Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-PFIZER INC-2014080883occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10024128Date Received20/03/2014transmissiondate02/10/2014serious2Date Last Updated20/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionSomnolenceOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductXANAXdrugauthorizationnumb018276drugdosagetextUNKactiondrug5

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)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, DAILYdrugstartdateformat602drugstartdate//2014actiondrug5

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)

drugcharacterization1medicinalproductWELLBUTRINdrugdosagetextUNKactiondrug5

openFDA Info on Medication

Application NumberNDA021515, NDA020358Brand NameWELLBUTRIN XL, WELLBUTRIN SRGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLC, GlaxoSmithKline LLCproduct_ndc0187-0730, 0187-0731, 0173-0135, 0173-0947, 0173-0722Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564, 993503, 993511, 993518, 993528, 993536, 993537spl_ida4bd6e04-f597-4ad4-966d-86cf2efbf5fa, ed416049-f26b-453e-b89a-10bdf7091734spl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21, cbc8c074-f080-4489-a5ae-207b5fadeba3Package NDC 0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07, 0173-0947- ... UNIIZG7E5POY8O

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014080883