Report

Version of Safety Report ID3Safety Report ID10875074primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious1seriousnessother1receivedateformat102Date Received27/02/2015receiptdateformat102Date Last Updated13/03/2015fulfillexpeditecriteria1companynumbUS-JAZZ-2015-US-002898duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-2015-US-002898

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age53Unit of Onset AgeyearsWeight87.75SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionMigraineOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionHypertensionOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionCryingOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductALBUTEROL SULFATE.drugdosageformINHALERdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameALBUTEROL SULFATE

openFDA Info on Medication

Application Number ANDA077788, ANDA210948, ANDA074454, NDA020983, ANDA074880, ANDA077839, NDA021457 ... Brand Name ALBUTEROL SULFATE, ALBUTEROL, VENTOLIN HFA, PROAIR HFA, PROVENTIL HFA, PROAIR DI ... Generic NameALBUTEROL SULFATEManufacturers Chartwell RX, LLC, Nivagen Pharmaceuticals Inc, Actavis Pharma, Inc., GlaxoSmith ... product_ndc 62135-189, 75834-273, 75834-274, 0472-0825, 0173-0682, 0487-9501, 0378-8270, 593 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION), INTRABRONCHIALActive IngredientsALBUTEROL SULFATERXCUI 755497, 197316, 197318, 801092, 801095, 859088, 2123076, 630208, 745752, 2123072 ... spl_id e0dda671-10d7-8721-e053-2a95a90a39e2, 5b89a3bb-e3bb-421d-89f7-f180e01a1b4d, d129 ... spl_set_id 560df50c-e2c4-459f-9d89-bf7e6588949e, b735e92d-eb1a-6fc1-e053-2995a90afce2, 8bac ... Package NDC 62135-189-41, 62135-189-47, 75834-273-01, 75834-274-01, 0472-0825-16, 0472-0825- ... UNII021SEF3731

2)

drugcharacterization2medicinalproductPERIDEXdrugdosagetextUNKdrugdosageformSOLUTIONdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/12/2014drugrecurreadministration3

activesubstance

activesubstancenameCHLORHEXIDINE GLUCONATE

openFDA Info on Medication

Application NumberNDA019028Brand NamePERIDEXGeneric NameCHLORHEXIDINE GLUCONATEManufacturers3M ESPE Dental Products, Xttrium Laboratories, Inc.product_ndc48878-0620, 0116-0620Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCHLORHEXIDINE GLUCONATERXCUI834127, 834135spl_id1eac23cc-35ed-4f93-b0de-c3644c44c3fc, b3d94a86-d00b-072e-e053-2a95a90acf69spl_set_id3fcd41c4-875a-4e54-b533-261f198011af, 4703eff7-b30b-5a7d-e054-00144ff88e88Package NDC 48878-0620-3, 48878-0620-1, 48878-0620-2, 0116-0620-04, 0116-0620-03, 0116-0620- ... UNIIMOR84MUD8E

3)

drugcharacterization2medicinalproductVITAMIN B12drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/12/2014drugrecurreadministration3

activesubstance

activesubstancenameCYANOCOBALAMIN

4)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/01/2015actiondrug4

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

5)

drugcharacterization2medicinalproductCALCIUM CARBONATE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/12/2014drugrecurreadministration3

activesubstance

activesubstancenameCALCIUM CARBONATE

openFDA Info on Medication

Application Numberpart331Brand Name WINCO FOODS ANTACID ULTRA STRENGTH, ASSORTED FRUIT ANTACID FLAVOR CHEWS, ANTACID ... Generic NameCALCIUM CARBONATEManufacturers WINCO FOODS, LLC, Meijer Distribution Inc., Meijer, Unifirst First Aid Corporati ... product_ndc 67091-358, 41250-108, 41250-135, 47682-088, 47682-089, 47682-092, 30142-300, 825 ... Product TypeHUMAN OTC DRUGRouteORAL, TOPICALActive IngredientsCALCIUM CARBONATE, DIMETHICONERXCUI 308892, 308915, 1492387, 313884, 1432465, 308907, 308906, 1538595, 1044532, 3088 ... spl_id abaf7a85-739d-4b26-bd2c-ab0203a5002e, cf6f4563-972f-1341-e053-2995a90aec27, cf6f ... spl_set_id 1858cf76-cf36-4c56-9e15-14db609aa10f, 3ce0c1cd-32dc-4f78-e054-00144ff88e88, 4c6c ... Package NDC 67091-358-72, 41250-108-60, 41250-135-54, 47682-088-69, 47682-088-64, 47682-088- ... UNIIH0G9379FGK, 92RU3N3Y1ONUIN0000010282Physiologic/Pharmacodynamic EffectSkin Barrier Activity [PE]

6)

drugcharacterization2medicinalproductMULTIVITAMINdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/12/2014drugrecurreadministration3

activesubstance

activesubstancenameVITAMINS

7)

drugcharacterization2medicinalproductLUNESTAdrugdosageformTABLETdrugindicationPRODUCT 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

