Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11094202primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/03/2016reporttype1serious1seriousnessother1receivedateformat102Date Received06/05/2015receiptdateformat102Date Last Updated17/12/2015fulfillexpeditecriteria1companynumbUS-UCBSA-119980duplicate1

Report Duplicate

duplicatesourceUCBduplicatenumbUS-UCBSA-119980

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age64Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionIntentional product misuseOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionInappropriate schedule of drug administrationOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.1ReactionInsomniaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionFatigueOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.1ReactionSleep apnoea syndromeOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.1ReactionBladder disorderOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductXYREMdrugbatchnumb3112102drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextFIRST DOSE: 4.5G, SECOND DOSE: 3G AND THIRD DOSE: 1.5GdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/04/2011actiondrug5drugrecurreadministration3

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)

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

3)

drugcharacterization1medicinalproductXYREMdrugdosagetext2.5G FIRST DOSE, 1.5G EVERY 2drugdosageformORAL SOLUTIONdrugadministrationroute048actiondrug5drugrecurreadministration3

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)

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

5)

drugcharacterization2medicinalproductLYRICAdrugindicationPRODUCT 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

6)

drugcharacterization1medicinalproductXYREMdrugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048actiondrug5drugrecurreadministration3

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)

drugcharacterization2medicinalproductHYDROXYCHLOROQUINEdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameHYDROXYCHLOROQUINE

8)

drugcharacterization2medicinalproductPROPRANOLOL HYDROCHLORIDE.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090321, ANDA071972, ANDA071976, ANDA070979, ANDA070690, ANDA212026, ANDA0784 ... Brand Name PROPRANOLOL HYDROCHLORIDE, INDERAL LA, INNOPRAN XL, HEMANGEOL, PROPRANOLOL HYDRO ... Generic NamePROPRANOLOL HYDROCHLORIDEManufacturers Zydus Pharmaceuticals (USA) Inc., Amneal Pharmaceuticals NY LLC, West Ward Pharm ... product_ndc 68382-161, 68382-162, 68382-163, 68382-164, 69238-2077, 69238-2078, 69238-2079, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI 856460, 856481, 856535, 856569, 856448, 856457, 856519, 856556, 856578, 856724, ... spl_id c3cf9407-83ca-40fa-9794-623ee06074d0, 1222defc-0f90-4ec9-bfc0-46438d59f164, 2788 ... spl_set_id 5a7858eb-9d2d-44d9-9f81-c78ba3ce1815, 14d0c95d-418f-40a8-bad3-e20c82424960, 8fe0 ... Package NDC 68382-161-16, 68382-161-01, 68382-161-05, 68382-161-10, 68382-161-30, 68382-161- ... UNIIF8A3652H1V

9)

drugcharacterization2medicinalproductASCORBIC ACID W/VITAMIN D NOSdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

10)

drugcharacterization2medicinalproductAMLODIPINE/BENAZEPRILdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameAMLODIPINE BESYLATE\BENAZEPRIL HYDROCHLORIDE

11)

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

12)

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

13)

drugcharacterization2medicinalproductVICODINdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

14)

drugcharacterization1medicinalproductPHENYTOIN.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

15)

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

16)

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

17)

drugcharacterization1medicinalproductXYREMdrugbatchnumb3067745drugstructuredosagenumb3drugstructuredosageunit002drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 G, 2X/DAY (BID)drugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationFIBROMYALGIAdrugstartdateformat610drugstartdate/11/2008drugenddateformat602drugenddate//2008actiondrug5drugrecurreadministration3

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

18)

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]

summary

narrativeincludeclinicalCASE EVENT DATE: 201104