Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10050101serious1Date Last Updated02/05/2014receiptdateformat102companynumbBR-ASTRAZENECA-2014SE20729occurcountryBRseriousnessother1duplicate1Date Received01/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryBR

Primary Source

reportercountryBRqualification5

Patient

Onset Age61Unit of Onset AgeyearsWeight97SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionRenal failureOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionHerpes virus infectionOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionAnaemiaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionCervix carcinomaOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionOsteopeniaOutcomeRecovering/resolving

6)

reactionmeddraversionpt17.0ReactionTachycardiaOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionFlatulenceOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeRecovering/resolving

9)

reactionmeddraversionpt17.0ReactionMemory impairmentOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.0ReactionSomnolenceOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt17.0ReactionVein disorderOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt17.0ReactionOff label useOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductNEXIUMdrugauthorizationnumb021153drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationGASTRIC DISORDERdrugstartdateformat610drugstartdate/06/2013drugenddateformat610drugenddate/07/2013actiondrug5

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 SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id416c365d-7271-4804-9285-643858cf578b, 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, L2C9GWQ43H

2)

drugcharacterization1medicinalproductSELOZOKdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb18275drugcumulativedosageunit003drugdosageformMODIFIED-RELEASE TABLETdrugadministrationroute048drugindicationTACHYCARDIAdrugstartdateformat602drugstartdate//2012actiondrug5

3)

drugcharacterization1medicinalproductCRESTORdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb14620drugcumulativedosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationBLOOD CHOLESTEROL INCREASEDdrugstartdateformat602drugstartdate//2011actiondrug5

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0751, 0310-0755, 0310-0752, 0310-0754Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id0abd2d1e-ee9a-4738-ad7e-610a2caa24abspl_set_idbb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-0755-90, 0310-0751-90, 0310-0751-39, 0310-0752-90, 0310-0752-39, 0310-0754- ... UNII83MVU38M7Q

4)

drugcharacterization1medicinalproductZOLOFTdrugdosagetextAS REQUIREDdrugadministrationroute065drugindicationANXIETYdrugstartdateformat602drugstartdate//2013actiondrug5

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

5)

drugcharacterization1medicinalproductGLIMEPIRIDEdrugdosagetextDAILYdrugadministrationroute048drugindicationTYPE 2 DIABETES MELLITUSdrugstartdateformat602drugstartdate//2010drugenddateformat610drugenddate/09/2012actiondrug1

openFDA Info on Medication

Application Number ANDA077911, ANDA077091, ANDA091220, ANDA078181, NDA020496, ANDA077370, ANDA20275 ... Brand NameGLIMEPIRIDE, AMARYLGeneric NameGLIMEPIRIDEManufacturers Carlsbad Technology, Inc., Dr. Reddy's Laboratories Limited, Micro Labs Limited, ... product_ndc 61442-115, 61442-116, 61442-117, 55111-320, 55111-321, 55111-322, 42571-100, 425 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGLIMEPIRIDERXCUI199245, 199246, 199247, 153842, 1361493, 1361495, 153591, 153843, 153845spl_id 94f7e51b-3f92-8633-e053-2995a90a8cf1, e3d50334-9896-b2f9-a481-8383eb84b16a, ab8d ... spl_set_id 72d88c6d-2f0a-4bf8-aa7f-1e1811794187, 07ad4366-4b21-f633-49f3-c2b35f88168d, 60e9 ... Package NDC 61442-115-01, 61442-115-05, 61442-115-10, 61442-116-01, 61442-116-05, 61442-116- ... NUIN0000175608, M0020795Established Pharmacologic ClassSulfonylurea [EPC]Chemical StructureSulfonylurea Compounds [CS]UNII6KY687524K

6)

drugcharacterization1medicinalproductCHEMOTHERAPYdrugadministrationroute065drugindicationCERVIX CARCINOMAdrugstartdateformat610drugstartdate/08/2013drugenddateformat602drugenddate//2013actiondrug5

7)

drugcharacterization1medicinalproductRADIOTHERAPYdrugadministrationroute065drugindicationCERVIX CARCINOMAdrugstartdateformat610drugstartdate/08/2013drugenddateformat602drugenddate//2013actiondrug5

