Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014-US-003172Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10048444Date Received27/03/2014transmissiondate28/05/2015serious1Date Last Updated27/10/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age44Unit of Onset AgeyearsWeight56.7SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionSinusitis

2)

reactionmeddraversionpt18.0ReactionImmune system disorder

3)

reactionmeddraversionpt18.0ReactionContusion

4)

reactionmeddraversionpt18.0ReactionFeeling abnormal

5)

reactionmeddraversionpt18.0ReactionSleep attacks

6)

reactionmeddraversionpt18.0ReactionSuture insertion

7)

reactionmeddraversionpt18.0ReactionUpper respiratory tract infection

8)

reactionmeddraversionpt18.0ReactionSomnolence

9)

reactionmeddraversionpt18.0ReactionInsomnia

10)

reactionmeddraversionpt18.0ReactionHead injury

11)

reactionmeddraversionpt18.0ReactionFall

12)

reactionmeddraversionpt18.0ReactionStress

13)

reactionmeddraversionpt18.0ReactionFatigue

Drug

1)

drugcharacterization2medicinalproductERRIN (NORETHISTERONE)

2)

drugcharacterization1medicinalproductXYREMdrugbatchnumbA26387drugauthorizationnumb021196drugstructuredosagenumb3drugstructuredosageunit002drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/02/2008

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id7b52ca71-8187-42aa-9f7c-6fb831dfc8b3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

3)

drugcharacterization2medicinalproductSERTRALINE

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

4)

drugcharacterization2medicinalproductVITAMIN D (COLECALCIFEROL)

5)

drugcharacterization2medicinalproductZOCOR

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application NumberNDA019766Brand NameZOCORGeneric NameSIMVASTATINManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0543, 0006-0749, 0006-0740, 0006-0735Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI104490, 104491, 152923, 198211, 200345, 213319, 312961, 314231spl_id41a60de3-6740-43c7-a8d7-7dbfd0a8d6a0spl_set_idfdbfe194-b845-42c5-bb87-a48118bc72e7Package NDC 0006-0543-31, 0006-0543-54, 0006-0749-31, 0006-0749-54, 0006-0740-54, 0006-0740- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

6)

drugcharacterization2medicinalproductADDERALL (AMPHETAMINE AND DEXTROAMPHETAMINE

summary

narrativeincludeclinicalCASE EVENT DATE: 2012

Report Duplicate

duplicatesourceJAZZduplicatenumb2014-US-003172