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
125224322	12522432	2	F	20040212	20160707	20160701	20160715	EXP		GB-MYLANLABS-2016M1026803	MYLAN		0.00				Y	0.00000		20160715		CN	GB	GB

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 FREQ
125224322	12522432	1	PS	PAROXETINE.	PAROXETINE	1	Unknown	15 MG, QD	11130	MG	U	U	77873	15	MG	QD
125224322	12522432	2	SS	PAROXETINE.	PAROXETINE	1	Unknown	UNK	11130	MG	U	U	77873
125224322	12522432	3	SS	PAROXETINE.	PAROXETINE	1	Oral	20 MG, BID	11130	MG	U	U	77873	20	MG	BID
125224322	12522432	4	SS	PAROXETINE.	PAROXETINE	1	Oral	30 MG, QD	11130	MG	U	U	77873	30	MG	QD
125224322	12522432	5	SS	PAROXETINE.	PAROXETINE	1	Oral	UNK			U	U	0
125224322	12522432	6	C	DRISTAN DECONGESTANT /00509501/		2		UNK				U	0
125224322	12522432	7	C	CIPRALEX	ESCITALOPRAM OXALATE	1	Unknown	UNK				U	0
125224322	12522432	8	C	DIAZEPAM.	DIAZEPAM	1	Unknown	2 MG, PRN				U	0	2	MG
125224322	12522432	9	C	FINASTERIDE.	FINASTERIDE	1		UNK				U	0
125224322	12522432	10	C	FLUOXETINE	FLUOXETINE HYDROCHLORIDE	1		UNK				U	0
125224322	12522432	11	C	HERBAL NOS	HERBALS	1		UNK				U	0
125224322	12522432	12	SS	PAXIL	PAROXETINE HYDROCHLORIDE	1		UNK	33440	MG	U	U	0
125224322	12522432	13	SS	PAXIL	PAROXETINE HYDROCHLORIDE	1		20 MG, BID	33440	MG	U	U	0	20	MG	BID
125224322	12522432	14	SS	SEROXAT	PAROXETINE HYDROCHLORIDE	1	Unknown	UNK	33440	MG	U	U	0
125224322	12522432	15	SS	SEROXAT	PAROXETINE HYDROCHLORIDE	1	Oral	20 MG, BID	33440	MG	U	U	0	20	MG	BID

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125224322	12522432	1	Depression
125224322	12522432	6	Rash
125224322	12522432	9	Alopecia
125224322	12522432	12	Depression

Outcome of event

Event ID	CASEID	OUTC COD
125224322	12522432	OT

Reactions reported

Event ID	CASEID	PT
125224322	12522432	Aggression
125224322	12522432	Anhedonia
125224322	12522432	Anxiety
125224322	12522432	Apathy
125224322	12522432	Balance disorder
125224322	12522432	Condition aggravated
125224322	12522432	Confusional state
125224322	12522432	Decreased appetite
125224322	12522432	Depressed mood
125224322	12522432	Derealisation
125224322	12522432	Disturbance in attention
125224322	12522432	Dizziness
125224322	12522432	Drug withdrawal syndrome
125224322	12522432	Fatigue
125224322	12522432	Frustration tolerance decreased
125224322	12522432	Hyperhidrosis
125224322	12522432	Hypoacusis
125224322	12522432	Loss of libido
125224322	12522432	Memory impairment
125224322	12522432	Myalgia
125224322	12522432	Nightmare
125224322	12522432	Palpitations
125224322	12522432	Photosensitivity reaction
125224322	12522432	Poor quality sleep
125224322	12522432	Rash pruritic
125224322	12522432	Suicidal ideation
125224322	12522432	Tearfulness
125224322	12522432	Thought insertion
125224322	12522432	Vertigo
125224322	12522432	Vision blurred
125224322	12522432	Visual impairment
125224322	12522432	Vitreous floaters

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
125224322	12522432	1	20060223
125224322	12522432	2	20050831	20081118
125224322	12522432	3	20030528	20061201
125224322	12522432	4	20051007	20060908
125224322	12522432	5	20070105	20070605
125224322	12522432	6	200402
125224322	12522432	7	20060223	200607
125224322	12522432	8	20051007
125224322	12522432	9	20070605
125224322	12522432	10	200806
125224322	12522432	11	200509
125224322	12522432	12	20130521
125224322	12522432	13	20030521	20121231
125224322	12522432	14	20030521
125224322	12522432	15	20030521	20121231