Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10015740serious1Date Last Updated21/05/2014receiptdateformat102companynumbGB-MYLANLABS-2014S1005093occurcountryGBduplicate1Date Received17/03/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryGB

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)

drugcharacterization1medicinalproductCITALOPRAMdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/02/2013actiondrug1drugrecurreadministration3

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

2)

drugcharacterization1medicinalproductQUETIAPINEdrugstructuredosagenumb400drugstructuredosageunit003drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/11/2013drugenddateformat610drugenddate/01/2014actiondrug1drugrecurreadministration3

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

3)

drugcharacterization1medicinalproductRISPERIDONEdrugauthorizationnumb076288drugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.5 MG, BIDdrugadministrationroute065drugindicationAGITATIONactiondrug1drugrecurreadministration3

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

4)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKNOWNdrugdosageformCAPSULEdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat102drugstartdate02/10/2012actiondrug1drugrecurreadministration3

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)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb60drugstructuredosageunit003drugdosagetext60 MG, UNKNOWNdrugdosageformCAPSULEdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/08/2013actiondrug1drugrecurreadministration3

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)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, UNKNOWNdrugdosageformCAPSULEdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/01/2013actiondrug1drugrecurreadministration3

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)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb18drugstructuredosageunit003drugdosagetext18 MG, UNKNOWNdrugdosageformCAPSULEdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/11/2012actiondrug1drugrecurreadministration3

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, UNKNOWNdrugdosageformCAPSULEdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/11/2013drugenddateformat610drugenddate/12/2013actiondrug1drugrecurreadministration3

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)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKNOWNdrugdosageformCAPSULEdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/10/2013drugenddateformat610drugenddate/10/2013actiondrug1drugrecurreadministration3

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)

drugcharacterization1medicinalproductSTRATTERAdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKNOWNdrugdosageformCAPSULEdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/05/2013actiondrug1drugrecurreadministration3

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, UNKNOWNdrugadministrationroute065drugindicationINSOMNIAdrugstartdateformat610drugstartdate/06/2013

12)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKNOWNdrugadministrationroute065drugindicationAGITATIONdrugstartdateformat610drugstartdate/10/2013

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

duplicatesourceMYLANduplicatenumbGB-MYLANLABS-2014S1005093

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use