Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10311925primarysourcecountryUStransmissiondateformat102transmissiondate28/05/2015reporttype1serious1seriousnessother1receivedateformat102Date Received15/07/2014receiptdateformat102Date Last Updated29/10/2014fulfillexpeditecriteria1companynumb2014-US-008409duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumb2014-US-008409

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age57Unit of Onset AgeyearsWeight65.8SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionNasal congestion

2)

reactionmeddraversionpt18.0ReactionCondition aggravated

3)

reactionmeddraversionpt18.0ReactionSomnolence

4)

reactionmeddraversionpt18.0ReactionMoaning

5)

reactionmeddraversionpt18.0ReactionSleep apnoea syndrome

6)

reactionmeddraversionpt18.0ReactionRestless legs syndrome

7)

reactionmeddraversionpt18.0ReactionBruxism

8)

reactionmeddraversionpt18.0ReactionCogwheel rigidity

9)

reactionmeddraversionpt18.0ReactionRestlessness

10)

reactionmeddraversionpt18.0ReactionConfusional state

Drug

1)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb2.25drugstructuredosageunit002drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/12/2009drugenddateformat602drugenddate//2009

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)

drugcharacterization1medicinalproductADDERALLdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

3)

drugcharacterization1medicinalproductCLONAZEPAM.drugindicationRESTLESS LEGS SYNDROME

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application Number ANDA077194, ANDA077171, ANDA074569, ANDA077147, ANDA211033, ANDA077856, NDA01753 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Teva Pharmaceuticals USA, Inc., Par Pharmaceutical, Inc., Accord Healthcare Inc. ... product_ndc 0093-9290, 0093-9291, 0093-9292, 0093-9293, 0093-9294, 49884-306, 49884-307, 498 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id 0a290597-0942-4e2e-bcf7-7486bf8b933e, a95f8799-0bb3-41d6-aa27-8a291127ad54, e7a6 ... spl_set_id cb2e209e-e69b-422b-8abb-34df2bc92caa, 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069 ... Package NDC 0093-9290-67, 0093-9291-67, 0093-9292-67, 0093-9293-67, 0093-9294-67, 49884-306- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

4)

drugcharacterization2medicinalproductZOLOFT

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_idca266f27-bd08-49ba-8d79-a6dba8699bd9spl_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

5)

drugcharacterization1medicinalproductLUNESTAdrugindicationRESTLESS LEGS SYNDROME

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

6)

drugcharacterization2medicinalproductLEXAPRO

activesubstance

activesubstancenameESCITALOPRAM OXALATE

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_idd6a08762-d20a-47c9-b92e-b5dde195489cspl_set_id13bb8267-1cab-43e5-acae-55a4d957630aPackage NDC 0456-2005-01, 0456-2010-01, 0456-2010-11, 0456-2010-63, 0456-2020-01, 0456-2020- ... UNII5U85DBW7LO

7)

drugcharacterization1medicinalproductMIRAPEXdrugstructuredosagenumb2.25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationANXIETY

activesubstance

activesubstancenamePRAMIPEXOLE DIHYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022421Brand NameMIRAPEX ERGeneric NamePRAMIPEXOLE DIHYDROCHLORIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0109, 0597-0285, 0597-0113, 0597-0286, 0597-0115, 0597-0287, 0597-0116Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAMIPEXOLE DIHYDROCHLORIDERXCUI 901534, 901537, 901541, 901543, 901546, 901547, 901550, 901551, 901555, 901557, ... spl_id77d8974c-9e8a-4700-8445-458b31b6ce31spl_set_ide2902ed1-cfeb-4815-adc3-129c577917a1Package NDC 0597-0109-30, 0597-0109-07, 0597-0109-17, 0597-0285-30, 0597-0285-07, 0597-0285- ... UNII3D867NP06J

8)

drugcharacterization2medicinalproductPROZAC

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018936Brand NamePROZACGeneric NameFLUOXETINE HYDROCHLORIDEManufacturersDista Products Companyproduct_ndc0777-3104, 0777-3105, 0777-3107Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI104849, 205535, 261287, 310384, 310385, 313989spl_ida99ea01f-e367-47b8-b25c-8f554314c534spl_set_idc88f33ed-6dfb-4c5e-bc01-d8e36dd97299Package NDC0777-3104-02, 0777-3105-02, 0777-3105-30, 0777-3107-30UNIII9W7N6B1KJ