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
89046706	8904670	6	F	2002	20160721	20121112	20160726	EXP		US-009507513-1211USA004393	MERCK		0.00			M	Y	0.00000		20160726		MD	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	DECHAL	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
89046706	8904670	1	PS	FOSAMAX	ALENDRONATE SODIUM	1	Oral	UNK	30590	MG			20560			TABLET
89046706	8904670	2	SS	FOSAMAX	ALENDRONATE SODIUM	1	Oral	70 MG, QW	30590	MG			20560	70	MG	TABLET	/wk
89046706	8904670	3	SS	ALENDRONATE SODIUM.	ALENDRONATE SODIUM	1	Oral	70 MG, UNK			U		20560	70	MG	TABLET
89046706	8904670	4	SS	ALENDRONATE SODIUM.	ALENDRONATE SODIUM	1	Oral	70 MG, UNK			U		0	70	MG
89046706	8904670	5	C	LUPRON	LEUPROLIDE ACETATE	1	Subcutaneous	22.5 MG, QD				U	0	22.5	MG	INJECTION	QD
89046706	8904670	6	C	ATENOLOL.	ATENOLOL	1	Unknown	UNK				U	0
89046706	8904670	7	C	ALTACE	RAMIPRIL	1	Unknown	5 MG, QD				U	0	5	MG		QD
89046706	8904670	8	C	HORMONES (UNSPECIFIED)	UNSPECIFIED INGREDIENT	1	Unknown					U	0
89046706	8904670	9	C	HYDROCHLOROTHIAZIDE.	HYDROCHLOROTHIAZIDE	1	Unknown	12.5 MG, UNK				U	0	12.5	MG		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
89046706	8904670	1	Osteoporosis
89046706	8904670	3	Osteoporosis
89046706	8904670	4	Osteoporosis
89046706	8904670	5	Radical prostatectomy
89046706	8904670	6	Hypertension
89046706	8904670	7	Hypertension
89046706	8904670	8	Product used for unknown indication
89046706	8904670	9	Hypertension

Outcome of event

Reactions reported

Event ID	CASEID	PT
89046706	8904670	Anaemia
89046706	8904670	Aortic valve incompetence
89046706	8904670	Arteriosclerosis
89046706	8904670	Atrioventricular block complete
89046706	8904670	Blood cholesterol increased
89046706	8904670	Bone infarction
89046706	8904670	Dementia
89046706	8904670	Drug ineffective
89046706	8904670	Dyspnoea
89046706	8904670	Dyspnoea exertional
89046706	8904670	Enchondromatosis
89046706	8904670	Fall
89046706	8904670	Femur fracture
89046706	8904670	Fluid retention
89046706	8904670	Foot deformity
89046706	8904670	Foot fracture
89046706	8904670	High turnover osteopathy
89046706	8904670	Hypokalaemia
89046706	8904670	Mitral valve incompetence
89046706	8904670	Neuropathy peripheral
89046706	8904670	Open reduction of fracture
89046706	8904670	Osteoarthritis
89046706	8904670	Peripheral swelling
89046706	8904670	Restrictive cardiomyopathy
89046706	8904670	Skin lesion
89046706	8904670	Syncope

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
89046706	8904670	1	199911
89046706	8904670	2	20021216	20110421
89046706	8904670	5	1992
89046706	8904670	6	2002	200611
89046706	8904670	7	200405	201103
89046706	8904670	9	20060421