Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11479470primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received09/09/2015receiptdateformat102Date Last Updated09/09/2015fulfillexpeditecriteria2companynumbUS-JAZZ-2015-US-009976duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-2015-US-009976

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionWrong technique in product usage processOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionIncorrect dose administeredOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductREQUIPdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameROPINIROLE HYDROCHLORIDE

2)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/03/2012actiondrug4

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

3)

drugcharacterization2medicinalproductALPRAZOLAM ERdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate07/04/2014drugrecurreadministration3

activesubstance

activesubstancenameALPRAZOLAM

4)

drugcharacterization2medicinalproductMETHOCARBAMOL.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate07/04/2014drugrecurreadministration3

activesubstance

activesubstancenameMETHOCARBAMOL

openFDA Info on Medication

Application Number ANDA200958, ANDA207522, ANDA204404, ANDA208507, ANDA040489, ANDA211504, ANDA2126 ... Brand Name METHOCARBAMOL, METHOCARBAMOL TABLETS, USP, 500 MG, METHOCARBAMOL TABLETS, USP, 7 ... Generic NameMETHOCARBAMOL, METHOCARBAMOL TABLETSManufacturers Westminster Pharmaceuticals, LLC, Somerset Therapeutics, LLC, Mylan Institutiona ... product_ndc 69367-255, 69367-256, 70069-101, 67457-273, 76385-123, 76385-124, 70868-901, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHOCARBAMOLRXCUI197943, 197944, 238175, 207014spl_id ae9df131-66a3-0ec7-e053-2995a90a02e4, 77cf2a2b-e3af-4755-8923-5226b81aea5c, b0da ... spl_set_id 2199b810-fb84-4dac-b787-ade2b5f67e92, 68dd9c24-4d41-48be-9f54-fceb787bb443, 14d9 ... Package NDC 69367-256-01, 69367-256-05, 69367-255-01, 69367-255-05, 70069-101-01, 70069-101- ... NUIN0000175730, N0000175737Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]Established Pharmacologic ClassMuscle Relaxant [EPC]UNII125OD7737X

5)

drugcharacterization2medicinalproductHYDROXYZINE HCLdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/10/2013drugrecurreadministration3

activesubstance

activesubstancenameHYDROXYZINE HYDROCHLORIDE

openFDA Info on Medication

6)

drugcharacterization2medicinalproductHYDROCODONE/APAPdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

7)

drugcharacterization2medicinalproductDETROL LAdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameTOLTERODINE TARTRATE

openFDA Info on Medication

Application NumberNDA021228Brand NameDETROL LAGeneric NameTOLTERODINE TARTRATEManufacturersPharmacia and Upjohn Company LLCproduct_ndc0009-5190, 0009-5191Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOLTERODINE TARTRATERXCUI855182, 855184, 855189, 855191spl_id54731895-ffd4-4d24-acb1-97fdde96382fspl_set_idc98eb213-9c80-4698-9710-a9855059b8bbPackage NDC 0009-5190-01, 0009-5190-02, 0009-5190-03, 0009-5190-04, 0009-5191-01, 0009-5191- ... UNII5T619TQR3R

8)

drugcharacterization2medicinalproductDIAZEPAM.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, NDA020124, ANDA210363, NDA020648, NDA211635, NDA013263, ANDA071583, ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Meridian Medical Technologies LLC, Dash Pharmaceuticals LLC, Baus ... product_ndc 0409-1273, 11704-600, 69339-136, 66490-650, 68682-650, 68682-652, 68682-655, 722 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, RECTAL, NASAL, ORALActive IngredientsDIAZEPAMRXCUI 1807459, 1807452, 2120550, 801957, 801958, 801961, 801966, 2272613, 2272619, 227 ... spl_id 14233fc1-606a-4e78-8da4-df9eedb1c793, 512dee3e-2c4c-4436-b92b-67113989cca5, 5b08 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, fa352464-14c8-49e9-b8b7-5a968b1cfa93, 6b8d ... Package NDC 0409-1273-03, 0409-1273-32, 11704-600-01, 69339-136-02, 69339-136-32, 69339-136- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

9)

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

10)

drugcharacterization2medicinalproductNORVASCdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA019787Brand NameNORVASCGeneric NameAMLODIPINE BESYLATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-1520, 0069-1530, 0069-1540Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 212542, 212549, 212575, 308135, 308136spl_id80f34426-dbf5-41e4-9aaa-75526d0f3cf0spl_set_idabd6a2ca-40c2-485c-bc53-db1c652505edPackage NDC 0069-1520-68, 0069-1530-68, 0069-1530-41, 0069-1530-72, 0069-1540-68, 0069-1540- ... UNII864V2Q084H

11)

drugcharacterization2medicinalproductPAXILdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenamePAROXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020936, NDA020031, NDA020710Brand NamePAXIL CR, PAXILGeneric NamePAROXETINE HYDROCHLORIDEManufacturersApotex Corpproduct_ndc 60505-3669, 60505-4377, 60505-4378, 60505-4379, 60505-3668, 60505-3670, 60505-45 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPAROXETINE HYDROCHLORIDE HEMIHYDRATERXCUI 1738803, 1738804, 1738805, 1738806, 1738807, 1738808, 207349, 207350, 211699, 21 ... spl_id 515815fa-b3ec-0e8e-f436-48f783f3f0f3, aa5aa202-64b2-a593-6ed9-46d0862f56fb, 46a9 ... spl_set_id 483bd97f-c4d0-4e23-aaa8-6334f4471e0c, ef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e, 584a ... Package NDC 60505-4377-3, 60505-4378-3, 60505-4379-3, 60505-3668-3, 60505-3669-3, 60505-3670 ... UNIIX2ELS050D8

12)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb2.25drugstructuredosageunit002drugdosagetext2.25 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/02/2005drugenddateformat610drugenddate/03/2005actiondrug4

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)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationCATAPLEXYactiondrug4

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)

drugcharacterization2medicinalproductPROVIGILdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMODAFINIL

openFDA Info on Medication

Application NumberNDA020717Brand NamePROVIGILGeneric NameMODAFINILManufacturersCephalon, Inc.product_ndc63459-101, 63459-201Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMODAFINILRXCUI205324, 213471, 226426, 260218spl_id22321588-2125-4ed0-b9ff-87a8513bf271spl_set_ide16c26ad-7bc2-d155-3a5d-da83ad6492c8Package NDC63459-101-01, 63459-101-30, 63459-201-01, 63459-201-30NUIN0000175729, N0000175651, N0000175769Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]Established Pharmacologic ClassSympathomimetic-like Agent [EPC]UNIIR3UK8X3U3D