Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID10694687primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious1seriousnessother1receivedateformat102Date Received07/01/2015receiptdateformat102Date Last Updated23/06/2015fulfillexpeditecriteria2companynumbUS-BAYER-2015-001624duplicate1

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2015-001624

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age25Unit of Onset Ageyearspatientagegroup5Weight90.7SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDepression

2)

reactionmeddraversionpt18.0ReactionDrug ineffective

3)

reactionmeddraversionpt18.0ReactionDevice dislocation

4)

reactionmeddraversionpt18.0ReactionEctopic pregnancy with contraceptive device

5)

reactionmeddraversionpt18.0ReactionDepression

6)

reactionmeddraversionpt18.0ReactionAbortion early

7)

reactionmeddraversionpt18.0ReactionPain

8)

reactionmeddraversionpt18.0ReactionInjury

9)

reactionmeddraversionpt18.0ReactionEmotional distress

10)

reactionmeddraversionpt18.0ReactionOff label use of device

11)

reactionmeddraversionpt18.0ReactionDevice misuse

Drug

1)

drugcharacterization2medicinalproductDAYPROdrugstructuredosagenumb600drugstructuredosageunit003drugdosagetext600 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate05/02/2011

activesubstance

activesubstancenameOXAPROZIN

openFDA Info on Medication

Application NumberNDA018841Brand NameDAYPROGeneric NameOXAPROZINManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-1381Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXAPROZINRXCUI207243, 312132spl_id1d508849-28b8-4a9c-b850-fa47e2481fd5spl_set_idea1de47e-3101-4414-817c-0a098af8988cPackage NDC0025-1381-31, 0025-1381-34, 0025-1381-51NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIMHJ80W9LRB

2)

drugcharacterization2medicinalproductLORTABdrugdosagetext5/500MG, UNKdrugstartdateformat102drugstartdate05/02/2011

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

openFDA Info on Medication

Application NumberANDA040881Brand NameLORTABGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturersAkornproduct_ndc17478-450Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, HYDROCODONE BITARTRATERXCUI1044427, 1442445spl_id912e747f-d400-4690-bf7a-d541f6ea6254spl_set_id21def91d-b6e3-4dde-983c-6925aedf0df0Package NDC17478-450-16UNII362O9ITL9D, NO70W886KK

3)

drugcharacterization2medicinalproductCIPROdrugstructuredosagenumb250drugstructuredosageunit003drugdosagetext250 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate05/02/2011

activesubstance

activesubstancenameCIPROFLOXACIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020805, NDA019537, NDA020780Brand NameCIPRO HC, CIPROGeneric Name CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE, CIPROFLOXACIN HYDROCHLORIDE, CIP ... Manufacturers Novartis Pharmaceuticals Corporation, Alcon Laboratories, Inc., Bayer HealthCare ... product_ndc0078-0855, 0065-8531, 50419-754, 50419-758, 50419-777, 50419-773Product TypeHUMAN PRESCRIPTION DRUGRouteAURICULAR (OTIC), ORALActive IngredientsCIPROFLOXACIN HYDROCHLORIDE, HYDROCORTISONERXCUI213320, 309305, 197511, 205769, 205770, 213224, 213226, 309308, 309309, 309310spl_id eff6ee40-6e52-4f61-b54d-edc612543f71, 47f67311-1fea-4376-8d03-403fdc14e2d6, 12e8 ... spl_set_id eff6ee40-6e52-4f61-b54d-edc612543f71, 70b19501-34b6-4f95-a8dd-dd3e67d22399, 888d ... Package NDC 0078-0855-26, 0065-8531-10, 50419-758-01, 50419-754-01, 50419-777-01, 50419-773- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII4BA73M5E37, WI4X0X7BPJ

4)

drugcharacterization2medicinalproductFLEXERILdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate05/02/2011

activesubstance

activesubstancenameCYCLOBENZAPRINE HYDROCHLORIDE

5)

drugcharacterization1medicinalproductMIRENAdrugauthorizationnumb021225drugstructuredosagenumb20drugstructuredosageunit004drugdosagetext20 MCG/24HR, CONTdrugdosageformINTRAUTERINE DELIVERY SYSTEMdrugadministrationroute015drugindicationCONTRACEPTIONdrugstartdateformat102drugstartdate01/07/2006drugenddateformat610drugenddate/11/2012actiondrug1

activesubstance

activesubstancenameLEVONORGESTREL

openFDA Info on Medication

Application NumberNDA021225Brand NameMIRENAGeneric NameLEVONORGESTRELManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-423Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAUTERINEActive IngredientsLEVONORGESTRELRXCUI804156, 807283spl_id21ce3b07-0588-4ac3-915b-d1c238d756easpl_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)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate05/02/2011

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

7)

drugcharacterization2medicinalproductVALIUMdrugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate05/02/2011

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application NumberNDA013263Brand NameVALIUMGeneric NameDIAZEPAMManufacturersRoche Laboratories Inc., Waylis Therapuetics LLCproduct_ndc0140-0004, 0140-0005, 0140-0006, 80725-004, 80725-005, 80725-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIAZEPAMRXCUI104699, 104700, 104701, 197589, 197590, 197591spl_idc0054f7c-9c38-4ac8-ae8f-5e6427e1fd14, dc250376-39ef-2207-e053-2a95a90a4901spl_set_id554baee5-b171-4452-a50a-41a0946f956c, 260e2041-2bb3-482f-850e-b5d47a7bdbe6Package NDC 0140-0004-01, 0140-0005-01, 0140-0005-14, 0140-0006-01, 0140-0006-14, 80725-004- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

8)

drugcharacterization2medicinalproductHYDROCODONEdrugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate05/02/2011

activesubstance

activesubstancenameHYDROCODONE

9)

drugcharacterization2medicinalproductDARVONdrugstructuredosagenumb65drugstructuredosageunit003drugdosagetext65 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate05/02/2011

activesubstance

activesubstancenamePROPOXYPHENE HYDROCHLORIDE

10)

drugcharacterization2medicinalproductPHENTERMINEdrugdosagetextUNKdrugadministrationroute048drugstartdateformat102drugstartdate05/02/2011

activesubstance

activesubstancenamePHENTERMINE

openFDA Info on Medication

Application NumberANDA204318Brand NamePHENTERMINEGeneric NamePHENTERMINE HYDROCHLORIDEManufacturersAurolife Pharma, LLCproduct_ndc13107-105, 13107-106Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPHENTERMINE HYDROCHLORIDERXCUI900038, 968766spl_id53dd7857-41fb-4da1-88f7-5c68a509bfb0spl_set_id737eef3b-9a6b-4ab3-a25c-49d84d2a0197Package NDC13107-105-30, 13107-105-01, 13107-106-30, 13107-106-01UNII0K2I505OTV

summary

narrativeincludeclinicalCASE EVENT DATE: 201102