Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11473441primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessother1receivedateformat102Date Received08/09/2015receiptdateformat102Date Last Updated08/09/2015fulfillexpeditecriteria1companynumbUS-JAZZ-2014-US-005026duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-2014-US-005026

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionBladder disorderOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.1ReactionCondition aggravatedOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.1ReactionIntentional product use issueOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionSleep apnoea syndromeOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.1ReactionInsomniaOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.1ReactionFatigueOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb3drugstructuredosageunit002drugdosagetext3 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationFIBROMYALGIAactiondrug4

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)

drugcharacterization1medicinalproductXYREMdrugbatchnumb3112102drugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, FIRST DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/04/2011actiondrug4

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)

drugcharacterization1medicinalproductXYREMdrugbatchnumb3112102drugauthorizationnumb021196drugstructuredosagenumb3drugstructuredosageunit002drugdosagetext3 G, SECOND DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/04/2011actiondrug4

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)

drugcharacterization2medicinalproductMETHOTREXATEdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMETHOTREXATE

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA209787, ANDA040632, ANDA201749, ANDA08123 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Alvogen Inc., ... product_ndc 61703-350, 61703-408, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 477 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRATHECAL, ORAL, INTRA-ARTERIALActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1655956, 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595 ... spl_id e7f451fd-9103-459a-8a81-115f1fc1077c, 17840925-09d5-493f-90ba-f2082d625a86, d2bf ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-408-41, 61703-350-09, 61703-350-10, 61703-408- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

5)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb2.5drugstructuredosageunit002drugdosagetext2.5 G, FIRST DOSEdrugdosageformORAL 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

6)

drugcharacterization2medicinalproductTRICORdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

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

7)

drugcharacterization1medicinalproductPHENYTOIN.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenamePHENYTOIN

openFDA Info on Medication

Application NumberANDA084427, ANDA040521, ANDA040342, NDA008762, ANDA200565Brand NamePHENYTOIN INFATABS, PHENYTOIN, DILANTIN INFATABS, DILANTIN-125Generic NamePHENYTOINManufacturers Greenstone LLC, Taro Pharmaceuticals U.S.A., Inc., Prasco Laboratories, Parke-Da ... product_ndc 59762-5210, 51672-4069, 66993-372, 0071-0007, 66689-036, 66689-775, 0071-2214, 5 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPHENYTOINRXCUI1313885, 1313112, 1313887, 1313884spl_id 1a091f70-5a1a-4c53-9930-2e1ee10c667d, e9176357-1e57-4c5e-8382-29166348f050, 0c76 ... spl_set_id 0c9321ae-cc4d-45f0-87d3-e2a5b4f60fde, 093fd736-5971-47af-b4ef-08c1696cebe8, 3580 ... Package NDC 59762-5210-1, 51672-4069-1, 66993-372-02, 0071-0007-40, 0071-0007-24, 66689-036- ... NUI N0000175753, N0000008486, N0000191266, N0000187064, N0000187063, N0000185607, N0 ... Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of Action Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochro ... UNII6158TKW0C5

8)

drugcharacterization2medicinalproductFISH OILdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFISH OIL

openFDA Info on Medication

Application NumberNDA210589Brand NameOMEGAVENGeneric NameFISH OILManufacturersFresenius Kabi USA, LLCproduct_ndc63323-205Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsFISH OILRXCUI2053499, 2053504, 2053513, 2053514spl_idc4f460d5-da90-4b9b-aff1-df3176a43d47spl_set_id5d9d0b24-e139-48bf-ab2d-536fb59cf8e0Package NDC63323-205-21, 63323-205-50, 63323-205-31, 63323-205-00UNIIXGF7L72M0F

9)

drugcharacterization2medicinalproductHYDROXYCHLOROQUINEdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameHYDROXYCHLOROQUINE

