Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10011330serious1Date Last Updated30/05/2016receiptdateformat102companynumbGB-JNJFOC-20140303245occurcountryGBduplicate1Date Received14/03/2014seriousnesshospitalization1transmissiondate15/08/2016primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age21Unit of Onset Ageyearspatientagegroup5Weight84SexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionAttention deficit/hyperactivity disorderOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt19.0ReactionBipolar I disorderOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt19.0ReactionMerycismOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt19.0ReactionSedationOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt19.0ReactionSomnolenceOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt19.0ReactionMajor depressionOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt19.0ReactionDepressionOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt19.0ReactionAgitationOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductCIRCADINdrugstructuredosagenumb8drugstructuredosageunit003drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationINSOMNIAdrugstartdateformat610drugstartdate/06/2013

activesubstance

activesubstancenameMELATONIN

2)

drugcharacterization1medicinalproductRISPERIDONE.drugauthorizationnumb020272drugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationAGITATIONdrugstartdateformat610drugstartdate/10/2013actiondrug1drugrecurreadministration2

activesubstance

activesubstancenameRISPERIDONE

openFDA Info on Medication

Application Number ANDA077328, ANDA202386, ANDA076904, NDA020588, ANDA078116, ANDA079088, ANDA07851 ... Brand NameRISPERIDONE, PERSERIS, RISPERDAL, RISPERDAL M-TAB, RISPERDAL CONSTAGeneric NameRISPERIDONEManufacturers Dr. Reddy's Laboratories Limited, Lannett Company, Inc., Hikma Pharmaceuticals U ... product_ndc 55111-207, 55111-208, 55111-209, 55111-470, 55111-471, 54838-563, 0054-0063, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, SUBCUTANEOUSActive IngredientsRISPERIDONERXCUI 401953, 401954, 403825, 616698, 616705, 199387, 312828, 312829, 312830, 312831, ... spl_id 9293825e-f154-ffc9-20b0-5846d813b7ec, 95f6336f-cac0-40b5-a7ad-29df965445a1, af95 ... spl_set_id c00809e1-e632-f246-97d9-73e1f9804587, 1219dff4-0320-4530-b1ad-b6ecdac376cf, cd74 ... Package NDC 55111-207-81, 55111-207-78, 55111-207-79, 55111-208-81, 55111-208-78, 55111-208- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIL6UH7ZF8HC

3)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/05/2013actiondrug1

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)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat102drugstartdate02/10/2012actiondrug1

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

5)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/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

6)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb18drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/11/2013actiondrug1

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

7)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/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

8)

drugcharacterization1medicinalproductCITALOPRAMdrugstructuredosagenumb20drugstructuredosageunit003drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationPRODUCT 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

9)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb8drugstructuredosageunit003drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationAGITATIONdrugstartdateformat610drugstartdate/10/2013

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

10)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationAGITATION

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

11)

drugcharacterization1medicinalproductQUETIAPINE.drugstructuredosagenumb400drugstructuredosageunit003drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/11/2013drugenddateformat610drugenddate/01/2014actiondrug1

activesubstance

activesubstancenameQUETIAPINE

openFDA Info on Medication

Application Number ANDA207655, NDA022047, ANDA201109, ANDA077745, NDA020639, ANDA202152, ANDA211405 ... Brand Name QUETIAPINE FUMARATE, SEROQUEL XR, QUETIAPINE, SEROQUEL, QUETIAPINE EXTENDED RELE ... Generic NameQUETIAPINE, QUETIAPINE EXTENDED-RELEASEManufacturers Aurobindo Pharma Limited, AstraZeneca Pharmaceuticals LP, BluePoint Laboratories ... product_ndc 65862-873, 65862-874, 65862-875, 65862-876, 65862-877, 0310-0280, 0310-0282, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721794, 721796, 853201, 895670, 721793, 721795, 721797, 853202, 895671, ... spl_id a9b33f56-b991-4396-989f-63f631a55b8c, 1a826d85-aac4-42e4-a3e2-a18df915dc33, b829 ... spl_set_id 6562eb60-0d70-4909-bd07-88d5c9241516, 473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 874e ... Package NDC 65862-873-60, 65862-873-01, 65862-873-05, 65862-874-60, 65862-874-01, 65862-874- ... UNII2S3PL1B6UJ

12)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/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

13)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationATTENTION 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

summary

narrativeincludeclinicalCASE EVENT DATE: 2013

Report Duplicate

duplicatesourceJANSSENduplicatenumbGB-JNJFOC-20140303245

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use