Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10027547serious1Date Last Updated21/03/2014receiptdateformat102companynumbUS-PFIZER INC-2014081199occurcountryUSseriousnessother1duplicate1Date Received21/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionSuicidal ideationOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionAgitationOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionOff label useOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugdosagetextUNKactiondrug5

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

2)

drugcharacterization1medicinalproductLATUDAdrugdosagetextUNKdrugadministrationroute048drugindicationMAJOR DEPRESSIONactiondrug1

openFDA Info on Medication

Application NumberNDA200603Brand NameLATUDAGeneric NameLURASIDONE HYDROCHLORIDEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-302, 63402-304, 63402-306, 63402-308, 63402-312Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLURASIDONE HYDROCHLORIDERXCUI 1040031, 1040036, 1040041, 1040043, 1235247, 1235249, 1297278, 1297357, 1431235, ... spl_id752ff649-e51b-47ac-8e2c-8c27a11308c8spl_set_idafad3051-9df2-4c54-9684-e8262a133af8Package NDC 63402-302-30, 63402-302-90, 63402-302-50, 63402-302-01, 63402-302-10, 63402-302- ... UNIIO0P4I5851I

3)

drugcharacterization1medicinalproductLATUDAdrugindicationSCHIZOPHRENIAactiondrug1

openFDA Info on Medication

Application NumberNDA200603Brand NameLATUDAGeneric NameLURASIDONE HYDROCHLORIDEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-302, 63402-304, 63402-306, 63402-308, 63402-312Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLURASIDONE HYDROCHLORIDERXCUI 1040031, 1040036, 1040041, 1040043, 1235247, 1235249, 1297278, 1297357, 1431235, ... spl_id752ff649-e51b-47ac-8e2c-8c27a11308c8spl_set_idafad3051-9df2-4c54-9684-e8262a133af8Package NDC 63402-302-30, 63402-302-90, 63402-302-50, 63402-302-01, 63402-302-10, 63402-302- ... UNIIO0P4I5851I

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014081199

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use