789655	12	20151001