Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-PFIZER INC-2014074085occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10013406Date Received14/03/2014transmissiondate02/10/2014serious2Date Last Updated14/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age12Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionWeight increasedOutcomeUnknown

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)

drugcharacterization2medicinalproductMELATONINdrugdosagetextUNK

openFDA Info on Medication

Brand NameMELATONIN, MELATONIN CORDGeneric NameMELATONINManufacturersBioActive Nutritional, Inc., Deseret Biologicals, Inc., Energique, Inc.product_ndc43857-0086, 43742-0205, 44911-0194, 43742-0771Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMELATONINspl_id e189499d-9da3-43fc-8a0b-9d5dd0923b11, a02d2040-67c7-40d6-8725-f774db2408c4, 51e3 ... spl_set_id cd82eb5d-a44a-4512-ad65-0fffae70d1d0, bb074765-ca7c-4c30-bd6f-b2292f0abb96, 9a59 ... Package NDC43857-0086-1, 43742-0205-1, 44911-0194-1, 43742-0771-1UNIIJL5DK93RCL

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014074085