Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10039905serious1Date Last Updated26/03/2014receiptdateformat102companynumbFR-PFIZER INC-2014082818occurcountryFRseriousnessother1duplicate1Date Received26/03/2014seriousnesshospitalization1transmissiondate02/10/2014primarysourcecountryFRseriousnessdisabling1

Primary Source

reportercountryFRqualification5

Patient

Onset Age55Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionAlcohol withdrawal syndromeOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionDepressionOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionMyalgiaOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionFatigueOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb020990drugdosagetextUNKdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat602drugstartdate//2013drugenddateformat102drugenddate15/10/2013

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)

drugcharacterization1medicinalproductLYSANXIAdrugdosagetext30-50MG, DAILYdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate25/09/2013actiondrug4

3)

drugcharacterization1medicinalproductBACLOFENdrugstructuredosagenumb10drugstructuredosageunit032drugdosagetext10 DF, DAILYdrugadministrationroute048drugstartdateformat102drugstartdate11/09/2013actiondrug2

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

4)

drugcharacterization1medicinalproductBACLOFENdrugdosagetextDECREASED DOSAGEdrugadministrationroute048actiondrug2

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

5)

drugcharacterization2medicinalproductAOTALdrugdosagetextUNK

6)

drugcharacterization2medicinalproductSERESTAdrugstructuredosagenumb200drugstructuredosageunit003drugdosagetext200 MG, UNKdrugstartdateformat102drugstartdate10/09/2013drugenddateformat102drugenddate25/09/2013

Report Duplicate

duplicatesourcePFIZERduplicatenumbFR-PFIZER INC-2014082818

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use