Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-ASTRAZENECA-2013SE53564occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10050598Date Received01/04/2014transmissiondate12/12/2014serious2Date Last Updated01/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age78Unit of Onset AgeyearsWeight61.2SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionCoughOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionAdverse eventOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductNEXIUMdrugauthorizationnumb021153drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat602drugstartdate//2008actiondrug2

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMspl_id3797ceb7-550b-4e9a-8314-8e1e4995360b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43HRXCUI486501, 603536

2)

drugcharacterization1medicinalproductNEXIUMdrugauthorizationnumb021153drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat610drugstartdate/06/2013actiondrug2

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMspl_id3797ceb7-550b-4e9a-8314-8e1e4995360b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43HRXCUI486501, 603536

3)

drugcharacterization2medicinalproductTOPROLdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationHYPERTENSION

openFDA Info on Medication

Application NumberNDA019962Brand NameTOPROL XLGeneric NameMETOPROLOL SUCCINATEManufacturersAstraZeneca Pharmaceuticals LP, Aralez Pharmaceuticals US Inc.product_ndc 0186-1088, 0186-1090, 0186-1092, 0186-1094, 70347-025, 70347-050, 70347-100, 703 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATERXCUI866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438spl_id03b2ba2e-c4b7-449d-8e07-9c0e08171f66, 259b9a5f-b63a-44a0-8d05-1bb38cfc85bdspl_set_id4a5762c6-d7a2-4e4c-10b7-8832b36fa5f4, 991fe00b-498b-400e-9e5b-921cb07d9b2cPackage NDC 0186-1088-05, 0186-1088-39, 0186-1088-30, 0186-1088-35, 0186-1090-05, 0186-1090- ... UNIITH25PD4CCB

4)

drugcharacterization2medicinalproductTEMAZEPAMdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationSLEEP DISORDERdrugstartdateformat602drugstartdate//2012

openFDA Info on Medication

Application Number ANDA203482, ANDA071620, ANDA211542, ANDA071456, ANDA071457, ANDA078581, ANDA0711 ... Brand NameTEMAZEPAM, RESTORILGeneric NameTEMAZEPAMManufacturers Amneal Pharmaceuticals LLC, Actavis Pharma, Inc., Alembic Pharmaceuticals Limite ... product_ndc 65162-556, 65162-583, 65162-584, 65162-557, 0228-2076, 0228-2077, 46708-379, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTEMAZEPAMRXCUI198241, 198242, 198243, 485489, 208463, 208464, 208465, 539384spl_id c21455f5-1c17-442d-b1d1-69d27d290d48, eac383e8-6227-4439-b72d-c1b1794ee031, 2676 ... spl_set_id be68c6e0-17ad-40fe-9bc1-58abe24b53f6, a4370eb4-b00d-4247-af8d-980e59fbbec6, db83 ... Package NDC 65162-583-03, 65162-583-10, 65162-583-50, 65162-583-11, 65162-556-03, 65162-556- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIICHB1QD2QSS

5)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextPRNdrugadministrationroute048drugindicationSLEEP DISORDERdrugstartdateformat602drugstartdate//2012

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)

drugcharacterization2medicinalproductVITAMIN Cdrugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

7)

drugcharacterization2medicinalproductCALCIUMdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationOSTEOPOROSISdrugstartdateformat602drugstartdate//1983

openFDA Info on Medication

Brand Name P D ALL, ONLYCAL, RESTO L, P D M, RESTORATION TREATMENT, TALL G U, C P RE, D T B ... Generic NameCALCIUMManufacturerscoexleaders co.,ltd.product_ndc 81445-0002, 81445-0005, 81445-0006, 81445-0003, 81445-0001, 81445-0008, 81445-00 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCALCIUMspl_id b9e7d910-8df8-ca9a-e053-2995a90a0d05, b9eb3dea-4f3e-1d23-e053-2995a90a4eb2, b9eb ... spl_set_id b9e7d869-d218-d60c-e053-2995a90af542, b9eb3cc9-e340-c77d-e053-2995a90a1628, b9eb ... Package NDC 81445-0002-1, 81445-0005-1, 81445-0006-1, 81445-0003-1, 81445-0001-1, 81445-0008 ... NUIM0003153, N0000175901, N0000175597, N0000020074Chemical StructureCalcium [CS]Established Pharmacologic ClassCalcium [EPC], Phosphate Binder [EPC]Mechanism of ActionPhosphate Chelating Activity [MoA]UNIISY7Q814VUP

8)

drugcharacterization2medicinalproductVITAMIN D3drugstructuredosagenumb1000drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationSUPPLEMENTATION THERAPYdrugstartdateformat602drugstartdate//2012

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

9)

drugcharacterization2medicinalproductGEMFIBROZILdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationBLOOD CHOLESTEROL INCREASEDdrugstartdateformat602drugstartdate//2012

openFDA Info on Medication

Application Number ANDA203266, NDA018422, ANDA204189, ANDA079072, ANDA077836, ANDA214603, ANDA20272 ... Brand NameGEMFIBROZIL, LOPIDGeneric NameGEMFIBROZILManufacturers Cadila Pharmaceuticals Limited, Parke-Davis Div of Pfizer Inc, Cadila Healthcare ... product_ndc 71209-008, 0071-0737, 70771-1431, 16714-101, 76282-225, 75834-131, 31722-128, 43 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGEMFIBROZILRXCUI310459, 205751spl_id ab179aa0-e982-4685-bd47-47b85bbdedf1, ef2b3c7e-b287-4cae-9bc3-86fb6ccbe9ae, d1d0 ... spl_set_id 0b50849a-66b6-4e8f-9f45-5425a875d366, c48855b7-215e-453b-b3b1-a0f9dee7221f, e6bc ... Package NDC 71209-008-03, 71209-008-08, 71209-008-10, 0071-0737-20, 0071-0737-30, 70771-1431 ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIQ8X02027X3

10)

drugcharacterization2medicinalproductLACTOSEdrugstructuredosagenumb250drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationLACTOSE INTOLERANCE

11)

drugcharacterization2medicinalproductLORSARTANdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat602drugstartdate//2011

12)

drugcharacterization2medicinalproductZANTACdrugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASE

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

13)

drugcharacterization2medicinalproductASPIRINdrugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationCARDIAC DISORDER

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

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duplicatesourceASTRAZENECAduplicatenumbUS-ASTRAZENECA-2013SE53564