Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-ASTRAZENECA-2012SE76560occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10336383Date Received23/07/2014transmissiondate26/03/2015serious2Date Last Updated23/07/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age56Unit of Onset AgeyearsWeight76.2SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionDiabetes mellitusOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionDrug dispensing errorOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionAmnesiaOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionDrug dose omissionOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionHallucination, auditoryOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionCryingOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionMental disorderOutcomeUnknown

8)

reactionmeddraversionpt17.1ReactionAgitationOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductXANAXdrugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationANXIETY

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

2)

drugcharacterization2medicinalproductWELLBUTRINdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationNERVOUS SYSTEM DISORDER

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021515, NDA020358Brand NameWELLBUTRIN XL, WELLBUTRIN SRGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLC, GlaxoSmithKline LLCproduct_ndc0187-0730, 0187-0731, 0173-0135, 0173-0947, 0173-0722Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564, 993503, 993511, 993518, 993528, 993536, 993537spl_ida4bd6e04-f597-4ad4-966d-86cf2efbf5fa, ed416049-f26b-453e-b89a-10bdf7091734spl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21, cbc8c074-f080-4489-a5ae-207b5fadeba3Package NDC 0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07, 0173-0947- ... UNIIZG7E5POY8O

3)

drugcharacterization1medicinalproductSEROQUEL XRdrugauthorizationnumb022047drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationMENTAL DISORDERdrugstartdateformat602drugstartdate//1992drugenddateformat610drugenddate/12/2013actiondrug3

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047Brand NameSEROQUEL XRGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671spl_id1a826d85-aac4-42e4-a3e2-a18df915dc33spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

4)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

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

5)

drugcharacterization1medicinalproductSEROQUEL XRdrugauthorizationnumb022047drugstructuredosagenumb125drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationBIPOLAR DISORDERactiondrug3

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047Brand NameSEROQUEL XRGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671spl_id1a826d85-aac4-42e4-a3e2-a18df915dc33spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

6)

drugcharacterization2medicinalproductZANTACdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationGASTRIC DISORDER

activesubstance

activesubstancenameRANITIDINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA019090Brand NameZANTACGeneric NameRANITIDINE HYDROCHLORIDEManufacturersTeligent, Inc., Teligent Pharma, Inc.product_ndc52565-096, 52565-101, 52565-102Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsRANITIDINE HYDROCHLORIDERXCUI104084, 312772, 1859553, 1859554spl_id4a3400a1-5ac0-407f-b4c9-cc75b5da4b82, f893211b-dae4-417b-8d5a-e4f54d0d3833spl_set_id95dc4515-7690-4881-ae14-9f8655a68dfe, c1b12354-9409-4e76-bcdc-024c190d6583Package NDC52565-096-04, 52565-101-25, 52565-102-05UNIIBK76465IHM

7)

drugcharacterization2medicinalproductMETFORMINdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDIABETES MELLITUS

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, a353 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

8)

drugcharacterization1medicinalproductSEROQUEL XRdrugauthorizationnumb022047drugstructuredosagenumb125drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationMENTAL DISORDERactiondrug3

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047Brand NameSEROQUEL XRGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671spl_id1a826d85-aac4-42e4-a3e2-a18df915dc33spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

9)

drugcharacterization1medicinalproductSEROQUEL XRdrugauthorizationnumb022047drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat602drugstartdate//1992drugenddateformat610drugenddate/12/2013actiondrug3

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047Brand NameSEROQUEL XRGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671spl_id1a826d85-aac4-42e4-a3e2-a18df915dc33spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

10)

drugcharacterization2medicinalproductWELLBUTRINdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationANXIETY

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021515, NDA020358Brand NameWELLBUTRIN XL, WELLBUTRIN SRGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLC, GlaxoSmithKline LLCproduct_ndc0187-0730, 0187-0731, 0173-0135, 0173-0947, 0173-0722Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564, 993503, 993511, 993518, 993528, 993536, 993537spl_ida4bd6e04-f597-4ad4-966d-86cf2efbf5fa, ed416049-f26b-453e-b89a-10bdf7091734spl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21, cbc8c074-f080-4489-a5ae-207b5fadeba3Package NDC 0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07, 0173-0947- ... UNIIZG7E5POY8O

11)

drugcharacterization2medicinalproductDOXEPINdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationSLEEP DISORDER

activesubstance

activesubstancenameDOXEPIN

openFDA Info on Medication

Application NumberANDA201951Brand NameDOXEPINGeneric NameDOXEPINManufacturersActavis Pharma, Inc.product_ndc0228-3315, 0228-3316Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDOXEPIN HYDROCHLORIDERXCUI966787, 966793spl_idaeefed70-09dc-4efa-809e-b80fe14656a6spl_set_idc42333f8-1add-4f33-9458-6fe4436874a1Package NDC0228-3315-03, 0228-3316-03UNII3U9A0FE9N5

summary

narrativeincludeclinicalCASE EVENT DATE: 201312

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbUS-ASTRAZENECA-2012SE76560