Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11487183primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received09/09/2015receiptdateformat102Date Last Updated09/09/2015fulfillexpeditecriteria2companynumbUS-JAZZ-2015-US-004101duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-2015-US-004101

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionProduct use issueOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionUrticariaOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductFLUOXETINE HCLdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/03/2015drugrecurreadministration3

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA202133Brand NameFLUOXETINE HCLGeneric NameFLUOXETINE HCLManufacturersAlmatica Pharma Inc.product_ndc52427-576Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI1190110spl_idbe947ac0-4be3-e37a-c8cd-de296c1514faspl_set_idb47b291f-3340-0c2a-3585-0926b9c1a71fPackage NDC52427-576-30UNIII9W7N6B1KJ

2)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb3drugstructuredosageunit002drugdosagetext3 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/05/2014actiondrug4

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)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/03/2015drugrecurreadministration3

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

4)

drugcharacterization2medicinalproductMUPIROCIN.drugdosagetextUNKdrugdosageformOINTMENTdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/03/2015drugrecurreadministration3

activesubstance

activesubstancenameMUPIROCIN

openFDA Info on Medication

Application Number ANDA213053, NDA050788, ANDA213076, ANDA065192, ANDA207116, ANDA201587, ANDA06508 ... Brand NameMUPIROCIN, CENTANY AT, CENTANY, PIRNUOGeneric NameMUPIROCIN, MUPIROCIN CALCIUMManufacturers Alembic Pharmaceuticals, Inc., Aleor Dermaceuticals Limited, Medimetriks Pharmac ... product_ndc 62332-624, 71589-015, 43538-310, 43538-300, 21922-029, 0168-0352, 16714-055, 684 ... Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICALActive IngredientsMUPIROCIN CALCIUM, MUPIROCINRXCUI311877, 106346, 404070, 2286614spl_id fa444224-a0df-47cc-a925-a53dcdc26dc5, 4182dbe3-d821-4708-89a0-1f85ff0d4a0f, db7e ... spl_set_id a69cd608-d2e6-4a7a-8cd7-f761bd333542, ba6f4d05-2392-4484-b857-c1bf5015c713, 3240 ... Package NDC 62332-624-15, 62332-624-30, 71589-015-15, 71589-015-30, 43538-310-30, 43538-300- ... UNIIRG38I2P540, D0GX863OA5NUIN0000175515, N0000175516Established Pharmacologic ClassRNA Synthetase Inhibitor Antibacterial [EPC]Mechanism of ActionRNA Synthetase Inhibitors [MoA]

5)

drugcharacterization2medicinalproductCLONIDINE.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCLONIDINE

openFDA Info on Medication

Application Number ANDA076166, ANDA209675, ANDA210052, NDA018891, ANDA203167, NDA022500, ANDA090873 ... Brand Name CLONIDINE, CLONIDINE HYDROCHLORIDE, CATAPRES-TTS-1, CATAPRES-TTS-2, CATAPRES-TTS ... Generic NameCLONIDINEManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Amneal Pharmaceuticals ... product_ndc 0378-0871, 0378-0872, 0378-0873, 50742-247, 69238-1426, 82089-101, 82089-102, 82 ... Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMAL, ORAL, EPIDURALActive IngredientsCLONIDINE, CLONIDINE HYDROCHLORIDERXCUI 998671, 998675, 998679, 1013930, 998673, 998677, 998681, 884221, 884225, 885880, ... spl_id c140d273-d4f3-444b-95b0-7aa0edd32b58, c48928af-0077-4c1b-b428-8c00237c3aa0, cec4 ... spl_set_id 7adfc439-e6d0-4593-87dd-0eef36d33c6d, 99485427-a120-4fc7-bb61-25857d1900ec, accb ... Package NDC 0378-0871-16, 0378-0871-99, 0378-0872-16, 0378-0872-99, 0378-0873-16, 0378-0873- ... NUIN0000009918, N0000175554Mechanism of ActionAdrenergic alpha2-Agonists [MoA]Established Pharmacologic ClassCentral alpha-2 Adrenergic Agonist [EPC]UNIIMN3L5RMN02, W76I6XXF06

6)

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

7)

drugcharacterization2medicinalproductPREDNISONE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/03/2015drugrecurreadministration3

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA215246, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., Novitium Pharma LLC, GeneYork Pharmaceuticals Gr ... product_ndc 75987-020, 75987-021, 75987-022, 70954-056, 71329-106, 0378-0640, 0378-0641, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id 96a17428-b512-4fd9-a64d-50160d22aaaa, 7335a293-992b-490c-ab8a-66a7ca1eea30, 4384 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, 7335a293-992b-490c-ab8a-66a7ca1eea30, be50 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

