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
102332926	10233292	6	F	2012	20160826	20140612	20160902	EXP		US-PFIZER INC-2014159413	PFIZER		81.00	YR		F	Y	62.00000	KG	20160902		MD	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
102332926	10233292	1	PS	PREMARIN	ESTROGENS, CONJUGATED	1		0.625 MG, UNK (20 DAYS A MONTH)	Y	KO614	4782	.625	MG	TABLET
102332926	10233292	2	SS	PREMARIN	ESTROGENS, CONJUGATED	1	Oral	0.625 MG, UNK (22 DAYS IN A MONTH)	Y		4782	.625	MG	TABLET
102332926	10233292	3	SS	PREMARIN	ESTROGENS, CONJUGATED	1	Oral	0.625 MG, 1X/DAY FOR THE FIRST 1-20 OR 25 DAYS	Y		4782	.625	MG	TABLET	QD
102332926	10233292	4	SS	PREMARIN	ESTROGENS, CONJUGATED	1	Oral	0.325 MG, 1X/DAY	Y		4782	.325	MG	TABLET	QD
102332926	10233292	5	SS	PREMARIN	ESTROGENS, CONJUGATED	1	Oral	0.3 MG, 1X/DAY	Y		4782	.3	MG	TABLET	QD
102332926	10233292	6	SS	PROVERA	MEDROXYPROGESTERONE ACETATE	1	Oral	2.5 MG, UNK (10 DAYS IN A MONTH (16TH DAY OF MONTH TO 25TH DAY OF MONTH)	Y		11839	2.5	MG	TABLET
102332926	10233292	7	SS	PROVERA	MEDROXYPROGESTERONE ACETATE	1	Oral	0.25 MG, 1X/DAY FOR DAYS 16-25 OF THE MONTH	Y		11839	.25	MG	TABLET	QD
102332926	10233292	8	SS	PROVERA	MEDROXYPROGESTERONE ACETATE	1			Y		11839			TABLET
102332926	10233292	9	C	LISINOPRIL.	LISINOPRIL	1	Oral	2.5 MG, 1X/DAY			0	2.5	MG	TABLET	QD
102332926	10233292	10	C	LISINOPRIL.	LISINOPRIL	1	Oral	5 MG, 1X/DAY			0	5	MG	TABLET	QD
102332926	10233292	11	C	VITAMIN D3	CHOLECALCIFEROL	1		1 DF, DAILY			0	1	DF
102332926	10233292	12	C	BIOTIN	BIOTIN	1		UNK			0
102332926	10233292	13	C	METOPROLOL.	METOPROLOL	1	Oral	12.5 MG, 1X/DAY (IT WAS A 25 MG PILL, BUT SHE ONLY TAKES HALF OF IT A DAY)			0	12.5	MG		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
102332926	10233292	1	Hot flush
102332926	10233292	2	Hyperhidrosis
102332926	10233292	3	Feeling abnormal
102332926	10233292	4	Life support
102332926	10233292	6	Hormone replacement therapy
102332926	10233292	7	Hot flush
102332926	10233292	8	Hyperhidrosis
102332926	10233292	9	Hypertension
102332926	10233292	11	Bone disorder
102332926	10233292	13	Cardiac disorder

Outcome of event

Event ID	CASEID	OUTC COD
102332926	10233292	HO
102332926	10233292	OT

Reactions reported

Event ID	CASEID	PT
102332926	10233292	Asthenia
102332926	10233292	Blood cholesterol increased
102332926	10233292	Blood disorder
102332926	10233292	Body height decreased
102332926	10233292	Breast oedema
102332926	10233292	Breast tenderness
102332926	10233292	Coronary artery occlusion
102332926	10233292	Drug prescribing error
102332926	10233292	Fatigue
102332926	10233292	Feeling abnormal
102332926	10233292	Inappropriate schedule of drug administration
102332926	10233292	Intentional product misuse
102332926	10233292	Mammogram abnormal
102332926	10233292	Muscle spasms
102332926	10233292	Postmenopausal haemorrhage
102332926	10233292	Sluggishness
102332926	10233292	Uterine leiomyoma
102332926	10233292	Uterine prolapse
102332926	10233292	Vaginal prolapse
102332926	10233292	Wrong technique in product usage process

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
102332926	10233292	1	197808
102332926	10233292	5	2012
102332926	10233292	7	201510
102332926	10233292	9	2014
102332926	10233292	13	201508