Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10296834primarysourcecountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnessother1receivedateformat102Date Received08/07/2014receiptdateformat102Date Last Updated08/07/2014fulfillexpeditecriteria2

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age36Unit of Onset AgeyearsWeight119.75SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionAnxiety

2)

reactionmeddraversionpt17.1ReactionSelf injurious behaviour

3)

reactionmeddraversionpt17.1ReactionAnger

4)

reactionmeddraversionpt17.1ReactionProduct substitution issue

5)

reactionmeddraversionpt17.1ReactionAgitated depression

Drug

1)

drugcharacterization2medicinalproductLUNESTA

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

2)

drugcharacterization2medicinalproductGLIPIZIDE.

activesubstance

activesubstancenameGLIPIZIDE

openFDA Info on Medication

Application Number NDA020329, ANDA074497, ANDA203499, ANDA074550, ANDA074226, ANDA076467, ANDA07615 ... Brand NameGLUCOTROL XL, GLIPIZIDE XL, GLIPIZIDE, GLIPIZIDE ERGeneric NameGLIPIZIDEManufacturers Roerig, Greenstone LLC, ANI Pharmaceuticals, Inc., Northstar Rx LLC., Accord Hea ... product_ndc 0049-0170, 0049-0174, 0049-0178, 59762-0540, 59762-0541, 59762-0542, 62559-315, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGLIPIZIDERXCUI310489, 314006, 315107, 865568, 865571, 865573, 310488, 310490spl_id 65586351-ffe1-429c-956f-6d45c635a422, cf7479ea-f3c5-4b69-8cb0-264436ec14f0, bbb3 ... spl_set_id eed99b60-d043-4249-9b2a-f05e46fb588d, c9c3fa3e-af0c-42b9-a7c0-181642d2b1ea, 252b ... Package NDC 0049-0170-01, 0049-0174-02, 0049-0174-03, 0049-0178-07, 0049-0178-08, 59762-0540 ... NUIN0000175608, M0020795Established Pharmacologic ClassSulfonylurea [EPC]Chemical StructureSulfonylurea Compounds [CS]UNIIX7WDT95N5C

3)

drugcharacterization2medicinalproductMECLIZINE

activesubstance

activesubstancenameMECLIZINE\MECLIZINE HYDROCHLORIDE

openFDA Info on Medication

Application Numberpart336, ANDA201451Brand NameMECLIZINE, MECLIZINE HYDROCHLORIDEGeneric NameMECLIZINE HCL 12.5 MG, MECLIZINE HCL 25MG, MECLIZINE, MECLIZINE HCL 12.5MGManufacturers RUGBY LABORATORIES, Pharbest Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, ... product_ndc0536-1297, 16103-387, 65162-441, 65162-442, 65162-444, 73057-386Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMECLIZINE HYDROCHLORIDERXCUI995624, 995632, 995666, 995686spl_id 4f0c6a9a-982d-4efd-be18-ba305c39772d, 887b312d-3c2c-4dcb-86eb-316dfb068bc9, a9e0 ... spl_set_id 8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35, 4bac2765-045c-405e-8006-8c5cfdfa89bc, 666d ... Package NDC 0536-1297-01, 0536-1297-10, 16103-387-08, 16103-387-11, 65162-441-03, 65162-441- ... UNIIHDP7W44CIO

4)

drugcharacterization2medicinalproductXANAX

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

5)

drugcharacterization2medicinalproductPROAIR HFA

activesubstance

activesubstancenameALBUTEROL SULFATE

openFDA Info on Medication

Application NumberNDA021457Brand NamePROAIR HFAGeneric NameALBUTEROL SULFATEManufacturersTeva Respiratory, LLCproduct_ndc59310-579Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsALBUTEROL SULFATERXCUI745752, 2123072spl_id07738d64-2ab5-4f96-bce1-f92bbb93ef18spl_set_id8e701d71-1dcb-4b84-bada-84e4f04f5e62Package NDC59310-579-22, 59310-579-23UNII021SEF3731

6)

drugcharacterization2medicinalproductFENOFIBRATE.

