Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10016427serious1Date Last Updated22/05/2014receiptdateformat102companynumbGB-ACTAVIS-2014-04599occurcountryGBseriousnessother1duplicate1Date Received17/03/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age21Unit of Onset AgeyearsWeight84SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDepressionOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionSomnolenceOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionBipolar I disorderOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionSedationOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.0ReactionAgitationOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionMajor depressionOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.0ReactionMerycismOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.0ReactionAttention deficit/hyperactivity disorderOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductQUETIAPINE (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugauthorizationnumb201762drugstructuredosagenumb400drugstructuredosageunit003drugdosagetext400 MG, UNKdrugdosageformUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/11/2013drugenddateformat610drugenddate/01/2014actiondrug1

activesubstance

activesubstancenameQUETIAPINE

2)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, DAILYdrugadministrationroute048drugstartdateformat610drugstartdate/11/2013drugenddateformat610drugenddate/12/2013actiondrug1

activesubstance

activesubstancenameATOMOXETINE HYDROCHLORIDE

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

3)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, DAILYdrugadministrationroute048drugstartdateformat610drugstartdate/10/2013drugenddateformat610drugenddate/10/2013actiondrug1

activesubstance

activesubstancenameATOMOXETINE HYDROCHLORIDE

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

4)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb18drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext18 MG, DAILYdrugadministrationroute048drugstartdateformat610drugstartdate/11/2012actiondrug1

activesubstance

activesubstancenameATOMOXETINE HYDROCHLORIDE

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)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKNOWNdrugadministrationroute065drugindicationAGITATIONdrugstartdateformat610drugstartdate/10/2013actiondrug5drugrecurreadministration3

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

6)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, DAILYdrugadministrationroute048drugstartdateformat102drugstartdate02/10/2012actiondrug1

activesubstance

activesubstancenameATOMOXETINE HYDROCHLORIDE

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)

drugcharacterization1medicinalproductCITALOPRAMdrugbatchnumbUNCONFIRMEDdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKNOWNdrugdosageformUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/02/2013actiondrug1

activesubstance

activesubstancenameCITALOPRAM HYDROBROMIDE

openFDA Info on Medication

Application Number ANDA077048, ANDA077043, ANDA077534, ANDA077042, ANDA077031, ANDA077289, ANDA0770 ... Brand NameCITALOPRAM, CITALOPRAM HYDROBROMIDE, CELEXAGeneric NameCITALOPRAM TABLETS, CITALOPRAM TABLET, CITALOPRAM, CITALOPRAM HYDROBROMIDEManufacturers Cosette Pharmaceuticals, Inc., West-Ward Pharmaceuticals Corp, Cipla USA Inc., M ... product_ndc 0713-4740, 0713-4741, 0713-4742, 0054-0062, 69097-822, 69097-823, 69097-824, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDERXCUI200371, 283672, 309314, 309313, 213344, 213345, 284591spl_id 8eadc3e4-81a3-4b3b-aa1c-1dc65151f94c, 23d9ce12-cfe2-4026-a3dd-6e177a9affb7, 24f9 ... spl_set_id cf7b6823-108b-ebff-8f41-91f8b8325e3a, 29408d84-7b00-4cee-969c-8095f8083ff5, 0580 ... Package NDC 0713-4740-01, 0713-4740-05, 0713-4741-01, 0713-4741-05, 0713-4742-01, 0713-4742- ... UNIII1E9D14F36

8)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MG, DAILYdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/08/2013actiondrug1

activesubstance

activesubstancenameATOMOXETINE HYDROCHLORIDE

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)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, DAILYdrugadministrationroute048drugstartdateformat610drugstartdate/05/2013drugenddateformat610drugenddate/10/2013actiondrug1

activesubstance

activesubstancenameATOMOXETINE HYDROCHLORIDE

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)

drugcharacterization1medicinalproductRISPERIDONE (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.5 MG, BIDdrugdosageformUNKdrugadministrationroute065drugindicationAGITATIONactiondrug1

activesubstance

activesubstancenameRISPERIDONE

11)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, DAILYdrugadministrationroute048drugstartdateformat610drugstartdate/01/2013actiondrug1

activesubstance

activesubstancenameATOMOXETINE HYDROCHLORIDE

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

12)

drugcharacterization2medicinalproductCIRCADINdrugstructuredosagenumb8drugstructuredosageunit003drugdosagetext8 MG, UNKNOWNdrugadministrationroute065drugindicationINSOMNIAdrugstartdateformat610drugstartdate/06/2013actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameMELATONIN

summary

narrativeincludeclinicalCASE EVENT DATE: 201302

Report Duplicate

duplicatesourceACTAVISduplicatenumbGB-ACTAVIS-2014-04599

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use