Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11477965primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received09/09/2015receiptdateformat102Date Last Updated09/09/2015fulfillexpeditecriteria2companynumbUS-JAZZ-2015-US-009387duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-2015-US-009387

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionConversion disorderOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionTremorOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionOral painOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionHyperhidrosisOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionAlopeciaOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionOral discomfortOutcomeUnknown

7)

reactionmeddraversionpt18.1ReactionStomatitisOutcomeUnknown

8)

reactionmeddraversionpt18.1ReactionDry mouthOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductADVILdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2001drugrecurreadministration3

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application NumberNDA201803, NDA018989, NDA020402Brand NameADVILGeneric NameIBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLET COATEDManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Mechanical Servants LLCproduct_ndc 0573-0133, 0573-0134, 0573-0150, 0573-0165, 0573-0154, 0573-0151, 0573-0161, 057 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIBUPROFEN SODIUM, IBUPROFENRXCUI153008, 310965, 310964, 731533spl_id aeda1ef6-01ea-48ce-81dd-15cef15b3c0d, eb3fc8e0-b90f-4141-a5fa-3d11db900f64, c997 ... spl_set_id 5be198b8-396e-4b44-8819-e2e3b5d2ad0e, 1a665e64-9f30-be37-4a83-38789f1f1e89, 1f01 ... Package NDC 0573-0133-20, 0573-0133-40, 0573-0133-80, 0573-0133-02, 0573-0133-04, 0573-0133- ... UNIIRM1CE97Z4N, WK2XYI10QMNUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]

2)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate15/01/2013drugrecurreadministration3

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

3)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048actiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

4)

drugcharacterization2medicinalproductTOPIRAMATE.drugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/11/2014drugrecurreadministration3

activesubstance

activesubstancenameTOPIRAMATE

openFDA Info on Medication

Application Number ANDA215414, ANDA078462, ANDA078235, ANDA079162, NDA020505, NDA020844, NDA205122, ... Brand NameTOPIRAMATE, TOPAMAX, EPRONTIA, QUDEXY XR, TROKENDI XRGeneric NameTOPIRAMATEManufacturers Camber Pharmaceuticals, Inc., Rising Pharma Holdings, Inc., Cadila Healthcare Li ... product_ndc 31722-181, 31722-182, 31722-183, 31722-184, 16571-705, 16571-706, 16571-707, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 199888, 199889, 199890, 151227, 151228, 151229, 152855, 205315, 205316, ... spl_id 18aa4aae-c619-4a0e-a69e-b8c5bd7466bc, 9bb758cd-a042-4d34-ae5a-42769a8e4a36, ecd7 ... spl_set_id cefbc5f4-ef5f-4732-ab96-a69a183f0b6b, 296c5387-1bf4-4137-87f2-2ebab4933e2c, 5701 ... Package NDC 31722-181-60, 31722-181-05, 31722-182-60, 31722-182-05, 31722-183-60, 31722-183- ... NUIN0000008486, N0000185506, N0000182140Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of ActionCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNII0H73WJJ391

5)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/10/2012actiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

6)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb2.25drugstructuredosageunit002drugdosagetext2.25 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat610drugstartdate/07/2012drugenddateformat610drugenddate/08/2012actiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

7)

drugcharacterization2medicinalproductCYMBALTAdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/02/2015drugrecurreadministration3

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

8)

drugcharacterization2medicinalproductYAZdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2011drugrecurreadministration3

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021676Brand NameYAZGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-405Product TypeHUMAN PRESCRIPTION DRUGRXCUI630734, 748797, 748798, 748856spl_id9184f52d-3cbf-4a4e-a153-0e2ea95e83f4spl_set_id065f33e4-b587-4e66-b896-ca9ab7b7c876Package NDC50419-405-03