8)

drugcharacterization2medicinalproductSUMATRIPTAN SUCCINATE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/12/2014drugrecurreadministration3

activesubstance

activesubstancenameSUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application Number ANDA076847, ANDA078593, ANDA090495, NDA208223, ANDA077744, ANDA078327, NDA206099 ... Brand NameSUMATRIPTAN SUCCINATE, ZEMBRACE SYMTOUCH, SUMATRIPTAN, ONZETRA XSAILGeneric NameSUMATRIPTAN SUCCINATEManufacturers Dr. Reddy's Laboratories Limited, Wockhardt USA LLC., Upsher-Smith laboratories, ... product_ndc 55111-291, 55111-292, 55111-293, 64679-728, 55111-693, 0245-0809, 68071-4562, 03 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, SUBCUTANEOUS, NASALActive IngredientsSUMATRIPTAN SUCCINATERXCUI 313160, 313161, 315223, 313165, 1657151, 1738576, 1738581, 1739332, 1739337, 179 ... spl_id 8c734b50-3369-df0f-8a18-5bd1bdf51093, 8fed49a8-01d7-422d-bbb6-212ef36952e4, d892 ... spl_set_id ac80d018-6abf-2e41-ddea-90b4ff9e9013, e0917960-87bf-4650-b60b-64bef2ccc4d6, 4e26 ... Package NDC 55111-291-30, 55111-291-36, 55111-291-90, 55111-291-01, 55111-291-05, 55111-291- ... UNIIJ8BDZ68989

9)

drugcharacterization1medicinalproductADDERALLdrugstructuredosagenumb15drugstructuredosageunit003drugdosagetext15 MG, UNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/12/2014drugenddateformat610drugenddate/02/2015actiondrug1

activesubstance

activesubstancename AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMP ...

openFDA Info on Medication

Application NumberANDA040422, NDA021303Brand NameADDERALL, ADDERALL XRGeneric Name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, ... ManufacturersTeva Pharmaceuticals USA, Inc., Takeda Pharmaceuticals America, Inc.product_ndc 57844-105, 57844-117, 57844-110, 57844-112, 57844-115, 57844-120, 57844-130, 540 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHA ... RXCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, ... spl_id12989a25-f31c-4550-9b5d-f354f7f0af45, e3546445-6a4a-46a2-af40-026167005259spl_set_idf22635fe-821d-4cde-aa12-419f8b53db81, aff45863-ffe1-4d4f-8acf-c7081512a6c0Package NDC 57844-105-01, 57844-117-01, 57844-110-01, 57844-112-01, 57844-115-01, 57844-120- ... UNIIJJ768O327N, O1ZPV620O4, G83415V073, 6DPV8NK46S

10)

drugcharacterization2medicinalproductSKELAXINdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/12/2014drugrecurreadministration3

activesubstance

activesubstancenameMETAXALONE

openFDA Info on Medication

Application NumberNDA013217Brand NameSKELAXINGeneric NameMETAXALONEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc60793-136Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETAXALONERXCUI351254, 352277spl_id69cd3a38-0558-4208-8fa8-487bde725a3espl_set_id7a4163f2-c553-4d14-7e98-d14c5c7f772aPackage NDC60793-136-01, 60793-136-05NUIN0000175730Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]UNII1NMA9J598Y

11)

drugcharacterization2medicinalproductCYMBALTAdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/12/2014drugrecurreadministration3

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

12)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb2.25drugstructuredosageunit002drugdosagetext2.25 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/12/2014actiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

13)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationCATAPLEXYactiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

14)

drugcharacterization2medicinalproductOXYCONTINdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/12/2014drugrecurreadministration3

activesubstance

activesubstancenameOXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022272Brand NameOXYCONTINGeneric NameOXYCODONE HYDROCHLORIDEManufacturersPurdue Pharma LPproduct_ndc59011-410, 59011-480, 59011-415, 59011-420, 59011-430, 59011-440, 59011-460Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, ... spl_id9686aad4-8ab9-47da-a74e-23e1d2496c2espl_set_idbfdfe235-d717-4855-a3c8-a13d26dadedePackage NDC 59011-480-20, 59011-480-10, 59011-410-10, 59011-410-20, 59011-415-10, 59011-415- ... UNIIC1ENJ2TE6C

15)

drugcharacterization2medicinalproductPROPRANOLOLdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/12/2014drugrecurreadministration3

activesubstance

activesubstancenamePROPRANOLOL\PROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075826Brand NamePROPRANOLOLGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersFresenius Kabi USA, LLCproduct_ndc63323-604Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856443spl_iddb24d808-268b-4bec-bd48-7b66d2bb5951spl_set_idf14ea537-dd5c-4c78-9037-9a85e9e610efPackage NDC63323-604-01UNIIF8A3652H1V

summary

narrativeincludeclinicalCASE EVENT DATE: 20150219

Adverse Event Report

Report

Report Duplicate

Primary Source

Sender

Receiver

Patient

Reaction

1)

2)

3)

Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

openFDA Info on Medication

6)

activesubstance

7)

activesubstance

openFDA Info on Medication

8)

activesubstance

openFDA Info on Medication

9)

activesubstance

openFDA Info on Medication

10)

activesubstance

openFDA Info on Medication

11)

activesubstance

openFDA Info on Medication

12)

activesubstance

openFDA Info on Medication

13)

activesubstance

openFDA Info on Medication

14)

activesubstance

openFDA Info on Medication

15)

activesubstance

openFDA Info on Medication

summary

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