Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014NUEUSA00303Version of Safety Report ID3receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10149325Date Received30/04/2014seriousnesshospitalization1transmissiondate26/03/2015serious1Date Last Updated11/08/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age63Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionCardiac arrest

2)

reactionmeddraversionpt17.1ReactionHypoacusis

3)

reactionmeddraversionpt17.1ReactionReading disorder

4)

reactionmeddraversionpt17.1ReactionFall

5)

reactionmeddraversionpt17.1ReactionHeadache

6)

reactionmeddraversionpt17.1ReactionEncephalopathy

7)

reactionmeddraversionpt17.1ReactionCognitive disorder

8)

reactionmeddraversionpt17.1ReactionConvulsion

9)

reactionmeddraversionpt17.1ReactionAffect lability

10)

reactionmeddraversionpt17.1ReactionHead injury

11)

reactionmeddraversionpt17.1ReactionFatigue

12)

reactionmeddraversionpt17.1ReactionSomnolence

13)

reactionmeddraversionpt17.1ReactionDisturbance in attention

14)

reactionmeddraversionpt17.1ReactionSerotonin syndrome

15)

reactionmeddraversionpt17.1ReactionVisual acuity reduced

16)

reactionmeddraversionpt17.1ReactionElectrocardiogram QT prolonged

17)

reactionmeddraversionpt17.1ReactionPyrexia

18)

reactionmeddraversionpt17.1ReactionLoss of consciousness

19)

reactionmeddraversionpt17.1ReactionArthralgia

20)

reactionmeddraversionpt17.1ReactionDisease progression

Drug

1)

drugcharacterization1medicinalproductNUEDEXTAdrugauthorizationnumb021879drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext1 CAP, Q12 HRSdrugindicationCRANIOCEREBRAL INJURYdrugstartdateformat102drugstartdate18/12/2003drugenddateformat102drugenddate07/02/2014

activesubstance

activesubstancenameDEXTROMETHORPHAN HYDROBROMIDE\QUINIDINE SULFATE

openFDA Info on Medication

Application NumberNDA021879Brand NameNUEDEXTAGeneric NameDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEManufacturersAvanir Pharmaceuticals, Inc.product_ndc64597-301Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATERXCUI1040054, 1040058spl_id6ad080f6-a98f-424d-9c2c-5f9867e6fa9aspl_set_id484e0918-3442-49dc-8ccf-177f1f3ee9f3Package NDC64597-301-13, 64597-301-60UNII9D2RTI9KYH, J13S2394HE

2)

drugcharacterization2medicinalproductADVIL (IBUPROFEN) TABLET

3)

drugcharacterization2medicinalproductCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE

4)

drugcharacterization2medicinalproductVITAMIN D (ERGOCALCIFEROL) CAPSULE

5)

drugcharacterization2medicinalproductSPIRONOLACTONE (SPIRONOLACTONE) TABLET

6)

drugcharacterization1medicinalproductNUEDEXTAdrugauthorizationnumb021879drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext1 CAP, Q12 HRSdrugindicationDEPRESSIONdrugstartdateformat102drugstartdate18/12/2003drugenddateformat102drugenddate07/02/2014

activesubstance

activesubstancenameDEXTROMETHORPHAN HYDROBROMIDE\QUINIDINE SULFATE

openFDA Info on Medication

Application NumberNDA021879Brand NameNUEDEXTAGeneric NameDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEManufacturersAvanir Pharmaceuticals, Inc.product_ndc64597-301Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATERXCUI1040054, 1040058spl_id6ad080f6-a98f-424d-9c2c-5f9867e6fa9aspl_set_id484e0918-3442-49dc-8ccf-177f1f3ee9f3Package NDC64597-301-13, 64597-301-60UNII9D2RTI9KYH, J13S2394HE

7)

drugcharacterization2medicinalproductCELEXA

activesubstance

activesubstancenameCITALOPRAM HYDROBROMIDE

openFDA Info on Medication

Application NumberNDA020822Brand NameCELEXAGeneric NameCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-4010, 0456-4020, 0456-4040Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDERXCUI200371, 213344, 213345, 283672, 284591, 309314spl_idcda4f42b-8154-4325-b1b0-451587c27d65spl_set_id4259d9b1-de34-43a4-85a8-41dd214e9177Package NDC 0456-4010-01, 0456-4020-01, 0456-4020-11, 0456-4020-63, 0456-4040-01, 0456-4040- ... UNIII1E9D14F36

