Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-PFIZER INC-2014073727occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10013415Date Received14/03/2014transmissiondate02/10/2014serious2Date Last Updated14/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionNauseaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCHANTIXdrugauthorizationnumb021928drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugstartdateformat602drugstartdate//2012actiondrug1

openFDA Info on Medication

Application NumberNDA021928Brand NameCHANTIXGeneric NameVARENICLINE TARTRATEManufacturersU.S. Pharmaceuticals, Pfizer Laboratories Div Pfizer Incproduct_ndc63539-473, 0069-0468, 0069-0469, 0069-0471Product TypeHUMAN PRESCRIPTION DRUGRXCUI636671, 636676, 637188, 637190, 749289, 795737, 749788, 795735spl_id3ef42766-c314-49db-81d5-611e46662c8f, bcade8bc-7ae1-4d9e-aa26-37d665b86935spl_set_idd52bc40b-db7b-4243-888c-9ee95bbc6545, f0ff4f27-5185-4881-a749-c6b7a0ca5696Package NDC63539-473-10, 0069-0468-56, 0069-0469-56, 0069-0469-03, 0069-0471-03RouteORALActive IngredientsVARENICLINE TARTRATEUNII82269ASB48

2)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugdosagetextUNKactiondrug1

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)

drugcharacterization1medicinalproductLITHIUMdrugdosagetextUNKactiondrug1

openFDA Info on Medication

Application NumberNDA018421Brand NameLITHIUMGeneric NameLITHIUM, LITHIUM BROMATUMManufacturersWest-Ward Pharmaceuticals Corp, Marco Pharma International LLC.product_ndc 0054-3527, 0054-8528, 0054-4527, 0054-8526, 0054-2526, 0054-8527, 0054-2527, 005 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLITHIUM CITRATE, LITHIUM BROMIDERXCUI197889, 197890, 197893, 311355, 756059spl_id8e25764e-8fda-438d-a778-411c43074aa7, b5ad884d-209d-cc5d-e053-2a95a90a0339spl_set_id7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e, f4a1d451-33ad-4df3-ae68-58cfbfccfa89Package NDC 0054-8528-25, 0054-4527-25, 0054-4527-31, 0054-8526-25, 0054-2526-25, 0054-8527- ... UNII5Z6E9K79YV, 2BMD2GNA4V, 864G646I84

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014073727