10)

drugcharacterization2medicinalproductINNOPRAN XLdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021438Brand NameINNOPRAN XLGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersANI Pharmaceuticals, Inc.product_ndc62559-590, 62559-591Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856460, 856471, 856569, 856576spl_id972d4663-058d-4dbb-9434-29e8b832b382spl_set_idcd5601b3-4d87-4c3b-acac-b476e787609dPackage NDC 62559-590-30, 62559-590-77, 62559-590-14, 62559-591-30, 62559-591-77, 62559-591- ... UNIIF8A3652H1V

11)

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

12)

drugcharacterization1medicinalproductXYREMdrugbatchnumb3112102drugauthorizationnumb021196drugstructuredosagenumb1.5drugstructuredosageunit002drugdosagetext1.5 G, THIRD DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/04/2011actiondrug4

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

13)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb1.5drugstructuredosageunit002drugdosagetext1.5 G, EVERY 2 HOUR INTERVAL WHEN HE WAKES UPdrugdosageformORAL 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

14)

drugcharacterization2medicinalproductEXCEDRIN EXTRA STRENGTHdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\ASPIRIN\CAFFEINE

openFDA Info on Medication

Application Numberpart343Brand NameEXCEDRIN EXTRA STRENGTHGeneric NameACETAMINOPHEN, ASPIRIN, AND CAFFEINEManufacturersLil Drug Store Products, Incproduct_ndc66715-9810Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, ASPIRIN, CAFFEINERXCUI209468, 308297spl_idc7a3f877-da9f-e27c-e053-2995a90a2f23spl_set_id7f0f8b3c-c226-4a3a-af46-a708f345e4f5Package NDC66715-9810-2, 66715-9810-3NUI N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832, N0000 ... Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic Effect Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE], Ce ... Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS], Xanthines [CS]Established Pharmacologic Class Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], ... UNII362O9ITL9D, R16CO5Y76E, 3G6A5W338E

15)

drugcharacterization2medicinalproductFOLIC ACID.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

Brand NameVENTRIXYL, FOLIC ACID, VENEXA, VITRAMYN, MULTITAM, VITREXYL, VITREXATE, VITRANOLGeneric NameFOLIC ACIDManufacturers PureTek Corporation, Leading Pharma, LLC, Amneal Pharmaceuticals of New York LLC ... product_ndc 59088-186, 69315-127, 53746-361, 10135-182, 59088-176, 71209-007, 11534-165, 586 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CALCIUM CARBONATE, CHOLECALCIFER ... spl_id c705632c-cd1a-0f43-e053-2995a90aa0b3, 92322e52-3179-4738-8c8a-14fef62311d4, ca64 ... spl_set_id c29dc729-93be-2a20-e053-2a95a90a8ca3, 1ba8c407-9613-4319-ac40-0a429cb0f3f4, fd85 ... Package NDC 59088-186-54, 69315-127-01, 69315-127-10, 53746-361-01, 53746-361-10, 10135-182- ... NUIN0000193618, M0001797, M0022797, N0000175952, M0022794, N0000175951Established Pharmacologic ClassVitamin C [EPC], Vitamin D [EPC], Vitamin B12 [EPC]Chemical StructureAscorbic Acid [CS], Vitamin D [CS], Vitamin B 12 [CS]UNII WR1WPI7EW8, PQ6CK8PD0R, H0G9379FGK, 1C6V77QF41, A150AY412V, P6YC3EG204, 935E97BO ... Application Number ANDA040796, ANDA040625, ANDA204418, ANDA202437, ANDA211064, ANDA202522, ANDA0911 ... RXCUI310410, 237786

16)

drugcharacterization2medicinalproductOMEPRAZOLE.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

17)

drugcharacterization2medicinalproductVICODINdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

18)

drugcharacterization2medicinalproductAMLODIPINE/BENAZEPRILdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameAMLODIPINE BESYLATE\BENAZEPRIL HYDROCHLORIDE

19)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

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

20)

drugcharacterization2medicinalproductLYRICAdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

21)

drugcharacterization2medicinalproductASCORBIC ACID W/VITAMIN D NOSdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3