Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10015596serious1Date Last Updated06/01/2015seriousnesslifethreatening1receiptdateformat102companynumbUS-BAYER-2014-038729occurcountryUSduplicate1Date Received17/03/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age26Unit of Onset Ageyearspatientagegroup5Weight57.6SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionAnxiety

2)

reactionmeddraversionpt18.0ReactionInjury

3)

reactionmeddraversionpt18.0ReactionUterine perforation

4)

reactionmeddraversionpt18.0ReactionPain

5)

reactionmeddraversionpt18.0ReactionAbdominal pain

6)

reactionmeddraversionpt18.0ReactionGeneral physical health deterioration

7)

reactionmeddraversionpt18.0ReactionDevice dislocation

8)

reactionmeddraversionpt18.0ReactionAnhedonia

9)

reactionmeddraversionpt18.0ReactionInfection

Drug

1)

drugcharacterization2medicinalproductAMBIENdrugdosagetextUNKdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat602drugstartdate//2011

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturersSanofi-Aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id6c172483-d1e2-4203-8dab-7f8a780a02ad, e932d227-dc7a-405f-855b-4994aabb85f4spl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

2)

drugcharacterization2medicinalproductBENADRYL

activesubstance

activesubstancenameDIPHENHYDRAMINE HYDROCHLORIDE

openFDA Info on Medication

Application Numberpart341Brand NameCHILDRENS ALLERGY RELIEF, BENADRYLGeneric NameBENADRYL, DIPHENHYDRAMINE HYDROCHLORIDEManufacturers Rite Aid Corporation, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcar ... product_ndc11822-0025, 50580-370, 50580-226Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI1049906, 1049630, 1049632spl_id fecb0ac3-0ede-4e4a-91c3-b6322f055b5c, ecd53790-6b06-46a1-a4ed-dd69293aa1c5, b09d ... spl_set_id 50434eaf-650c-4416-a357-d174f86d729f, 2884d2dc-2d4a-4ca6-ab73-688a80b428eb, 702f ... Package NDC 11822-0025-4, 50580-370-01, 50580-226-50, 50580-226-51, 50580-226-53, 50580-226- ... UNIITC2D6JAD40

3)

drugcharacterization1medicinalproductMIRENAdrugbatchnumbTU0098Zdrugauthorizationnumb021225drugstructuredosagenumb20drugstructuredosageunit004drugdosagetext20 MCG/24HR, CONTdrugdosageformINTRAUTERINE DELIVERY SYSTEMdrugadministrationroute015drugindicationCONTRACEPTIONdrugstartdateformat102drugstartdate06/06/2011drugenddateformat102drugenddate10/05/2012actiondrug1

activesubstance

activesubstancenameLEVONORGESTREL

openFDA Info on Medication

Application NumberNDA021225Brand NameMIRENAGeneric NameLEVONORGESTRELManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-423Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAUTERINEActive IngredientsLEVONORGESTRELRXCUI804156, 807283spl_id66f86bba-49cd-4a8a-9769-605ccb9f94f7spl_set_iddcbd6aa2-b3fa-479a-a676-56ea742962fcPackage NDC50419-423-01, 50419-423-08NUIN0000175830, M0447349, N0000175602, N0000175832Physiologic/Pharmacodynamic EffectInhibit Ovum Fertilization [PE]Chemical StructureProgesterone Congeners [CS]Established Pharmacologic ClassProgestin [EPC], Progestin-containing Intrauterine Device [EPC]UNII5W7SIA7YZW

4)

drugcharacterization2medicinalproductLEXAPROdrugdosagetextUNKdrugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat602drugstartdate//2011

activesubstance

activesubstancenameESCITALOPRAM OXALATE

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAM OXALATEManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_idf7659260-4527-4446-9aa5-15a2895c5b0espl_set_id13bb8267-1cab-43e5-acae-55a4d957630aPackage NDC 0456-2005-01, 0456-2010-01, 0456-2010-11, 0456-2010-63, 0456-2020-01, 0456-2020- ... UNII5U85DBW7LO

5)

drugcharacterization1medicinalproductMIRENAdrugauthorizationnumb021225drugstructuredosagenumb20drugstructuredosageunit004drugdosagetext20 MCG/24HR, CONTdrugdosageformINTRAUTERINE DELIVERY SYSTEMdrugadministrationroute015drugindicationCONTRACEPTIONdrugstartdateformat102drugstartdate01/02/2008drugenddateformat602drugenddate//2010actiondrug1

activesubstance

activesubstancenameLEVONORGESTREL

openFDA Info on Medication

Application NumberNDA021225Brand NameMIRENAGeneric NameLEVONORGESTRELManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-423Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAUTERINEActive IngredientsLEVONORGESTRELRXCUI804156, 807283spl_id66f86bba-49cd-4a8a-9769-605ccb9f94f7spl_set_iddcbd6aa2-b3fa-479a-a676-56ea742962fcPackage NDC50419-423-01, 50419-423-08NUIN0000175830, M0447349, N0000175602, N0000175832Physiologic/Pharmacodynamic EffectInhibit Ovum Fertilization [PE]Chemical StructureProgesterone Congeners [CS]Established Pharmacologic ClassProgestin [EPC], Progestin-containing Intrauterine Device [EPC]UNII5W7SIA7YZW

6)

drugcharacterization2medicinalproductXANAXdrugindicationPANIC ATTACK

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_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

7)

drugcharacterization2medicinalproductADDERALLdrugdosagetextUNKdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat602drugstartdate//2011

activesubstance

activesubstancename AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMP ...

openFDA Info on Medication

Application NumberANDA040422, NDA021303Brand NameADDERALL, ADDERALL XRGeneric Name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, ... ManufacturersTeva Pharmaceuticals USA, Inc., Takeda Pharmaceuticals America, Inc.product_ndc 57844-105, 57844-117, 57844-110, 57844-112, 57844-115, 57844-120, 57844-130, 540 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMI ... RXCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, ... spl_ide9cd0754-917c-4545-8963-e0b5b8fe544a, 05c01190-093d-41b3-8fe6-4ad8d6e2aee3spl_set_idf22635fe-821d-4cde-aa12-419f8b53db81, aff45863-ffe1-4d4f-8acf-c7081512a6c0Package NDC 57844-105-01, 57844-117-01, 57844-110-01, 57844-112-01, 57844-115-01, 57844-120- ... UNIIJJ768O327N, G83415V073, 6DPV8NK46S, O1ZPV620O4

8)

drugcharacterization2medicinalproductZOLOFT

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

9)

drugcharacterization2medicinalproductPERCOCET

activesubstance

activesubstancenameACETAMINOPHEN\OXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, ACETAMINOPHENRXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNII362O9ITL9D, C1ENJ2TE6C

summary

narrativeincludeclinicalCASE EVENT DATE: 201203

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-038729

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use