Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10060391serious1Date Last Updated04/04/2014receiptdateformat102companynumbUS-ACTAVIS-2014-06267occurcountryUSseriousnessother1duplicate1Date Received04/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Weight100SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug withdrawal syndromeOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionHallucinations, mixedOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionPanic attackOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionAngerOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionLethargyOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionSomnolenceOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionDrug interactionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLONAZEPAM (AELLC)drugbatchnumbUNKNOWNdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, TIDdrugdosageformTABLETdrugadministrationroute048drugindicationPANIC ATTACKdrugenddateformat102drugenddate06/03/2014actiondrug4

2)

drugcharacterization1medicinalproductCLONAZEPAM (AELLC)drugbatchnumbUNKNOWNdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, TIDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate18/03/2014actiondrug4

3)

drugcharacterization2medicinalproductSEROQUELdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, DAILYdrugadministrationroute048drugindicationBIPOLAR DISORDERdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_id1a826d85-aac4-42e4-a3e2-a18df915dc33, bca31730-a1ed-4b8f-93d8-2f64143a91faspl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

4)

drugcharacterization2medicinalproductZOLOFTdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, DAILYdrugadministrationroute048drugindicationDEPRESSIONdrugrecurreadministration3

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

Report Duplicate

duplicatesourceACTAVISduplicatenumbUS-ACTAVIS-2014-06267

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use