The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASE I F COD FOLL SEQ IMAGE EVENT DT MFR DT FDA DT REPT COD MFR NUM MFR SNDR AGE AGE COD GNDR COD E SUB WT WT COD REPT DT OCCP COD DEATH DT TO MFR CONFID REPORTER COUNTRY
5798441 6558621 F 5798441-3 20000724 20080619 20080630 EXP 2008AP000272 APOTEX INC. 44 YR F N 20080627 UNITED KINGDOM

Drug(s) used by person

Event ID DRUG SEQ ROLE COD DRUGNAME VAL VBM ROUTE DOSE VBM DECHAL RECHAL LOT NUM EXP DT NDA NUM
5798441 1010123936 PS PAROXETINE HCL 1 ORAL 20 MG; QD; PO; 30 MG, QD; PO; 20MG, QD, PO; 40 MG, QD, PO U U 75356
5798441 1010163680 C AMITRIPTLINE HYDROCHLORIDE TAB 1
5798441 1010163681 C CITALOPRAM HYDROBROMIDE 1
5798441 1010163684 C CITALOPRAM HYDROBROMIDE 1
5798441 1010163686 C DIAZEPAM 1
5798441 1010163687 C VENLAFAXINE HCL 1
5798441 1010163688 C SERTRALINE 1
5798441 1010163689 C FLUOXETINE HCL 1
5798441 1010163690 C VENLAFAXINE HCL 1
5798441 1010163691 C BENDROFLUMETHIAZIDE (BENDROFLUMETHIAZIDE) 2

Indications of drugs used

Event ID DRUG SEQ INDI PT
5798441 1010123936 DRUG USE FOR UNKNOWN INDICATION

Outcome of event

Event ID OUTC COD
5798441 OT

Reactions reported

Event ID PT
5798441 AGGRESSION
5798441 AGITATION
5798441 AGORAPHOBIA
5798441 ANOREXIA
5798441 ANXIETY
5798441 BEREAVEMENT REACTION
5798441 CONFUSIONAL STATE
5798441 DECREASED APPETITE
5798441 DEPRESSED MOOD
5798441 DIARRHOEA
5798441 DISTURBANCE IN ATTENTION
5798441 DIZZINESS
5798441 DRUG INEFFECTIVE
5798441 DRUG WITHDRAWAL SYNDROME
5798441 FATIGUE
5798441 HYPERHIDROSIS
5798441 HYPERTENSION
5798441 HYPOAESTHESIA
5798441 INFLUENZA
5798441 INSOMNIA
5798441 IRRITABILITY
5798441 LETHARGY
5798441 MEMORY IMPAIRMENT
5798441 MOOD SWINGS
5798441 NAUSEA
5798441 NIGHTMARE
5798441 PANIC ATTACK
5798441 PARAESTHESIA
5798441 SLEEP DISORDER
5798441 SUICIDAL IDEATION
5798441 TREMOR
5798441 TRICHOTILLOMANIA
5798441 VAGINAL CANDIDIASIS
5798441 VOMITING

Reporting Sources (this data is often not reported and may therefore be missing here)

Event ID RPSR COD
5798441 HP
5798441 OTH

Therapies reported

Event ID DRUG SEQ START DT END DT DUR DUR COD
5798441 1010123936 19990326
5798441 1010123936 20000329
5798441 1010123936 20000530
5798441 1010123936 20010501