Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10068747serious1Date Last Updated12/03/2015receiptdateformat102companynumbUS-ABBVIE-14P-163-1220726-00occurcountryUSduplicate1Date Received09/04/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age8Unit of Onset AgeyearsWeight108.51SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionHepatic failureOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionMuscle spasmsOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionMood alteredOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionMental disorderOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionDrug dependenceOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionAnxietyOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.0ReactionInfertility maleOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.0ReactionPurine metabolism disorderOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionSperm concentration decreasedOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt18.0ReactionAlanine aminotransferase abnormalOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt18.0ReactionSpermatozoa progressive motility decreasedOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt18.0ReactionDepressionOutcomeUnknown

13)

reactionmeddraversionpt18.0ReactionRashOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt18.0ReactionHallucinationOutcomeRecovered/resolved

15)

reactionmeddraversionpt18.0ReactionIncreased appetiteOutcomeRecovered/resolved

16)

reactionmeddraversionpt18.0ReactionWeight increasedOutcomeRecovered/resolved

17)

reactionmeddraversionpt18.0ReactionDermatitisOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt18.0ReactionAspartate aminotransferase abnormalOutcomeNot recovered/not resolved

19)

reactionmeddraversionpt18.0ReactionInsomniaOutcomeUnknown

20)

reactionmeddraversionpt18.0ReactionAbdominal pain upperOutcomeRecovered/resolved

21)

reactionmeddraversionpt18.0ReactionBreast disorder maleOutcomeUnknown

22)

reactionmeddraversionpt18.0ReactionConfusional stateOutcomeRecovered/resolved

23)

reactionmeddraversionpt18.0ReactionGait disturbanceOutcomeNot recovered/not resolved

24)

reactionmeddraversionpt18.0ReactionAbdominal discomfortOutcomeRecovered/resolved

25)

reactionmeddraversionpt18.0ReactionCrohn^s diseaseOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductZOLOFTdrugindicationANXIETY

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

2)

drugcharacterization1medicinalproductDEPAKOTEdrugbatchnumb00074-6214-13drugauthorizationnumb018723drugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/10/1997drugenddateformat610drugenddate/03/1998

activesubstance

activesubstancenameDIVALPROEX SODIUM

openFDA Info on Medication

Application NumberNDA021168, NDA018723, NDA019680Brand NameDEPAKOTE ER, DEPAKOTE, DEPAKOTE SPRINKLESGeneric NameDIVALPROEX SODIUMManufacturersAbbVie Inc.product_ndc0074-3826, 0074-7126, 0074-6212, 0074-6214, 0074-6215, 0074-6114Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIVALPROEX SODIUMRXCUI 1099563, 1099565, 1099569, 1099571, 1099625, 1099626, 1099678, 1099679, 1099870, ... spl_id bda1168f-9cb8-cfc6-ccea-f576f45e25a6, 3c11ce81-9241-56ec-0783-7843408c10b9, f636 ... spl_set_id 0dc024ce-efc8-4690-7cb5-639c728fccac, 08a65cf4-7749-4ceb-6895-8f4805e2b01f, 4619 ... Package NDC 0074-3826-13, 0074-3826-11, 0074-7126-13, 0074-7126-53, 0074-7126-11, 0074-7126- ... UNII644VL95AO6

3)

drugcharacterization2medicinalproductREMICADEdrugindicationCROHN^S DISEASE

activesubstance

activesubstancenameINFLIXIMAB

openFDA Info on Medication

Application NumberBLA103772Brand NameREMICADEGeneric NameINFLIXIMABManufacturersJanssen Biotech, Inc.product_ndc57894-030Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsINFLIXIMABRXCUI213361, 310994spl_idba599d34-1a9a-47db-8414-8e7cfcb5d49dspl_set_ida0a046c1-056d-45a9-bfd9-13b47c24f257Package NDC57894-030-01NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIB72HH48FLU

summary

narrativeincludeclinicalCASE EVENT DATE: 199710

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1220726-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use