Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10225186serious1Date Last Updated30/08/2016receiptdateformat102companynumbUS-PFIZER INC-2014157234occurcountryUSseriousnessother1duplicate1Date Received09/06/2014seriousnesshospitalization1transmissiondate09/11/2016primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

SexMale

Reaction

1)

reactionmeddraversionpt19.1ReactionPneumoniaOutcomeUnknown

2)

reactionmeddraversionpt19.1ReactionSeizureOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductXANAXdrugauthorizationnumb018276drugdosagetextUNK

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

2)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugdosagetextUNK

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

summary

narrativeincludeclinicalCASE EVENT DATE: 2016

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014157234

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use