8)

drugcharacterization2medicinalproductSALICYLIC ACID.drugdosagetextUNKdrugdosageformGELdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/03/2015drugrecurreadministration3

activesubstance

activesubstancenameSALICYLIC ACID

openFDA Info on Medication

Application Numberpart358H, part358F, part333D, part358B, part333A, part346Brand Name HAIRCARE PHYSICIANS RECOMMENDED, SALICYLIC ACID, ATRIX CLARIFYING TONER, BODY WA ... Generic Name SALICYLIC ACID, MEDICATED CORN REMOVERS, LIQUID WART REMOVER, ULTRA THIN CORN RE ... Manufacturers LAWRENCE E SAMUELS MD INC, Harris Teeter, LLC, PureTek Corporation, Vi-Jon, LLC, ... product_ndc 82499-267, 69256-030, 59088-444, 0869-0353, 81136-019, 67234-007, 69968-0471, 63 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICAL, TRANSDERMAL, ORALActive IngredientsSALICYLIC ACID, BENZETHONIUM CHLORIDE, DYCLONINE HYDROCHLORIDE, WITCH HAZELRXCUI 205023, 240559, 251577, 562600, 252296, 865105, 248684, 797885, 199308, 1241639, ... spl_id d5052774-df2a-e349-e053-2995a90a08eb, c791f2e9-345a-348d-e053-2995a90afcc6, bd5c ... spl_set_id 095fcc1c-8f5b-47bd-a32a-7f5da5d162cd, 0a8f8a45-bf6c-4a1e-9170-cf5b86581f16, 191a ... Package NDC 82499-267-00, 69256-030-09, 59088-444-08, 0869-0353-23, 81136-019-01, 67234-007- ... UNIIO414PZ4LPZ, PH41D05744, ZEC193879Q, 101I4J0U34

9)

drugcharacterization2medicinalproductZONISAMIDE.drugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/03/2015drugrecurreadministration3

activesubstance

activesubstancenameZONISAMIDE

openFDA Info on Medication

Application Number ANDA077645, NDA020789, ANDA077625, ANDA077634, ANDA077869, ANDA214492, ANDA07765 ... Brand NameZONISAMIDE, ZONEGRANGeneric NameZONISAMIDEManufacturers Aurobindo Pharma Limited, Concordia Pharmaceuticals Inc., Cadila Healthcare Limi ... product_ndc 59651-378, 59651-379, 59651-380, 59212-680, 59212-681, 70771-1142, 70771-1143, 7 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZONISAMIDERXCUI314285, 403966, 403967, 284408, 404725spl_id 2de9e3a1-2be7-4e6d-9f0e-2a43cbb37dcd, 7de9d196-dab7-49de-955c-e944bfddb20a, 73e0 ... spl_set_id ab0631ca-5339-4570-bc27-f1dd92de1d6f, d12de43e-3ac3-4335-bc85-70d7366a91eb, 4a4d ... Package NDC 59651-378-03, 59651-378-60, 59651-378-01, 59651-378-05, 59651-379-03, 59651-379- ... NUIN0000175753, N0000008486, M0020790, N0000000235, N0000185503Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Chemical StructureSulfonamides [CS]Mechanism of ActionCarbonic Anhydrase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]UNII459384H98V

10)

drugcharacterization2medicinalproductASPIRIN.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343, NDA203697Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN TABLET 325MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 36800-545, 0363-0587, 70000-0218, 63 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 260847, 198471, 825180 ... spl_id 70f66f99-a450-4ab6-a3b9-c5d9207e0a79, da59962f-0c77-5c08-e053-2a95a90aaee7, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

11)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb3drugstructuredosageunit002drugdosagetext3 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat610drugstartdate/01/2009drugenddateformat602drugenddate//2009actiondrug4

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)

drugcharacterization2medicinalproductCLOBETASOLdrugdosagetextUNKdrugdosageformCREAMdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/03/2015drugrecurreadministration3

activesubstance

activesubstancenameCLOBETASOL

13)

drugcharacterization2medicinalproductCOENZYME Q10drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameUBIDECARENONE

14)

drugcharacterization2medicinalproductALPRAZOLAM.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/03/2015drugrecurreadministration3

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA074174 ... Brand NameALPRAZOLAM, XANAX XR, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZOLAM XRGeneric NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 94163352-f78e-400a-b7da-b3075e9213eb, 35398b0f-4f2a-4504-b254-bb6010a4101e, f364 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

15)

drugcharacterization2medicinalproductFIORICETdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\BUTALBITAL\CAFFEINE

openFDA Info on Medication

Application NumberANDA040885Brand NameFIORICETGeneric NameBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEManufacturersActavis Pharma, Inc.product_ndc52544-080Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, BUTALBITAL, CAFFEINERXCUI889520, 1432261spl_id14ca4151-a727-4708-8e35-8eb08e175db8spl_set_idc018be7d-f7b8-45e2-97b8-8e7a71740657Package NDC52544-080-01NUIN0000175693, M0002177, N0000175739, N0000175729, N0000175790, M0023046Established Pharmacologic ClassBarbiturate [EPC], Central Nervous System Stimulant [EPC], Methylxanthine [EPC]Chemical StructureBarbiturates [CS], Xanthines [CS]Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE]UNII362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E

16)

drugcharacterization2medicinalproductVALACYCLOVIR HCLdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameVALACYCLOVIR HYDROCHLORIDE

17)

drugcharacterization2medicinalproductMELATONINdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMELATONIN

openFDA Info on Medication

Brand NameMELATONIN, MELATONIN PHENOLIC, MELATONIN CORD, MELATONIN 1527Generic NameMELATONINManufacturers BioActive Nutritional, Inc., Energique, Inc., Professional Complementary Health ... product_ndc43857-0086, 44911-0247, 44911-0194, 63083-1527, 43742-0771Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMELATONINspl_id e189499d-9da3-43fc-8a0b-9d5dd0923b11, 904c041a-ff84-4152-9b10-ea5d1b669d24, 0673 ... spl_set_id cd82eb5d-a44a-4512-ad65-0fffae70d1d0, 895cb8a5-33ea-4764-86a6-1da513dcd2c1, 9a59 ... Package NDC43857-0086-1, 44911-0247-1, 44911-0194-1, 63083-1527-1, 43742-0771-1UNIIJL5DK93RCL