8)

drugcharacterization2medicinalproductFLECTOR (DICLOFENAC EPOLAMINE) PATCH

9)

drugcharacterization2medicinalproductSYNTHROID

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_iddb21fc0c-4a2d-9922-39bd-8128e429bebcspl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

10)

drugcharacterization2medicinalproductTESTOPEL (TESTOSTERONE) IMPLANTATION

11)

drugcharacterization1medicinalproductKEPPRAdrugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationCONVULSION

activesubstance

activesubstancenameLEVETIRACETAM

openFDA Info on Medication

Application NumberNDA021872, NDA021505, NDA021035, NDA022285Brand NameKEPPRA, KEPPRA XRGeneric NameLEVETIRACETAMManufacturersUCB, Inc.product_ndc 50474-002, 50474-001, 50474-594, 50474-595, 50474-596, 50474-597, 50474-598, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsLEVETIRACETAMRXCUI 647121, 647123, 261335, 261336, 284391, 311288, 311289, 311290, 387003, 403884, ... spl_id 4a48c061-40c9-41d9-be30-e9521c3e03b5, f5f32bff-c998-43b5-920c-02f3fea3b46b, d6d8 ... spl_set_id c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e, 3ca9df05-a506-4ec8-a4fe-320f1219ab21, 2919 ... Package NDC 50474-002-63, 50474-594-40, 50474-595-40, 50474-596-40, 50474-597-66, 50474-001- ... NUIN0000008486Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII44YRR34555

12)

drugcharacterization2medicinalproductENTERIC ASPIRIN (ACETYLSALICYLIC ACID) TABLET

13)

drugcharacterization2medicinalproductFLUTICASONE (FLUTICASONE) NASAL DROP

14)

drugcharacterization2medicinalproductMULTIVITAMIN (VITAMIN NOS) TABLETS

15)

drugcharacterization2medicinalproductOMEPRAZOLE (OMEPRAZOLE) ENTERIC TABLET

16)

drugcharacterization1medicinalproductZOFRANdrugauthorizationnumb020103drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020103Brand NameZOFRANGeneric NameONDANSETRON HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0675, 0078-0676Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsONDANSETRON HYDROCHLORIDERXCUI104895, 104896, 198052, 312086spl_id5de8b98b-16d8-4540-8991-ebaace847a66spl_set_id555f81bc-4ce0-4f77-b394-b974838c4440Package NDC0078-0675-15, 0078-0676-15UNIINMH84OZK2B

17)

drugcharacterization2medicinalproductCARVEDILOL (CARVEDILOL)

activesubstance

activesubstancenameCARVEDILOL

18)

drugcharacterization2medicinalproductHYDROCORTISONE (HYDROCORTISONE) TABLET

19)

drugcharacterization1medicinalproductNUEDEXTAdrugauthorizationnumb021879drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext1 CAP, Q12 HRSdrugindicationAFFECT LABILITYdrugstartdateformat102drugstartdate18/12/2003drugenddateformat102drugenddate07/02/2014

activesubstance

activesubstancenameDEXTROMETHORPHAN HYDROBROMIDE\QUINIDINE SULFATE

openFDA Info on Medication

Application NumberNDA021879Brand NameNUEDEXTAGeneric NameDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEManufacturersAvanir Pharmaceuticals, Inc.product_ndc64597-301Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATERXCUI1040054, 1040058spl_id6ad080f6-a98f-424d-9c2c-5f9867e6fa9aspl_set_id484e0918-3442-49dc-8ccf-177f1f3ee9f3Package NDC64597-301-13, 64597-301-60UNII9D2RTI9KYH, J13S2394HE

20)

drugcharacterization1medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

21)

drugcharacterization2medicinalproductADDERALL

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 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMI ... RXCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, ... spl_ide9cd0754-917c-4545-8963-e0b5b8fe544a, 05c01190-093d-41b3-8fe6-4ad8d6e2aee3spl_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- ... UNII6DPV8NK46S, G83415V073, O1ZPV620O4, JJ768O327N

summary

narrativeincludeclinicalCASE EVENT DATE: 20140201

Report Duplicate

duplicatesourceAVANIRduplicatenumb2014NUEUSA00303