activesubstance

activesubstancenameFENOFIBRATE

openFDA Info on Medication

Application Number ANDA211080, ANDA209950, ANDA207378, ANDA211122, ANDA210606, ANDA090715, NDA02169 ... Brand NameFENOFIBRATE, FENOFIBRATE FILM COATED, ANTARA, TRICOR, LIPOFEN, FENOGLIDEGeneric NameFENOFIBRATEManufacturers Solco Healthcare US, LLC, Amneal Pharmaceuticals NY LLC, Northstar Rx LLC, Gravi ... product_ndc 43547-430, 43547-431, 69238-1262, 69238-1263, 16714-739, 16714-740, 16714-741, 6 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFENOFIBRATERXCUI 477560, 477562, 349287, 351133, 200311, 310288, 310289, 483425, 483427, 1442163, ... spl_id 165e6912-1ca0-4fad-8c3c-97a927d0d249, eabb010f-d348-4d41-afac-20c21ef60800, 502b ... spl_set_id 085109a6-f006-44f0-a170-980d8899a365, 7e79d495-5d59-485e-b3c2-7c31ba044948, e47b ... Package NDC 43547-430-09, 43547-430-50, 43547-431-09, 43547-431-50, 69238-1262-9, 69238-1263 ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIU202363UOS

7)

drugcharacterization1medicinalproductANY GENERIC ZOLOFTdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 (2-100 MG) ?QD?PO?drugadministrationroute048drugindicationGENERALISED ANXIETY DISORDER

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

8)

drugcharacterization2medicinalproductLISINOPRIL.

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

9)

drugcharacterization2medicinalproductGLUCOPHAGE

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

10)

drugcharacterization2medicinalproductTRICOR

activesubstance

activesubstancenameFENOFIBRATE

openFDA Info on Medication

Application NumberNDA021656Brand NameTRICORGeneric NameFENOFIBRATEManufacturersAbbVie Inc.product_ndc0074-3173, 0074-6122, 0074-6123, 0074-3189Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFENOFIBRATERXCUI477560, 477562, 540281, 544518spl_id2ae06243-4345-4d86-82d6-46edcbf3876espl_set_idb693e68d-f812-4993-54b6-852e3517c344Package NDC 0074-6122-71, 0074-6122-90, 0074-6123-71, 0074-6123-90, 0074-3173-90, 0074-3189- ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIU202363UOS

11)

drugcharacterization1medicinalproductANY GENERIC ZOLOFTdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 (2-100 MG) ?QD?PO?drugadministrationroute048drugindicationMAJOR DEPRESSION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

12)

drugcharacterization2medicinalproductHYDROXYZINE

activesubstance

activesubstancenameHYDROXYZINE\HYDROXYZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040808Brand NameHYDROXYZINE HYDROCHLORIDEGeneric NameHYDROXYZINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-575, 65162-671, 65162-577Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYZINE HYDROCHLORIDERXCUI995218, 995258, 995281spl_id8dad3af3-9788-466a-992a-6e261a3a7600spl_set_id89901966-724b-4773-98b8-ea663ceabd53Package NDC 65162-575-10, 65162-575-11, 65162-575-50, 65162-671-10, 65162-671-11, 65162-671- ... UNII76755771U3

13)

drugcharacterization2medicinalproductZYRTEC

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429, NDA021621Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779, 50580-753Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023, 1014674, 1020022spl_idcea20e63-c9ab-38c7-e053-2995a90adebe, dfe981c1-d2ce-2fbc-e053-2995a90ab14fspl_set_id605adf29-734f-451a-8ff3-74be7b5814a6, dc613bd5-70fd-1d9b-e053-2995a90a41cdPackage NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65, 50580-753-24UNII64O047KTOA

14)

drugcharacterization1medicinalproductANY GENERIC ZOLOFTdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 (2-100 MG) ?QD?PO?drugadministrationroute048drugindicationPOST-TRAUMATIC STRESS DISORDER

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

15)

drugcharacterization2medicinalproductSYNTHROID

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

16)

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 IngredientsACETAMINOPHEN, OXYCODONE HYDROCHLORIDERXCUI1049214, 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, 63481-629-70UNIIC1ENJ2TE6C, 362O9ITL9D

summary

narrativeincludeclinicalCASE EVENT DATE: 20061107