8)

drugcharacterization2medicinalproductDIAMICRONdrugadministrationroute048drugindicationTYPE 2 DIABETES MELLITUSdrugstartdateformat610drugstartdate/09/2012

9)

drugcharacterization2medicinalproductASPIRINAdrugdosagetextDAILYdrugadministrationroute048drugindicationISCHAEMIC HEART DISEASE PROPHYLAXISdrugstartdateformat602drugstartdate//2006

10)

drugcharacterization2medicinalproductGALVUSdrugdosagetextTWO TIMES A DAYdrugadministrationroute048drugindicationTYPE 2 DIABETES MELLITUSdrugstartdateformat602drugstartdate//2003

11)

drugcharacterization2medicinalproductALENDRONATE SODIUMdrugdosagetextONCE A WEEKdrugadministrationroute048drugindicationOSTEOPENIAdrugstartdateformat610drugstartdate/09/2012

openFDA Info on Medication

Application NumberANDA076768, NDA202344, ANDA090124, ANDA090520, ANDA075710, ANDA090258, NDA020560Brand NameALENDRONATE SODIUM, BINOSTO, ALENDRONATE, FOSAMAXGeneric NameALENDRONATE SODIUMManufacturers Exelan Pharmaceuticals Inc., ASCEND Therapeutics, Aurobindo Pharma Limited, Hikm ... product_ndc 76282-681, 76282-682, 17139-400, 65862-327, 65862-328, 65862-329, 0054-0282, 690 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALENDRONATE SODIUMRXCUI904396, 904431, 1248077, 1248083, 904419, 904447, 904405, 904425, 904433spl_id 86438706-8e32-42db-b5d0-456a24844db6, 5eaf3f34-2326-46d0-a58b-089d1df479e6, 6253 ... spl_set_id 91a0f73a-d8cd-4197-b431-40707a2150b9, b278a11a-b8d7-49f3-9b38-29b67c4c417e, 815a ... Package NDC 76282-681-45, 76282-681-46, 76282-682-45, 76282-682-46, 17139-400-04, 17139-400- ... UNII2UY4M2U3RA

12)

drugcharacterization2medicinalproductPANTOPRAZOLEdrugdosagetextDAILYdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX PROPHYLAXISdrugstartdateformat602drugstartdate//2004drugenddateformat610drugenddate/06/2013

openFDA Info on Medication

Application NumberANDA205119, ANDA077619Brand NamePANTOPRAZOLE SODIUM, PANTOPRAZOLEGeneric NamePANTOPRAZOLEManufacturersAmneal Pharmaceuticals LLC, Dr.Reddy's Laboratories Limitedproduct_ndc65162-636, 65162-637, 55111-332, 55111-333Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI251872, 314200spl_id5c7a8fef-13ea-42c4-9e13-d8bc23c8f8a4, 02f0a994-cbaa-6f9b-56bd-48e9952540ecspl_set_idf3ded82a-cf0d-4844-944a-75f9f9215ff0, 564709e8-358f-c185-4ecb-b3849c3fe59cPackage NDC 65162-636-03, 65162-636-09, 65162-637-03, 65162-637-09, 65162-637-11, 65162-637- ... UNII6871619Q5X

13)

drugcharacterization2medicinalproductPANTOPRAZOLEdrugdosagetextDAILYdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX PROPHYLAXISdrugstartdateformat610drugstartdate/07/2013

openFDA Info on Medication

Application NumberANDA205119, ANDA077619Brand NamePANTOPRAZOLE SODIUM, PANTOPRAZOLEGeneric NamePANTOPRAZOLEManufacturersAmneal Pharmaceuticals LLC, Dr.Reddy's Laboratories Limitedproduct_ndc65162-636, 65162-637, 55111-332, 55111-333Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI251872, 314200spl_id5c7a8fef-13ea-42c4-9e13-d8bc23c8f8a4, 02f0a994-cbaa-6f9b-56bd-48e9952540ecspl_set_idf3ded82a-cf0d-4844-944a-75f9f9215ff0, 564709e8-358f-c185-4ecb-b3849c3fe59cPackage NDC 65162-636-03, 65162-636-09, 65162-637-03, 65162-637-09, 65162-637-11, 65162-637- ... UNII6871619Q5X

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbBR-ASTRAZENECA-2014SE20729

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use