Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11590751primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/03/2016reporttype1serious1seriousnessother1receivedateformat102Date Received02/10/2015receiptdateformat102Date Last Updated28/10/2015fulfillexpeditecriteria1companynumbUS-JAZZ-2015-US-014856duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-2015-US-014856

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age30Unit of Onset AgeyearsWeight81SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionFallOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.1ReactionLip haemorrhageOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionConcussionOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.1ReactionLoss of consciousnessOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.1ReactionHead injuryOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb2.25drugstructuredosageunit002drugdosagetext2.25 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/06/2010drugenddateformat602drugenddate//2010actiondrug4

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

2)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb3.75drugstructuredosageunit002drugdosagetext3.75 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationCATAPLEXYdrugstartdateformat602drugstartdate//2010drugenddateformat602drugenddate//2014actiondrug4

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

3)

drugcharacterization2medicinalproductCONCERTAdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate23/09/2015drugrecurreadministration3

activesubstance

activesubstancenameMETHYLPHENIDATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021121Brand NameCONCERTAGeneric NameMETHYLPHENIDATE HYDROCHLORIDEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-585, 50458-588, 50458-586, 50458-587Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPHENIDATE HYDROCHLORIDERXCUI1091155, 1091157, 1091170, 1091172, 1091185, 1091187, 1091210, 1091212spl_ide07a69ac-3422-4eac-8a0e-bd720a91d991spl_set_id1a88218c-5b18-4220-8f56-526de1a276cdPackage NDC50458-585-01, 50458-588-01, 50458-586-01, 50458-587-01UNII4B3SC438HI

4)

drugcharacterization2medicinalproductEFFEXORdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationCATAPLEXYdrugstartdateformat102drugstartdate01/01/2001drugrecurreadministration3

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020699Brand NameEFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0833, 0008-0837, 0008-0836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI313581, 313583, 313585, 729929, 729931, 729932spl_id932efe9b-6185-488f-ac7b-5e12203a7821spl_set_id53c3e7ac-1852-4d70-d2b6-4fca819acf26Package NDC 0008-0837-20, 0008-0837-21, 0008-0837-22, 0008-0837-02, 0008-0837-03, 0008-0833- ... UNII7D7RX5A8MO

5)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2001drugenddateformat102drugenddate24/09/2015drugrecurreadministration3

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

6)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat602drugstartdate//2014actiondrug4

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)

drugcharacterization2medicinalproductIBUPROFEN.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate23/09/2015drugenddateformat102drugenddate24/09/2015drugrecurreadministration3

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA074937, ANDA075139, ANDA078682, ANDA079174, NDA019012, ANDA20231 ... Brand Name CAREONE IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN, WELBY CHILDRENS I ... Generic Name IBUPROFEN, IBUPROFEN 200MG, IBUPROFEN CAPSULES 200 MG, IBUPROFEN ORAL, IBUPFROFE ... Manufacturers American Sales Company, Strategic Sourcing Services LLC, CVS Pharmacy, Rite Aid ... product_ndc 41520-495, 62011-0214, 59779-392, 11822-3307, 50804-199, 64024-003, 55910-847, 2 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 197803, 310964, 201126, 204442, 310963, 731536, 197805, 197806, 197807, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 397d86de-d7a7-4087-a017-f714b1c1dd5a, a2fe ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 1d81eea7-0104-4b3d-842c-c763e290581c, 29b2 ... Package NDC 41520-495-71, 41520-495-78, 62011-0214-1, 59779-392-14, 59779-392-08, 59779-392- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

8)

drugcharacterization2medicinalproductRITALINdrugdosagetextUNKdrugdosageformTABLETdrugindicationNARCOLEPSYdrugstartdateformat102drugstartdate23/09/2015drugrecurreadministration3

activesubstance

activesubstancenameMETHYLPHENIDATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA010187, NDA021284Brand NameRITALIN, RITALIN LAGeneric NameMETHYLPHENIDATE HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0439, 0078-0440, 0078-0441, 0078-0370, 0078-0371, 0078-0372, 0078-0424Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPHENIDATE HYDROCHLORIDERXCUI 1091150, 1091379, 1091392, 1091395, 1091497, 1091500, 1091143, 1091167, 1091182, ... spl_id24697cdc-7470-4b76-a755-5c223048c1ce, 8c4180f5-acfa-486f-a7ed-f5712f0682f7spl_set_idc0bf0835-6a2f-4067-a158-8b86c4b0668a, effd952d-ac94-47bb-b107-589a4934dccaPackage NDC 0078-0439-05, 0078-0440-05, 0078-0441-05, 0078-0370-05, 0078-0371-05, 0078-0372- ... UNII4B3SC438HI

summary

narrativeincludeclinicalCASE EVENT DATE: 201408