Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10149786serious1Date Last Updated02/05/2014receiptdateformat102companynumbIT-JNJFOC-20140415859occurcountryITseriousnessother1duplicate1Date Received02/05/2014transmissiondate12/12/2014primarysourcecountryIT

Primary Source

reportercountryITqualification5

Patient

Onset Age53Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionSelf injurious behaviourOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionIntentional overdoseOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionIntentional product misuseOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionSluggishnessOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductRISPERDALdrugauthorizationnumb020272drugstructuredosagenumb3drugstructuredosageunit003drugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/04/2014drugenddateformat102drugenddate21/04/2014actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020272, NDA020588Brand NameRISPERDALGeneric NameRISPERIDONEManufacturersJanssen Pharmaceuticals, Inc.product_ndc 50458-300, 50458-301, 50458-302, 50458-320, 50458-330, 50458-350, 50458-395, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRISPERIDONERXCUI 104781, 104782, 104783, 104784, 199387, 211489, 262077, 262222, 312828, 312829, ... spl_idb192f7b6-639a-11ea-b722-633bfc2ca371spl_set_id7e117c7e-02fc-4343-92a1-230061dfc5e0Package NDC 50458-301-04, 50458-301-50, 50458-301-01, 50458-302-06, 50458-302-50, 50458-302- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIL6UH7ZF8HC

2)

drugcharacterization1medicinalproductFLUNOXdrugstructuredosagenumb15drugstructuredosageunit003drugdosageformCapsulesdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/04/2014drugenddateformat102drugenddate21/04/2014actiondrug5

3)

drugcharacterization1medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/04/2014drugenddateformat102drugenddate21/04/2014actiondrug5

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

4)

drugcharacterization1medicinalproductXANAXdrugstructuredosagenumb.5drugstructuredosageunit003drugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/04/2014drugenddateformat102drugenddate21/04/2014actiondrug5

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_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

5)

drugcharacterization1medicinalproductTIKLIDdrugstructuredosagenumb250drugstructuredosageunit003drugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/04/2014drugenddateformat102drugenddate21/04/2014actiondrug5

Report Duplicate

duplicatesourceJANSSENduplicatenumbIT-JNJFOC-20140415859

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use