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Field-by-field reference
Report
reporttype
1
receiptdateformat
102
companynumb
US-PFIZER INC-2014085684
occurcountry
US
Version of Safety Report ID
1
receivedateformat
102
duplicate
1
transmissiondateformat
102
fulfillexpeditecriteria
2
Safety Report ID
10042023
Date Received
27/03/2014
transmissiondate
02/10/2014
serious
2
Date Last Updated
27/03/2014
primarysourcecountry
US
Receiver
receivertype
6
receiverorganization
FDA
Primary Source
reportercountry
US
qualification
5
Sender
sendertype
2
senderorganization
FDA-Public Use
Patient
Onset Age
65
Unit of Onset Age
years
Weight
98
Sex
Male
Contents
Reaction
1)
2)
3)
4)
5)
Drug
1)
openFDA Info on Medication
2)
Reaction
1)
reactionmeddraversionpt
17.0
Reaction
Headache
Outcome
Unknown
2)
reactionmeddraversionpt
17.0
Reaction
Hyperhidrosis
Outcome
Unknown
3)
reactionmeddraversionpt
17.0
Reaction
Anxiety
Outcome
Unknown
4)
reactionmeddraversionpt
17.0
Reaction
Diarrhoea
Outcome
Unknown
5)
reactionmeddraversionpt
17.0
Reaction
Dizziness
Outcome
Unknown
Drug
1)
drugcharacterization
1
medicinalproduct
ZOLOFT
drugauthorizationnumb
019839
drugstructuredosagenumb
100
drugstructuredosageunit
003
drugseparatedosagenumb
1
drugintervaldosageunitnumb
1
drugintervaldosagedefinition
804
drugdosagetext
100 MG, 1X/DAY
drugdosageform
FILM-COATED TABLET
drugadministrationroute
048
drugindication
DEPRESSION
actiondrug
1
openFDA Info on Medication
Application Number
NDA020990, NDA019839
Brand Name
ZOLOFT
Generic Name
SERTRALINE HYDROCHLORIDE
Manufacturers
Roerig
product_ndc
0049-0050, 0049-4960, 0049-4900, 0049-4910
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Active Ingredients
SERTRALINE HYDROCHLORIDE
RXCUI
208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066
spl_id
665a145d-44fb-4fef-a3c1-2aac26e0715c
spl_set_id
fe9e8b7d-61ea-409d-84aa-3ebd79a046b5
Package NDC
0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ...
Show All
UNII
UTI8907Y6X
2)
drugcharacterization
2
medicinalproduct
INSULIN
drugdosagetext
UNK
drugindication
DIABETES MELLITUS
Report Duplicate
duplicatesource
PFIZER
duplicatenumb
US-PFIZER INC-2014085684
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