Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10016430serious1Date Last Updated17/03/2014receiptdateformat102companynumbGB-ACTAVIS-2014-04599occurcountryGBduplicate1Date Received17/03/2014seriousnesshospitalization1transmissiondate02/10/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age21Unit of Onset AgeyearsWeight84SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionBipolar I disorderOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionDepressionOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionMerycismOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionMajor depressionOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionAttention deficit/hyperactivity disorderOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionSomnolenceOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionSedationOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionAgitationOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductCITALOPRAM (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKNOWNdrugdosageformUnkdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/02/2013actiondrug1

2)

drugcharacterization1medicinalproductQUETIAPINE (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugauthorizationnumb201762drugdosagetextUNKdrugdosageformUnkdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/11/2013drugenddateformat610drugenddate/01/2014actiondrug1

3)

drugcharacterization1medicinalproductRISPERIDONE (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.5 MG, BIDdrugdosageformUnkdrugadministrationroute065drugindicationAGITATIONactiondrug1

4)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/11/2013drugenddateformat610drugenddate/12/2013actiondrug1

openFDA Info on Medication

Application NumberNDA021411Brand NameSTRATTERAGeneric NameATOMOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3227, 0002-3238, 0002-3228, 0002-3229, 0002-3239, 0002-3250, 0002-3251Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATOMOXETINE HYDROCHLORIDERXCUI 349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, ... spl_idbef991ff-4775-4854-94c1-88081bbf9354spl_set_id309de576-c318-404a-bc15-660c2b1876fbPackage NDC 0002-3227-30, 0002-3238-30, 0002-3228-30, 0002-3229-30, 0002-3239-30, 0002-3250- ... UNII57WVB6I2W0

5)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKNOWNdrugadministrationroute065drugstartdateformat610drugstartdate/10/2013drugenddateformat610drugenddate/10/2013actiondrug1

openFDA Info on Medication

Application NumberNDA021411Brand NameSTRATTERAGeneric NameATOMOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3227, 0002-3238, 0002-3228, 0002-3229, 0002-3239, 0002-3250, 0002-3251Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATOMOXETINE HYDROCHLORIDERXCUI 349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, ... spl_idbef991ff-4775-4854-94c1-88081bbf9354spl_set_id309de576-c318-404a-bc15-660c2b1876fbPackage NDC 0002-3227-30, 0002-3238-30, 0002-3228-30, 0002-3229-30, 0002-3239-30, 0002-3250- ... UNII57WVB6I2W0

6)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb60drugstructuredosageunit003drugdosagetext60 MG, UNKNOWNdrugadministrationroute065drugstartdateformat610drugstartdate/08/2013actiondrug1

openFDA Info on Medication

Application NumberNDA021411Brand NameSTRATTERAGeneric NameATOMOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3227, 0002-3238, 0002-3228, 0002-3229, 0002-3239, 0002-3250, 0002-3251Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATOMOXETINE HYDROCHLORIDERXCUI 349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, ... spl_idbef991ff-4775-4854-94c1-88081bbf9354spl_set_id309de576-c318-404a-bc15-660c2b1876fbPackage NDC 0002-3227-30, 0002-3238-30, 0002-3228-30, 0002-3229-30, 0002-3239-30, 0002-3250- ... UNII57WVB6I2W0

7)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKNOWNdrugadministrationroute065drugstartdateformat610drugstartdate/05/2013actiondrug1

openFDA Info on Medication

Application NumberNDA021411Brand NameSTRATTERAGeneric NameATOMOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3227, 0002-3238, 0002-3228, 0002-3229, 0002-3239, 0002-3250, 0002-3251Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATOMOXETINE HYDROCHLORIDERXCUI 349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, ... spl_idbef991ff-4775-4854-94c1-88081bbf9354spl_set_id309de576-c318-404a-bc15-660c2b1876fbPackage NDC 0002-3227-30, 0002-3238-30, 0002-3228-30, 0002-3229-30, 0002-3239-30, 0002-3250- ... UNII57WVB6I2W0

8)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, UNKNOWNdrugadministrationroute065drugstartdateformat610drugstartdate/01/2013actiondrug1

openFDA Info on Medication

Application NumberNDA021411Brand NameSTRATTERAGeneric NameATOMOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3227, 0002-3238, 0002-3228, 0002-3229, 0002-3239, 0002-3250, 0002-3251Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATOMOXETINE HYDROCHLORIDERXCUI 349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, ... spl_idbef991ff-4775-4854-94c1-88081bbf9354spl_set_id309de576-c318-404a-bc15-660c2b1876fbPackage NDC 0002-3227-30, 0002-3238-30, 0002-3228-30, 0002-3229-30, 0002-3239-30, 0002-3250- ... UNII57WVB6I2W0

9)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb18drugstructuredosageunit003drugdosagetext18 MG, UNKNOWNdrugadministrationroute065drugstartdateformat610drugstartdate/11/2012actiondrug1

openFDA Info on Medication

Application NumberNDA021411Brand NameSTRATTERAGeneric NameATOMOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3227, 0002-3238, 0002-3228, 0002-3229, 0002-3239, 0002-3250, 0002-3251Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATOMOXETINE HYDROCHLORIDERXCUI 349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, ... spl_idbef991ff-4775-4854-94c1-88081bbf9354spl_set_id309de576-c318-404a-bc15-660c2b1876fbPackage NDC 0002-3227-30, 0002-3238-30, 0002-3228-30, 0002-3229-30, 0002-3239-30, 0002-3250- ... UNII57WVB6I2W0

10)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKNOWNdrugadministrationroute065drugstartdateformat610drugstartdate/10/2012actiondrug1

openFDA Info on Medication

Application NumberNDA021411Brand NameSTRATTERAGeneric NameATOMOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3227, 0002-3238, 0002-3228, 0002-3229, 0002-3239, 0002-3250, 0002-3251Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATOMOXETINE HYDROCHLORIDERXCUI 349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, ... spl_idbef991ff-4775-4854-94c1-88081bbf9354spl_set_id309de576-c318-404a-bc15-660c2b1876fbPackage NDC 0002-3227-30, 0002-3238-30, 0002-3228-30, 0002-3229-30, 0002-3239-30, 0002-3250- ... UNII57WVB6I2W0

11)

drugcharacterization2medicinalproductCIRCADINdrugstructuredosagenumb8drugstructuredosageunit003drugdosagetext8 MG, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/06/2013actiondrug5drugrecurreadministration3

12)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKNOWNdrugadministrationroute065drugindicationAGITATIONdrugstartdateformat610drugstartdate/10/2013actiondrug5drugrecurreadministration3

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

Report Duplicate

duplicatesourceACTAVISduplicatenumbGB-ACTAVIS-2014-04599

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use