Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10098643serious1Date Last Updated23/04/2014receiptdateformat102companynumbUS-ASTRAZENECA-2014SE26486occurcountryUSseriousnessother1duplicate1Date Received23/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUS

Patient

Onset Age74Unit of Onset AgeyearsWeight72.1SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionSinus disorderOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionMyocardial infarctionOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionEar disorderOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionUpper respiratory tract infectionOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionFatigueOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionDry throatOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionThroat irritationOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionAngioedemaOutcomeUnknown

10)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeUnknown

11)

reactionmeddraversionpt17.0ReactionRashOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.0ReactionOral candidiasisOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt17.0ReactionDysphoniaOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt17.0ReactionDrug effect incompleteOutcomeUnknown

15)

reactionmeddraversionpt17.0ReactionOff label useOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSYMBICORTdrugauthorizationnumb021929drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext160/4.5 , 2 PUFFS BIDdrugadministrationroute055drugindicationDYSPNOEAdrugstartdateformat610drugstartdate/06/2013actiondrug1

openFDA Info on Medication

Application NumberNDA021929Brand NameSYMBICORTGeneric NameBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0186-0370, 0186-0372Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsBUDESONIDE, FORMOTEROL FUMARATERXCUI1246288, 1246290, 1246304, 1246306, 1246314, 1246315, 1246316, 1246317spl_id5b03fd09-2533-4975-88da-a0b9c8495d1espl_set_idfafa4cf1-99c2-43d5-73ad-51f256de3be0Package NDC 0186-0370-20, 0186-0370-28, 0186-0370-60, 0186-0372-20, 0186-0372-28, 0186-0372- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIQ3OKS62Q6X, W34SHF8J2K

2)

drugcharacterization1medicinalproductLISINOPRILdrugstructuredosagenumb5drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationBLOOD PRESSURE ABNORMALdrugstartdateformat602drugstartdate//2008actiondrug4

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, NDA208401, ANDA078402, ANDA212041, ANDA076180, ANDA07616 ... Brand NameLISINOPRIL, QBRELIS, PRINIVIL, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Azurity Pharmac ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 526 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 1806884, 1806890, 205326, 311353, 206764, 206765 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, 2fdc ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 9f6e ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

3)

drugcharacterization1medicinalproductMETROPOLOL TARTRATEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationCARDIAC DISORDERactiondrug4

4)

drugcharacterization2medicinalproductALLEGRAdrugdosagetextUNK DAILYdrugindicationHYPERSENSITIVITY

5)

drugcharacterization2medicinalproductASPIRINdrugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationCARDIAC 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

6)

drugcharacterization2medicinalproductGENERIC ZANTACdrugstructuredosagenumb150drugstructuredosageunit003

7)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugindicationDEPRESSION

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

8)

drugcharacterization2medicinalproductMUTIVITAMINS

9)

drugcharacterization2medicinalproductINHALERdrugdosagetextPRN

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbUS-ASTRAZENECA-2014SE26486

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use