Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10062152serious1Date Last Updated06/08/2014receiptdateformat102companynumbBR-PFIZER INC-2014072761occurcountryBRseriousnessother1duplicate1Date Received07/04/2014transmissiondate26/03/2015primarysourcecountryBR

Primary Source

reportercountryBRqualification5

Patient

Onset Age62Unit of Onset AgeyearsWeight50SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionPhysical assaultOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionHyperhidrosisOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionFearOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionPalpitationsOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionBlood pressure fluctuationOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionPanic attackOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionSomnolenceOutcomeUnknown

8)

reactionmeddraversionpt17.1ReactionConfusional stateOutcomeUnknown

9)

reactionmeddraversionpt17.1ReactionFibromyalgiaOutcomeUnknown

10)

reactionmeddraversionpt17.1ReactionDrug ineffectiveOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductFRONTALdrugauthorizationnumb018276drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, 1X/DAYdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat610drugstartdate/02/2014drugenddateformat602drugenddate//2014actiondrug3drugrecurreadministration3

activesubstance

activesubstancenameALPRAZOLAM

2)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 TABLET OF STRENGTH 50 MG, 1X/DAYdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationSLEEP DISORDERactiondrug4

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

3)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugstartdateformat602drugstartdate//2014actiondrug4

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

4)

drugcharacterization1medicinalproductFRONTALdrugauthorizationnumb018276drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 TABLET, 2X/DAYdrugdosageformTABLETdrugadministrationroute048drugstartdateformat602drugstartdate//2014drugenddateformat602drugenddate//2014actiondrug3drugrecurreadministration3

activesubstance

activesubstancenameALPRAZOLAM

5)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext75 MG, 1X/DAY (IN THE MORNING)drugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat610drugstartdate/02/2014drugenddateformat602drugenddate//2014actiondrug4

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

6)

drugcharacterization2medicinalproductLIVOLONdrugdosagetextUNKdrugindicationHORMONE REPLACEMENT THERAPY

activesubstance

activesubstancenameTIBOLONE

7)

drugcharacterization1medicinalproductFRONTALdrugauthorizationnumb018276drugstructuredosagenumb1.5drugstructuredosageunit002drugdosagetext1.5 G, DAILYdrugdosageformTABLETdrugadministrationroute048drugstartdateformat610drugstartdate/02/2014actiondrug3drugrecurreadministration3

activesubstance

activesubstancenameALPRAZOLAM

8)

drugcharacterization1medicinalproductFRONTALdrugauthorizationnumb018276drugdosagetext0.25 NO UNITS PROVIDED, UNKdrugdosageformTABLETdrugadministrationroute048drugindicationSLEEP DISORDERdrugstartdateformat602drugstartdate//2013actiondrug3drugrecurreadministration3

activesubstance

activesubstancenameALPRAZOLAM

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourcePFIZERduplicatenumbBR-PFIZER INC-2014072761

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use