Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10369319primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious2receivedateformat102Date Received07/08/2014receiptdateformat102Date Last Updated07/08/2014fulfillexpeditecriteria2companynumbUS-ABBVIE-14P-163-1247183-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1247183-00

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age58Unit of Onset AgeyearsWeight48.58SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionMobility decreasedOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.1ReactionDepressionOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.1ReactionDrug level increasedOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionHypokinesiaOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.1ReactionAnxietyOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.1ReactionDrug ineffectiveOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.1ReactionStressOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.1ReactionInsomniaOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt17.1ReactionManiaOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.1ReactionWrong technique in drug usage processOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductDEPAKOTE ERdrugbatchnumbUNKNOWNdrugauthorizationnumb021168drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat602drugstartdate//2013drugenddateformat610drugenddate/05/2014actiondrug2

activesubstance

activesubstancenameDIVALPROEX SODIUM

openFDA Info on Medication

Application NumberNDA021168Brand NameDEPAKOTE ERGeneric NameDIVALPROEX SODIUMManufacturersAbbVie Inc.product_ndc0074-3826, 0074-7401, 0074-7126, 0074-7402Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIVALPROEX SODIUMRXCUI1099563, 1099565, 1099569, 1099571spl_id94b6d88a-6c23-4f4a-b3bd-3c8b451ffb43spl_set_id0dc024ce-efc8-4690-7cb5-639c728fccacPackage NDC 0074-3826-13, 0074-3826-11, 0074-7401-13, 0074-7126-13, 0074-7126-53, 0074-7126- ... UNII644VL95AO6

2)

drugcharacterization2medicinalproductSYNTHROIDdrugindicationTHYROID DISORDER

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

3)

drugcharacterization1medicinalproductDEPAKOTE ERdrugbatchnumbUNKNOWNdrugauthorizationnumb021168drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat610drugstartdate/05/2014drugenddateformat610drugenddate/06/2014actiondrug2

activesubstance

activesubstancenameDIVALPROEX SODIUM

openFDA Info on Medication

Application NumberNDA021168Brand NameDEPAKOTE ERGeneric NameDIVALPROEX SODIUMManufacturersAbbVie Inc.product_ndc0074-3826, 0074-7401, 0074-7126, 0074-7402Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIVALPROEX SODIUMRXCUI1099563, 1099565, 1099569, 1099571spl_id94b6d88a-6c23-4f4a-b3bd-3c8b451ffb43spl_set_id0dc024ce-efc8-4690-7cb5-639c728fccacPackage NDC 0074-3826-13, 0074-3826-11, 0074-7401-13, 0074-7126-13, 0074-7126-53, 0074-7126- ... UNII644VL95AO6

4)

drugcharacterization2medicinalproductLUNESTAdrugindicationINSOMNIA

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

5)

drugcharacterization1medicinalproductDEPAKOTE ERdrugbatchnumbUNKNOWNdrugauthorizationnumb021168drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1/2 TABLET IN EVENINGdrugdosageformTABLETdrugadministrationroute048drugstartdateformat610drugstartdate/05/2014drugenddateformat610drugenddate/06/2014actiondrug2

activesubstance

activesubstancenameDIVALPROEX SODIUM

openFDA Info on Medication

Application NumberNDA021168Brand NameDEPAKOTE ERGeneric NameDIVALPROEX SODIUMManufacturersAbbVie Inc.product_ndc0074-3826, 0074-7401, 0074-7126, 0074-7402Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIVALPROEX SODIUMRXCUI1099563, 1099565, 1099569, 1099571spl_id94b6d88a-6c23-4f4a-b3bd-3c8b451ffb43spl_set_id0dc024ce-efc8-4690-7cb5-639c728fccacPackage NDC 0074-3826-13, 0074-3826-11, 0074-7401-13, 0074-7126-13, 0074-7126-53, 0074-7126- ... UNII644VL95AO6

6)

drugcharacterization2medicinalproductLISINOPRIL.drugindicationHYPERTENSION

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, ANDA077622, NDA208401, ANDA078402, ANDA208920, ANDA21204 ... Brand NameLISINOPRIL, QBRELIS, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Rising Pharma H ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 205326, 311353, 1806884, 1806890, 104375, 104376 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, c031 ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, c031 ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

7)

drugcharacterization2medicinalproductXANAXdrugindicationANXIETY

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, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_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

8)

drugcharacterization2medicinalproductMELATONINdrugindicationINSOMNIA

activesubstance

activesubstancenameMELATONIN

openFDA Info on Medication

Brand NameMELATONIN, MELATONIN PHENOLIC, MELATONIN CORD, MELATONIN 1527Generic NameMELATONINManufacturers BioActive Nutritional, Inc., Energique, Inc., Professional Complementary Health ... product_ndc43857-0086, 44911-0247, 44911-0194, 63083-1527, 43742-0771Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMELATONINspl_id e189499d-9da3-43fc-8a0b-9d5dd0923b11, 904c041a-ff84-4152-9b10-ea5d1b669d24, 0673 ... spl_set_id cd82eb5d-a44a-4512-ad65-0fffae70d1d0, 895cb8a5-33ea-4764-86a6-1da513dcd2c1, 9a59 ... Package NDC43857-0086-1, 44911-0247-1, 44911-0194-1, 63083-1527-1, 43742-0771-1UNIIJL5DK93RCL

summary

narrativeincludeclinicalCASE EVENT DATE: 201405